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2
NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
“NIH SBIR Grant Application Mentor: An Educational How-to Manual, 1st Edition” is published by
Scientific Researchers Resources, Inc., 9990 Coconut Road, Suite 316, Bonita Springs, FL 34135 USA.
Telephone: (800) 303-0129 ~ Fax: (239) 676-0146 ~ Email: [email protected] ~
Website: www.principalinvestigators.org
This report is endorsed as a valuable tool for continuing professional development by Principal
Investigators Association.
Retired Founder: Leslie C. Norins, MD, PhD
© 2014 Principal Investigators Association. The entire contents of this publication are protected by
Copyright, worldwide. All rights reserved. Reproduction or further distribution by any means, beyond the
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Economical rates for bulk or electronic purchases are available upon request; institutional inquiries welcome.
Principal Investigators Association — as well as this educational manual — is completely independent
and not controlled by any government agency, organization or society, consultancy, contractor, or
vendor. It is not endorsed by, nor does it have any official connection with, the National Institutes of
Health. Opinions expressed by private authors are their own, and not official government opinions.
Although the publisher believes the presented information is accurate, grant writing is part science,
part art, and interpretations and strategies differ, even among experts. Also, individual circumstances
vary. Therefore, no warranty is made that the information will apply in any particular case, or that a
grant application will result in an award.
3
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Table of Contents
Table of Contents
Introduction................................................................................................... 6
Chapter 1: Beginning the Grant Application Process................................... 8
Before Writing Your Application............................................................... 9
Qualifying for an SBIR Grant ................................................................ 10
Planning................................................................................................. 27
Deciding on Your Project....................................................................... 32
Make a Writing Schedule....................................................................... 42
Conclusion............................................................................................ 44
Chapter 2: Summarizing Your Project and Your Qualifications to be PI...... 46
Creating Your Project Summary/Abstract.............................................. 49
Project Narrative.................................................................................... 54
The Biographical Sketch....................................................................... 56
Tips to Writing Strong Letters of Support.............................................. 74
Conclusion............................................................................................ 79
Chapter 3: Small Company Resources and Commitment.......................... 80
Showcase Your Facilities and Other Resources.................................... 80
List Your Available Equipment............................................................... 83
Resources Sharing Plan....................................................................... 85
Conclusion............................................................................................ 90
Chapter 4: Describing Your Proposed Research........................................ 92
The Specific Aims Section.................................................................... 93
Research Strategy................................................................................ 98
Significance......................................................................................... 101
Innovation............................................................................................ 107
Overall Impact Ties Everything Together............................................. 116
Bibliography and References.............................................................. 119
Conclusion.......................................................................................... 122
Chapter 5: Special Considerations........................................................... 124
Human Subjects.................................................................................. 126
Use of Vertebrate Animals.................................................................. 139
What About the Use of “Select Agents”?............................................ 143
Conclusion.......................................................................................... 150
Chapter 6: Your Proposal’s Budget........................................................... 152
What is the “Fee” ?.............................................................................. 153
How about “Program Income”?........................................................... 154
Budget Limits...................................................................................... 156
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Table of Contents
Budget Creation.................................................................................. 159
Special Instructions for Preparing Applications with a Subaward/............ Consortium.......................................................................................... 170
Conclusion.......................................................................................... 172
Chapter 7: Application Submission........................................................... 174
Make Sure Everything is Attached and Submitted.............................. 175
The Cover Letter................................................................................. 179
Tips When Making Peer Review Suggestions..................................... 180
Go Over Your Proposal One More Time for Content........................... 182
Application Submission....................................................................... 184
Application Withdrawal........................................................................ 185
Conclusion.......................................................................................... 186
Chapter 8: Application Review Process.................................................... 188
Brief Overview..................................................................................... 188
What Does the CSR Look for During Their Check of Your Application?.. 190
Application Number Assignment......................................................... 190
Assignment to an IRG, SRG, and Institute/Center.............................. 191
Submitting Additional Information....................................................... 193
Peer Review ....................................................................................... 194
SBIR/STTR Study Sections................................................................ 195
The Review Process........................................................................... 195
Tracking Your Application.................................................................... 199
New Program Certifications Required for SBIR and STTR Awards-2013..... 201
Just-in-Time Information..................................................................... 204
Resubmission (A1) or New Application (A0)....................................... 208
Appendix A: A Few Words Regarding Phase II SBIR Awards.................. 216
Appendix B: Index..................................................................................... 223
Color Key:
Throughout this report, we have used highlighted text to indicate the following:
5
— original text by authors of this report
(no color)
(pink)
— directly quoted NIH information
— paraphrased NIH information
(yellow)
(blue)
— directly quoted information from successful NIH grant applications
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Introduction
Introduction
The Small Business Innovation Research (SBIR) program is a highly
competitive program encouraging small businesses to explore their technological
potential by supporting research alone as well as research and product or
technology development. In so doing, this program provides the incentive to profit
from any outcomes which are successfully commercialized. Coordinated by the
Small Business Administration (SBA) of the federal government, this program has
set-aside funds (2.8% of an agency’s extramural budget in FY2014), and increase
on 0.1% over the FY2013 budget, for qualified domestic small business concerns to
engage in these activities. The agency which the SBA is referring to is the National
Institutes of Health (NIH). SBIR Programs are fully integrated within NIH research
agenda to improve human health through prevention, detection, diagnosis and
treatment of disease or disability, speed the discovery process, reduce the cost of
medical care, improve research tools with an eye towards reducing research costs,
and increase the health knowledge base.
The SBIR Program is structured in three phases. The Phase I goal is to
determine technical merit, feasibility, and commercialization potential of the
proposed project while at the same time verifying the performance quality of the
awardee organization. This verification is crucial before the small business can
receive Phase II funding. Phase II support is directly related to the achievements
made during Phase I, in addition to the commercial potential and the scientific and
technical merit of the new work proposed during Phase II. Assuming that all goes
according to the plan followed during Phase I and II, Phase III is when the small
business uses non-SBIR funds to realize the commercialization objectives resulting
from the Phase I and II activities.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Introduction
This manual will guide you through the SBIR program application process,
with the goal of positioning your proposal in the best place possible for funding
consideration. While the SBIR program has a total of three phases, Phase I will
be covered in detail with reference to Phase II, since these are the two phases that
directly involve applying to government agencies for funding. *Keep in mind
that Phase I awardees are the only ones eligible to apply for a Phase II. So, while
being awarded a Phase II is not automatic, the competition for these monies is far
less than it is for a Phase I, which often translates into higher funding rates for this
phase.
*NIH Implements an SBIR Direct-to-Phase-II Funding Option. On February 5, 2014,
the NIH published a new Funding Opportunity Announcement (“FOA”), PAR-14-088. See
http://grants.nih.gov/grants/guide/pa-files/PAR-14-088.html.
Direct from NIH:
Under Section 5106 of the Reauthiorization Act, NIH may ‘issue a Phase II award to
a small business concern that did not receive a Phase I award for that research/research
& development’. This is a so-called ‘Direct-to-Phase II’ SBIR award. This authority
would permit small businesses to submit Direct-to-Phase-II SBIR applications, if the small
business had performed the Phase I stage-type of research through other funding sources.
The legislative rationale for permitting the Direct-to-Phase II award is to allow a SBC
that has already built a technology prototype and tested its feasibility (i.e. completed
Phase-I-type R&D) to move directly into a Phase-II-type R&D that tests the functional
viability of the prototype according to scientific methods and potential for commercial
development The Direct-to-Phase-II SBIR mechanism eliminates the need for the SBCs to
propose additional small feasibility studies, if the technology is ready for the Phase II
stage of development. The Direct-to-Phase II authority is not available to the STTR
program and not available for the CDC, FDA, and ACF SBIR progams.
Learn more here: http://grants.nih.gov/grants/guide/pa-files/PAR-14-088.html
Note from Author: This educational manual will assist you with the grant application
process for the NIH SBIR Phase I, NIH SBIR Phase II and the NIH Direct to Phase II.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
Chapter 1:
Beginning the Grant Application Process
While true for any worthwhile task under consideration, having a solid plan
of approach for writing an SBIR grant goes a long way towards managing the
process and optimizing the likelihood for a successful outcome. Breaking the
process down into distinct steps and having well defined starting and stopping
points will help ensure process completion while reducing the chance of becoming
overwhelmed. First and foremost, come up with a solid description of the idea
for the research project. Development of this description is seldom easy, nor is it
usually straightforward. A refined description of the idea becomes the foundation
for further development into a focused and strong project. Mapping out the strategy
for your writing should include:
• Making certain that the SBIR program is the appropriate funding
mechanism for your idea.
• Leveraging your passion and scientific strengths for the project while making
sure that the project addresses the mission and priorities of the agency
• Enlisting the help of colleagues who have depth and breadth of experience
in competing for SBIR grants and who understand your project goals so
they can provide critical feedback
Putting together a schedule for your writing will help to keep you on track
so that you can monitor your progress and to make sure that important dates
and submission deadlines are not missed. Developing this schedule with your
colleagues who have agreed to help will go a long way towards ensuring that the
proposal receives the critical attention it deserves.
There are fundamental concepts which every SBIR application must include to
be considered for review; project title and how the hypothesis or feasibility study
is conveyed can impact the chances of the grant being awarded. The remaining
sections of this manual will further detail the steps in this process.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
Before Writing Your Application
Ideally, a small business would first identify an unmet public health need and
then spend time and effort developing a product or service technology that would
address this unmet need. As a small business, you will need a clear vision of the
product you will make, or the service you will provide with your technology,
well in advance of writing a grant application. Product development and service
pathways both require market research and strategic planning; it is probably a poor
idea to let SBIR Funding Opportunity Announcements (FOA) dictate what you
make or what problem you try to solve by developing new technology. For your
product or technology, you will need to fully understand its market advantages and
the milestones which must be met to achieve commercialization, as well as the time
and costs to reach each milestone. Finally, you must also develop your exit strategy
along the development pathway.
SBIR Program Participating Agencies
Listed below are the current Federal agencies that participate in the SBIR
program:
• Department of Agriculture
• Department of Commerce - National Institute of Standards and Technology
• Department of Commerce - National Oceanic and Atmospheric
Administration
• Department of Defense
• Department of Education
• Department of Energy
• Department of Health and Human Services
• Department of Homeland Security
• Department of Transportation
• Environmental Protection Agency
• National Aeronautics and Space Administration
• National Science Foundation
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
This manual will use the Department of Health and Human Services (DHHS)
agency to illustrate the steps of the application process. While all of these agencies
solicit proposals for research and research and development projects on topics
relevant to their goals and mission statements, each individual agency controls
how it administers its own program. The one common feature for all of these
agencies is that every award is made on a competitive basis after proposal review.
So, while the focus of this manual will be on SBIR grant applications submitted
to the DHHS, the information contained herein can also be applied to applications
submitted to other agencies.
Qualifying for an SBIR Grant
There are many excellent proposals that are never considered simply because
they failed to meet the requirements set by the NIH and its Institutes, Centers and
Offices. Make certain that your proposal address the mission statement of the NIH,
which states:
“NIH’s mission is to seek fundamental knowledge about the nature and behavior
of living systems and the application of that knowledge to enhance health, lengthen
life, and reduce the burdens of illness and disability.”
The goals of the agency are:
• to foster fundamental creative discoveries, innovative research strategies, and
• their applications as a basis for ultimately protecting and improving health;
• to develop, maintain, and renew scientific human and physical resources that
will ensure the Nation’s capability to prevent disease;
• to expand the knowledge base in medical and associated sciences in order to
enhance the Nation’s economic well-being and ensure a continued high return
on the public investment in research; and
• to exemplify and promote the highest level of scientific integrity, public
accountability, and social responsibility in the conduct of science.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
In realizing these goals, the NIH provides leadership and direction to programs
designed to improve the health of the Nation by conducting and supporting research:
• in the causes, diagnosis, prevention, and cure of human diseases;
• in the processes of human growth and development;
• in the biological effects of environmental contaminants;
• in the understanding of mental, addictive and physical disorders; and
• in directing programs for the collection, dissemination, and exchange of
information in medicine and health, including the development and support
of medical libraries and the training of medical librarians and other health
information specialists.
What this means:
The agency supports a wide range of biomedical research areas that have the
potential to improve human health, contribute towards disease prevention, and
improve treatment outcomes. It achieves this goal by:
• Fostering fundamental creative discoveries, innovative research strategies and
their applications as a basis for ultimately protecting and improving health
• Facilitating the development, maintenance, and review of scientific human
and physical resources that will ensure the nation’s capability to prevent
disease
• Expanding the knowledge base in medical and associated sciences to enhance
the nation’s economic well-being and ensure a continued high return on the
public investment in research; and
• Exemplifies and promotes the highest level of scientific integrity, public
accountability and social responsibility in the conduct of science
The agency conducts and supports research addressing the:
•
•
•
•
•
11 Causes, diagnosis, prevention and cure of human diseases
Processes of human growth and development
Biological effects of environmental contaminants
Understanding of mental, addictive and physical disorders
Programs for the collection, dissemination and exchange of information in
medicine and health, including development and support of medical libraries
and the training of medical librarians and other health information specialists.
Principal Investigators Association | www.principalinvestigators.org
NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
After carefully reviewing these criteria, make sure there is a good match with
your proposed research and development idea. If you decide that there is not a good
match, you may want to consider approaching another organization for support. Be
advised, however, that for commercial businesses, the SBIR program is one of the
few federal grant programs which support research and development; alternative
granting organizations for companies is extremely limited.
If there is a good match with your idea and the NIH mission, then moving on
to determine that your idea is consistent with the mission and goals of the SBIR
program is next in order.
SBIR Program Mission and Goals
If you can answer ‘yes’ to these following questions, you are well on your way
towards being aligned with the mission and goals of the SBIR Program:
TIP:
For commercial
businesses, the
SBIR program is
one of the few federal grant programs
which support
research and development; alternative
granting organizations for companies
is extremely limited.
1. Are you as an individual, or are you employed by, a small business?
2. Are you on the lookout for research and development (R&D) potentials?
3. Would receipt of funding to address scientific and technological areas
identified by federal agencies assist in the commercial growth of your
business?
The mission statement and program goals are as follows:
“The mission of the SBIR program is to support scientific excellence and
technological innovation through the investment of Federal research funds in
critical American priorities to build a strong national economy.”
The program’s goals are four-fold:
• Stimulate technological innovation
• Meet Federal research and development needs.
• Foster and encourage participation in innovation and entrepreneurship by
socially and economically disadvantaged persons.
• Increase private-sector commercialization of innovations derived from
Federal research and development funding.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
What this means:
The objectives of the SBIR program are to:
• Leverage the resources and expertise residing in small businesses to stimulate
technological innovation
• Enlist the efforts of small business to meet Federal research and research and
development needs
• Socially and economically disadvantaged small business and women-owned
businesses are especially encouraged to apply
• Increase commercialization of more research and research and development
efforts while increasing small business participation in Federal research and
research and development activities
If there is a good match with your idea and the SBIR program mission, then the
next step is to determine your company’s SBIR eligibility.
SBIR Program Eligibility
“To receive an SBIR or STTR award, the awardee must qualify as a Small
Business Concern (SBC) as defined by SBA regulations at 13 C.F.R. §§ 701-705.
The eligibility requirements for the SBIR/STTR programs are unique and do not
correspond to those of other small business programs.
A Small Business Concern (SBC) must satisfy the following conditions on the
date of award for both Phase I and Phase II funding agreements:
1. is organized for profit, with a place of business located in the United
States, which operates primarily within the United States or which makes a
significant contribution to the United States economy through payment of
taxes or use of American products, materials or labor;
2. is in the legal form of an individual proprietorship, partnership, limited
liability company, corporation, joint venture, association, trust or
cooperative, except that if the concern is a joint venture, each entity to the
venture must meet the requirements set forth in paragraph (3) below;
13 Principal Investigators Association | www.principalinvestigators.org
NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
3. is more than 50 percent directly owned and controlled by one or more
individuals (who are citizens or permanent resident aliens of the United
States), other small business concerns (each of which is more than 50%
directly owned and controlled by individuals who are citizens or permanent
resident aliens of the United States), or any combination of these; and
4. has, including its affiliates, not more than 500 employees. (For explanation
of affiliate see www.sba.gov/size).
What this means:
Only small companies residing in the United States and meeting all of the
REMEMBER:
Only small
businesses with
less than 500
people are
eligible to apply.
following are eligible to apply:
• Must be a for-profit business in the United States
• Majority ownership and control must be by US citizens or permanent
residents, or
• Majority ownership and control by another for-profit business, which is also
majority owned and controlled by US citizens or permanent residents. A
new SBA rule, which became effective on January 28, 2013, now expressly
permits participation of Venture Capital -backed small businesses in the
SBIR program. A small business may be majority-owned by multiple venture
capital operating companies, hedge funds, or private equity firms and still be
eligible to receive an award.
• Must be a total of 500 employees or less, which includes associates, partners,
and any other members working for the company or in companies affiliated
with the company.
You will notice that the agency mentions SBIR and STTR (Small Business
Technology Transfer) together. The STTR is a similar program, except that the PI’s
primary employment is not stipulated, so he/she may be from the small business or
the collaborating non-profit research institution. These differences will be covered in
more detail later in this chapter.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
The Value of SBIR Funding for Small Companies
SBIR funding is an excellent mechanism to provide seed money for high risk/
REMEMBER:
Winning a grant
is an acknowledgement of the
research and development efforts
pursued by the
business, and
provide scientific
credibility and
validation for
the company’s
program.
15 high return innovative projects to start or further develop an existing business.
The small business retains all rights to intellectual property developed with this
funding, and an SBIR award provides recognition and visibility for the company.
Winning a grant is also an acknowledgement of the research and development
efforts pursued by the business, and provides scientific credibility and validation.
Used strategically, the grant can also be leveraged to attract additional capital,
assess the market and business opportunities, determine competitive advantage,
and balance costs, benefits, and risks.
Principal Investigators Association | www.principalinvestigators.org
NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
NIH INSTITUTES, CENTERS, AND OFFICES (ICOS)
The NIH is comprised of 27 semiautonomous ICOs, each having their own
defined research and research and development focus. The DHHS releases an
annual Funding Opportunity Announcement (FOA) inviting eligible United
States small business concerns (SBCs) to submit Small Business Innovation
Research (SBIR) grant applications. Unsolicited proposals are not accepted for
the SBIR programs, a proposal must respond to a solicitation published by one
or more of the participating agencies. SBIR solicitations are specific Requests for
Proposals released by the federal agencies participating in the program which may
result in the award of Phase I SBIR funding agreements. SBIR Pre-Solicitation
Announcements, released by SBA, contain pertinent data on SBIR solicitations that
are about to be released by the participating federal agencies.
The activity codes for SBIR grants are R43 for the Phase I, and R44 for the
Phase II. Of the 27 ICOs, the following accept SBIR grant applications as per
the most recent FOA, PA-13-34, which is a re-issue of PHS 2013-02 Omnibus
REMEMBER:
Unsolicited
proposals are not
accepted for the
SBIR program,
a proposal must
respond to a solicitation published by
one or more of the
participating
agencies.
Solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation
Research Grant Applications (Parent SBIR [R43/R44]):
AWARDING COMPONENT AND FOCUS
PROGRAM CONTACT
National Institute on Aging
http://www.nia.nih.gov
Biomedical, social and behavioral aspects of the
aging process, age-related disease and
disability prevention.
Dr. Michael-David A.R.R. Kerns
Phone:301-402-7713
Fax: 301-402-2945
Email: [email protected]
National Institute on Alcohol Abuse and
Alcoholism
http://www.niaaa.nih.gov
Research to improve the treatment and prevention of alcoholism and alcohol-related problems.
Dr. Gary Murray
Phone:301-443-9940
Fax: 301-594-0673
Email:[email protected]
National Institute of Allergy and Infectious
Diseases
http://www.niaid.nih.gov
Research on understanding, treating, and preventing infectious, immunologic, and allergic
diseases.
Dr. Paula Strickland
Phone:301-435-8563
Fax:301-480-1993
Email: [email protected]
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17 Chapter 1: Beginning the Grant Application Process
PROGRAM CONTACT
National Institute of Arthritis and
Musculoskeletal and Skin Diseases
http://www.niams.nih.gov/
Research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin
diseases; basic and clinical scientist training to
carry out this research.
National Institute of Biomedical Imaging and
Bioengineering
http://www.nibib.nih.gov/
Fundamental discoveries, design, development,
translation and assessment of technological
capabilities in biomedical imaging and bioengineering, enabled by relevant areas of information science, physics, chemistry, mathematics,
materials science and computer sciences.
National Cancer Institute
http://www.nci.nih.gov
or http://www.cancer.gov
http://sbir.cancer.gov
Basic and clinical biomedical research and
training; supports research regarding cancer
prevention and/or manageability, early-stage
identification, innovative treatment development.
Eunice Kennedy Shriver
National Institute of Child Health and
Human Development
http://www.nichd.nih.gov
Child-centered research regarding fertility,
pregnancy, growth, development and medical
rehabilitation.
National Institute on Drug Abuse
http://www.nida.nih.gov
Research across several disciplines to improve
drug abuse and addiction prevention, treatment
and policy.
Dr. Xibin Wang
Phone:301-451-3884
Fax:301-480-1284
Email:[email protected]
National Institute on Deafness and Other
Communication Disorders
http://www.nidcd.nih.gov
Biomedical research and research training on
normal mechanisms, diseases and disorders of
hearing, balance, smell, taste, voice, speech and
language.
Dr. Roger L. Miller
Phone:301-402-3458
Fax: 301-402-6251
Email:[email protected]
Mr. Todd Merchak
Phone:301-496-8592
Fax: 301-480-1614
Email:[email protected]
Mr. Michael Weingarten
Dr. Greg Evans
Dr. Andrew Kurtz
Phone:240-276-5300
Fax: 240-276-5236
Email:[email protected]
Louis A. Quatrano, Ph.D.
Phone:301-402-4221
Fax:301-402-0832
Email: [email protected]
Elena Koustova, Ph.D., MBA
Phone:301-496-8768
Email: [email protected]
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
AWARDING COMPONENT AND FOCUS
Chapter 1: Beginning the Grant Application Process
PROGRAM CONTACT
National Institute of Dental and Craniofacial
Research
http://www.nidcr.nih.gov
Research to understand, treat, and prevent
infectious and inherited craniofacial-oral-dental
diseases and disorders.
Dr. R. Dwayne Lunsford
Phone:301-594-2421
Fax:301-480-8319
Email:[email protected]
National Institute of Diabetes and Digestive
and Kidney Diseases
http://www.niddk.nih.gov
Supports basic and applied research regarding
diabetes, endocrinology and metabolic diseases;
digestive diseases and nutrition; kidney, urologic
and hematologic diseases.
National Institute of Environmental Health
Sciences
http://www.niehs.nih.gov
Define how environmental exposures, genetic
susceptibility and age interact to affect health.
National Eye Institute
http://www.nei.nih.gov
Research to prevent and treat eye diseases,
vision disorders, sight-saving treatments, visual
impairment and blindness reduction.
National Institute of General Medical Sciences
http://www.nigms.nih.gov/
Basic biomedical research not targeted to specific diseases. Includes studies on genes, proteins
and cells, cell-cell communication, energy usage,
response to pharmaceuticals, research training
programs, encouragement of underrepresented
minorities to pursue biomedical research careers.
National Heart, Lung, and Blood Institute
http://www.nhlbi.nih.gov
Focuses on treating diseases of the heart, blood
vessels, lungs and blood; blood resources; and
sleep disorders.
National Human Genome Research Institute
http://www.genome.gov
Advancing health through genome research.
Ms. Christine Densmore
Phone:301-402-8714
Fax:301-480-8300
Email: [email protected]
Principal Investigators Association | www.principalinvestigators.org
Dr. Daniel T. Shaughnessy
Phone:919-541-2506
Fax: 919-541-4606
Email: [email protected]
Dr. Jerome Wujek
Phone:301-451-2020
Fax: 301-496-2297
Email:[email protected]
Dr. Scott Somers
Phone:301-594-3827
Fax:301-480-2802
Email: [email protected]
Kurt Marek, Ph.D.
Phone:301-443-8778
Fax:301-480-0422
Email:[email protected]
Bettie J. Graham, Ph.D.
Phone:301-496-7531
Fax: 301-480-2770
Email: [email protected]
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19 Chapter 1: Beginning the Grant Application Process
PROGRAM CONTACT
National Institute of Mental Health
http://www.nimh.nih.gov
Understanding, treating and preventing mental
illnesses through basic research on the brain and
behavior, and through clinical, epidemiological
and services research.
Dr. Margaret C. Grabb
Phone:301-443-3563
Fax: 301-443-1731
Email:[email protected]
National Institute on Minority Health and
Health Disparities
http://www.nimhd.nih.gov/
Understanding the causes of health disparities,
developing effective interventions to eliminate
these disparities, strengthen research capacity
in institutions with significant numbers of racial
and ethnic minority group students, research on
health disparities within several disease areas
including cancer, cardiovascular diseases, stroke,
diabetes, nutrition, obesity and maternal and
infant health.
National Institute of Neurological Disorders
and Stroke
http://www.ninds.nih.gov
Basic and clinical research on the normal and
diseased nervous system, investigator training
in basic and clinical neurosciences, and understanding, diagnosis, treatment and prevention of
neurological disorders.
National Institute of Nursing Research
http://www.ninr.nih.gov/
Clinical and basic research to establish a scientific basis for individual patient care, including
patient management during illness and recovery;
risk reduction for disease and disability; promoting healthy lifestyles and quality of life for those
with chronic illness; and caring for those at the
end of life. This research may also include families within a community context, and may focus
on the special needs of at-risk and underserved
populations, emphasizing health disparities.
Mr. Vincent A. Thomas, Jr., MSW, MPA
Phone:301-402-2516
Fax:301-480-4049
Email:[email protected]
Ms. Stephanie Fertig
Phone:301-496-1779
Fax: 301-402-1501
Email:[email protected]
Dr. Paul A. Cotton
Phone:301-402-6423
Fax: 301-480-8260
Email:[email protected]
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
AWARDING COMPONENT AND FOCUS
Chapter 1: Beginning the Grant Application Process
PROGRAM CONTACT
National Center for Advancing Translational
Sciences
http://www.ncats.nih.gov
Using science to create powerful new tools and
technologies that can be adopted widely by
translational researchers in all sectors.
Lili M. Portilla, MPA
Phone:301-402-0304
Fax: 301-480-3661
Email:[email protected]
National Center for Complementary and
Alternative Medicine
http://www.nccam.nih.gov/
Explores complementary and alternative medicine (CAM) practices in the context of rigorous
science and trains CAM researchers.
National Library of Medicine
http://www.nlm.nih.gov
Research in biomedical communications, training, medical library resources, and biomedical
informatics and communications research.
Division of Program Coordination, Planning,
and Strategic Initiatives, Office of Research
Infrastructure Programs
http://dpcpsi.nih.gov/ORIP/index.aspx
Provides grants for comparative medicine and
for K-12 educational resources.
Administration for Children and Families
http://www.acf.hhs.gov
Promotes the economic and social well-being of
families, children, individuals and communities.
Dr. Craig Hopp
Phone:301-496-5825
Fax: 301-480-1587
Email:[email protected]
Dr. Jane Ye
Phone:301-594-4882
Fax: 301-402-2952
Email:[email protected]
Dr. Miguel Contreras
Phone:301-594-9410
Fax:301-480-3819
Email:[email protected]
Anne F. Bergan
Phone:202-260-8515
Fax: 202-205-3598
Email: [email protected]
How might your particular research or research and development idea fit into an area of interest
for one of these ICOs? The first place to look is on the nih.gov website and search for the current
Omnibus Solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation Research
Grant Applications (Parent SBIR [R43/R44]) document. This document is a wealth of information
regarding what the specific ICOs, and their respective divisions, are looking for. To illustrate, the
Division of Aging Biology (DAB), under the National Institute on Aging (NIA), sponsors research
on the molecular, cellular, genetic, and physiological causes and consequences of aging processes.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
Of particular interest is molecular probe development for studying cellular
senescence and longevity in cultured cells and in animals. These probes include
antibodies, unique DNA and RNA sequences, and expression vectors. Another
area of specific interest is development and validation of interventions which can
TIP:
enhance longevity or slow the aging process, once again in cultured cells and
Look on the nih.gov
website and search
for the current Omnibus Solicitation
of the NIH, CDC,
FDA and ACF for
Small Business Innovation Research
Grant Applications
(Parent SBIR [R43/
R44]) to see where
your research and
development idea
may best fit.
animal models, but also in humans. If your idea is to commercially develop a
reporter assay for cells about to go into senescence, using an RNA intron sequence,
this may be the place for your proposal. On the other hand, if you are developing
an intervention to combat the aging effects of an environmental toxin, the National
Institute of Environmental Health Sciences (NIEHS) may be a better audience for
your application.
One of the better tactics for selecting which ICO(s) might be the best fit is to
contact program officers at specific institutions and have a discussion with them
about your idea. All institutes have a link to contacts on their website. To help
narrow down your choices, take a look at the types of SBIR awards that have been
made under the various ICO’s. This may be accomplished by accessing the NIH
RePorter website (http://projectreporter.nih.gov/reporter.cfm) and choosing from
the Agency/Institute/Center dropdown menu. To limit the search to SBIR awards,
check the SBIR/STTR box found in the Activity Code dropdown menu. Is there
one that is somehow like yours – similar topic area, question being addressed,
model system, technology? This can help you better target your proposal.
Remember that program officers are at least as busy as you are, so to get the most
REMEMBER:
out of this discussion, perhaps you can schedule a phone call well in advance
Remember that
your proposal could
fit with more than
one ICO, so take
advantage of contacting program
officers at other
institutes for
guidance.
and provide a short written layman’s synopsis (1 page or less) for them to review
21 beforehand. That way, the focal point of the discussion can be on funding ideas
rather than on fine technical details. Often you can gain some insight into their
level of enthusiasm for your project and how it may fit into any initiatives under
consideration. Take any offered advice seriously, as the program officer can be
your champion during the submission and review process, and all proposals need
a champion to be best positioned for funding. Also remember that your proposal
could fit with more than one ICO, so take advantage of contacting program officers
at other institutes for guidance.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
Another approach to see where your idea best fits is to take a look at past SBIR
topic solicitations. If you wait until the current solicitation is posted to draft a
proposal, and then go ahead and make contact with the sponsor, you will be off to a
very late start with regard to submission deadlines. Seek topics that align well with
your research capabilities and take note of the sponsoring agency and the program
officer for follow up. SBIR grants are often sponsored by the same smaller group
within a much larger agency, so there is a very good chance that past program
officers will be sponsoring additional research and research and development
efforts.
There are study sections dedicated to reviewing SBIR and STTR
applications. They can be found at http://public.csr.nih.gov/StudySections/
SmallBusinessTechnologyTransfer/Pages/default.aspx. These study sections have
more representation from industry than standard study sections, but the majority of
the reviewers are still academicians.
How to Identify SBIR Funding Priorities
Just as the funding goals for each NIH institute, center, and office changes over
time, so do the goals of the SBA. These changes are in direct response to advances
in science and emerging new technologies, and will invariably be reflected in SBIR
funding priorities. These changes can provide new grant opportunities for you. You
may want to consider subscribing to a weekly e-mail with new NIH Guide postings
(http://grants.nih.gov/grants/guide/listserv.htm) so that you are continually up-to-date.
Another efficient way to identify new and existing funding opportunities is
to regularly visit the NIH website. There is a ‘Grants & Funding” tab, which will
take you to a funding search box which has a ‘Funding Opportunities & Notices’.
This link will allow you to search the NIH Guide for Grants and Contracts for
active Request for Applications (RFAs), Request for Proposals (RFPs), Program
Announcements (PAs), and Notices. New funding-related announcements and
Requests for Information (RFIs), in which the agency requests input from the
scientific community regarding a specific question or general topic are also readily
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
available to potential applicants at each institute’s website. These pages are updated
as new notices are announced, and the NIH encourages you to visit these pages
often to view new opportunities. You may also sign up to receive email updates
from the institutes SBIR & STTR Program announcing new notices and funding
opportunities. The NIH describes these funding mechanisms accordingly:
Request for Application (RFA)
An RFA is a formal statement that solicits grant or cooperative agreement
applications in a well-defined scientific area to accomplish specific program
objectives. An RFA indicates the estimated amount of funds set aside for the
competition, the estimated number of awards to be made, whether cost sharing is
required, and the application submission date(s). For cooperative agreements, the
RFA will describe the responsibilities and obligations of NIH and awardees as well
as joint responsibilities and obligations. Applications submitted in response to an
RFA are usually reviewed by a Scientific Review Group (SRG) specially convened
by the awarding component that issued the RFA.
Request for Proposals (RFP)
Announces that NIH would like to award a contract to meet a specific need,
such as the development of an animal model. RFPs have a single application
receipt date and are published in the NIH Guide for Grants and Contracts.
Program Announcement (PA)
A PA is a formal statement about a new or ongoing extramural activity or
program. It may serve as a reminder of continuing interest in a research area,
describe modification in an activity or program, and/or invite applications for grant
support. Most applications in response to PAs may be submitted to a standing
submission date and are reviewed with all other applications received at that time
using standard peer review processes. NIH may also make funds available through
PARs (PAs with special receipt, referral, and/or review considerations) and PASs
(PAs with set-aside funds).
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
PAs may be used for any support mechanism other than construction awards.
Unless otherwise specified in the PA, new applications (and associated renewal
and revision applications) submitted in response to PAs are treated as investigatorinitiated. PAs also are used to annually solicit applications for the SBIR and STTR
programs. Those applications must be received by the dates specified in the PA.
Notice (NOT)
A Notice (Guide Notice) is an official NIH announcement relating to a change
in policy, procedure, form, or system. Notices are posted on the NIH website and
users can be notified via a variety of NIH listservs. You can search for notices and
funding opportunities at the NIH Guide.
What this means:
A Request for Applications (RFA) is an invitation to submit grant proposals
focused on defined, high-priority, and high-opportunity areas of science relevant to
the agency mission. Often these requests are designed to address unmet needs that
have either pre-existed in a particular field, or have just recently been identified.
RFAs often require a letter of intent to be submitted prior to the submission
deadline for the full application. The intent by the agency here is to gauge the
response, so that they will be prepared for the number of applications needing
review. They can also assess their budget to see if it is in alignment with the
scientific community’s view of the cost to address the subject area. If the RFA
requires a pre-proposal submission, the information you provide may be used to
determine if your idea is in alignment with the intent of the request. The agency
may use this pre-proposal as the first cut, and notify the applicants as to whether
TIP:
According to the
National Institutes
of Health, a cooperative agreement
includes characteristics of a research
grant and a contract job.
they should or should not submit a full proposal. Such requests may add review
requirements (often topical) or adjust eligibility criteria, so as to elicit proposals
that aim to accomplish the specific goals of the announcement.
Depending on the RFA, there can be single or multiple submission dates, which
generally do not fall on the standing SBIR submission dates on the 5th of April,
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
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August, and December of each year. Cooperative agreements generally involve
substantial involvement by Federal programmatic staff. The intent here is to assist
the investigators during their conducting of the work described in the award. Thus,
a cooperative agreement is not a true grant, although the investigators do receive
funding support for their research. According to the National Institutes of Health,
a cooperative agreement includes characteristics of a research grant and a contract
job. With a federal contract, federal managers take a larger role in administrating
the contract and directing the investigators.
Request for Proposals (RFP) are focused on awarding a contract to have
specific and defined work performed. Just as with a cooperative agreement, which
contains a federal contract-like component, federal managers take a more direct
and visible role in managing the contract and directing the scientists.
Program Announcements (PA) describe regular, established agency
funding programs, using standard criteria for eligibility, review, and regular
submission deadlines. The SBIR and STTR programs are prime examples of a PA.
A Notice (NOT) can alert you to changes in an application date for a
particular funding opportunity announcement. This mechanism is also used by the
NIH to established a list of Frequently Asked Questions (FAQs) and answers for a
particular announcement, to announce additional research objectives and funding,
and clarification of applicant eligibility, just to name a few. So, it is vital to you
and your research and development program that you remain up-to-date with the
current programs in the NIH ICO’s that most interest you.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
Your Company Must Be Qualified to Receive SBIR Awards
Businesses applying to the SBIR program must self-certify at the time an award
is made that their company meets the definition of an SBC for the program and
is not otherwise ineligible. The primary place of employment for the proposed
project’s principal investigator must be the small business, and this small business
is the prime contractor or grantee. The research space occupied by the business
must be available to, and be under the control of, the business for the conduct of its
portion of the proposed project. The business must also be federally registered and
have an EIN/TIN number. Companies should make certain that they are compliant
TIP:
It is to your advantage to have the
company founded
before you apply for
an SBIR award.
with the eligibility requirements prior to formally certifying as an SBC. One
question that often comes up is whether the company needs to be founded before a
proposal can be submitted. While the answer to this question is ‘no’, the business
does need to be established to fulfill an eligibility requirement to receive an award.
If your company is not yet founded, to avoid potential complications, a discussion
with the procuring agency’s contracts or grants officer prior to grant submission
may be in order.
The Company Registry is a new element of the SBIR data system and
application process that is now in place. All applicants to the SBIR programs must
register on the Company Registry. Once your company has registered, an SBIR
identification number for that company will be issued. You must register prior
to submitting an application to any SBIR agency solicitation since you will be
providing a copy of this registration to the agency.
Qualifying as a Principal Investigator (PI) on an SBIR Award
The PI is the person who takes direct responsibility for the scientific and
technical direction of the project, completion of the project and reporting to the
funding agency. The person in this role is not required to have US citizenship, but
the PI must legally reside in the United States and must be available to make sure
that the research proposed for the duration of the project is performed. There is no
requirement that a PI spend a set or minimum amount of time and effort on a single
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
SBIR project. Nor is there a requirement that the PI have an advanced degree
such as a Ph.D. or an M.D. What is required of the PI is that they be “primarily
employed” by the small business during the conduct of the SBIR project, which
REMEMBER:
The PI must be
“primarily employed” by the small
business during
the conduct of the
SBIR project, which
essentially means
that the PI cannot
work full time for
any other employer.
essentially means that the PI cannot work full time for any other employer. The PI
must also be able to demonstrate that he/she possess the expertise to oversee the
project both scientifically and technically.
Planning
Writing a SBIR proposal is much like presenting a business plan to a bank for
approval of a loan. Unlike a loan, the difference here is that if you are awarded
grant funding, you do not have to pay the money back. It needs to be appreciated
that the granting process takes a considerable amount of time from start to
completion. A minimum of 2 months is the amount of time that the more successful
SBIR award winners spend on their applications. If your research or research and
development idea involves animal work or human subjects, add another 2-4 months
of time to get the application ready for submission. This extra time will be needed
to get the proper protocols and approvals in place. In the best situation, your
application fares well during the review process and is awarded funding; it will
still take another 3 months or more for you to receive the money. In some cases
your proposal may be approved for funding, but due to budget constraints, it is not
awarded. With success rates for Phase I SBIR applications at around 15%, most
applicants must revise and resubmit their proposals. This translates to an additional
9-12 months, or possibly more, before you may have funding to work on your
idea. With SBIR submission dates falling every 4 months during the calendar year,
having a game plan for your application is crucial to minimize the time between
submission and award.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
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Determining Your Strategy
SBIR awards are ideal mechanisms to support development of new
technologies or to advance existing ones for your business. The length of time
for a Phase I award cannot exceed 1 year, and for a Phase II award it is 2 years.
Total funding support (direct costs, indirect costs, fees) normally may not exceed
$150,000 for Phase I awards and $1,000,000 for Phase II awards. As such, this
program is clearly not intended to support large-scale research and development
efforts that require numerous personnel or significant budgets for equipment or
consumables. When assembling your proposal, keep in mind how this project
can fit into future and longer-term research and development efforts at your small
business. Not only will this help to keep you focused on the main ideas of the
current proposal, but once this grant is awarded, you need to be considering what
will go into a successful Phase II.
Making Sure that the SBIR Mechanism is Right for You
To be a good match for the SBIR program, make sure that your idea is a
novel and innovative technical advance that will likely lead to the development
of an enabling technology and advance the state of the art. Also keep in mind the
commercialization aspect of the program, so ask yourself if your project will create
a business opportunity or fill an unmet need.
Once you have identified the appropriate ICO for your idea, the NIH has other
funding mechanisms in addition to the SBIR program for which small businesses
are also eligible to apply. There is no prerequisite that a company have prior or
current SBIR funding to apply. Here is a summary of the different mechanisms:
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Award
Mechanism
R01
Title
Research Project
Grant
Scope and
Purpose
Chapter 1: Beginning the Grant Application Process
R03
NIH Small Grant NIH Exploratory
Program
/ Development
Grant Award
Supports:
Supports:
Supports project
performed by the
named investiga- • Pilot or feasitor in an area rep- bility studies
resenting their
specific interests
• Secondary
and competencies
analysis of existing data
• Small, selfcontained research projects
• Development
of research
methodology
• Development
of new research
technology
Award Length 5 years
(Maximum)
Allowable
direct costs
(Maximum)
2 years
$500,000/yr
unless permission received by
agency to exceed
this amount
$50,000/yr
Renewable;
Non-renewable;
No-cost extension for 1 year
may be allowed
Renewability/ Competing conRestrictions tinuation (Type
2) applications
accepted
29 R21
STTR
Small Business
Technology
Transfer grant
Stimulate technological innovation
• New research
projects early in
development
Foster technology
transfer through
cooperative R&D
between small
• May involve
considerable risk businesses and
research institutions
• Development
of novel techIncrease private
niques, agents,
methodologies, sector commermodel, or appli- cialization of innovations derived
cations
from federal
R&D
• Breaks new
ground or extends previous
discoveries in
new directions
or for new applications
1 year for Phase I
2 years
2 years for Phase
II
$275,000 for
$100, 000 for
entire period
Phase I
Non-renewable
$750,000 for
Phase II
Non-renewable,
only Phase I
awardees are
allowed to apply
for a Phase II
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 1: Beginning the Grant Application Process
It needs to be pointed out that while small business are eligible to apply for
R01, R03, and R21 grants, these three funding mechanisms are the primary sources
of funding to academicians to support their laboratory research efforts. Due most
certainly to the number of applying academicians far exceeding the number of
small business applicants, the success rate for small businesses is exceptionally
low for these mechanisms. This is probably why small companies do not generally
make the effort to apply for these types of awards.
In contrast, the STTR program supports opportunities for small businesses and
nonprofit research institutions, such as colleges and universities, to work together
on joint ventures.
STTR differs from SBIR in three important aspects:
1. The SBC and its partnering institution are required to establish an
TIP:
Make sure that your
idea is a novel and
innovative technical advance that
will likely lead to
development of an
enabling
technology and
advance the state
of the art.
intellectual property agreement detailing the allocation of intellectual
property rights and rights to carry out follow-on research, development or
commercialization activities.
2. STTR requires that the SBC perform at least 40% of the R&D and the
single partnering research institution to perform at least 30% of the R&D.
3. Unlike the SBIR program, STTR does not require the Principal Investigator
to be primarily employed by the SBC.
What this means:
1. Intellectual property (Patents), or at least patent filings, are ‘have to haves’
for many small business concerns (SBC) which are trying to generate value.
Make sure that representatives from both the business and the college or
university have a discussion on who has rights to any intellectual property
developed during the course of the work performed. It is best to have this
discussion prior to the start of any laboratory work the project.
2. Most of the research and development work must be accomplished by the
small business.
3. The Principal Investigator can be primarily employed by the academic
partner.
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The STTR program, like the SBIR program, is also a practical one for
commercial companies as this program also specifically requires small business
involvement. The STTR program also has set-aside monies, amounting to 0.4%
TIP:
Many more SBIR
awards can be
made due to a
larger amount of
set-aside monies
compared to STTR
awards.
(for FY 2014) for federal agencies with extramural research and development
budgets over $1 billion. Contrast this with the current 2.8% for the SBIR program,
and it should be clear that many more SBIR awards can be made than STTR
awards. Nonetheless, should you decide that the STTR program may be a better fit
for your proposal, the information contained in this SBIR manual can also be used
when applying to the STTR program.
Get the Buy-in from Your Small Company
Unless you are the owner or sole proprietor of a small company, then you
are an employee who more than likely has a management team that will have
to support your applying to the SBIR program. Here are several questions to
consider from the management side of the small business:
• Are the projects in mind a good match with the research, development, and
business strategies of the company?
• Does the timing of the funding provided by the SBIR program fit with the
company timeline for product research and development?
• Does the company have the capabilities, in terms of a credible PI with
experience and expertise, along with the facilities and equipment, to
complete the proposed work?
• Are the finances of the SBIR award adequate to complete the project, or
•
•
•
•
will the budget need to be supplemented with company funds? If yes, are
these funds available?
Is the commercial potential of this technology a product or a service?
Is there a strategy, and a clear pathway, to commercialization?
Are there issued patents around the technology this company wishes to
develop? If so, who holds them? Is there freedom to operate?
Does this small business need to file patents prior to grant submission so
that intellectual property rights will not be jeopardized?
Answers to these questions are a must before doing any actual writing on
the grant application.
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Deciding on Your Project
Here are some recommendations to aid in your decision making for which proposal idea to submit as an application, with SBIR-specific requirements in mind.
• Play to your research and development strengths. The project needs to
be within your area of expertise. Direct knowledge regarding the science
and the methodology to accomplish the specific aims in the application are
crucial. Any gaps in personal experience can be filled with consultants. Reviewers will be looking to see that your application supports your expertise
in the proposed area of investigation.
• Perform a gap-analysis for your field. Take a look at your field as it is
today and then think about where it can go. Be well versed in the current
literature so you understand the challenges while avoiding what has already
been undertaken. It is better to not become involved in crowded areas, as
STRATEGY:
It is better to not
become involved in
crowded areas, as
distinguishing yourself from others will
be much more difficult. Discuss your
ideas with trusted
colleagues and
collaborators.
distinguishing yourself from others will be much more difficult. Discuss
your ideas with trusted colleagues and collaborators.
• Your goal should be to make a big impact on a focused area. Field advancement is something that grant reviewers will be trying to determine
from your application, and a focused effort is more likely to be judged feasible. Taken together, these two factors are often the determinants of whether or not your proposal is awarded funding. Keep these questions in mind
when picking your research topic:
o How will this research and development project effect a change?
For example, will the newly developed technology facilitate new
areas of discovery, or perhaps enable new approaches to solve
existing problems?
o How excited will the reviewers be when they finish reading your
proposal? While you feel strongly that your research area is of high
priority, will the reviewers feel the same way? Have trusted
colleagues and collaborators read through it and get their opinions.
o How will your idea fare against the review criteria for SBIR
proposals? We will examine these criteria in later chapters of this
manual.
Principal Investigators Association | www.principalinvestigators.org
TIP:
Field advancement
is something that
grant reviewers will
be trying to determine from your application, and a focused effort is more
likely to be judged
feasible. Taken
together, these two
factors are often
the determinants of
whether or not
your proposal is
awarded funding.
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• Your project needs to be achievable. Try composing a sentence or two
that demonstrates how your project is keenly-focused, impacts the focused
area, and is hypothesis driven or testing feasibility. By limiting yourself to
this level of description brevity, this should help you decide if you can truly
accomplish your research and development goals within the allotted award
period using the resources that you request. Also make sure that your science and technology relates to human health, disease prevention, patient
treatment outcomes - priorities of the NIH - as well as stimulating technological innovation and increasing private-sector commercialization of innovations – goals of the SBIR program.
• Ask for an evaluation of your proposal’s merits. Approach the program
TIP:
Approach the program officer and
ask if they would
be willing to give
you their opinion
on your research
and development
idea and pay close
attention to their
choice of words.
officer and ask if they would be willing to give you their opinion on your
research and development idea. While the officer cannot tell you how to
guarantee funding, they will often provide sound advice which you should
take advantage of. Also pay close attention to their choice of words during the conversation. For example, while discussing the relevance of your
project to the mission of the agency, if the program officer describes your
idea as reaching the minimal requirements for submission and funding consideration, you are best advised to figure a way to make your project more
appealing. Also see if you can get their insight on the composition of the
review panel that will evaluate your proposal; will it be widely focused on
multiple areas or narrow focused on just a few? Will there be any experts
in your subject area or not? Make sure to enlist any experts and colleagues
that you can find to get their input concerning your proposed research’s impact. Based on their comments, somehow rate the impact of your topic. If it
scores poorly it is best to refine your idea. If is scores very poorly, you may
want to consider picking another topic.
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Chapter 1: Beginning the Grant Application Process
Put Yourself in the Reviewer’s Place – How Does Your Proposed
Topic Look
Take a good, hard, objective look at your proposal as a reviewer would, and ask
those you have asked to review and evaluate your topic to do the same. Identify the
Study Sections that would likely review your area of science and prepare a list of
probable reviewers. Familiarize yourself with their work and keep them in mind as
you assemble and review your application. This will give you some insight as to how
they might view your proposal; anticipate their criticism so you can address it and
build their enthusiasm. While those you identify may not turn out to be your actual
reviewers, they will probably have similar expertise to those who are.
After working through these recommendations, you should be in a better position
to make a final decision on your research and development topic. The next step is to
refine your topic into a focused idea so that assembling your application is more efficient. Define the objectives of the proposed work by generating a clear and testable
hypothesis, or feasibility study, in the form of specific aims. These aims can then be
used to create an outline and a provisional title.
Defining Your Project
As a general rule, when shaping what your research project will involve, the
prevailing wisdom is that the most successful grant proposals are hypothesis driven.
While this generally holds true for SBIR proposals also, this program specifically
states that Phase I grants provide funding for proof-of-concept or feasibility studies.
While hypothesis driven research and development and proof-of-concept or feasibil-
REMEMBER:
Phase I grants
provide funding for
proof-of-concept or
feasibility studies.
ity studies all ask and answer questions, how the questions are framed can make a
difference.
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Hypothesis-driven
Your hypothesis should be specific, readily testable, and above all it needs to
be clearly stated. If your reviewers have to infer what your hypothesis is, this may
STRATEGY:
create a question in their mind that perhaps you are not certain of the hypothesis,
Be sure that your
application makes
it clear that you
will ask and answer questions,
not merely collect
information, and
that the specific
aims of your project
directly address the
hypothesis.
which could dampen their enthusiasm for the proposal. Be sure that your application
makes it clear that you will ask and answer questions, not merely collect information,
and that the specific aims of your project directly address the hypothesis. There is
always the question of which approach is better; to have a general, all-encompassing
hypothesis covering the entire proposal, or a specific hypothesis for each specific aim.
Given the 1 year maximum length of the Phase I award period, keeping your research
proposal tightly focused with a single hypothesis is probably the more sensible
approach. Reviewers of SBIR grants often are most enthusiastic about proposals that
have the potential to significantly impact future technological development, and a
sound, testable hypothesis can provide that impact.
Be careful not to propose vague statements in the hope that they will pass as
a hypothesis. For example, a statement such as “we will test the hypothesis that
endothelial cells protect against blood clot formation during mechanical blood
circulation” adds little to what questions will be asked and addressed. A better
statement would be “we will test the hypothesis that a confluent lining of the patients’
own endothelial cells will provide a more anti-thrombogenic and biocompatible
surface for mechanical circulatory assist devices.”
Feasibility Studies
A feasibility study evaluates a system’s potential for success, with the goal of
objectively testing its strengths, weaknesses, and limitations. Feasibility studies
go beyond hypothesis driven research in that they are often technology or tooldriven investigations. As in hypothesis statements, you want to make sure that
the feasibility statement in your grant adequately describes what questions you
will be asking and addressing. For example, a statement such as “the objective
of this proposal is to test the feasibility of using endothelial colony forming cells
in a high-throughput assay to detect environmental toxins” sounds like a fishing
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Chapter 1: Beginning the Grant Application Process
expedition where you will be gathering data with no clear end-point analysis.
A better statement would be “we will determine the feasibility of endothelial
colony forming cells as a platform for high-throughput chemical toxicity testing of
bisphenol A, perfluorooctanoic acid and cadmium by quantifying the mechanistic
effects of these toxicants on cell viability, proliferation, and differentiation.”
STRATEGY:
Descriptive Title of the Project
Enter a brief descriptive title of the project. This field is required (Part I:
Instructions for Preparing and Submitting an Application I-47PHS SF424 (R&R)
Adobe Forms Version C Application Guide).
A “new” application must have a different title from any other PHS project
submitted for the same application due date with the same PD/PI. A “resubmission”
Many grant-writing
experts suggest
that you write your
Project Summary/
Abstract last as
you construct
your application
materials.
or “renewal” application should normally have the same title as the previous grant
or application. If the specific aims of the project have significantly changed, choose
a new title.
A “revision” application must have the same title as the currently funded grant.
NIH and other PHS agencies limit title character length to 200 characters,
including the spaces between words and punctuation.
What this means
All study section reviewers will read the application title, so it needs to be
informative and convey what you will be doing, how it will be done, and what the
expected results will be. The title will give reviewers their first impression of your
application. So, to have this first impression be the best that it can be, your title
needs to communicate imagination, novelty, and inventiveness. A title that will
REMEMBER:
NIH limits your title
to 200 characters,
including letters,
numbers,
spaces and any
punctuation.
distinguish your proposal from others and makes the reviewers look forward to
reading it may give you that additional advantage on the competition. As the SBIR
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program is focused on product commercialization, pointing to this aspect in your
title is also advised. At the same time, the NIH grant application limits your title to
200 characters, including letters, numbers, spaces and any punctuation.
TIP:
The title will give
reviewers their first
impression of your
application. So,
to have this first
impression be the
best that it can be,
your title needs to
communicate imagination, novelty, and
inventiveness.
While this may be small consolation, your colleagues in other departments
of your company also have character limits in their writings, particularly those in
advertising and communications. These departments are involved in the selling
of your business activities or its products; perhaps they can help you with your
title because just like them, you are ‘selling’ something - your research and
development project. Your title will become finalized after you complete your
application. Up to this point, it is more of a ‘work in progress’, as it may be
adjusted once you have your specific aims in place.
Some tips in developing a descriptive title are as follows:
• Uniqueness. Review published government databases for titles of existing
applications, such as those accessible through NIH RePORTER. (http://
projectreporter.nih.gov/reporter.cfm) After reviewing, see to it that your title
choice is not the same or closely similar to another.
• Be succinct. Include clear and accurate words that emphasize the suitability
of your project for the ICO to which you are submitting the application. Be
concise. It should also be apparent why your proposal was sent to the ICO
which you chose.
• Be confident. The reviewers need to be assured that you know what you are
writing about.
• Use key words the agency is familiar with. This will help a great
deal with getting your proposal to the most appropriate study section.
Even though you can suggest that a specific Study Section review your
application, it is the NIH’s Center for Scientific Review (CSR) staff
that makes the final decision, after performing the initial review of your
proposal before assigning it to one of its review panels. Guiding them with
title language they are used to seeing will help your cause.
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Chapter 1: Beginning the Grant Application Process
• Plain language should be used. This is not the place to use fancy words.
• Your word choices should be results orientated. Stay away from words
that refer to your process or experimental approach to the technology. For
example, “Hollow Fiber Catheter for Drug Delivery into the Prostate”
concisely conveys two pieces of information: the product and problem it
addresses.
• Share your title with peers to get their comments. Get input from
peer scientists and individuals outside your field, preferably someone
with a degree in English or an editor for proofreading and language use.
Colleagues with grant-writing experience can be especially helpful.
REMEMBER:
The Summary
should be a
faithful, although
condensed, replica
of the narrative.
The Title Must Convey One Product and One Problem in 200
Characters
The following questions were compiled by Dr. Gregory Milman, NIAID, and
taken from a slide contained in a presentation he has made to help businesses
successfully compete for SBIR and STTR awards. Keep these in mind when you
are developing the title for your proposal:
What is the public health problem?
• How large is the problem?
• What are current solutions and their drawbacks?
• What progress is being made?
• What is your product?
Why is it better than what is available?
• What are the requirements to sell it?
• What are the milestones necessary to bring your product to the point of
sales?
• What are the estimated time and cost to reach milestone?
• What is your exit strategy along the development pathway?
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Chapter 1: Beginning the Grant Application Process
Examples of Actual Phase I SBIR Applications Titles (Product,
Problem)
Your title should concisely convey two pieces of information: the product and
problem it addresses within the title’s character limit. The following were also
compiled by Dr. Gregory Milman, NIAID, and taken from a slide contained in a
presentation he has made to help businesses successfully compete for SBIR and
STTR awards.
1. “Development of Antimicrobial Peptides” does not identify a pathogen or
public health problem.
2. “Antigen Detection Assay for the Diagnosis of Visceral Leishmaniasis”
states both the product and problem.
3. “Enteric-coated Vector Microparticles for Oral Vaccination” describes
technology but not a problem.
4. “Coupled Enzyme Reporter Assay for Proteases” does not identify a
pathogen or public health problem
5. ”An Immunoadhesin Therapy for Gastrointestinal Anthrax” identifies a
product and a problem
6. “Proteolytic Antibodies for Treatment of Psoriasis” identifies a product and
a problem
7. “A Dynamic Web-Based Geospatial Data Visualization and Distribution
System”. I do not understand this title, do you?
8. “Virus-like Particle (VLP) Vaccine for RSV” identifies a product and a
problem.
9. “Molecular Screen for Antiviral Agents” describes technology but not a
specific disease.
10.“Multi-antigen Peptide Assay for the Serodiagnosis of Lyme Disease”
identifies a product and a problem
11.“Rapid, Low Cost, Point-of-Care Diagnostic Device for Group B
Streptococcus” identifies a product and a problem
12.“Potential Benefits of Personalized Interferons” does not identify a
problem.
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Chapter 1: Beginning the Grant Application Process
Finally, remember that the NIH uses your title — as well as your abstract — to
assign your application to a study section and institute for review. The agency also
uses it to report your research dollars to Congress. So your title plays a vital role
not only in the review process, but also throughout the life of your research grant.
REMEMBER:
When Should You Apply
Deadlines for SBIR applications have fallen on the same dates for a number of
years, and the recent re-issue of PHS 2013-02 Omnibus Solicitation of the NIH,
CDC, FDA and ACF for Small Business Innovation Research Grant Applications
(Parent SBIR [R43/R44]) maintains these same dates of April 5 (Cycle I), August 5
(Cycle II), and December 5 (Cycle II) for all new, resubmissions, and revisions of
Your title and
abstract play a vital
role not only in the
review process, but
also throughout
the life of your
research grant.
Phase I and Phase II SBIR applications. Review and award cycles for these dates
are as follows:
Review and Award Cycles
Scientific Merit Review
Advisory Council
Round
Earliest Project Start
Date
Cycle I
Cycle II
Cycle III
June - July
October - November
February - March
August or October*
January
May
September or December*
April
July
The agency asks that you please note:
“The actual date of the Advisory Council may occur in the month before or
after the month listed. For example, some ICs may actually hold the January
Advisory Council meeting in February or the October Advisory Council meeting in
September.
Awarding components may not always be able to honor the requested start
date of an application. Before incurring any pre-award obligations or expenditures
applicants should be aware of NIH policy governing pre-award costs prior to
receiving a Notice of Award. See the NIH Grants Policy Statement.
Principal Investigators Association | www.principalinvestigators.org
REMEMBER:
There are 3
deadlines each
year for SBIR
submissions;
April 5, August 5,
and December 5.
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Chapter 1: Beginning the Grant Application Process
*Advisory Council Round for Cycle I applications may be August or October,
and their earliest project start date may be September or December respectively.”
It is best to anticipate that changes may sometimes occur with these standing
TIP:
deadline schedules. It is safest to reconfirm these deadlines relevant to your
The time of
proposal submission is irrelevant to
an outstanding proposal. So, proceed
with submitting
your application as
soon as you are
confident that is the
best that it will be.
anticipated application submission. At the same time, if your proposal is a response
to a special request or funding announcement for a specific research topic, there
may be a different deadline, or deadlines, than the standing ones above. This
information will be provided in the announcement.
There is always a great deal of speculation among applicants that competition
for funding may be greater, or less, for particular deadline dates. For instance, some
believe that submitting towards the end of the year when the agencies are ‘running
out of money’ due to all of the earlier awards is not a favorable strategy, unless you
have a previous submission that scored near the funding cutoff, and the agency
wants to make sure that you get funded because you were ‘so close’. However, this
has yet to translate into a better success rate. The position that the NIH takes is that
proposal quality should be the deciding factor for submission, not any supposed
difference in successful award rates. The idea here is that time of submission is
irrelevant to an outstanding proposal. So, proceed with submitting your application
as soon as you are confident that is the best that it will be.
Outlining the Proposal
Creating a basic outline and crafting a provisional title for the proposal is next
on your agenda. The goal here is to end up with a workable framework for your
writing plan, and to finalize the ICO to which you will submit your proposal.
Ideally, this exercise should be relatively straightforward, assuming that you
have been discussing research and development topics with colleagues, keeping
up-to-date with the literature, and regularly checking with NIH announcements.
At its minimum, the project outline needs to clearly state the specific aims, as a
hypothesis and/or a feasibility statement, and the basic approach of how you plan
on achieving these aims. One way to move ahead is to think about the Project
Summary that you will write as you complete the proposal. While this is covered in
more detail later in this manual, the Project Summary:
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Chapter 1: Beginning the Grant Application Process
• is meant to serve as a succinct and accurate description of the proposed work
containing the application’s broad, long-term objectives and specific aims
• make reference to the health relatedness of the project (i.e., relevance to the
mission of the agency)
• describe the research design and methods
The proposal outline should also be the theme of at least one meeting with
your colleagues who have offered you their help. The outline should be as polished
as you can make it, with attention paid to focus, clarity, feasibility, and impact. It
should be a page long at is maximum, and perhaps be a bulleted list.
Make a Writing Schedule
Begin with an assumption that two months is the minimum amount of time it
will take to put together a successful proposal. Now it may be possible to do so
STRATEGY:
The outline should
be as polished as
you can make it,
with attention paid
to focus, clarity, feasibility, and impact.
It should be a page
long at is maximum, and perhaps
be a
bulleted list.
in less time, if your proposal is not very complex, you have very keen abilities,
and your schedule is relatively open. For many, at least one of these parameters is
lacking, so it may actually take longer than two months. In fact, some previous
applicants may suggest that six months is more likely. Also build in at least one
month, to be on the safe side, to send your proposal to peers and colleagues and
receive their responses. Allow yourself an additional two weeks to integrate any
changes you agree with based on their suggestions, as well as final proofreading of
the document before submission.
By this time you should have developed your idea to the point of being able to
create a writing schedule so that you can track your progress, stay on task while
ideally minimizing your stress, and meet the submission deadline you have chosen.
Avoid submitting a proposal that does not quite measure up because you were
rushed or just ran out of time to do it right; reviewers look for reasons to reject
proposals, and they do not need your help by submitting an application that is weak
and laden with errors.
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Chapter 1: Beginning the Grant Application Process
Then, set up a task list with due dates, based on the major components of the
application, which will also be discussed in greater detail in later chapters. As you
work through each task, do not attempt perfection on your first go-through; view
this phase of the writing as fluid and expect changes. Below is a sample task list:
Task Description
Due Date
Focus research and development topic to attainable goals
Review PHS 2013-02 Omnibus Solicitation of the NIH, CDC,
FDA and ACF for Small Business Innovation Research Grant
Applications (Parent SBIR [R43/R44])
Download an copy of SF424 (R&R) SBIR/STTR Application
Guide for NIH and Other PHS Agencies and review
Develop hypothesis/feasibility study statement
Decide on a provisional title
Get feedback for peers and colleagues on hypothesis and title
Prepare Significance and Innovation statements
Develop specific aims for the proposal
Etc.
Writing the proposal is by far the major task, and once that is finished, the last
few items you need to attend to is the assembly of all application components and
having the entire package reviewed by trusted colleagues. These colleagues should
include someone who is an excellent proofreader in addition to those familiar with
the science. After you receive all comments, the application is just about ready.
What you have left is to make your final review of the entire package, including
any last-minute editing and rewriting to ensure that the sections flow as coherently
as possible. Finally, and while you may have questioned whether the proposal
would ever make it to this stage, submit the completed application before the
deadline.
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Chapter 1: Beginning the Grant Application Process
Conclusion
The time and effort you put into clearly defining your research and
development project, deciding on a title that will compel the reviewer to read
the application, refining your hypothesis/feasibility statements, and sticking to
your writing schedule, is time and effort well spent. Having colleagues critique
your work prior to actual submission will mean that your ideas have already been
vetted and should be competitive with others under study section review with
yours. At this stage, you are in the best position you can possibly be for writing
and assembling your application for the SBIR program. These grants require
considerable amounts of information, time, and effort; careful planning helps you
to stay on task and focused. n
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45 Chapter 1: Beginning the Grant Application Process
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 2: Summarizing Your Project and Your Qualifications
Chapter 2:
Summarizing Your Project and Your
Qualifications to Be PI
As part of the SBIR application package, you will be required to summarize
your research topic and your plan for execution. The place for this information is in
the Project Summary/Abstract section. This section of your application is arguably
one of the most important components because all of the reviewers on the study
section will read it as it contains information relating to all five review criteria,
which will be covered in detail later on. One of the best approaches to help wrap
your head around this section is to picture yourself as a storyteller who will take
the reviewers on a journey through your project. Success in getting the reviewers hooked on your story is how you will get them to champion your application.
Remember that all compelling stories have a resolution at the end; yours will be
how your research and development will advance the field and make future investigations possible, particularly the Phase II portion of this project. Since the abstract
will be made public once you receive an award, do not include any proprietary
TIP:
Since the abstract
will be made public
once you receive
an award, do not
include any proprietary information
belonging to the
company.
information belonging to the company.
More in-depth than a general biography, the principal investigator’s (PI) Biographical Sketch will also be covered in this chapter. This sketch must include a
personal statement. With some imagination and creativity, there are ways you can
use this statement to increase your chances of successfully being awarded funds.
Also included in the biosketch is an accounting of the PI’s positions and honors, a
listing of peer-reviewed publications or manuscripts in press, and research support.
Rounding out this chapter will be an explanation of how letters of support can
strengthen your proposal. Suggestions will also be made on the types of people you
should approach to provide a letter, and why it is best if you write the first draft for
them.
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Chapter 2: Summarizing Your Project and Your Qualifications
Make a Writing Schedule
Taken directly from the SBIR/STTR SF424 (R&R) Adobe Forms Version B
Application Guide:
Project Summary/Abstract
The Project Summary must contain a summary of the proposed activity suitable
for dissemination to the public. It should be a self-contained description of the
project and should contain a statement of objectives and methods to be employed.
It should be informative to other persons working in the same or related fields
and insofar as possible understandable to a scientifically or technically literate lay
reader. This Summary must not include any proprietary/confidential information.
The Project Summary is meant to serve as a succinct and accurate description
of the proposed work when separated from the application. State the application’s
broad, long-term objectives and specific aims, making reference to the health
relatedness of the project (i.e., relevance to the mission of the agency). Describe
concisely the research design and methods for achieving the stated goals. This
section should be informative to other persons working in the same or related fields
and insofar as possible understandable to a scientifically or technically literate
reader. Avoid describing past accomplishments and the use of the first person.
Finally, please make every effort to be succinct. This section must be no longer
than 30 lines of text, and follow the required font and margin specifications. An
abstract which exceeds this allowable length may be flagged.
What this means:
Make sure you describe:
•
•
•
•
•
The public health problem
Any concerns about current resolutions to the problem
How you will approach the problem to get better resolution
The unmet need your technology, and ultimately your product, will address
Any collaborators, consultants, and what they can provide to strengthen
your application
• The specific aims of the proposal
• How the achievements of the Phase I will justify the Phase II and continued
product development
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Make sure to present your ideas as the solution to the problem, and be specific
about your activities and impacts.
The initial review of your application will take place at the Center for Scientific
Research (CSR), and they will most certainly use the Project Summary/Abstract
to assign your application to a particular Scientific Review Group (SRG) or study
section, as well as to the peer reviewers who will examine it in great detail. Using
REMEMBER:
keywords familiar to the agency will ensure that SRG staff can readily assign your
It is not uncommon
for reviewers to
make a conclusion
about your proposal’s merit once
they read the first
page or two of your
application. They
will read the rest of
the application to
bolster their
conclusion.
application and the NIH computer systems can retrieve it properly. Many times
SRG members who are not the primary reviewers will rely on your summary/
abstract almost entirely to comprehend your proposal during the general meeting
during which application fundability is discussed.
With so much riding on this Project Summary/Abstract of your proposal, it may
be advised to write this section last, after the rest of the application is competed.
The rationale here is that you will attain a more comprehensive appreciation of
your proposal if you write it last. If you do decide to write this section before
others are completed, treat it as conditional and return to it after the other sections
are finished.
In contrast, writing the Project Summary/Abstract earlier will help to focus
the main ideas for you during the writing of the other sections. Highlighting key
words important for understanding your research and development project in the
other sections of the grant will make it easier for you to circle back to the project
summary and make sure these words are used in correct context.
Storytelling to Engage the Reviewers
Think of the Project Summary/Abstract as the beginning chapter of your story,
which provides a glimpse into what the subsequent prose will contain. The reader
will expect the abstract to be a mini-version of your story; make sure the story does
not contain important ideas that are left out of the abstract, and vice versa.
In speaking with those PI’s who have served on study sections, it is not
uncommon for reviewers to make a conclusion about your proposal’s merit once
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they read the first page or two of your application. They will read the rest of the
application to bolster their conclusion. If that conclusion is a positive one, then they
will read the remainder of the application to support this view and you now have
someone on your side to champion your cause. If that conclusion is negative, they
will still read to bolster their conclusion, but now it is to search for weaknesses.
Project Summary/Abstract Examples
The NIH Research Portfolio Online Reporting Tools project (RePORTER)
website (http://projectreporter.nih.gov/reporter.cfm) can be queried for abstracts
of awarded Phase I SBIR projects. While the exact text for the project description
as published on this site is quoted below, the text has been broken up and subheadings have been inserted to indicate the relevant sections.
Example #1 from NIDDK
Proposal Title: DEVELOPMENT OF CDK4/6 INHIBITORS AS NOVEL
RENAL PROTECTANTS
Significance of the proposed research:
Acute kidney injury (AKI) is common, expensive, and highly morbid. There
are currently no therapies for AKI, and prevention and treatment represents
a $6.3 billion market opportunity annually in the U.S. Moreover, patients are
developing AKI more frequently and the number of patients that survive severe
AKI is growing. Between the years of 1988 and 2002, the number of patients who
survived AKI requiring dialysis increased from 2.4 to 19.4 per 100,000 population.
Although some patients may recover from AKI, many progress to chronic kidney
disease (CKD). The proportion of AKI survivors who progress to the most severe
form of CKD, end-stage renal disease, has increased over the last two decades, at
an enormous societal cost. It has been estimated that caring for patients with CKD
accounted for 19% of the Medicare budget in 2002. Novel therapies are urgently
needed for the treatment of both AKI and CKD.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 2: Summarizing Your Project and Your Qualifications
Innovation and unique features of the proposal:
G-Zero Therapeutics (GZ) is ready to meet this urgent need for effective renal
protectants by leveraging intellectual property surrounding a novel therapeutic
approach utilizing proprietary small molecule CDK4/6 inhibitors to induce
pharmacological quiescence (PQ). GZ is developing and commercializing
their novel Pharmacological Quiescence (PQ) technology. PQ is based on
the observation that many cell types are more sensitive to toxic insult when
proliferating as opposed to when non-dividing (i.e. quiescent). Crucially, a few
specific cell types can be rendered transiently and reversibly quiescent by treatment
with small molecule inhibitors of two cyclin dependent kinases (CDK4/6). Thus,
certain cells types can be protected by PQ, without the generalized toxicity (e.g.
myelosuppression) of non-specific anti-mitotics. GZ has shown that protective PQ
can be induced in CDK4/6-dependent cell types at the time of insult (e.g. cytotoxic
chemotherapy), and that these cells can then be released to re- enter the cell cycle
and proliferate when the insulting exposure has terminated. The PQ approach
has been initially used by GZ to afford protection of hematopoietic stem and
progenitor cells (HSPC) within the bone marrow from the toxicity of radiation and
chemotherapy.
Specific Aims:
The Phase I portion of this proposal will be accomplished in two significant
aims: (1) To evaluate the in vitro efficacy and cellular toxicity of GZ proprietary
small molecule CDK4/6 inhibitors as novel renal protectants. (2) To evaluate
potential GZ lead candidate’s ability to induce PQ in vivo in pharmacodynamic
(PD) assays predictive of renal protection efficacy.
Re-emphasis of the proposal’s innovation:
This proposal capitalizes on the recent discovery from Dr. Sharpless and Dr.
Benjamin Humphreys at Harvard Medical School (a consultant on this proposal),
that, like HSPC, renal epithelial cells also depend on the catalytic activity of
CDK4/6 for proliferation. GZ’s preliminary data show that epithelial cells in
the kidney can be rendered quiescent transiently by CDK4/6 inhibitors, and that
this affords significant protection from renal insults such as chemotherapy and
ischemia, thereby ameliorating AKI.
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Example #2 from NIEHS
Proposal Title: A FUNCTIONALIZED NANOPARTICLE-BASED
HANDHELD DEVICE FOR RAPID AND SENSITIVE DETEC
Significance of the proposed research:
Organophosphate (OP) pesticides are highly toxic compounds used to control
insect populations in a number of agricultural and landscaping applications. The
widespread use of these toxic chemicals has generated serious environmental health
risks. It is vital to sensitively and accurately bio monitoring of environmental
exposure to OP pesticides and assessment of its health risk. However, simple, rapid,
and quantitative diagnostic technologies and devices for detecting environmental
OP exposure are not available.
Innovation and unique features of the proposal:
This Small Business Innovation Research Project is to develop a handheld
bio monitoring device incorporating a functionalized nanoparticle and a lateral
flow test strip for simple, rapid, cost-effective, and quantitative detection of
environmental exposure to OP using a blood sample. This project takes advantage
of phosphorylated cholinesterase (OP-ChE) as a biomarker of OP exposure.
Specific Aims:
In phase I, there are three specific aims: (1) Develop Zr (IV)-functionalized
fluorescence nanoparticles (Zr-FFNPs) that bind to OP-ChE. (2) Develop a ZrFFNP-based new immunoassay for detecting OP-ChE. (3) Adapt the Zr-FFNPbased immunoassay to a lateral flow test strip system for detecting OP-ChE.
The research will determine the detection limits, response time, dynamic range,
and other key performance metrics of the device using blood samples in vitro
dosed with three typical pesticides and prove the feasibility of the handheld bio
monitoring device for sensitively detecting OP exposure.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 2: Summarizing Your Project and Your Qualifications
Reference to Proposed Phase II:
Phase II will further develop a specialized hand-held bio monitoring device
for detecting exposure to OP. The device will be validated with blood in vitro
dosed with a wide range of OP pesticides and blood samples from students in
schools near farms and family members of workers who involved in the used of OP
pesticides.
Re-emphasis of the proposals innovation:
The portable biomonitoring device developed under this program will provide
a point-of-care tool for rapid, sensitive, cost-effective, and real-time detection of
environmental exposure to OP pesticides.
Notice that in this example, the project title exceeded the 81 character limit (now
increased to 200 characters), and abruptly ends in the middle of the word ‘detection’.
Example #3 from NIGM
Proposal Title: OPTIMIZATION OF ISORAFT TECHNOLOGY FOR STEM
CELL MARKET
Significance of the proposed research:
Cell Microsystems is a North Carolina-based start-up biotechnology company
whose mission is to commercialize a novel, yet affordable, platform for the
efficient isolation of viable, single cells or colonies from a mixed population
while the cell/colony remains adherent or encapsulated to a solid surface. The
company’s “IsoRaft” technology is based on a unique cell array recently developed
at the University of North Carolina (UNC) at Chapel Hill, and represents an ideal
opportunity for the translation of an academic technology to the marketplace
through the SBIR program. Cell Microsystems has obtained license from UNC to
commercialize the technology for a broad market in academic labs, as well as in the
biotechnology and pharmaceutical industries.
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Innovation and unique features of the proposal:
The products consist of disposable microarray (the IsoRaft Array) for culturing
cells and a simple device for isolating the cell/colony of interest. Prototypes of
arrays and devices have been completed and are being tested in a number of
academic labs as an Early Adoption Program (EPA) at nearby research institutes.
Specific Aims:
In this Phase I SBIR proposal, we will explore the feasibility of using the
IsoRaft technology for stem cell research. Particularly we will focus on design and
optimize the IsoRaft Array for stem cells, and develop strategies for cell imaging,
identification, tracking and retrieval of targeted stem cells/colonies.
Re-emphasis of the proposals innovation:
Our goal is to expand the use of this technology for stem cell research to the
large community in the life science market. The studies in Phase I will deliver a
1st generation commercial device and consumables that provide a flexible and
powerful means to perform unique stem cell assay and sorting experiments at
significant cost and time reduction.
Take note that all of the successfully awarded examples shown follow the same
general formula of significance/innovation/specific aims/re-emphasis of innovation;
Example #2 also references the Phase II.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 2: Summarizing Your Project and Your Qualifications
Project Narrative
Taken directly from the SBIR/STTR SF424 (R&R) Adobe Forms Version B
Application Guide:
Project Narrative
Provide Project Narrative in accordance with the announcement and/or agencyspecific instructions.
For NIH and other PHS agencies applications, this attachment will reflect the
Relevance of the proposed project. Using no more than two or three sentences,
describe the relevance of this research to public health. In this section, be succinct
and use plain language that can be understood by a general, lay audience.
A separate Research Plan form is required for NIH and other PHS agencies
applications. Refer to Section 5.4, Research Plan Form, for separate file uploads
and instructions.
What this means:
The Project Narrative should summarize the essence of your project’s relevance
to public health, so that a non-scientist can understand. The NIH RePORTER
online grant award reporting tool often refers to the Project Narrative as the “Public
Health Relevance Statement.” It is included in the RePORTER tool and therefore
will become a part of the public record.
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Project Narrative Examples
With all this in mind, use the following examples of Project Narratives taken
from successful SBIR Phase I grant applications:
Example #1 from NIEHS
Proposal Title: Novel assays for screening the effects of chemical toxicants on
cell differentiation
Proposal Narrative: In this study, we propose to test a novel, robust, and
comprehensive platform for toxicological risk assessment utilizing donor-specific
pluripotent cells. Such platform would be an invaluable tool for the functional
analysis of human genetic diversity and identification of population subgroups most
vulnerable to toxicants.
Example #2 from NIDDK
Proposal Title: Commercialization of a Human Myocyte and Adipocyte CoCulture System
Proposal Narrative: At the completion of this project, a commercially available,
fully validated human skeletal myocyte system, skeletal myocyte / adipocyte coculture system, and related assay kits will be offered to researchers. The availability
of these systems will provide opportunities for new approaches in the investigation
of metabolic disease and a unique methodology to examine the complex interaction
between these two cell types.
Example # 3 from NCRR
Proposal Title: Commercialization of Human Omental Mesothelial Cells for
Research
Proposal Narrative: At the completion of this project, a commercially available,
fully characterized primary human mesothelial cell system and support reagents will
be offered to researchers. The accessibility of this currently unavailable system will
provide wider opportunity to investigate novel methods to inhibit ovarian tumor
attachment, prolong the utility of peritoneal dialysis, and treat peritonitis.
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NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
Chapter 2: Summarizing Your Project and Your Qualifications
The Biographical Sketch
The NIH Application Guides states, which is reiterated in the SBIR/STTR
SF424 (R&R) Adobe Forms Version B Application Guide:
Use the sample format on the Biographical Sketch Format Page to prepare this
section for all (modular and other) grant applications. Include biographical sketches
of all Senior/Key Personnel and Other Significant Contributors. The Biographical
Sketch may not exceed four pages per person. This 4-page limit includes the table
at the top of the first page.
What this means:
The Biographical Sketch, also referred to as the Biosketch, is limited to a
maximum of four pages per person, and this information must be contained
in the form provided for presenting this information. Your application must
include a complete Biosketch for all Senior/ Key Personnel and Other Significant
Contributors.
NIH defines Senior/Key Personnel as the Project Director (PD)/Principal
Investigator (PI) “and other individuals who contribute to the scientific
development or execution of the project in a substantive, measureable way,
whether or not salaries or compensation are requested under the grant.” Usually,
these Senior/Key Personnel have doctoral or other professional degrees, NIH says,
adding that you should also include those with master’s and baccalaureate degrees
if their involvement meets the above definition.
TIP:
Reviewers scrutinize this section
to ensure that you
and other investigators and proposed
staff have the
proper experience
with the proposed
techniques.
You will also need a Biosketch for any Other Significant Contributors, those
who commit to contribute to the project’s scientific development or execution, NIH
states. They are usually listed as presenting “effort of zero person months” or “as
needed” on your application. Consultants likely will be in this category.
The Biosketch is your opportunity to detail your knowledge, skills and ability
to carry out and manage the proposed research. Demonstrate that you are the
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individual most qualified to do it. Reviewers scrutinize this section to ensure that
you and other investigators and proposed staff have the proper experience with the
proposed techniques.
The form for the biosketch is only the first page and provides space for only the
key personnel’s education. There is no template for the additional three pages to
complete the individual’s Biographical Sketch. The educational information should
begin with baccalaureate or other initial professional education, moving forward to
Click for More Info on This Form
doctorate, postdoctoral training, residency training, etc. as applicable.
Program Director/Principal Investigator (Last, First, Middle):
BIOGRAPHICAL SKETCH
Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form Page 2.
Follow this format for each person. DO NOT EXCEED FOUR PAGES.
NAME
POSITION TITLE
eRA COMMONS USER NAME (credential, e.g., agency login)
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and
residency training if applicable.)
DEGREE
INSTITUTION AND LOCATION
MM/YY
FIELD OF STUDY
(if applicable)
Please refer to the application instructions in order to complete sections A, B, C, and D of the Biographical
Sketch.
What Should Be Included in Your Biosketch:
The NIH Application Guides states:
Following the educational block, complete sections A, B, C, and D as described
below.
A. Personal Statement. Briefly describe why your experience and qualifications
make you particularly well-suited for your role (e.g., PD/PI, mentor) in the
project that is the subject of the application.
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B. Positions and Honors. List in chronological order previous positions,
concluding with your present position. List any honors. Include present
membership on any Federal Government public advisory committee.
C. Selected Peer-reviewed Publication and Patent Citations (in chronological
order). NIH encourages applicants to limit the list of selected peer-reviewed
publications, manuscripts in press, and patent citations to no more than
15. Do not include manuscripts submitted or in preparation. The individual
may choose to include selected publications based on recency, importance
to the field, and/or relevance to the proposed research. When citing articles
that fall under the Public Access Policy, were authored or co-authored by the
applicant and arose from NIH support, provide the NIH Manuscript
Submission reference number (e.g., NIHMS97531) or the Pubmed Central
(PMC) reference number (e.g., PMCID234567) for each article. If the
PMCID is not yet available because the Journal submits articles directly
to PMC on behalf of their authors, indicate “PMC Journal - In Process.”
A list of these journals is posted at: http://publicaccess.nih.gov/submit_
process_journals.htm. Citations that are not covered by the Public Access
Policy, but are publicly available in a free, online format may include URLs
or PMCID numbers along with the full reference (note that copies of
publicly available publications are not acceptable as appendix material).
D. Research Support. List both selected ongoing and completed (during the
last three years) research projects (Federal or non-Federal support). Begin
with the projects that are most relevant to the research proposed in this
application. Briefly indicate the overall goals of the projects and
responsibilities of the Senior/Key Person identified on the Biographical
Sketch. Do not include number of person months or direct costs.
What this means:
The sections below must be included in the Biosketch, but remember that the
Biosketch cannot exceed four pages in total length:
• Personal Statement — Briefly describe why your experience and
qualifications make you ideally suited for your role on this project, as PI,
mentor, etc.
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• Positions and Honors — List your previous positions in chronological
order, concluding with your present one. Include any honors and list any
memberships on federal government public advisory committees.
• Peer-Reviewed Publications and Manuscripts in Press (in chronological
order) — NIH suggests that you limit the list of selected peer-reviewed
publications or manuscripts in press, and patent citations to no more than
15. You should not include manuscripts submitted or in preparation, but
you may include selected publications based upon most recent release,
importance in the field, relevance to the proposed research and development
effort. If the article happens to fall under the Public Access Policy, was
authored or co-authored by the applicant and arose from NIH support, you
need to provide only the NIH Manuscript Submission reference number or
the PubMed Central (PMC) reference number.
• Research Support — List both selected ongoing and completed (during the
last three years) research projects. Begin with the most relevant to your
current application, and briefly state the overall goals of the project and the
responsibilities of the Senior/Key Personnel. Do not include the number of
person months or direct costs.
In the next section, we will go into more detail for each of the Biosketch
features and their relevance to your application.
Personal Statement
This is the section where you get to detail why you are the best individual for
a chosen role in the project. Reviewers will carefully consider the information
you include here when they examine your qualifications. You may include your
pedigree, research experience, management experience, mentoring, or your track
record of product and technology research and development. Indicate specifically
why you feel that you are the most qualified person to lead this proposed project.
You need to avoid sounding boastful, so point to specific objectives and criteria in
your background, grant funding you have previously received, and publications
resulting from those grants.
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If you have been employed with a company for a significant length of time
during your career, you may not have had the opportunity to publish or compete
for grants to the same level as an academician. Since company value often relies
on intellectual property, it would be appropriate here to describe any intellectual
property you have contributed to, such as trade secrets, patent filings or patents
awarded. You may also include here any previous products you have developed,
product testing in clinical trials, or contracts awarded to you and your company.
Within this section you may, at your discretion, briefly describe factors such
as family care responsibilities, illness, disability, and active duty military service
that may have affected your scientific advancement or productivity. You may also
reference presentations you made, or address changing fields of study.
The idea here is that the personal statement will provide an overview of your
TIP:
Personal
Statement is
where you may
describe your
contributions to
your company’s
intellectual
property
portfolio.
research and product development capabilities, and why it is worth the reviewer’s
time to read your proposal and award the SBIR program’s money. It should
contain your objectives for wanting to conduct the work. It would explain your
personal motivations for wanting the award and why you deserve it. Your personal
statement can give a good first impression to the study section that will review your
application.
Here is an example of a personal statement from a recently awarded Phase I
SBIR:
The goal of the proposed research is to test the feasibility of human endothelial
progenitor cells or endothelial colony forming cells (ECFCs), a population of
CD31+/CD34+ pluripotent cells found in circulation, for toxicological risk
assessment. I have expertise in cellular and molecular biology. For the past 8 years,
my scientific interest has been associated regulation of cell signaling, cell-cell,
and cell environment communication. I also interested in finding efficient ways
to conduct biological research and I founded [Company Name] in 2010 with an
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idea to capitalize on and advance novel technologies associated with human stem/
progenitor cells. Our company focuses on research and manufacturing of barrier
tissues, i.e.,endothelium and epithelium. We see a value in stem/progenitor cells,
which can be isolated from any person, especially in the area of diagnostics.
Together with [Academic Institution Name], we concluded a study where we
identified the first biomarker for low-dose ionizing radiation (LDIR). We found
that human endothelial progenitor, or endothelial colony-forming cells (ECFCs)
are highly sensitive to LDIR. ECFCs can be (a) isolated in a noninvasive manner,
(b) easily expanded in culture, and (c) cryopreserved without loss of viability. We
realize that ECFC can be valuable for high-throughput analysis of environmental
hazards. The overall goal of this research is to evaluate the effect of chemical
toxicants on viability, proliferation, and differentiation of ECFCs derived from
different individuals.
Notice the following features:
• The statement begins by identifying the main point for the research and
helps to keep the rest of the statement focused and on track.
• Objectives are identified – describe why you want your application to be
approved and how your research will benefit the field. You have to make
the reviewers understand why this study is significant and that it addresses
and unmet commercial need.
• Personal statement is in essay form – Come straight to the point and
envision that you are straightforwardly answering a question as to why your
proposal should be considered and that you are doing it in full detail.
• Specific discussion of background – Covers past relevant work, and your
role, that lead up to this proposed study.
• Uses the first person perspective - This is a personal statement so you need
to use “I”. It is here where you have an opportunity to say something about
yourself and the personal significance of the grant. This is your chance to
include pertinent details that were not included in the application forms.
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Positions and Honors
This is the section where you list your employment history. Include the dates,
places, and nature of the position. For SBIR applications, this listing is in chronological
order, concluding with your present position. Include any honors and memberships to
organizations that you hold, as well as present membership on any Federal Government
public advisory committee.
The NIH provides this example:
B. Positions and Honors
Positions and Employment
1998-2000 Fellow, Division of Intramural Research, National Institute
of Drug Abuse, Bethesda, MD
2000-2002 Lecturer, Department of Psychology, Middlebury College,
Middlebury, VT
2001-
2002-2005
Consultant, Coastal Psychological Services, San Francisco, CA
Assistant Professor, Department of Psychology, Washington
University, St. Louis, MO
2007- Associate Professor, Department of Psychology, Washington
University, St. Louis, MO
Other Experience and Professional Memberships
1995-
Member, American Psychological Association
1998-
Member, Gerontological Society of America
1998-
Member, American Geriatrics Society
2000-
Associate Editor, Psychology and Aging
2003-
Board of Advisors, Senior Services of Eastern Missouri
2003-05
NIH Peer Review Committee: Psychobiology of Aging, ad
hoc reviewer
2007-11
NIH Risk, Adult Addictions Study Section, member Honors
2003
Outstanding Young Faculty Award, Washington University, St.
Louis, MO
2004
Excellence in Teaching, Washington University, St. Louis, MO
2009
Award for Best in Interdisciplinary Ethnography, International
Ethnographic Society
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Peer-Reviewed Publications and Manuscripts in Press
The publications list allows you to demonstrate that you have a track record of
success as researcher. Applicants are encouraged to list no more than 15 selected
peer-reviewed publications or manuscripts in press, do not include any submitted
TIP:
manuscripts, manuscripts not published, or manuscripts in preparation. While
While you application won’t be
tossed out if you
provide more than
15 publications,
don’t irritate the
reviewers by having
them go through a
long list of your papers to try and find
the ones relevant to
your application –
highlight them
for ease of
identification.
your application won’t be tossed out if you provide more than 15 publications,
don’t irritate the reviewers by having them go through a long list of your papers
to try and find the ones relevant to your application – highlight them for ease of
identification.
One approach in selecting these 15 is to pick the five most recent, the five most
important to your field, and five which are most relevant to your proposed research
and development project. Most reviewers will be focused on what you have done
during the last five years, regardless of whether this can be covered in 5 or 10
papers. If the majority of your recent publications are directly relevant to your
current proposal, then you may be able to use your most recent 15 papers to satisfy
all of the aforementioned areas. In contrast, if your most recent 15 do not give an
accurate picture of your strength and ability as an investigator, you may go back to
five or six older publications showing that you have worked in the field, you have a
track record of accomplishments, and you have made an impact. Another approach
towards indicating to the reviewers that you have an extensive publication record
is to make a statement such as ‘selected publications from the last 10 years’, or
‘selected publications out of 90’ before listing your papers.
Below is an example, provided by the NIH, of the Peer-Reviewed
Publications or Manuscripts in Press portion of the Biosketch.
C. Selected Peer-reviewed Publications (Selected from 42 peer-reviewed
publications)
Most relevant to the current application
1. Merryle, R.J. & Hunt, M.C. (2004). Independent living, physical disability
and substance abuse among the elderly. Psychology and Aging, 23(4), 1022.
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2. Hunt, M.C., Jensen, J.L. & Crenshaw, W. (2007). Substance abuse and
mental health among community-dwelling elderly. International Journal of
Geriatric Psychiatry, 24(9), 1124-1135.
3. Hunt, M.C., Wiechelt, S.A. & Merryle, R. (2008). Predicting the substanceabuse treatment needs of an aging population. American Journal of Public
Health, 45(2), 236-245. PMCID: PMC9162292
4. Hunt,M.C., Newlin, D.B. & Fishbein, D. (2009). Brain imaging in
methamphetamine abusers across the life-span. Gerontology, 46(3), 122145.
5. Hunt, M.C. & Sher, K.A. (2009). Successful intervention models for older
drug-abusers: Research across the life-span. American Psychologist, in
press. NIHMSID: NIHMS99135
Additional recent publications of importance to the field (in chronological
order)
1. Gryczynski, J., Shaft, B.M., Merryle, R., & Hunt, M.C. (2002). Community
based participatory research with late-life addicts. American Journal of
Alcohol and Drug Abuse, 15(3), 222-238.
2. Shaft, B.M., Hunt, M.C., Merryle, R., & Venturi, R. (2003). Policy
implications of genetic transmission of alcohol and drug abuse in female
nonusers. International Journal of Drug Policy, 30(5), 46-58.
3. Hunt, M.C., Marks, A.E., Shaft, B.M., Merryle, R., & Jensen, J.L. (2004).
Early-life family and community characteristics and late-life substance
abuse. Journal of Applied Gerontology, 28(2),26-37.
4. Hunt, M.C., Merryle, R. & Jensen, J.L. (2005). The effect of social support
networks on morbidity among elderly substance abusers. Journal of the
American Geriatrics Society, 57(4), 15-23.
5. Hunt, M.C., Pour, B., Marks, A.E., Merryle, R. & Jensen, J.L. (2005).
Aging out of methadone treatment. American Journal of Alcohol and Drug
Abuse, 15(6), 134-149.
6. Hunt, M.C., Marks, A.E., Venturi, R., Crenshaw, W. & Ratonian, A. (2007).
Community-based intervention strategies for reducing alcohol and drug
abuse in the elderly. Addiction, 104(9), 1436-1606. PMCID: PMC9000292
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7. Merryle, R. & Hunt, M.C. (2007). Randomized clinical trial of cotinine in
older nicotine addicts. Age and Ageing, 38(2), 9-23. PMCID: PMC9002364
8. Hunt, M.C., Jensen, J.L. & Merryle, R. (2008). The aging addict:
ethnographic profiles of the elderly drug user. NY, NY: W. W. Norton &
Company.
9. Hunt, M.C. (2009). Contrasting ethnicity with race in the older alcoholic.
The Journals of Gerontology Series B: Psychological Sciences and Social
Sciences, in press. PMCID: PMC Journal – In Process.
10.Hunt, M.C. (2009). Intervening successfully with the older methadone
patient. Journal of Applied Gerontology, 13(4), 67-79.
Take note that this applicant chose to divide their 15 publications into two
distinct groups (most relevant and importance to the field) and that these choices
were selected from a much larger group (42).
Upcoming Changes to the Biosketch Format
NIH’s plan to modify the current biosketch format is scheduled to roll
out for all grant applications received for FY 2016 funding and beyond
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-091.html). In practice,
this means that applications submitted in early 2015 will use this new format
which is described on the SF424 (R&R) Applications and Electronic Submission
Page (http://grants.nih.gov/grants/funding/424/index.htm). Until this time, read
any RFAs you plan to apply for very carefully, since they may be part of the pilot
phase of the implementation that requires use of the new biosketch format. In
summary, these changes include:
• Increasing the total biosketch length to five pages, instead of two or four.
• There is a new Section C - Contributions to Science. This section will
succeed the Selected Peer-Reviewed Publications section. In this new
section C, applicants will briefly describe up to five of their most significant
contributions to science. Each description should be no longer than one half
page, including figures and citations. For each contribution, the applicant
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Chapter 2: Summarizing Your Project and Your Qualifications
will reference up to four peer-reviewed publications relevant to that specific
contribution. Be sure to provide a URL to a full list of your published work
as found in a publicly available digital database such as PubMed or My
Bibliography.
OMB No. 0925-0046 (Approved Through 5/31/2016)
BIOGRAPHICAL SKETCH—Pilot Format (To Be Used for Specific FOAs only)
Provide the following information for the Senior/key personnel and other significant contributors.
Follow this format for each person. DO NOT EXCEED FIVE PAGES.
NAME
POSITION TITLE
eRA COMMONS USER NAME (credential, e.g., agency login)
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and
residency training if applicable.)
DEGREE
INSTITUTION AND LOCATION
MM/YY
FIELD OF STUDY
(if applicable)
NOTE: The Biographical Sketch may not exceed five pages. Follow the formats and instructions below.
A. Personal Statement
Briefly
whythe
you format?
are well-suited for your role in the project described in this application. The relevant
Whydescribe
change
factors may include aspects of your training; your previous experimental work on this specific topic or related
topics; your technical expertise; your collaborators or scientific environment; and your past performance in this
or related fields (you may mention specific contributions to science that are not included in Section C). Also,
you The
may identify
upof
to four
peer
reviewed
publications
specifically highlight
your experience
purpose
these
changes
has
best beenthat
summarized
by Dr. Sally
Rockey, and
qualifications for this project. If you wish to explain impediments to your past productivity, you may include a
description
of factors
such asfor
family
care responsibilities,
disability, and
duty on
military
NIH’s Deputy
Director
Extramural
Research.illness,
Her complete
webactive
posting
this service.
B.
Positions
Honorsat
subject
mayand
be found
http://nexus.od.nih.gov/all/2014/05/22/changes-to-the-
List
in chronological order previous positions, concluding with the present position. List any honors. Include
biosketch/:
present membership on any Federal Government public advisory committee.
C. Contributions to Science
The
primary
themost
newsignificant
NIH biosketch
willtobescience.
the magnitude
Briefly
describe
up tofocus
five ofof
your
contributions
For each and
contribution, indicate the
historical background that frames the scientific problem; the central finding(s); the influence of the finding(s) on
significance
the scientific
advances
associated
with
a researcher’s
discoveries
the
progress of of
science
or the application
of those
finding(s)
to health
or technology;
and your specific role in
the described work. For each of these contributions, reference up to four peer-reviewed publications that are
and the specific role the researcher played in those findings. This change will
relevant to that contribution. The description of each contribution should be no longer than one half page
including
figures and
citations.
Please
alsowhere
provideyou’ve
a URL to
a full list oforyour
published
work as found in a
help reviewers
evaluate
you
not by
published
how
many times,
publicly available digital database such as PubMed or My Bibliography, which are maintained by the US
National
Library
Medicine.
but instead
byofwhat
you’ve accomplished. Hopefully, this change will redirect
D.
theResearch
focus of Support
reviewers
and the scientific community more generally from widely
List both selected ongoing and completed research projects for the past three years (Federal or non-FederallyquestionedBegin
metrics,
like
the number
published
papers,
the number
ofincitations
supported).
with the
projects
that are of
most
relevant to
the research
proposed
the application. Briefly
indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical
received by those papers, or one of several statistical approaches used to normalize
Sketch. Do not include number of person months or direct costs.
citations.
Public reporting burden for this collection of information is estimated to average one hour per response, including the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate
or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705
Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0046). Do not return the completed form to this address.
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Chapter 2: Summarizing Your Project and Your Qualifications
We strongly believe that allowing a researcher to generate an account of his
or her own work will provide a clearer picture of each individual’s contributions
and capabilities. But one might question whether this new biosketch will have a
negative impact on younger investigators whose body of work may not be as robust
as more established investigators. I believe the contrary is true; this new format
will give early career investigators a platform for describing and framing the
significance of their contributions, which should help reviewers better understand
their accomplishments without having to rely simply on a list of publications.
The NIH provides the following example of the new Section C:
C. Contributions to Science
1. My early publications directly addressed the fact that substance abuse is
often overlooked in older adults. However, because many older adults were
raised during an era of increased drug and alcohol use, there are reasons to
believe that this will become an increasing issue as the population ages. These
publications found that older adults appear in a variety of primary care settings
or seek mental health providers to deal with emerging addiction problems.
These publications document this emerging problem but guide primary care
providers and geriatric mental health providers to recognize symptoms, assess
the nature of the problem and apply the necessary interventions. By providing
evidence and simple clinical approaches, this body of work has changed
the standards of care for addicted older adults and will continue to provide
assistance in relevant medical settings well into the future. I served as the
primary investigator or co-investigator in all of these studies.
a. Gryczynski, J., Shaft, B.M., Merryle, R., & Hunt, M.C. (2002).
Community based participatory research with late-life addicts.
American Journal of Alcohol and Drug Abuse, 15(3), 222-238.
b. Shaft, B.M., Hunt, M.C., Merryle, R., & Venturi, R. (2003). Policy
implications of genetic transmission of alcohol and drug abuse in
female nonusers. International Journal of Drug Policy, 30(5), 46-58.
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c. Hunt, M.C., Marks, A.E., Shaft, B.M., Merryle, R., & Jensen, J.L.
(2004). Early-life family and community characteristics and late-life
substance abuse. Journal of Applied Gerontology, 28(2),26-37.
d. Hunt, M.C., Marks, A.E., Venturi, R., Crenshaw, W. & Ratonian, A.
(2007). Community-based intervention strategies for reducing alcohol
and drug abuse in the elderly. Addiction, 104(9), 1436-1606. PMCID:
PMC9000292
2. In addition to the contributions described above, with a team of collaborators,
I directly documented the effectiveness of various intervention models for older
substance abusers and demonstrated the importance of social support networks.
These studies emphasized contextual factors in the etiology and maintenance
of addictive disorders and the disruptive potential of networks in substance
abuse treatment. This body of work also discusses the prevalence of alcohol,
amphetamine, and opioid abuse in older adults and how networking approaches
can be used to mitigate the effects of these disorders.
a. Hunt, M.C., Merryle, R. & Jensen, J.L. (2005). The effect of social
support networks on morbidity among elderly substance abusers.
Journal of the American Geriatrics Society, 57(4), 15-23.
b Hunt, M.C., Pour, B., Marks, A.E., Merryle, R. & Jensen, J.L. (2005).
Aging out of methadone treatment. American Journal of Alcohol and
Drug Abuse, 15(6), 134-149.
c. Merryle, R. & Hunt, M.C. (2007). Randomized clinical trial of
cotinine in older nicotine addicts. Age and Ageing, 38(2), 9-23. PMCID:
PMC9002364.
3. Methadone maintenance has been used to treat narcotics addicts for many years
but I led research that has shown that over the long-term, those in methadone
treatment view themselves negatively and they gradually begin to view
treatment as an intrusion into normal life. Elderly narcotics users were shown
in carefully constructed ethnographic studies to be especially responsive
to tailored social support networks that allow them to eventually reduce their
maintenance doses and move into other forms of therapy. These studies also
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Chapter 2: Summarizing Your Project and Your Qualifications
demonstrate the policy and commercial implications associated with these
findings.
a. Hunt, M.C. & Jensen, J.L. (2003). Morbidity among elderly substance
abusers. Journal of the Geriatrics, 60(4), 45-61.
b. Hunt, M.C. & Pour, B. (2004). Methadone treatment and personal
assessment. Journal Drug Abuse, 45(5), 15-26.
c. Merryle, R. & Hunt, M.C. (2005). The use of various nicotine delivery
systems by older nicotine addicts. Journal of Ageing, 54(1), 24-41.
PMCID: PMC9112304
d. Hunt, M.C., Jensen, J.L. & Merryle, R. (2008). The aging addict:
ethnographic profiles of the elderly drug user. NY, NY: W. W. Norton &
Company.
Complete List of Published Work in My Bibliography: http://www.ncbi.nlm.nih.
gov/sites/myncbi/collections/public/1PgT7IEFIAJBtGMRDdWFmjWAO/?sort=dat
e&direction=ascending
When writing this section, keep the following in mind:
• What do you consider your most significant contributions to science? This can
be contributions to science in general, to a specific scientific discipline, or a
combination.
• The background for the scientific question or problem you are highlighting in
each contribution
• A recap of the critical findings for each
• How these findings were used to guide future progress in addressing healthrelated problems or advancing technology
• What was your specific role in the described work?
Sections A, B, and D, (Personal Statement, Positions and Honors, and Research
Support, respectively) have remained the same.
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Chapter 2: Summarizing Your Project and Your Qualifications
Research Support
In this section, list any ongoing and completed projects which received funding
from outside of your company. This is typically limited to federal sources for an
SBIR application, since non-federal sources of funding (i.e. private foundations)
for small companies is generally scarce. Do not include any research and
development contract work funded by another company.
Begin with any projects that are most relevant to the current application and
indicate their overall goals in addition to the responsibilities of the Senior/Key
Personnel involved in the current proposal. This section, however, is not the place
to detail the personnel time and effort or the direct costs. “Research Support” and
“Other Support” are different and not interchangeable. The Biosketch’s Research
Support section highlights your scientific accomplishments and your role in selected
awards. This information will be used by reviewers to assess each individual’s
qualifications for a specific role in the project, as well as their roles within the
research group.
The Other Support section includes information required for all applications
that are selected to receive awards. NIH staff will request complete and up-todate Other Support information from awarded researchers after peer review and
then check this information to make certain that the proposed research has not
already been federally funded.
NIH provides the following example of the Research Support portion of the
Biosketch:
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D. Research Support
Ongoing Research Support
R01 DA942367-03
Hunt (PI)
09/01/08-08/31/13
Health trajectories and behavioral interventions among older substance abusers
The goal of this study is to compare the effects of two substance abuse
interventions on health outcomes in an urban population of older opiate addicts.
Role: PI
R01 MH922731-05
Merryle (PI)
12/15/07-11/30/12
Physical disability, depression and substance abuse in the elderly
The goal of this study is to identify disability and depression trajectories and
demographic factors associated with substance abuse in an independently-living
elderly population.
Role: Co-Investigator
Faculty Resources Grant, Washington University
08/15/09-08/14/11
Opiate Addiction Database
The goal of this project is to create an integrated database of demographic,
social and biomedical information for homeless opiate abusers in two urban
Missouri locations, using a number of state and local data sources.
Completed Research Support
K02 AG442898
Hunt (PI)
02/01/02-01/31/05
Drug Abuse in the Elderly
Independent Scientist Award: to develop a drug addiction research program with
a focus on substance abuse among the elderly.
Role: PI
R21 AA998075
Hunt (PI)
01/01/02-12/31/04
Community-based intervention for alcohol abuse
The goal of this project was to assess a community-based strategy for reducing
alcohol abuse among older individuals.
Role: PI
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Letters of Support (e.g., Consultants)
Directly from the SBIR/STTR SF424 (R&R) Adobe Forms Version B
Application Guide:
Attach all appropriate letters of support, including any letters necessary to
demonstrate the support of consortium participants and collaborators such as
Senior/Key Personnel and Other Significant Contributors included in the grant
application. Letters are not required for personnel (such as research assistants)
not contributing in a substantive, measurable way to the scientific development or
execution of the project. Letters should stipulate expectations for co-authorship,
and whether cell lines, samples or other resources promised in the letter are freely
available to other investigators in the scientific community or will be provided to
the particular investigators only. For consultants, letters should include rate/charge
for consulting services and level of effort/number of hours per year anticipated.
In addition, letters ensuring access to core facilities and resources should stipulate
whether access will be provided as a fee-for-service. Do not place these letters
in the Appendix. Consultant biographical sketches should be in the Biographical
Sketch section.
Phase I, Phase II, Phase IIB, and Fast-Track SBIR/STTR Applications:
Involvement of consultants and collaborators in the planning and research stages
of the project is permitted. Include with the application letters from each individual
and/or collaborator confirming their role(s) in the project. Following is guidance
for such documentation: The letter(s) should be prepared on the consultant or
collaborator’s letterhead and addressed to the Small Business Concern (SBC). One
page is recommended.
At a minimum, each consultant and collaborator letter should (1) verify their
commitment to the project; (2) refer to the specific project by name, acknowledging
the PD/PI as the lead on the project; and (3) specify what services /tasks the
consultant or collaborator will contribute (e.g. expertise, number of hours/ percent
of effort, summary of tasks to be completed). For consultants, the letter should also
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include the rate/charge for consulting services. Also include biographical sketches
for each consultant.
For STTR projects, the single “partnering” research institution must provide
a letter to the applicant small business concern certifying that at least 30% of the
work of the STTR project will be performed by the research institution.
Letters of interest from potential commercial partners or investors and letters
of commitment of funds or other resources that will enhance the likelihood of
commercialization should be placed following the letters of support for consultants
and collaborators.
What this means:
Letters of support from consultants will fill in any capability gaps that may
exist in your Biographical Sketch. Since these letters do not fall within the
application page limitations, you are free to include as many as you feel are
necessary. You will need a strong, specific letter of support from that individual,
or a representative from a collaborating company, declaring exactly what will
be provided to the project and demonstrating enthusiasm for it. It works to
your advantage if you can write a draft for each consultant to review and sign,
after making sure you determine what aspects of your proposal would be most
interesting and relevant to each of your consultants. No one knows your grant
application strategy better than you do. Describing to your consultant precisely
what your needs are and what you need them to cover can be challenging and take
up a lot of time. If you draft it for them, you can get what you need in a timely
fashion, since editing your letter is much easier than having them craft it from
scratch. Remember to make each of your supporting letters look different.
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Tips to Writing Strong Letters of Support
When you write a letter of support, here are a few tips to keep in mind:
• Clearly define duties and timelines. Be specific with your expectations
and any deadlines. This will sidestep any confusion between you and the
consultant. Be sure that the letter draws the reviewer’s attention to you, the
applicant, and what you have achieved relevant to the SBIR requirements.
• Write it from the consultant’s point of view. Craft each letter as if the
consultant wrote it, tailoring it to their specific duties. Use unique language
for each consultant letter.
• Display enthusiasm. The letter needs to effectively communicate
the consultant’s enthusiasm for the project. This can be achieved by
summarizing specifics like resource and time commitment, as well as
interest in the project’s details.
• Get the standard details correct. Address the letter according to the
REMEMBER:
Letters of support
from consultants
will fill in any capability gaps that may
exist in you Biographical Sketch.
grant’s guidelines. The final written version needs to be on the consultant’s
letterhead and it needs to be signed.
A suggested structure for these letters is as follows:
• Statement of support — Using no more than three sentences, demonstrate
enthusiasm and identify the specific project by name.
• Supporting paragraphs — Describe how the consultant’s expertise and
technical skills will support the applicant. Detail the consultant’s relevant
experience and past performance on similar projects. If there has been a
previous working relationship, describe the project and the results. Lastly,
explain specific responsibilities.
• Cordial closing — The closing’s formality will depend on the relationship
between the applicant and the consultant who is supporting them. If the two
have a previous productive working relationship, it can be less formal. If
that relationship is more limited, the closing should be more formal.
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Multiple Program Directors/Principle Investigators
Taken from the SBIR/STTR SF424 (R&R) Adobe Forms Version B Application
Guide :
Multiple PD/PI Leadership Plan
For applications designating multiple PD/PIs, a leadership plan must be
included. For applications designating multiple PD/PIs, all such individuals
must be assigned the PD/PI role on the Senior/Key Profile form, even those at
organizations other than the applicant organization. A rationale for choosing a
multiple PD/PI approach should be described. The governance and organizational
structure of the leadership team and the research project should be described,
including communication plans, process for making decisions on scientific
direction, and procedures for resolving conflicts. The roles and administrative,
technical, and scientific responsibilities for the project or program should be
delineated for the PD/PIs and other collaborators. Do not submit a leadership plan
if you are not submitting a Multiple PD/PI application.
If budget allocation is planned, the distribution of resources to specific
components of the project or the individual PD/PIs should be delineated in the
Leadership Plan. In the event of an award, the requested allocations may be
reflected in a footnote on the Notice of Grant Award.
What this means:
While there is no page limit on this document, it should include the following:
A. The reason for choosing a multiple PD/PI approach to lead the proposed
research.
B. The governance and organization structure of the leadership team and
the research project, including:
• Communication plans;
• Process for making decisions regarding scientific direction; and
• Procedures for resolving conflict.
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C. The roles and administrative, technical and scientific responsibilities
for the project or program for each of the PDs/PIs and other
collaborators.
If you have planned the budget allocation, your Leadership Plan should detail
resource distribution to specific project components or individual PDs/PIs.
NIH offers the following examples of Leadership Plans, noting that
applications should follow any special instructions offered by individual ICOs:
Example 1
Principal Investigator #1 and Principal Investigator #2 will provide oversight
of the entire Program and development and implementation of all policies,
procedures and processes. In these roles, PI#1 and PI#2 will be responsible for the
implementation of the Scientific Agenda, the Leadership Plan and the specific aims
and ensure that systems are in place to guarantee institutional compliance with US
laws, DHHS and NIH policies including biosafety, human and animal research,
data and facilities.
Specifically, PI#1 will oversee aim 1 and be responsible for all animal research
approvals. PI#2 is responsible for aims 2, 3, and 4 including the implementation
of all human subjects research and approvals. PI#1 will serve as contact PI
and will assume fiscal and administrative management including maintaining
communication among PI s and key personnel through monthly meetings. He will
be responsible for communication with NIH and submission of annual reports. The
responsibilities of the contact PI will be rotated to PI #2 in even years of the grant
award. Publication authorship will be based on the relative scientific contributions
of the PIs and key personnel.
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Example 2
Principal Investigator #1 at Institution A will be responsible for the oversight
and coordination of project management for aim 1 involving the molecular design
and production of vectors expressing tumor specific antigens. Principal Investigator
#2 at Institution B will be responsible for aims 2 and 3 including the in vivo and in
vitro testing of vaccines. Each PI will be responsible for his own fiscal and research
administration.
The PIs will communicate weekly, either by phone, e-mail, or in person, to
discuss experimental design, data analysis, and all administrative responsibilities.
All PIs will share their respective research results with other PIs, key personnel,
and consultants. They will work together to discuss any changes in the direction of
the research projects and the reprogramming of funds, if necessary. A publication
policy will be established based on the relative scientific contributions of the PIs
and key personnel.
PI#1 will serve as contact PI and be responsible for submission of progress
reports to NIH and all communication.
Intellectual Property
The Technology Transfer Offices at Institutions A and B will be responsible for
preparing and negotiating an agreement for the conduct of the research, including
any intellectual property. An Intellectual Property Committee composed of
representatives from each institution that is part of the grant award, will be formed
to work together to ensure the intellectually property developed by the PIs is
protected according to the policies established in the agreement.
Conflict Resolution
If a potential conflict develops, the PIs shall meet and attempt to resolve the
dispute. If they fail to resolve the dispute, the disagreement shall be referred to an
arbitration committee consisting of one impartial senior executive from each PI’s
institution and a third impartial senior executive mutually agreed upon by both PIs.
No members of the arbitration committee will be directly involved in the research
grant or disagreement.
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Change in PI Location
If a PI moves to a new institution, attempts will be made to transfer the
relevant portion of the grant to the new institution. In the event that a PI cannot
carry out his/her duties, a new PI will be recruited as a replacement at one of the
participating institutions.
Example 3
Principal Investigator #1, Principal Investigator #2, and Principal Investigator
#3 will serve as PIs for the project. PI#1 will be responsible for the gene
expression studies. He will supervise Technician #1 for all microarrays. PI#2
will be responsible for the endothelial cell studies and flow cytometry studies
proposed in the grant. She will supervise the Technician #2 at 50% effort for the
flow cytometry studies and the post Doc for the endothelial cell studies. PI#3 will
oversee all bioinformatics work in the gene expression and flow cytometry studies
and will work with PI#1 and PI#2 on all data analysis.
The PIs will form a Steering Committee (membership may include PIs, key
personnel, consultants, etc.) that will manage the oversight and coordination of
project management, research administration, publications and data sharing, and
integration of all resources needed for the project. The Institution will subdivide
the award funds and each PI will be responsible for his own budget.
The Steering Committee will oversee decisions on minor changes in research
direction and have the authority to reallocate funds and resources between
PIs. PI#1 will serve as Chair of the Steering Committee and be responsible
for communication among PIs, including meeting schedules and agendas.
The position of Chair will rotate among the PIs on a yearly basis. PI#2 will
be designated the contact PI and be responsible for submitting all necessary
documents to NIH, including IRB approvals, and annual progress reports.
Intellectual Property
The PIs will grant necessary access rights to the pre-existing patents and or
the patents potentially generated within the frame of this project for the purpose
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of this research project to all the other PIs and key personnel on a non-exclusive
royalty-free basis. Each PI shall take appropriate measures to ensure that he/she can
grant these access rights. Right in any pre-existing intellectual property will remain
the property of the party that created and/or controls it.
Conflict Resolution
If a potential conflict develops, the appropriate Departmental administrators
representing the PIs shall meet and attempt in good faith to settle any dispute,
claim or controversy arising out of or relating to the interpretation, performance
or breach of this disagreement. However, if the Departmental administrators fail
to resolve the disagreement within thirty business days, then such disagreement
shall be referred for resolution to a designated senior executive of the parties who
has the authority to settle the disagreement but who is not directly involved in the
disagreement.
Change in PI Location
If one of the PIs moves to a new institution, attempts will be made to transfer
the relevant portion of the grant to the new institution. In the event that a PI cannot
carry out his/her duties, a new PI will be recruited as a replacement, subject to the
approval of the Steering Committee and the Institution.
CONCLUSION
Clear, focused, and enthusiastic writing of your abstract will be the hook to
get the reviewers interested in reading your proposal. Your Biographic Sketch will
be the place where the reviewers will make their determination of whether or not
you have the background, ability, and expertise to accomplish the research and
development goal you propose. These sections have limited space with which you
can get your points across to prove that your proposal is worth funding. Use these
sections to help the reviewer become your ally. n
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Chapter 3: Small Company Resources and Commitment
Chapter 3:
Small Company Resources and Commitment
Reviewers will pay close attention to the environment in which you plan to
execute the research and development proposal. They need to determine that
you will have adequate resources, in terms of company support, equipment, and
physical items needed to successfully complete the work. This section of the grant
will be scored and is arguably the easiest section to receive a high mark in. Any
unique features of your scientific environment or consulting and collaborative
arrangements will benefit your project. These elements are detailed in the Facilities
and Other Resources and Equipment sections of the application.
Showcase Your Facilities and Other Resources
Taken directly from the SBIR/STTR SF424 (R&R) Adobe Forms Version B
Application Guide:
Facilities & Other Resources
This information is used to assess the capability of the organizational
resources available to perform the effort proposed. Identify the facilities to be used
(Laboratory, Animal, Computer, Office, Clinical and Other). If appropriate, indicate
their capacities, pertinent capabilities, relative proximity and extent of availability
to the project. Describe only those resources that are directly applicable to the
proposed work. Provide any information describing the Other Resources available
to the project (e.g., machine shop, electronic shop) and the extent to which they
would be available to the project.
The research to be performed by the applicant small business concern and its
collaborators must be in United States facilities (i.e., foreign sites must be approved
by the funding officer) that are available to and under the control of each party for
the conduct of each party’s portion of the proposed project.
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No special form is required but this section must be completed and attached
for submissions to NIH and other PHS agencies unless otherwise noted in an
FOA. Describe how the scientific environment in which the research will be
done contributes to the probability of success (e.g., institutional support, physical
TIP:
Reviewers will pay
close attention to
the environment in
which you plan
to execute the
research and
development proposal; any unique
features of your
scientific environment or consulting
and collaborative
arrangements will
benefit your project.
resources, and intellectual rapport). In describing the scientific environment in
which the work will be done, discuss ways in which the proposed studies will
benefit from unique features of the scientific environment or subject populations or
will employ useful collaborative arrangements.
For Early Stage Investigators, describe institutional investment in the success
of the investigator, e.g., resources for classes, travel, training; collegial support
such as career enrichment programs, assistance and guidance in the supervision of
trainees involved with the ESI’s project, and availability of organized peer groups;
logistical support such as administrative management and oversight and best
practices training; and financial support such as protected time for research with
salary support.
If there are multiple performance sites, describe the resources available at each site.
Describe any special facilities used for working with biohazards or other
potentially dangerous substances. Note: Information about select agents must be
described in the Research Plan, Section 11 (Select Agent Research).
What this means:
As you compose the Facilities and Other Resources section, keep these
questions in mind:
1. What facilities will you be using? Break this question into subheadings and
describe the capacities (including square footage), relevant capabilities,
proximity and extent of availability of each to your project:
• Laboratory
• Clinical
• Animal
• Computer
• Office
• Other, such as machine shop, electronic shop, etc.
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2. How do you see this environment promoting your success? This section
is also best described using subheadings. Explain how your work will
benefit from any unique features of the scientific environment, subject
populations, and useful collaborative arrangement:
• Institutional support
• Physical resources
• Intellectual support
3. If your research and development will be performed at more than one site,
include a description of the available resources at each site.
4. Provide information on any special facilities you plan to use for working
with biohazards or other potentially dangerous substances. If you are
working with something classified as a Select Agent, make sure to describe
any special facilities used for working with these materials. Here, you list
any unique features, which may include the following:
• A distinctive set of technical capabilities
• Access to an unusual human populations for tissue or blood samples
• The collaborative nature of interactions between you and your
consultants
• Emphasis in a particular area, such as high-throughput screening
This section has a two-fold purpose; by informing reviewers how your
institution will support your proposed project, it also underscores your
qualifications as the best person to conduct this research and development project.
While there is no limitation on this section’s length, make sure the information you
provide only relates to your available facilities and resources. Elements you should
consider including, if applicable to your project, are:
• A description of any collaborations that you may have with colleagues
within the company who can impact your research and development
project; intellectual support is invaluable.
• Matching the budget request section of the proposal with the Facilities and
Other Resources section.
• Leveraging appropriate adjectives when describing your resources, such as
“cutting- edge technology”, “state-of-the-art equipment”, “centralized core
TIP:
While there is no
limitation on this
section’s length,
make sure the
information you
provide only relates
to your available
facilities and
resources.
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For projects involving live vertebrate animals, your company must ensure that
all Project/Performance Sites hold an OLAW-approved Animal Welfare Assurance.
In the likely event that your company does not have an animal facility on-site,
and the animal work will be conducted at an institution with an Animal Welfare
Assurance, you must obtain an Inter-institutional Assurance from OLAW prior to
an award.
List Your Available Equipment
Here is an example of a Facilities and Other Resources section from a successful
SBIR Phase I grant application:
Facilities and Other Resources available at [Company Name].
The laboratory for [Company Name] is located in [City and State] in close
proximity to [Academic and Commercial Institutions] and other research institutions
facilitating collaborative efforts and exchange of expertise. The laboratory facilities
occupy 2600 square feet and contain all the necessary equipment for tissue culture,
biochemistry, and molecular biology including: positive pressure HEPA filtered air
system, chemical fume hood, 7, 6 foot laminar flow biological safety cabinets, 2, 4
foot laminar flow biological safety cabinets, 11 CO2 cell incubators, 5 Zeiss inverted
microscopes, a Leica DM IRB fluorescence microscope, an Agilent 2100 Bioanalyzer,
and a Nanodrop ND-1000 spectrophotometer. The laboratory is also equipped with
a BD FACSCalibur flow cytometer with cell sorting capabilities, an Accuri C6 flow
cytometer, 2 COBE Cell Processors, Kodak imaging system, 4 microplate readers,
2 CBS isothermal V-3000 liquid nitrogen vapor storage systems with automatic fill/
monitoring, and 6 additional liquid phase cryogenic storage containers.
[Company Name] is also equipped for laboratory automation with a Matrix
PlateMate 2x3 workstation, 2 Multidrop 384 machines, an AutoMACS Pro Cell
Separator, and a Biotek ELx405 Cell Washer. Our scientists are skilled in the use of
robotics to miniaturize cell based assays to 384-well format for compound screening.
We have successfully incorporated robotics into our contract assay services and have
processed tens of thousands of compounds through our human primary cell based
systems.
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Other Equipment Available for use includes a BioRad ChemiDoc, a Shimadzu
Prominence HPLC system, a Flexcell FX5000 Tension system, 2 refrigerated ultra
centrifuges, 3 refrigerated table top centrifuges, 3 balances, an ABI 7900HT real time
PCR machine, an Eppendorf Mastercycler PCR machine, Perkin Elmer scintillation
counter/luminometer, an MVE Cryogenics CRF2000 liquid nitrogen step down
freezer.
Additional equipment includes refrigeration, freezers, 3 -80°C freezers, a radiation
license, and back-up power capable of running all systems.
The equipment listed is also utilized for [Company Name] other manufacturing
and production activities. However, there is ample time available for the equipment to
be used on this project.
[Company Name] has office and meeting room space of approximately 2600
square feet. Finance personnel have managed Phase I and Phase II SBIR grants in
addition to over $15 million in financial transactions over the company’s history.
In this particular case, the writer chose not to use subheadings, and instead used
a more integrated prose, while still describing the laboratory space and the available
equipment. While there is no special form required by the agency for this document,
the following outline may be helpful in your own writing process. In fact, you may
find that subheadings are again useful in organizing the requested information, whose
content is based on the information asked for by the SBIR program:
• Company: Describe the general scientific environment in which you will
carry out your research and development work, and how your company will
contribute to successful outcomes.
• Research Population: If you are using tissue or blood specimens from human
subjects, include this section and describe how your research and development
will benefit from the subject populations.
• Research Facilities: Signify how your company’s resources will support your
proposed research and development. Convey any specific divisions that will
be available, such as a machine shop, electronic shop, etc., and the extent to
which they will be available. If there are multiple research sites, describe the
resources available at each site.
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• Biohazard Facility: If your project involves the use of biohazards or other
potentially dangerous substances, you must describe any special facilities for
working with them.
• Collaborative Arrangements/Intellectual Connection: Detail any
collaborative relationships with your company colleagues and consultants
• Company Support: As discussed previously, indicating your company’s
support for you and your research and development efforts is key for
reviewers, and you should use this section for this purpose.
• Laboratory: Explain your laboratory space, including the location(s), number
of rooms, dimensions and equipment available.
• Animal: If your work will involve test animals, use this section to note
AAALAC accreditation or, if that is lacking, provide information regarding
animal care resources.
• Computer: Here, you should indicate the computers, databases, servers and
other data storage/computing equipment available for your project.
• Office: Will office space be provided by your company for you and your
consultants? If yes, provide a brief description, including location(s), number
of office(s) and square footage.
Resources Sharing Plan
Taken directly from the SBIR/STTR SF424 (R&R) Adobe Forms Version B
Application Guide:
NIH considers the sharing of unique research resources developed through
NIH-sponsored research an important means to enhance the value and further the
advancement of the research. When resources have been developed with NIH funds
and the associated research findings published or provided to NIH, it is important
that they be made readily available for research purposes to qualified individuals
within the scientific community. See Part III, 1.5 Sharing Research Resources.
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Supplemental Instructions:
1. Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-03-032.html. Data Sharing Plan: Investigators seeking
$500,000 or more in direct costs (exclusive of consortium F&A) in any
year are expected to include a brief 1-paragraph description of how final
research data will be shared, or explain why data-sharing is not possible
(for example human subject concerns, the Small Business Innovation
Development Act provisions, etc.). Specific funding opportunity
announcements may require that all applications include this information
regardless of the dollar level. Applicants are encouraged to read the specific
opportunity carefully and discuss their data-sharing plan with their program
contact at the time they negotiate an agreement with the Institute/Center
(IC) staff to accept assignment of their application. See Data-Sharing Policy
or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
2. Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
Sharing Model Organisms: Regardless of the amount requested, all
applications where the development of model organisms is anticipated
are expected to include a description of a specific plan for sharing and
distributing unique model organisms or state why such sharing is restricted
or not possible. See Sharing Model Organisms Policy, and NIH Guide
NOT-OD-04-042.
3. Genome Wide Association Studies (GWAS): Applicants seeking funding
for a genome-wide association study are expected to provide a plan for
submission of GWAS data to the NIH-designated GWAS data repository, or
an appropriate explanation why submission to the repository is not possible.
GWAS is defined as any study of genetic variation across the entire genome
that is designed to identify genetic associations with observable traits (such
as blood pressure or weight) or the presence or absence of a disease or
condition. For further information see Policy for Sharing of Data Obtained
in NIH Supported or Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088, and http://gds.nih.gov/.
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What this means:
These are separate documents that you upload as part of your application, but
they do not count toward the application page limit. The reviewers will comment
on your resource sharing plans; if you argue that your resources should not be
shared, they will scrutinize any rationale you propose as well.
As a small business, the specific nature of the data you collect will determine
TIP:
As a small business, specific
nature of the data
you collect will
determine whether
or not you decide
to share the final
dataset. If the final
data are not open
to sharing, if they
are proprietary for
instance, then you
need to explain this
in your application.
whether or not you decide to share the final dataset. If the final data are not open to
sharing, if they are proprietary for instance, then you need to explain this in your
application. Under the Small Business Act, SBIR awardees may withhold their
data for four years after the end of the award. The Small Business Act provides
authority for NIH to protect from disclosure and nongovernmental use of all SBIR
data developed from work performed under an SBIR funding agreement for a
period of four years after the closeout of either a Phase I or Phase II grant, unless
NIH obtains permission from the awardee to disclose these data. The data rights
protection period lapses only upon expiration of the protection period applicable to
the SBIR award, or by agreement between the small business concern and NIH.
Here is an example of a Data Sharing Plan from a funded SBIR Phase I
application:
Data sharing and other inventions that are developed as part of NIH-funded
research work will be assessed on a case-by-case basis to determine the best
strategy possible in order to meet the NIH guidelines for sharing of research tools.
If intellectual property protection is not appropriate, data will be shared
with the research community at the end of the project period through several
mechanisms, which could include NIH-based sites and mechanisms to promote
sharing of inventions and technologies. Additionally, we will publish results in
peer-reviewed journals, present our findings at research conferences.
Where it is appropriate to proceed with patent protection for the development
of a research tool as a potential product for sale and distribution to the research
community, such protection will be pursued. Following appropriate protection, the
data will be shared with the research community as described above. Licensing
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of inventions to a manufacturer or distributor for the further development of a
research tool is consistent with the goals of the Bayh-Dole Act and might be
most appropriate. If so, once proper protection of intellectual property rights has
occurred, sharing detailed information and other inventions with the research
community will be implemented in a timely manner.
[Award Company Name] and [Collaborating Company Name] internal
monitoring of all intellectual property and material transfer activities includes
oversight of potential relationships with third-parties interested in commercializing
biomaterials or other research tools from NIH-funded research. As a result,
the possibility of inappropriate “reach-through” requirements regarding the
transfer of biomaterials that might be encouraged by for-profit third-parties and
are addressed at the outset of negotiations. These third-parties are informed
that such requirements are inconsistent with NIH-funded research tools and are
not appropriate as part of any research, material transfer, or commercialization
agreements involving these biomaterials or research tools.
As this example illustrates, protecting the small business’s intellectual
property position is of paramount importance, and is a legitimate reason for not
sharing data until this protection has been realized. Unless you are absolutely
certain that you will have data to share, it may be best to take the position of
assessing the work “on a case-by-case basis to determine the best strategy
possible in order to meet the NIH guidelines for sharing of research tools”, as in
the above example. Remember, if you do submit a data-sharing plan, the agency
will expect you to follow through with that plan. Failure to comply may result in
unpleasant consequences for you and your small company, as the NIH, and perhaps
the SBA, will act to protect their interests.
If you do decide to provide a plan, the precise content will be dependent upon
the type of data you generate and how you plan to share it. For example, your datasharing plan might be as simple as describing:
• Anticipated data-sharing schedule
• Final format of the data
REMEMBER:
Remember, if you
do submit a datasharing plan, the
agency will expect you to follow
through with that
plan. Failure to
comply may result in unpleasant
consequences for
you and your small
company, as the
NIH, and perhaps
the SBA, will act to
protect their
interests.
• Documentation to be shared
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• Any analytic tools
• A brief description of the data-share agreement, if needed
• Mode of data sharing.
Model Organisms and GWAS
Model organisms are defined as new, genetically modified organisms developed
for research. In these organisms, genetic modifications include those which have
been induced by chemicals, irradiation, transposons or transgenesis, as well as
spontaneous mutations and congenic or consomic strains. They may be shared as
mature organisms, sperm, eggs, embryos or vectors used to generate transgenic or
knockout organisms. Model organisms can include mammalian models, such as
mice and rats, and non-mammalian models, like budding yeast, social amoebae,
roundworm, Arabidopsis, fruit fly, zebra fish and frog. The NIH provides examples
of model organisms on the Model Organism for Biomedical Research Web site at
www.nih.gov/science/models.
A genome-wide association study (GWAS) involves scanning markers across
the complete sets of DNA of multiple individuals looking for genetic variations
which can be associated with a particular disease state. Upon identification of
new genetic associations, the information can be used to develop more effective
strategies to detect, treat and prevent the disease. Such studies are extremely
valuable in elucidating genetic variations contributing to common, complex
diseases including asthma, cancer, diabetes, heart disease and mental illnesses.
This same rationale for your Data Sharing Plan is applicable for both the
Sharing Model Organisms Plan and the Genome Wide Association Studies
(GWAS) requirement; state in your application that you will assess the work on
a case-by-case-basis and decide the best course or action to meet the agency’s
sharing guidelines.
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CONCLUSION
The facilities in which you will perform your research and development
studies is one of the core criteria that reviewers will use to assess your SBIR grant
application. As such, do not skimp on your discussion in your Facilities and Other
Resources section. While important, providing merely a list of lab equipment and
supplies that you will have access to is not sufficient. You also have to convince
the reviewers that your small business supports you and your research and
development endeavors. With regards to the agency requirement for you to disclose
plans for data, model organisms and GWAS sharing, the plans you put forth will be
part of the materials reviewers will examine and use to evaluate your application.
Describe these plans carefully, especially if you chose not to initially share your
data, as is the case for many small businesses. n
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Chapter 4: Describing Your Proposed Research
Chapter 4:
Describing Your Proposed Research
There is perhaps nothing more important to your SBIR application than
describing your proposed research and development project. This information
will be conveyed to the reviewers in both the Specific Aims and Research
Strategy sections of the application. It is in these sections that you will address the
Significance and Innovation of your project, as well as the Approach you will take
REMEMBER:
towards successfully achieving the project’s objectives. These three criteria are
Goals are strategic and high-level
views, objectives
are mid-level
views, and aims are
close-up views.
included in the five that will be used to score your application.
To put a finer point on this, we are specifically referring to the Specific
Aims and Research Strategy sections. They address your project’s Significance,
Innovation and Approach, which are three of the five scored grant criteria that
reviewers will use to grade your application (the other two being the Investigator(s)
and environment, covered in the previous chapter). Your application’s Impact Score
will depend heavily on how the reviewers perceive your specific aims and research
strategy. While there is no specific section or template to detail the overall impact
of your proposal, the agency wants you to clearly describe your project’s “impact”
as you see fit. In this chapter, we will examine how you can use the Specific
Aims and Research Strategy sections to satisfy the Significance, Innovation, and
Approach criteria, as well as support the Overall Impact of your research and
development.
While composing these sections, be conscious of your use of the words “goals”,
“objectives” and “aims”. Goals are strategic and high-level views. For instance,
“The overall goal of this research is to evaluate the effect of chemical toxicants
on viability, proliferation, and differentiation of ECFCs derived from different
individuals.” Objectives are more mid-level views, and will address a more focused
aspect of the goal, such as, “to delineate the pathway and functional role of TAK1
in ECFC differentiation.” Finally, Aims are close-up views, and will outline
your tactical approach towards the work to be performed. For example, “Aim 1:
To analyze the dose-effect relationship between toxicants and ECFC’s viability,
proliferation, and differentiation.”
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The Specific Aims Section
Taken directly from SF424 (R&R) SBIR/STTR Application Guide for NIH and
Other PHS Agencies (updated November 1, 2013):
Specific Aims
The Specific Aims attachment is required unless otherwise specified in the
FOA.
Phase I Applications: State the specific objectives of the Phase I research and
development effort, including the technical questions you will try to answer to
determine the Phase I feasibility of the proposed approach and the impact that the
results of the proposed research will exert on the research field(s) involved. State
concisely and realistically what the proposed research is intended to accomplish
in terms of its potential for technological innovation and commercial application.
Define the proposed product, process or service to ultimately be developed. Include
milestones for each of the aims as these will be used in the evaluation process.
What this means:
In this section, the FOA directs that you should briefly list the specific
objectives of your research and development, which may include:
• Solving a specific technical challenge
• Addressing an unmet commercial need
• Developing new technology
• Developing a new commercial product
Milestones are stages in the project at which something is completed, usually
a key deliverable; they mark an important decision point which can affect the
future course of the project. Think of them as a pausing point in the project where
you will make an assessment of what has been accomplished and determine if any
adjustments need to be made to your overall project plan.
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Reviewers tend to look more favorably upon a smaller focused project than
they do upon a larger spread-out project. If they like what they see, they will most
likely read the rest of the proposal for details to support their initial impression
and you will have a chance at being funded. If they do not like what they see, they
will perhaps look for flaws in the remaining document to justify their negative
impression, thus putting you out of funding consideration.
Keep in mind that the Specific Aims section will quite likely be the only section
that others in the study section will look at to grasp your Approach, Innovation,
and Overall Impact. While not your primary reviewers, giving the other members
of your study section a favorable view of your project may help sway a funding
decision during their discussions. The Specific Aims is a one-page document that
you will upload in the Research Plan Attachments area of the application.
Pitfalls to Steer Clear Of
REMEMBER:
Milestones are
pausing points in
the project where
you will make an
assessment of
what has been
accomplished and
determine if any
adjustments need
to be made to your
overall project plan.
With so much riding on the Specific Aims section, two common pitfalls that
you should work toward avoiding are as follows:
1. What if your reviewer likes your Specific Aims but is on the fence
regarding their enthusiasm for the project? More than likely they will read
the remainder of the application and come to a conclusion regarding the
project’s feasibility. Assuming they decide that it is indeed feasible, they
will next look to the impact of the project – so spell it out for them; if
they have to work to find it, their enthusiasm may diminish. For example,
“This proposal describes an approach to the discovery of new drugs with
novel chemistries that will activate AMPK and modulate cellular energy
utilization for the treatment of metabolic disease”.
2. What if reviewers see the aims as interdependent, and are left with the
impression that if Aim 1 doesn’t work, then Aim 2 is also a bust? The best
grant applications are those with interconnected — but not interdependent
— aims. Reviewers look for those experiments where the results do not
particularly matter because the various outcomes are equally interesting.
Thus, your aims should be interconnected but not dependent on the
successful outcome of another aim.
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EXAMPLE:
• Bad– Aim 2 cannot proceed until the studies in Aim 1 are completed.
• Good– Aim 2 proceeds in parallel with Aim 1 and findings from Aim 1
TIP:
Avoid interdependent specific aims
at all costs.
might direct future studies in Aim 2 or possibly Aim 3.
Crafting Your Specific Aims
While there is no rule on how many specific aims your proposal can or should
have, given the maximum award length of one year for a Phase I SBIR award,
2-3 specific aims seems to be the popular number for many applicants. Some
applications will have four. A word of caution: four specific aims may be viewed
as not feasible within the time period of the award. In addition, space limitations
TIP:
Two or three
specific aims is
about all that may
be accomplished in
the 6-12 month time
frame of a Phase I
SBIR.
will not easily permit you to convincingly describe four aims, leading the reviewers
to suspect that you have not fully developed your plan. The Specific Aims will
comprise the bulk of your research and development plan; think of them as the
power source for your proposal.
Advice from Someone on the Inside
Dr. Gregory Milman, NIAID, has made several presentations to help businesses
successfully compete for SBIR and STTR awards. For the specific aims section, he
suggests the following:
Begin your Specific Aims section with a paragraph briefly describing the
problem and why it is significant. Then, briefly describe the current status
of solutions and unmet public health needs. Check the ICO’s WebPages for
background information that may help you.
Describe your product in the next paragraph. Hypothesize why your product is
an innovative solution to the problem.
Present your Specific Aims in bullet format. Describe two to four measurable
Specific Aims for Phase I research and for each, the criteria by which success will
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be judged. Make your Specific Aims “end points” as opposed to a “best effort.”
Your Specific Aims may be milestones, or if appropriate, each of your Specific
Aims may be subdivided into milestones.
A review committee should easily be able to determine if your Specific Aims
have been achieved and agree that successfully accomplishing them justifies
Phase II funding. Propose a timeline for achieving your Specific Aims in table or
graphic format. Do not propose more work than reviewers would think reasonable
to achieve in Phase I. Estimate the additional time and funding necessary to bring
your product to market after the completion of Phase I.
Example from a Funded Phase I Application
Keep in mind that as originally submitted, this section takes up just one page:
A. Specific Aims
The majority of breast cancers originate in the lobular or ductal cells of the
milk-producing glands. In these structures, there are two main cell types: the
inner luminal cells surrounded by basal myoepithelium. These cell types are the
precursors to various forms of breast cancer making it important to study them
independently and in co-culture systems. Current methods for culturing human
mammary epithelial cells select for those of a basal phenotype. Thus, there are no
commercial sources of quality-controlled, matched basal and luminal cells (from
individual donors) in the U.S. forcing researchers to isolate and characterize the
cells on their own. This process is time consuming, requires access to human
tissue, and introduces variation in the preparation and characterization of the cells.
Primary cultured human mammary-derived cells are an ideal model currently used
to investigate the genesis and understanding of human breast cancer. Currently
there is no consistent commercial source of primary human cultured breast-derived
luminal and basal cells.
[Company Name] will address this need by providing a well characterized
system to the research community. [Company Name] is a small biotechnology
company that specializes in providing primary human cells and support products
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to researchers worldwide. The company is uniquely positioned to undertake this
project with an already well-established breast tissue procurement network and
twelve-plus years of human primary cell isolation experience. [Company Name] is
a leading commercial source for human primary cell systems and has the existing
infrastructure to successfully bring new products to the market. Phase I of this
proposal is focused on optimizing the isolation, propagation, and characterization
of primary human luminal and basal epithelium cells from breast tissue to
establish a robust primary cell product. Extensions of this product and further
characterization of the cells will be undertaken in Phase II resulting in additional
products and services provided by [Company Name].
The goal of this proposal is to solicit SBIR Phase I funding to commercially
provide quality controlled human primary cells to the breast cancer research
community in a cost effective manner. Accordingly, the Specific Aims of this
project are:
1. Identify an effective method for isolation of primary luminal and basal
cells from human breast tissue. This will involve assessment of two
contemporary approaches for establishing luminal and basal cell cultures.
Several biomarkers specific for luminal or basal cells will be used to
determine cell purity. We will also employ a trans-differentiation assay as
an additional index of specific cellular activity. The main criteria will be a
method that can reproducibly provide homogeneous cell populations while
maintaining sufficient cell yields for commercialization.
2. Optimize growth conditions during initial expansion phase. From our
experience in commercial development of primary cell lines, at least 20 x
106 cells per tissue isolation (after the second passage) are required. While
our preliminary data suggest this can be accomplished we would like to
further optimize the conditions during the initial propagation and expansion
phase in order to increase initial yields while minimizing the number of
passages.
3. Determine lifespan of basal and luminal cells in culture and optimize
freezing and storage conditions. In order to provide a quality commercially
available primary cell line we will need to determine the lifespan of the
luminal and basal cell lines in culture. In addition, we will also establish
optimal conditions for cryopreservation.
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Successful completion of Phase I will generate standard operating procedures
required to provide well characterized human primary breast-derived basal and
luminal cells and support products to researchers in a variety of areas. This will
provide a platform with which to further investigate the mechanisms that lead to
the formation of breast tumors as well as for use in drug screening programs.
Research Strategy
Taken directly from SF424 (R&R) SBIR/STTR Application Guide for NIH and
Other PHS Agencies (updated November 1, 2013):
Organize the Research Strategy in the specified order and using the instructions
provided below. Start each section with the appropriate section heading –
Significance, Innovation, Approach. Cite published experimental details in the
Research Strategy section and provide the full reference in the Bibliography and
References Cited section (Part I Section 4.4.9).
Follow the page limits for the Research Strategy in the table of page limits
(Table 2.6-1), unless specified otherwise in the FOA. Note that the page limit for
this attachment will be validated as a single file.
(a) Significance
• Explain the importance of the problem or critical barrier to progress in the
field that the proposed project addresses.
• Explain how the proposed project will improve scientific knowledge,
technical capability, and/or clinical practice in one or more broad fields.
• Describe how the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field will be changed if the
proposed aims are achieved.
• Explain the project’s potential to lead to a marketable product, process or
service.
• For Phase II, Fast-Track, and Phase IIB Competing Renewals, explain
how the commercialization plan demonstrates a high probability of
commercialization.
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(b) Innovation
• Explain how the application challenges and seeks to shift current research
or clinical practice paradigms.
• Describe any novel theoretical concepts, approaches or methodologies,
instrumentation or interventions to be developed or used, and any advantage
over existing methodologies, instrumentation, or interventions.
• Explain any refinements, improvements, or new applications of theoretical
concepts, approaches or methodologies, instrumentation, or interventions.
(c) Approach
• Describe the overall strategy, methodology, and analyses to be used to
accomplish the specific aims of the project. Provide a tentative sequence or
timetable for the project. Unless addressed separately in Item 15 (Resource
Sharing Plan), include how the data will be collected, analyzed, and
interpreted as well as any resource sharing plans as appropriate.
• Discuss potential problems, alternative strategies, and benchmarks for
success anticipated to achieve the aims.
• If the project is in the early stages of development, describe any strategy to
establish feasibility, and address the management of any high risk aspects of
the proposed work.
• Point out any procedures, situations, or materials that may be hazardous to
personnel and precautions to be exercised. A full discussion on the use of
select agents should appear in Item 11, below.
• If research on Human Embryonic Stem Cells (hESCs) is proposed but
an approved cell line from the NIH hESC Registry cannot be identified,
provide a strong justification for why an appropriate cell line cannot be
chosen from the Registry at this time.
If an applicant has multiple Specific Aims, then the applicant may address
Significance, Innovation and Approach for each Specific Aim individually, or
may address Significance, Innovation and Approach for all of the Specific Aims
collectively.
As applicable, also include the following information as part of the
Research Strategy, keeping within the three sections listed above: Significance,
Innovation, and Approach.
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Preliminary Studies for Phase I Applications: Preliminary data are not
required for Phase I applications; however, such results may assist reviewers in
assessing the likelihood of success of the proposed project and may be included in
the Research Strategy section.
What this means:
Your 6-page Research Strategy section will have three main parts:
1. Significance
2.Innovation
3.Approach
These correspond to three primary criteria reviewers use to evaluate and
score your proposal, and you should begin each section with the corresponding
subheading.
In addition, although not required for submission, your Research Strategy
should also include a Preliminary Studies section. You can address this by
including the appropriate subheading — Preliminary Studies - within one of the
main sections listed above.
Preliminary data may best be placed at the end of the Approach section, as this
serves as a good segue into the description of how you will address the specific
aims. Wherever you decide to include your preliminary data, reviewers seem to
prefer these data being in a separate, headed section. If you feel that, while you are
describing a specific aim in the Specific Aim Section you need to disclose some
preliminary data to make your point, you can always reference the specific aim in
the separate, headed, preliminary data section.
You may find that you need more room for one section over another, and must
take the needed space from another section. When making this choice, remember
that your Approach and Significance sections often make up the heart and soul of
your proposal, so you may not want to take space from them.
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Significance
Dr. Gregory Milman, NIAID, suggests the following:
Describe the significance of the public health problem. My advice is to appeal
to reviewers by focusing on a single disease even if your technology has multiple
applications. Describe the number and composition of the population affected.
Give references to supporting statistical data. Provide background on the current
solutions to the problem, their limitations, and the discoveries needed. Show
reviewers you know the field by the breadth of your knowledge of both published
and unpublished work by others, some of whom could be your reviewers.
Here is an example from a funded Phase I SBIR, illustrating Dr. Milman’s
points:
Significance
A decline in the quality of skeletal muscle tissue and its capacity for
regeneration is prevalent in the aging population and in a number of specific
diseases [1-2]. This is usually accompanied by replacement of muscle tissue with
adipose and fibrous tissues. The resulting decrease in muscle function is associated
with an increase in the number of falls and injury, loss of independence and a
reduced quality of life [3]. This leads to a health care burden in the aged population
reported to cost $18.5 billion in the year 2000. By the year 2025, the Census
Bureau estimates an 80% increase in the geriatric population [4]. Currently, there
are no small molecule therapeutics that target skeletal muscle maintenance or
regeneration.
In addition to sarcopenia associated with aging, there are a number of other
specific diseases that have muscle wasting as part of their pathophysiology. COPD
is among the most prominent followed by cachexia, end-stage renal disease and
disuse atrophy [5-8]; all of which would benefit from new medicines that improve
skeletal muscle function. There is a major unmet medical need to keep the elderly
independent from nursing homes or other caretakers and, importantly, able to
function in a positive manner that contributes to society rather than being a burden.
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A major factor that promotes this is the physical ability to independently manage
one’s day-to-day activities. Overall, novel therapies that can improve or extend the
health of muscle tissue will be essential to extend the productive life of seniors.
It is clear that aging has a significant effect on the ability of satellite cells to
regenerate, and this serves as an appropriate model system with which to apply
a drug discovery program. The majority of data accumulated to date that address
potential mechanisms by which aging alters satellite cell growth are derived
from rodent studies. Based on these studies, proposed mechanisms leading to a
decline in satellite cell regenerative capacity fall into two major categories. First,
age-associated changes in the stem cell niche (i.e. local environment) have been
shown to be responsible for the decline in cell growth. Second, other studies have
shown that changes develop in the aged cell itself. Interestingly, this change can
be reversed by (poorly characterized) circulating factors from young animals [910]. Our preliminary data are supportive of this hypothesis and show that there is a
difference in proliferative capacity between satellite cells isolated from young and
elderly human skeletal muscle biopsies. These results are also in agreement with
those from a recent publication [11]. Our studies will provide additional insight
into the age-dependent mechanisms that reduce satellite cell proliferative activity,
as well as establish a human cell-based system that can be applied to a high
throughput drug discovery program.
Be aware that reviewers do use this section to guide them in assigning your
application to an institute for possible funding; the words you choose in describing
this section will affect that assignment decision. You may also consider writing the
Approach section before facing the Significance section, because you will have a
TIP:
Be aware that reviewers do use this
section to guide
them in assigning
your application to
an institute for possible funding; the
words you choose
in describing this
section will affect
that assignment
decision.
clearer overall picture of your proposal if you do so in this order.
Significance is Not the Same as Impact
Direct from NIH:
Significance: Does the project address an important problem or critical barrier
to progress in the field? If the aims of the project are achieved, how will scientific
knowledge, technical capability, and/or clinical practice be improved? How will
successful completion of the aims change the concepts, methods, technologies,
treatments, services, or preventative interventions that drive this field?
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Overall Impact: Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a sustained, powerful
influence on the research field(s) involved, in consideration of the following five core
review criteria, and additional review criteria (as applicable for the project proposed).
What this means:
In short, if the project is worth doing, then it is “significance”; what the agency
gets in return for its monetary investment is the “impact.”
The NIH also provides the following details for clarification:
Significance is one of the five scored review criteria. It is only one of the
elements that will be taken into consideration when deciding the Overall Impact of
the application.
Significance:
• Is used for applications for research grants and cooperative agreements,
among other programs.
• Is evaluated and scored independently of the evaluation and scoring of
investigator(s), innovation, approach and environment.
• Assumes that the “aims of the project are achieved” and/or will be
“successfully completed.”
• Reviewers should evaluate the significance of the project within the context
of a (research) field(s). For example, autism is a significant field of study
but not all studies (projects) of autism are significant.
• Research field(s) may vary widely, so reviewers should identify in their
reviews the research field(s) within which the project addresses an
important problem or critical barrier to progress.
• For more guidance on Impact and Significance, refer to Guide Notice
NOT-OD-09-025 and the Overall Impact versus Significance document.
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Overall Impact
• Takes into consideration, but is distinct from, the core review criteria
(significance, investigator(s), innovation, approach and environment).
• Is not an additional review criterion.
• Is not necessarily the arithmetic mean of the scores for the five scored
review criteria.
• Is the synthesis/integration of the five core review criteria that are scored
individually and the additional review criteria, which are not scored
individually.
Writing Your Significance Section
Make sure that you use plain, uncomplicated language when you write; the
reviewer needs to be told upfront what you are going to attain that is different. Keep
these questions in mind while composing this section:
1. Why are the results from my studies so important?
2. How will this work change the field?
3. Will patient lives be saved, or their quality of life made better? If yes, how?
4. Will this work lead to better treatment strategies?
When composing your Significance section, you should be able to describe all of
your main points in 3-4 four paragraphs. The following are examples from funded
SBIR awards:
1. Introduction to the problem: “Metabolic diseases such as type 2 diabetes
(T2D), obesity and their related co-morbidities have reached epidemic proportions
worldwide. According to a statement from the Centers for Disease Control, if
current trends continue, as many as 1 in 3 adults are predicted to have diabetes by
2050. A significant component in this predicted value is related to the increase in
the prevalence of obesity. Diabetes and obesity are already an enormous burden
to our healthcare system. While progress continues to be made into the molecular
mechanisms involved in both obesity and T2D, the identification and development
of safe, efficacious therapeutic modalities is significantly limited. This is exemplified
by the fact that two-thirds of patients receiving medication for T2D in the US and
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Europe do not achieve their therapeutic goals (1-3). Similarly there are no effective
drug treatments for obesity. There is an urgent need for innovative medicines to
combat both obesity and diabetes”.
2. Additional background: “AMPK is a key regulator of metabolic activity
in cells. Activation of AMPK drives an increase in fatty acid uptake and oxidation,
glucose uptake and glycolysis, as well as mitochondrial biogenesis (4). In addition,
activation of AMPK reduces fatty acid-, cholesterol- and protein biosynthesis, as
well as switching off gluconeogensis (4, 5). This shift to a catabolic state occurs,
at least in part, in response to raised cellular levels of AMP/ATP in the presence of
LKB1, the protein kinase that phosphorylates and activates AMPK. Metformin, the
most prescribed oral anti-diabetic agent in the US and Europe, works in part through
activation of AMPK (6). However, the efficacy of metformin is limited by low
potency, GI tolerability (~25% of patients stop treatment because of GI disturbance)
and 36% of patients are poor responders because they express a less active form of
the organic cation transporter 1 which transports metformin into hepatocytes (7)”.
3. Describe the approach that will be used: “This proposal describes
an approach to the discovery of new drugs with novel chemistries that will
activate AMPK and modulate cellular energy utilization for the treatment of
metabolic disease. Fyn is a tyrosine protein kinase and has recently been shown to
phosphorylate LKB1 at Y261 and Y365, and to regulate the LKB1-AMPK pathway,
resulting in a major impact on cellular energy metabolism (8, 9). Phosphorylation of
LKB1 blocks its translocation to the cytoplasm, thereby reducing access of LKB1 to
its substrate, AMPK. Thus, phosphorylation of LKB1 effectively inhibits activation
of AMPK by LKB1. Fyn knockout mice (Fyn KO) have been generated (8, 9). These
mice display increased cytoplasmic levels of LKB1 (a constitutively active Ser/
Thr kinase), which then activate AMPK and deliver profound metabolic advantages
of reduced body weight, reduced adiposity and improved insulin sensitivity. When
compared with WT controls, Fyn KO mice had 20% less body weight at birth, which
is maintained at this level throughout life, and which was shown to be a consequence
of reduced white fat. White adipose tissue (WAT) mass was reduced by 70% in
Fyn KO, even when adjusted for body weight. Importantly, Fyn KO mice have the
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hallmarks of increased insulin sensitivity, with reduced fasting plasma levels of
glucose (30%↓) and insulin (60%↓), when compared with WT animals. Furthermore,
glucose excursions following an IPGTT were significantly lower in both Fyn null
mice, and heterozygous (Fyn+/-) mice. This latter finding suggests a gene titration
effect, since the body weight of Fyn+/- mice was only 5% less than WT controls, an
effect that might be mimicked by a 50% pharmacological inhibition of the enzyme.
In addition, fasting plasma triglyceride (TG) and non-esterified fatty acid (NEFA)
levels were reduced by ~40%; this was accompanied by 55-75% reductions of TG
and NEFA levels in tissues. Bastie et al (8) found that Fyn null mice exhibit increased
Akt phosphorylation (2-fold in WAT), a key event in insulin signaling; as well as
increased oxygen consumption (10%) and energy expenditure (40%). Loss of Fyn
resulted in a tissue specific increase in fatty acid uptake (WAT 2-fold and muscle
~1.5-fold) and in fatty acid oxidation (WAT 4-fold and muscle ~2.5-fold). The
authors also established a link between the increased fatty acid oxidation observed in
Fyn KO mice and increased mitochondrial content in WAT, BAT and skeletal muscle,
but not in liver. These data strongly suggest that pharmacological intervention of Fyn
would provide an excellent target for the discovery of novel drugs to treat metabolic
disease. Indeed, Yamada et al (9) have shown that the non-specific Fyn kinase
inhibitor, SU6656, was able to reduce WAT weight in mice following a single 4mg/kg
injection, without affecting lean mass. These findings were consistent with increases
in fatty acid oxidation, energy expenditure and respiratory quotient (RQ) observed
with SU6656. It is also important to note that the reduced RQ in Fyn KO mice is not
reduced further by administration of SU6656”.
4. Emphasize the commercial significance in a broader context: “Diabetes
and obesity major worldwide health issues. Novel, safe and effective treatments are
needed. Recent evidence lends strong support to Fyn kinase as a novel drug target for
metabolic disease. Our phase 1 goal is to identify an effective and highly selective
inhibitor of Fyn kinase. Even as a small biotech company, we realize the enormous
physical and financial effort required to get a small molecule therapy to market. Our
phase 2 efforts will provide additional in vivo data necessary for an initial IND. At
this stage we will identify a larger pharmaceutical partner to help drive additional
pre-clinical and clinical research”.
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Innovation
In the NIH’s instructions to grant writers regarding innovation, they state:
(b) Innovation
• Explain how the application challenges and seeks to shift current research or
clinical practice paradigms.
• Describe any novel theoretical concepts, approaches or methodologies,
instrumentation or intervention(s) to be developed or used, and any advantage
over existing methodologies, instrumentation or intervention(s).
• Explain any refinements, improvements, or new applications of theoretical
concepts, approaches or methodologies, instrumentation or interventions.
It must be appreciated that “innovation” does not necessarily mean “new”. There
are plenty of awarded SBIRs that have taken existing ideas and technology, then
applied them to a different problem that itself was or was not new, and that was
innovative. Innovation solves a problem in a manner that has not been previously
demonstrated. To convince the reviewer that you are breaking new ground, present
your project in the context of what is already known and what the problems are.
Be clear – make your background section brief but concise, state what is new and
revolutionary about your proposal, and use the word “innovative” in your writing.
The bullet points above are good guidelines, you do not have to break the section up
into subheadings. To be confident that you have a thorough Innovation section, make
sure you cover all three points. Here is an example from a funded SBIR grant. Note
that a narrative approach was taken:
“The innovation of the project has both a conceptual and a technical aspect.
Conceptually, the use of autologous cells for regenerative medicine has been
envisioned by others. However, the use of donor-specific cells for multiple cell-based
assays is innovative. The population-based approach in developing the platform for
toxicological testing is also novel. The main technical innovation is the development
of a proprietary cell growth supplement allowing us to derive ECFCs from small
volumes of blood.”
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Remember that what you propose in your application must be possible; being too
creative can make reviewers skeptical. The best way to fend off this skepticism is the
content of your Preliminary Data section, which supports your innovation, and your
track record as a scientist, illustrating that your creativity has paid off. Ultimately,
how your reviewers respond to your Innovation section depends on how much
novelty and risk they are willing to tolerate.
Approach
The Approach section is the heart of your Research Strategy. Here you will
provide the details of your research and development to convince reviewers that you
know what work needs to be done and that you have the resources and expertise to
REMEMBER:
“Innovation” does
not necessarily mean “new”;
innovation solves a
problem in a manner that has not
been previously
demonstrated.
conduct the investigation.
From the NIH Quick Guide to Grant Applications:
Purpose: The purpose of the approach section is to describe how the research
will be carried out. This section is crucial to how favorably an application is
reviewed.
Content: The research design and methods section should include the following:
• PI’s preliminary studies, data, and experience relevant to the application and
the experimental design;
• the overview of the experimental design;
• a description of methods and analyses to be used to accomplish the specific
aims of the project;
• a discussion of potential difficulties and limitations and how these will be
overcome or mitigated;
• expected results, and alternative approaches that will be used if unexpected
results are found;
• a projected sequence or timetable (work plan);
• if the project is in the early stages of development, describe any strategy to
establish feasibility, and address the management of any high risk aspects of
the proposed work;
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• a detailed discussion of the way in which the results will be collected,
analyzed, and interpreted;
• a description of any new methodology used and why it represents an
improvement over the existing ones;
Suggestions
Number the sections in this part of the application to correspond to the numbers
of the Specific Aims.
1. Preliminary data, or a progress report, may be included before the Specific
Aims sections. Alternatively, integrate preliminary data with the methods
description for each Specific Aim. Preliminary data can be an essential part
of a research grant application and helps establish the likelihood of success of
the proposed project.
2. Avoid excessive experimental detail by referring to publications that describe
the methods to be employed. Publications cited should be by the applicants,
if at all possible. Citing someone else’s publication establishes that you know
what method to use, but citing your own (or that of a collaborator) establishes
that the applicant personnel are experienced with the necessary techniques.
3. If relevant, explain why one approach or method will be used in preference to
others. This establishes that the alternatives were not simply overlooked. Give
not only the “how” but the “why.”
4. If employing a complex technology for the first time, take extra care to
demonstrate familiarity with the experimental details and potential pitfalls.
Add a co-investigator or consultant experienced with the technology, if
necessary.
5. Explain how the research data will be collected, analyzed, and interpreted as
well as any resource sharing plans as appropriate.
6. Develop alternative strategies for potential problems.
7. Document proposed collaborations and offers of materials or reagents of
restricted availability with letters from the individuals involved.
8. Point out any procedures, situations, or materials that may be hazardous to
personnel and precautions to be exercised (i.e., use of Select Agents).
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Since the Approach is so vital to your Research Strategy section, you will end
up spending more of your writing time on it compared to the other sections. In turn,
this is the section that reviewers will spend most of their time assessing. Potential
problems, alternative strategies, and milestones are key elements they will be on
the lookout for. Take the time to explain the rationale of each aim, stating why you
are doing it and outlining the experiment related to each one. Including a figure or
a table is a good idea; it will convey to the reviewer a sense of confidence that you
are indeed the expert capable of successfully executing this project Be sure to relate
the different areas of your proposal together, as this will better support your overall
application.
Reviewers want to make sure of the following:
• How thorough were you in thinking through the problem you want to solve?
• What is your first action to deal with the problem you want to solve?
• What is the likelihood that this action will work?
• What are the possible things that could go wrong?
• What is your plan for dealing with things that go wrong?
Keeping these questions in mind, and pre-emptively addressing them in your
writing, should help you to avoid negative impressions from reviewers such as
“applicant is overambitious”, “aims are unfocused”, “inadequate description of
results”, and the ultimate show-stopper, “aims are too risky and not supported”. You
can also use your Approach section to provide details regarding novel aspects of your
work.
Regarding the Research Design section, Dr. Gregory Milman, NIAID, goes on to
say:
The Research Design section of your Research Plan should spell out in detail
what you are going to do, how you are going to do it, and your criteria for success.
Reviewers will use this section to evaluate your approach and innovation. Make it
easy for reviewers by organizing this section by Specific Aims and include a timeline
in table or diagram format to quickly convey your entire project to reviewers.
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Give a rationale for each set of experiments. Convince reviewers that your
methods are appropriate to your Specific Aims. If your methods are innovative,
show how you have changed existing or proven methods while avoiding technical
problems. Provide supporting data and references.
Describe the kinds of results you expect and how they will support continuation
of your project. Present other possible outcomes and contingency plans.
Define the criteria for evaluating the success or failure of each set of experiments.
If possible, include statistical analysis as reviewers are impressed by statistics.
Describe hazards anticipated and precautions you propose. Spell out your sources
of important reagents and equipment, and details of any use of animals or human
subjects. Be sure to follow NIH guidelines.
Explain how credible collaborators will participate in your proposed research
You should include letters that describe collaborators agreements with you,
including their role on the project and hours to be committed.
Here is an example from a funded SBIR Phase I application. This is not a full
section due to its length, but what is excerpted here should give you a feel for the
structure and content. In this case, the applicant has described the overall approach in
the opening paragraph, followed it with preliminary data, and then broke the section
down addressing each Specific Aim. In this example, only two sections of the first
aim are detailed.
Example 1.
Approach
The overall goal of this application is to establish and validate a human satellite
cell system for use in a drug discovery program. These Phase 1 efforts will focus
on enrichment of the satellite cell population, determining assay parameters and
validating the platform by screening a well-annotated chemical library. Successful
completion of these studies will be followed by Phase 2 studies that will focus
on significantly expanding the screening efforts and a more detailed elucidation\
validation of the pathways involved in muscle regeneration. As described in more
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detail below, we have compared the proliferative capacity of satellite cells isolated
from elderly subjects (age 65 – 80) with those obtained from young subjects (age
21-30). Our preliminary data show significant differences between the two groups.
These observations point to a site of action of at least one mechanism to explain,
in part, the differences in regenerative ability between young and elderly muscle
tissue. We expect to better understand these molecular mechanisms in the “older”
cell population by assessing their response to highly annotated agents that have been
shown to act at specific control points in important signaling pathways. Along with
prior knowledge from muscle regeneration studies in rodent models, we should be
able to pinpoint the pathways most suitable for therapeutic intervention. Overall, this
therapeutic area in regenerative medicine is poised for major advancements. A robust
human assay system that can measure the effects of agents on aged skeletal muscle
progenitor cells will be essential in the search for new drugs to treat muscle wasting
conditions.
Aim 1: Optimize the isolation of progenitor satellite cells from human
skeletal muscle and create a cell-based assay system to measure proliferation.
Methods for the isolation of satellite cells. The tissue sources available to
[Company Name] for skeletal muscle biopsies fall into the following categories:
muscle biopsies (vastus lateralis), hernia repair, orthopaedic surgeries (tensor
fasciae), and bariatric surgery (rectus abdominus). For the proposed studies, we will
exclusively use vastus lateralis. The first step in the procedure to isolate the cells will
be conducted as described by Blau and Webster [17] and modified by [Company
Name] (see Preliminary Data). The muscle tissue is placed in Hank’s Balanced Salt
solution……….. The satellite cell population will be enriched by using anti-CD56
coated magnetic beads (Miltenyi Biotec). Our preliminary data suggest this approach
will be adequate. However, if we find inconsistencies an alternative approach would
include high speed FACS. We have access to and have used the fee-for-service FACS
core located at NCSU. Both magnetic bead and FACS technologies have been used to
enrich the satellite cell population in rodent and human muscle preparations [19-20].
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Analysis of satellite cell growth. Using the isolation procedures described
above, the satellite cells from both young and old donors displayed greater than
90% purity. As shown in Table 2, an increase in the doubling time was observed
with satellite cells from old subjects when compared to cells from young subjects.
These preliminary data are highly suggestive that a difference exists in proliferative
capacity between satellite cells isolated from young vs. elderly donors, and that this
defect would most likely be a component in the overall mechanism responsible for
decreased skeletal muscle regeneration in elderly subjects. These data were obtained
using the CellTiter-Blue assay. While this is an effective method it does not allow
us to analyze the potential effects of test agents on commitment of the satellite cells
to myoblast differentiation. Thus we will employ high throughput cell imaging that
allows us to directly count live cells, and concomitantly analyze transitional states
of cell commitment to differentiation (see below) in one assay platform. [Company
Name] is a biotech company offering high throughput cell imaging hardware,
software and services. We have previously worked with [Dr. PM] in successfully
establishing imaging solutions for human adipocytes [14]. Under the current proposal
we will extend our collaboration (see letter of support) with [Company Name] to
utilize their systems for assessing cell growth and satellite cell commitment. As
described in detail above in Preliminary Results, the automated microscopy will
be used for counting cells positive for DAPI staining as well as specific antibody
staining. In brief, following incubation with test agents (see Aim 2) the cells will
be fixed and stained with DAPI. Imaging of the stained cells is performed using a
Beckman Coulter IC1000 image cytometer with a 10x objective and a digital camera
using 2x2 binning [14]. Multiple images will be taken per well and then stitched
together using Vala’s CytSeer software. The same software determines the number
of positively stained nuclei per well using a specific counting algorithm. This high
content screening application can acquire images from 140,000 wells/day; reading
over 350 384-well plates.
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As can be seen from the example above, this applicant included Preliminary
Data, which was included immediately after the paragraph explaining the overall
approach, just before diving into the Specific Aims. Dr. Gregory Milman, NIAID,
who has made several presentations to help businesses successfully compete for
SBIR and STTR awards, offers another suggestion for the Approach section:
Although the SBIR/STTR solicitation states that “Preliminary data are not
required,” most applications include preliminary data. Review committees are
likely to have greater enthusiasm for proposals with good preliminary data. Poorly
presented or poorly interpreted preliminary data can hurt your score.
Include preliminary studies that support the feasibility of your project. They may
consist of your own publications and those of others, as well as unpublished data
from your laboratory. To improve your “Investigator” score, emphasize work you
have accomplished that indicates you can direct the proposed research and achieve
your Specific Aims. Interpret results critically and evaluate alternative meanings
but do not over interpret. You can be assured that critical members of the review
committee will look for explanations other than the ones you propose.
The preliminary studies section of your Research Plan should convince reviewers
TIP:
Although not
required, review
committees are
likely to have
greater enthusiasm
for proposals that
include good preliminary data.
that your approach could work. Reviewers may also use your work described in this
section to assess the investigator criterion.
Be aware that the Phase I progress report in your Phase II application will list the
milestones proposed and achieved in Phase I.
What this means:
Include preliminary data. More than likely you will be fighting a losing battle to
convince the reviewers that you have something worth funding if you do not show
them anything to support your approach.
Here is an example of Preliminary Data from the same grant example above:
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Preliminary Data.
Enrichment of CD56+ cells. Based on modifications of our existing protocols
[12], we have established procedures to enrich the isolation of satellite cells from
skeletal muscle tissue. In this procedure, one gram of skeletal muscle tissue was used
as a source of CD56+ satellite cells. The donor tissue is washed, minced, and digested
with 0.2% trypsin / 0.1% collagenase in HBSS + 1% BSA. Following digestion, the
liberated cells are pelleted by centrifugation, washed extensively and resuspended
in a minimal amount of PBS/BSA and blocked with human FcR blocking reagent
(Miltenyi Biotec). After a round of filtration to remove any remaining cellular debris,
the single cell suspension is incubated with a mouse monoclonal anti-CD56. A
separate small aliquot of the cell suspension is incubated in parallel with mouse IgG
as a control. Following incubation at 4°C, unbound antibody is removed by washing
and rat antimouse IgG-coupled magnetic Microbeads (Miltenyi Biotec) are added to
the cell suspensions. After a brief incubation, the microbeads are isolated by magnetic
separation and washed following manufacturer’s protocols. CD56+ cells are retained
on the beads and washed as the unbound cells passed through the separation column.
Retained cells are collected by removing the magnetic field and resuspending in PBS/
BSA. Following a typical isolation, 1-2% of the total cell population in the tissue
digest can be specifically isolated by the CD56 antibody under these conditions
(Table 1).
Table 1. CD56+ Cell Enrichment
115 Skeletal Muscle Tissue in Grams
1.0 g
Total cells liberated by enzymatic digestion
~10 million
Cells specifically isolated using CD56 antibody
176,000
Percent CD56+ population
1-2%
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As per Dr. Milner’s suggestion regarding a timeline in a table format, an example
is provided below:
Timeline:
Study Event
Month 1-2
Protocol Set up
X
Month 3-9
Experiments
Month 6-11
Month 9-12
X
Data Analysis
X
Report
Preparation
X
Overall Impact Ties Everything Together
Taken from NOT-OD-09-025:
• Overall Impact is the synthesis/integration of the five core review criteria
that are scored individual and the additional review criteria which are not
scored individually.
• To evaluate, the reviewer(s) make an assessment of the likelihood for the
project to exert a sustained, powerful influence on the research field(s)
involved, in consideration of the scored review criteria, and additional
review criteria (as applicable for the project proposed).
o Likelihood (i.e., probability) is primarily derived from the investigator(s), approach and environment criteria.
o Sustained powerful influence is primarily derived from the significance
and innovation criteria.
o Research field(s) may vary widely, so it would be helpful if reviewers
identify in their reviews the research field(s) they believe will be
influenced by each project.
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What this means:
Reviewers have been tasked to determine the probability that the experiments you
propose will succeed. If they do not succeed, there will be no impact, regardless of
whether the research is highly significant.
The NIH provides the following case study to illustrate the difference between
Significance and Overall Impact:
Case Study #1:
An investigator proposes using a novel method of viral vector-mediated siRNA
delivery to knock-down the gene for a particular CNS receptor subtype in specific
brain regions he/she hypothesizes to be involved in cognitive aspects of a rare mental
illness. He/she proposes to use this method to examine disruption of this receptor
subtype on cognitive performance in three animal models of the illness.
Scenario 1:
A. Reviewer 1 is an expert on research of the rare mental illness. He argues that
the PI has previously confirmed the proposed hypothesis using pharmacological
and genetic approaches. This reviewer felt that the successful accomplishment of
the proposed aims would very minimally advance knowledge in the field of study
devoted to the rare mental illness. Thus, Reviewer 1 feels the application is of low
significance. Reviewer 1 notes that the proposed method is highly innovative, that the
models used are appropriate, and that the investigator and environment are strong.
Nevertheless, in light of the low Significance of the proposal, Reviewer 1 feels the
Overall Impact would be modest and scores accordingly.
B. Reviewer 2 is an expert on viral vector-mediated siRNA delivery methods.
He disagrees that the project’s significance is low. He concedes that the proposed
hypothesis has already been confirmed in the investigator’s previous work. He
argues, however, that the proposed technique is highly innovative and if successful,
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has the potential not only to transform the way scientists manipulate receptor
function in the laboratory, but also has potential to provide the foundation for
clinical application for many diseases. He suggests that the proposed replication
of previous findings is actually a strength because it would confirm the successful
implementation of the highly innovative methods. Thus, on the basis of the work’s
potential to transform technical capability and shape clinical practice in the future,
Reviewer 2 argues that the application has high Significance. On the basis of high
Significance and strengths in the other review criteria, Reviewer 2 believes the
Overall Impact should be rated as high.
Scenario 2:
Both reviewers agree that the application addresses an important problem and
that the hypothesis and methods are highly innovative. They believe that if the
proposed aims were achieved, the project would significantly advance knowledge
in the field and promote substantially new research directions in research on the
rare mental illness as well as the broader field of mental health. Therefore, they rate
Significance as high. They have strong reservations, however, about the application
relative to other review criteria. The investigator and his/her colleagues do not appear
to have the relevant training and expertise to successfully accomplish the work and
there are some flaws in the approach that may reflect their inexperience with critical
methods. Therefore, they rate the Overall Impact as moderate.
There is no set or standard rule that reviewers use to equate your individual
criterion scores to your overall impact score. It is likely that each reviewer will rate
each criterion somewhat differently. Your impact score can be based almost entirely
on your experimental approach, or on Innovation and Significance, it all depends on
the reviewer’s preferences.
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Impact Should ‘Come Through’ When Reading the Proposal
Impact should be clearly described throughout the application. Use whatever
terms are relevant to your proposed project. Reviewers want to be sure that you
are tackling an opportune and critical problem that can be completed in the time
TIP:
period of the award with the available resources and those requested. You might
You might want to
include an “impact
statement” somewhere in each of
the five scored
criteria sections.
want to include an “impact statement” somewhere in each of the five scored
criteria sections. For example, in the innovative section, for developing a new drug
delivery device, you may say “To our knowledge, this device has not been used as
a means to promote the transient, non-invasive, and targeted delivery of therapeutic
compounds in human patients. Using localized/site-directed treatment, as described
in this proposal, there is an extraordinary opportunity to control biodistribution and
enhance the effect of chemotherapeutic drugs by increasing tissue penetration and
subsequent cell permeability”.
Likewise, the Project Summary/Abstract section is also a good place, since it
is one of the first elements of your application reviewers will read. For example:
“Successful completion of these specific aims will establish proof-of concept
to justify moving forward with the design and manufacture of a novel drug
delivery device for the clinic, capable of locally directing biodistribution of cellimpermeable molecules to tumor areas.”
Bibliography and References
Directly from SF424 (R&R) SBIR/STTR Application Guide for NIH and Other
PHS Agencies (updated November 1, 2013):
Bibliography & References Cited
Provide a bibliography of any references cited in the Project Narrative. Each
reference must include the names of all authors (in the same sequence in which
they appear in the publication), the article and journal title, book title, volume
number, page numbers, and year of publication. Include only bibliographic
citations. Applicants should be especially careful to follow scholarly practices in
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providing citations for source materials relied upon when preparing any section of
the application.
Unless otherwise noted in an FOA, this section is required for submissions to
NIH and other PHS agencies. This section (formerly “Literature Cited”) should
include any references cited in the PHS 398 Research Plan form (see Section
5.4 for details on completing that form). When citing articles that fall under the
Public Access Policy, were authored or co-authored by the applicant and arose
from NIH support, provide the NIH Manuscript Submission reference number
(e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g.,
PMCID234567) for each article. If the PMCID is not yet available because the
Journal submits articles directly to PMC on behalf of their authors, indicate “PMC
Journal – In Process.” A list of these journals is posted at:
http://publicaccess.nih.gov/submit_process_journals.htm.
Citations that are not covered by the Public Access Policy, but are publicly
available in a free, online format may include URLs or PubMed ID (PMID)
numbers along with the full reference (note that copies of publicly available
publications are not accepted as appendix material). The references should be
limited to relevant and current literature. While there is not a page limitation, it is
important to be concise and to select only those literature references pertinent to
the proposed research.
What this means:
Full references are provided so that reviewers can access them on online. Do not
include any copies of publications whether they are available on line or not; Phase I
SBIR applications are not to include appended materials unless specifically asked for
by the agency.
Here is an abbreviated example of a Bibliography from a funded SBIR
application:
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1. Bauer, J.M. and C.C. Sieber, Sarcopenia and frailty: a clinician’s controversial
point of view. Exp Gerontol, 2008. 43(7): p. 674-8.
2. Morley, J.E., D.R. Thomas, and M.M. Wilson, Cachexia: pathophysiology
and clinical relevance. Am J Clin Nutr, 2006. 83(4): p. 735-43.
3. Rantanen, T., R. Sakari-Rantala, and E. Heikkinen, Muscle strength before
and mortality after a bone fracture in older people. Scand J Med Sci Sports,
2002. 12(5): p. 296-300.
4. Janssen, I., et al., The healthcare costs of sarcopenia in the United States. J
Am Geriatr Soc, 2004. 52(1): p. 80-5.
5. Inui, A., Cancer anorexia-cachexia syndrome: current issues in research and
management. CA Cancer J Clin, 2002. 52(2): p. 72-91.
6. McKinnell, I.W. and M.A. Rudnicki, Molecular mechanisms of muscle
atrophy. Cell, 2004. 119(7): p. 907-10.
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CONCLUSION
Take the time and effort needed to write the Research Strategy section of
your proposal. Significance, Innovation and Approach are all scored criteria the
reviewers will use to decide the fundability of your project and its value to your
scientific field, technology development, and commercialization. In addition, your
project’s Overall Impact score will likely depend heavily on what you write in
these sections. n
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Chapter 5: Special Considerations
Chapter 5:
Special Considerations
The SBIR program does not generally support human clinical studies, especially
in a Phase I application. Exceptions to this generality may be found in funding
opportunity announcements, and even then funding for clinical studies is usually
restricted to Phase II projects, nonetheless, your project may still involve samples or
data from human subjects. If so, you must inform the agency by completing specific
portions of the application regarding this use. Similarly, if your work involves the
use of vertebrate animals, in this case as actual test subjects or as a source of tissue
samples, there are a different set of forms that need to be filled out. Both you and
your company must assure the NIH that human and animal test subjects will be
protected. NIH cannot award any grant until such assurances are on file with the
REMEMBER:
The SBIR program
does not generally support human
clinical studies.
agency.
In reading over the guidelines, it seems apparent that they were developed with
academic institutions in mind. This makes sense, as most of the extramural NIH
funding awards are made to academic scientists. Unlike large universities, small
companies eligible for the SBIR program seldom if ever have the resources to
conduct human clinical studies on their own; they would subcontract that work to
another vendor, perhaps even a university. The same holds true for animal studies;
the expense and infrastructure involved to have an animal facility is almost always
too steep for a small company to invest resources in, so this work would be
contracted out. Nonetheless, any company engaged in non-exempt human subjects
research conducted or supported by the NIH must submit a written assurance of
compliance to the Office of Human Research Protections (OHRP). The Federalwide
Assurance (FWA) is the only type of assurance of compliance accepted and approved
by OHRP. (See http://www.hhs.gov/ohrp for further information.) If your project
includes vertebrate animal work at a subcontractor site, and the subcontractor
has an Institutional Animal Care and Use Committee (IACUC) approval for the
animal work, you will need an Interinstitutional Agreement before an award can
be made. The NIH’s Office of Laboratory Animal Welfare (OLAW) negotiates
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Interinstitutional Agreement Assurances of Compliance when an awardee institution,
in this case your company, without an animal care and use program will rely on a
research partner to conduct the animal work. This agreement insures that all involved
parties are aware of their responsibilities regarding animal use and proper procedures
are followed.
This chapter will cover your responsibilities with respect to informing the agency
about your use of human subjects and vertebrate animals. As mentioned above, since
SBIR awards do not support clinical trials, the main purpose for the human subjects’
forms in the application, what you have to provide to the agency for an SBIR is
abbreviated compared to other NIH grant applications. The same is true for SBIR
projects that propose to use vertebrate animals.
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Human Subjects
According to the DHHS IRB Guidebook, conducting a controlled study involving
human subjects, designed to evaluate prospectively the safety and effectiveness of
new drugs or devices or of behavioral interventions, is a clinical trial. Regarding
human subjects, the Code of Federal Regulations (45 CFR 46.102(f) states “Human
subject means a living individual about whom an investigator (whether professional
or student) conducting research obtains:
(1) data through intervention or interaction with the individual, or
(2) identifiable private information.” (45 CFR 46.102(f))
What it means:
Intervention includes both physical procedures by which data are gathered (for
example, venipuncture) and manipulations of the subject or the subject’s environment
that are performed for research purposes. Interaction includes communication or
interpersonal contact between investigator and subject. Private information includes
information about behavior that occurs in a context in which an individual can
reasonably expect that no observation or recording is taking place, and information
which has been provided for specific purposes by an individual and which the
individual can reasonably expect will not be made public (for example, a medical
record). Private information must be individually identifiable (i.e., the identity of the
subject is or may readily be ascertained by the investigator or associated with the
information) in order for obtaining the information to constitute research involving
human subjects.
What is meant by “publicly available sources”?
This language in the regulation was intended to apply to public sources of data,
such as census data. Its meaning with respect to human tissue specimens is widely
debated, and to date there is no firm position by the agency. This question comes
about because there are organizations that make human cells and tissues broadly
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accessible to the research community, yet these materials are not usually available to
the public at large and are not generally considered to be publicly available.
Deciding Whether You Have Human Subjects in Your Research
Plan or Not
Supplemental SF-424 (R&R) Instructions for Preparing the Human Subjects
Section of the Research Plan provides the following scenarios, and how to address
them in the application:
Scenario A. No Human Subjects Research
If no human subjects research is proposed in the application, you will have
designated No in Item 1 on the SF424 R&R Other Project Information page.
If your proposed research involves the use of human data and/or biological
specimens, you must provide a justification for your claim that no human subjects
are involved in the Protection of Human Subjects section of the Research Plan. See
the instructions for Scenario A. Unless you are providing a special justification as
described above, no additional information is necessary if no human subjects are
involved.
What it means:
(Instructions for Scenario A) If you are planning on using human data or human
tissue, you need to provide a justification as to why you state that no human subjects
are involved. The justification could include a description of the source of the data/
biological specimens; whether any intervention or interaction with the subjects took
place by you to obtain the specimens and data; what identifiers will be associated
and who will have access to them; the role(s) of providers of the data/biological
specimens in the proposed research; and the manner by which the privacy of research
participants and confidentiality of data will be protected.
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Research that does not involve intervention or interaction with living individuals,
or identifiable private information, is not human subjects research.
Research involving the use of coded private information or biological specimens
may not constitute human subjects research if the conditions of the OHRP Guidance
on Research Involving Coded Private Information or Biological Specimens have
been met (http://www.hhs.gov/ohrp/policy/cdebiol.html), whereby access to this
private information is controlled and secure.
Research that only proposes the use of cadaver specimens is not human subjects
research because human subjects are defined as “living individuals.” The use of
cadaver specimens is not regulated by 45 CFR part 46, but may be governed by other
REMEMBER:
Federal, State or local laws.
Research that only
proposes the use of
cadaver specimens
is not human subjects research because human subjects are defined as
“living individuals.”
This scenario seems to be the most common one for SBIRs, involving tissue
samples or data from a third party, not the awardee. In such cases, the third party
has to assure you, the awardee that human subjects are not involved, based on the
agency’s definition above. However, it is still your responsibility as the awardee to
verify this information that no human subjects are involved.
Scenario B. Non-Exempt Human Subjects Research
If research involving human subjects is anticipated to take place under the award,
you will have designated Yes in Item 1 on the SF424 R&R Other Project Information
page and entered your OHRP assurance number in Item 1a. In the Protection
of Human Subjects section of the Research Plan, you must provide sufficient
information for reviewers to determine that the proposed research meets (1) the
requirements of the DHHS regulations to protect human subjects from research risks
(45 CFR part 46), and (2) the requirements of PHS policies on inclusion of women,
minorities, and children. See the instructions for Scenario B.
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What it means:
(Instructions for Scenario B). In the application narrative, provide the required
information for each of the following topics below.
• Protections of Human Subjects
• Inclusion of Women and Minorities
• Targeted/Planned Enrollment
• Inclusion of Children
If your project involves collaborating sites or subprojects, this information needs
to be included for each participating site.
Clinical studies fall under this category, and remember, the SBIR program does
not generally support clinical studies. However, your proposed project may meet the
NIH definition of “Clinical Research”:
Research with human subjects that is:
1. Patient-oriented research. Research conducted with human subjects (or on
material of human origin such as tissues, specimens, and cognitive phenomena) for
which an investigator (or colleague) directly interacts with human subjects. Excluded
from this definition are in vitro studies that utilize human tissues that cannot be linked
to a living individual. It includes:
• mechanisms of human disease
• therapeutic interventions
• clinical trials
• development of new technologies
2. Epidemiological and behavioral studies.
3. Outcomes research and health services research.
Studies falling under 45 CFR part 46.101(b) (4) (Exemption 4) are not considered
clinical research by this definition.
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If your work falls into this category, below is an example from a funded SBIR on
how to address the requested information:
Protection of Human Subjects
1. RISKS TO THE SUBJECT
A. Human Subjects Involvement and Characteristics
• When subjects undergo elective surgery they will be asked if a small sample
of breast tissue removed during the course of the surgery could be used in
this study. If they say yes and sign the consent form, the sample is removed,
placed in a container and relevant medical information such as type of
surgery, patient demographics, current medications, and medical history is
included with the sample. The patient has no further involvement with the PI
or any part of this study. No information about the patient’s identity is passed
to the PI by the surgeon. At no time is information such as case numbers,
social security numbers, insurance information, names, or addresses passed
on to the PI. The PI can in no way contact the patient, request additional
information from the patient, or interact with the patient in any way.
• The subject population will be drawn from subjects undergoing volunteer
surgery. We anticipate that over the period of research a minimum of 30
subjects will be involved. The age range is difficult to predict though we
will be accepting tissue from patients as young as 18. We anticipate the age
characteristics to closely mirror those that we have received over a randomly
selected 4 months in 2004. They are: age range 21-66 with a mean age of
42.65 modal age of 40 and median age of 41 with 51 samples from females
and 15 samples from males. Of those samples, 3 were African American, 2
were Hispanic, 3 were unknown, and 58 were Caucasian. The health status is
variable and may be influenced by being obese.
• All patients who are undergoing elective surgery with our participating
surgery groups will be given the opportunity to participate in this study.
People under the age of 18 are excluded as explained in the inclusion
of children section below. Additionally, we will remove tissue that tests
positive for HIV1, HIV 2, HTLV 1, HTLV 2, HBV, or HVC. The reason for
excluding these patients is the unknown affect these disease states have on the
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proliferation of mesothelial cells. Those studies should be undertaken under a
separate research program once parameters for normal growth parameters are
determined.
• There are no classes of subjects that will be specifically included or excluded
as a part of this research with the exception of those under the age of 18
addressed elsewhere.
B. Sources of Materials
• The materials obtained from living human beings are breast tissue samples
• removed during the course of elective breast-reduction surgery. The samples
are expected to range in size from 50-100 grams. Data will be recorded about
the type of surgery along with information about the patient.
• Data to be received and recorded by [Company Name] about patients
is limited to the following: age, race, gender, height, weight, smoking /
non-smoking, diabetic / nondiabetic, current medication(s). Additional
information about the sample will be recorded including specimen size, the
location it was removed from, surgeon who performed the surgery, date of the
surgery, date the sample was processed, and the results of pathogen testing
once it is completed.
• There is no easy or established way to link a tissue lot number back to a
patient. No personally identifiable patient information is stored at [Company
Name] which will associate a particular patient with a particular [Company
Name] issued tissue lot number. The surgical groups working with [Company
Name] have no information about [Company Name] tissue lot numbers
or any way to connect an individual patient with a tissue lot number. It is
extremely unlikely, but within the realm of possibility, that a patient may
be able to be linked with a tissue sample. To do that, a person would have
to have the willing participation of both [Company Name] and the surgical
group. Patients have been warned about this potential loss of confidentiality
in IRB approved patient consent forms. Additionally, in the 12 years
[Company Name] has been collecting tissue samples using this protocol, no
patient has lost confidentiality.
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• A consented patient will have a sample of breast tissue removed during
voluntary surgery ranging in size from approximately 50-100 grams. The
surgeon will remove this tissue, place it in a specimen cup with media and
then send it to the PI for research. The sample is surgical waste tissue and
would otherwise be discarded. Data about the patient will be recorded as
outlined in bullet point 2 above. This information has already been collected
from the surgeon prior to surgery as a regular part of the procedure and is
being provided to the PI in order to better understand how different factors
influence the growth of human cells in culture.
C. Potential Risks
• Risks to patients as a result of participating in this study are minimal. No
health risks in addition to the ones already assumed for the elective surgery
have been experienced or identified as possibilities. Breast samples removed
generally aren’t large and in all cases are, in point of fact, surgical remnants.
There are no reasonably anticipated social, psychological, legal, ethical, or
other risks identified with participating in this study.
a. Recruitment and Informed Consent
• Subjects are recruited from patients undergoing elective surgery. Written
• consent will be obtained by a Registered Nurse (RN) during the course of
completing surgical paperwork. The RN will go through the consent form and
ask the patient if they have any questions about the research. The patient is
then given the opportunity to review the form, ask any additional questions
and sign the form if they so desire. No patients except for those under the age
of 18 will be excluded from the study.
• Consent will be obtained by a RN working with the surgical group and
documented by the patient’s signature on the consent form. The forms are
maintained by the surgical group and the PI will at no time have access to the
forms. Information to be provided includes: Purpose of the study, procedures
to be followed, risks associated with the study, how to withdraw consent if
the patient changes their mind, the fact that there is no financial or diagnostic
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benefit to the patient, alternatives to participation in the study, how to contact
the MD with any questions about the study, the fact that there are no costs
to the patient for the study, and that [Company Name] pays for the costs the
hospital or surgery group may incur while participating in the study.
b. Protection Against Risk
• No additional reasonable risks beyond loss of confidentiality have been
identified. While the risk of losing confidentiality exists it has been
minimized by not maintaining patient information at [Company Name] or
maintaining [Company Name] tissue lot numbers at the surgical center’s site.
There is no established protocol for the patient to be identified utilizing only
the information possessed by [Company Name] or only the information at the
surgical center site. Additionally [Company Name] has been collecting tissue
from voluntary surgery patients using this protocol for over 12 years and has
not had any issues with loss of confidentiality.
2. POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE
SUBJECTS AND OTHERS
• The patient is not expected to benefit directly from participation in the study.
The information gained from the study will not be used in the diagnosis or
treatment of their current problem. There is no payment or reimbursement
paid to the patient for their participation in the study. [Company Name] pays
for costs the hospital or surgery group may incur while participating in the
study.
• The risk of loss of confidentiality is the only identified risk for participation
in the study. The patient, with full knowledge of that risk, chooses to donate
the tissue without any financial compensation. One can only guess at the
otivation of the patient to participate. However, it is presumed that many
participants are well informed about breast cancer and the importance
of research in its prevention. Therefore, this research may be personally
important enough to them to take on the risk of losing confidentiality.
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3. IMPORTANCE OF THE KNOWLEDGE TO BE GAINED
• The outcomes of study will be a robust, well characterized human-based
platform for discovering the causes of and treatments for various forms of
breast cancer.
• The patient has accepted the risk of loss of confidentiality as being reasonable
for participation in the study. [Company Name] and the PI have taken steps to
minimize that risk and believe that the likelihood of the loss of confidentiality
has been successfully mitigated. The importance of a well validated
human mammary-derived basal/luminal cell discovery platform cannot be
understated. The value of being able to validate or eliminate compounds in
a cultured human primary cell model is both economic and health related.
There is currently no human primary basal/luminal culture system on the
market in the U.S. The development and availability of this system will
provide advancements in existing research and establish new areas of
research.
Inclusion of Women and Minorities
Tissue samples taken for this set of protocols will be from elective surgery
patients. Due to the nature of elective surgery, we are unable to accurately predict
the percentages of women or minorities that will participate in this study. However,
no tissue samples will be rejected based on gender or minority status. The expected
patient demographics are discussed in the human subjects section of this application.
Targeted/Planned Enrollment
Tissue will be procured from elective surgeries with no targeted population for
the study. No tissue samples will be rejected based on donor demographics.
Inclusion of Children
We are including children in this study for the following reasons. The current
protocols involve taking human material while receiving an elective surgical
procedure. As this is an elective procedure and the tissue is surgical waste tissue
we there should be no health risks associated with participating in the study. Only
children from 18 – 21 will be included in this study since our surgical practices do
not routinely have patients under 18 undergoing breast reduction surgeries.
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Scenario C. Exempt Human Subjects Research
If all of the proposed human subjects research meets the criteria for one
or more of the exemptions from the requirements in the DHHS regulations
(46.101(b)), Yes should be designated in Item 1 on the SF424 R&R Other
Project Information page, the appropriate exemption number checked in Item
1a, and “NA” entered for the Human Subject Assurance Number since no OHRP
assurance number is required for exempt research. In the section on Protection of
Human Subjects in the Research Plan, provide a justification for the exemption(s)
containing sufficient information about the involvement of the human subjects to
allow a determination by peer reviewers and HRSA staff that claimed exemption(s)
is/are appropriate.
The PHS will make a final determination as to whether the proposed activities
are covered by the regulations or are in an exempt category, based on the
information provided in the Research Plan. When in doubt, consult with the Office
for Human Research Protections (OHRP), Department of Health and Human
Services by accessing their Web site http://www.hhs.gov/ohrp/ for guidance and
further information. The six categories of research exempt from the DHHS human
subjects regulations are found at the end of this document. Please note: If the
proposed research involves only the use of human data or biological specimens,
you should first determine whether the research involves human subjects. The
exemptions do not apply if the research does not involve human subjects. See the
instructions for Scenario C.
The exemptions are:
Exemption 1: Research conducted in established or commonly accepted
educational settings, involving normal educational practices, such as (i) research
on regular and special education instructional strategies, or (ii) research on the
effectiveness of or the comparison among instructional techniques, curricula, or
classroom management methods.
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Exemption 2: Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures, interview procedures, or
observation of public behavior, unless: (i) information obtained is recorded in such
a manner that human subjects can be identified directly or through identifiers linked
to the subjects and (ii) any disclosure of the human subjects’ responses outside the
research could reasonably place the subjects at risk of criminal or civil liability or
be damaging to the subjects’ financial standing, employability, or reputation.
Exemption 2 for research involving survey or interview procedures or
observation of public behavior, does not apply to research with children (see 45
CFR part 46, Subpart D), except for research involving observations of public
behavior when the investigator(s) do not participate in the activities being
observed.
Exemption 3: Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures, interview procedures,
or observation of public behavior that is not exempt under paragraph (b)(2) of
this section if: (i) the human subjects are elected or appointed public officials or
candidates for public office; or (ii) Federal statute(s) require(s) without exception
that the confidentiality of the personally identifiable information will be maintained
throughout the research and thereafter.
Exemption 4: Research involving the collection or study of existing data,
documents, records, pathological specimens, or diagnostic specimens, if these
sources are publicly available or if the information is recorded by the investigator
in such a manner that subjects cannot be identified, directly or through identifiers
linked to the subjects.
The humans subjects regulations decision charts (http://www.hhs.gov/ohrp/
policy/checklists/decisioncharts.html) of the Office for Human Research Protection
(OHRP) will determine whether the research falls under the human subjects
regulations and if so, whether it meets the criteria for Exemption 4.
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Research that meets the criteria for Exemption 4 is not considered “clinical
research” as defined by PHS. Therefore the PHS policies for inclusion of women,
minorities and children in clinical research, do not apply to research projects
covered by Exemption 4.SF-424 (R&R) Supplemental Instructions Human Subjects
21.
Exemption 5: Research and demonstration projects that are conducted by or
subject to the approval of Department or Agency heads and that are designed to
study, evaluate, or otherwise examine: (i) public benefit or service programs (ii)
procedures for obtaining benefits or services under those programs (iii) possible
changes in or alternatives to those programs or procedures or (iv) possible changes
in methods or levels of payment for benefits or services under those programs.
Note: It is uncommon for investigators applying for a PHS grant to qualify for
this exemption. Please seek guidance from HRSA staff if you think your project is
eligible for Exemption 5.
Exemption 6: Taste and food quality evaluation and consumer acceptance
studies (i) if wholesome foods without additives are consumed or (ii) if a food is
consumed that contains a food ingredient at or below the level and for a use found
to be safe, or agricultural, chemical, or environmental contaminant at or below the
level found to be safe, by the Food and Drug Administration or approved by the
Environmental Protection Agency or the Food Safety and Inspection Service of the
U.S. Department of Agriculture.
What it means:
While there is no specific page limitation for this section of the application, be
brief. While your research may be exempt from the DHHS regulatory requirements,
it is still research which involves human subjects, and the application must follow
the instructions for each of the following topics and provide the information that is
requested. In the application narrative, provide the required information for each of
the following topics below:
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Protections for Human Subjects – Include the following statement: ‘This
Human Subjects Research falls under Exemption(s) … .’ Clearly identify which
exemption(s) (1, 2, 3, 4, 5, 6) you are claiming, and justify why the research meets
the criteria for exemption that you have claimed.
For SBIR applications claiming Exempt Human Research Studies, Exemption 4
is the most appropriate for those studies using human tissue specimens.
Additional Form
If, however, your project includes women and minorities, and if you answered
“Yes” to the question “Are human subjects involved, and your research and
development project does not fall under Exemption 4, you will need to complete
the Planned Enrollment Report illustrated below.
Planned Enrollment Report
This report format should NOT be used for collecting data from study participants.
Study Title:
Domestic/Foreign:
Domestic
Comments:
Ethnic Categories
Racial Categories
Not Hispanic or Latino
Female
Total
Hispanic or Latino
Male
Female
Male
American Indian/ Alaska
Native
0
Asian
0
Native Hawaiian or Other
Pacific Islander
0
Black or African American
0
White
0
More Than One Race
0
Total
0
PHS 398 / PHS 2590 (Rev. 08/12 Approved Through 8/31/2015)
Page
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0
0
0
0
OMB No. 0925-0001/0002
Planned Enrollment Report
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Use of Vertebrate Animals
If you propose the use of live vertebrate animal in your research and
development plan, reviewers will need to evaluate how you will involve them. To
adequately do so, you must provide additional documentation to support using the
animals. This information will be provided as a separate document to upload when
completing your application.
Direct from NIH:
This section is required for applicants answering “Yes” to the question “Are
vertebrate animals involved?” on the R&R Other Project Information form. If
Vertebrate Animals are involved in the project, address each of the five points
below. This section should be a concise, complete description of the animals and
proposed procedures. While additional details may be included in the Research
Strategy, the responses to the five required points below must be cohesive and
include sufficient detail to allow evaluation by peer reviewers and NIH staff. If
all or part of the proposed research involving vertebrate animals will take place
at alternate sites (such as project/performance or collaborating site(s)), identify
those sites and describe the activities at those locations. Although no specific
page limitation applies to this section of the application, be succinct. Failure to
address the following five points will result in the application being designated
as incomplete and will be grounds for the PHS to defer the application from the
peer review round. Alternatively, the application’s impact/priority score may be
negatively affected.
If the involvement of animals is indefinite, provide an explanation and indicate
when it is anticipated that animals will be used. If an award is made, prior to
the involvement of animals the grantee must submit to the NIH awarding office
detailed information as required in points 1-5 below and verification of IACUC
approval. If the grantee does not have an Animal Welfare Assurance, then an
applicable Animal Welfare Assurance will be required (see Part III Section 2.2
Vertebrate Animals for more information).
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The five points are as follows:
1. Provide a detailed description of the proposed use of the animals in the
work outlined in the Research Strategy section. Identify the species, strains,
ages, sex, and numbers of animals to be used in the proposed work.
2. Justify the use of animals, the choice of species, and the numbers to be
used. If animals are in short supply, costly, or to be used in large numbers,
provide an additional rationale for their selection and numbers.
3. Provide information on the veterinary care of the animals involved.
4. Describe the procedures for ensuring that discomfort, distress, pain,
and injury will be limited to that which is unavoidable in the conduct of
scientifically sound research. Describe the use of analgesic, anesthetic,
and tranquilizing drugs and/or comfortable restraining devices, where
appropriate, to minimize discomfort, distress, pain, and injury.
5. Describe any method of euthanasia to be used and the reasons for its
selection. State whether this method is consistent with the recommendations
of the American Veterinary Medical Association (AVMA) Guidelines on
Euthanasia. If not, include a scientific justification for not following the
recommendations.
Do not use the vertebrate animal section to circumvent the page limits of the
Research Strategy.
What it means:
This section should be a brief, yet complete, description of the animals and
proposed procedures they will be subjected to. The agency wants you to address
the following five points:
1. A detailed description of how you propose to use the animals, complete
with identification of the species, strains, ages, sex, and numbers of animals
planned to be used.
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Here is an example of how this may read:
“Cultured glioma cells will be used to induce tumors in the brains of adult
Fischer rats. Blood brain barrier (BBB) impermeable cisplatinum, administered
systemically followed by localized microwave irradiation, will be used to test
microwave-assisted delivery of the drug across the BBB and its effect on glioma
mass in vivo. The microwave procedure and duration used does not generate
heat, thus adding no additional discomfort to the animal. Standard procedures for
generating glioma tumors in rats will be followed. A total of 12 rats will be used for
this study. Control group will have 3 males and 3 females, experimental group will
consist of the same”.
2. Justification for animal usage, choice of species and the numbers you plan
to use. If animals are not abundant, expensive, or to be used in large numbers,
provide an additional rationale regarding why you selected them and at the
numbers you indicate.
Here is an example of how this may read:
“Experimental animals are needed because there are no mathematical,
computer or in vitro biological models that can simulate the BBB permeability to
compounds. Rats are the standard model for gliomas. The scope of the proposed
work requires this modest number of rats for the planned assays”.
3. Veterinary care of the animals
For example:
“Rats will be housed in the pathogen-free animal care facility at [University
Name]. The facility is an approved facility of the State University system. The
animals will be cared for following the procedures for adequate maintenance
and veterinary care as described in “Guide for the Care and Use of Laboratory
Animals,” HHS, NIH Pub. No. 86-23, 1985”.
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4. Describe the procedures for ensuring that discomfort, distress, pain, and
injury will be limited to that which is unavoidable in the conduct of scientifically
sound research.
Here is an example:
“Animals will be comfortably restrained in a stereotactic device for cell
injections into the cranium, as well as injections of compound into the femoral
vein. Animals will be placed in a comfortable shielding tube so that microwave
energy, which does not generate heat at the wattage and duration used, is localized
to the tumor-containing area only”.
Animals will be sedated as indicated below:
MATERIAL
FREQUENCY
DOSE (mg/kg)
ROUTE
CONCENTRATION
Ketamine
Once, PRN
100 mg/kg* with supplemental doses of 30 mg/
kg**
IP
33.3 mg/ml
Xylazine
Once, PRN
3 mg/kg* with supplemental doses of 1 mg/
kg**
IP
3.3 mg/ml
*initial dosing
**Supplemental dosing every 15 to 20 minutes to maintain anesthesia
5. Describe any method of euthanasia to be used and the reasons for its
selection.
Please see following example:
“All rats to be used for the experiments described in this proposal will be
sacrificed by methods consistent with the recommendations of the Panel on
Euthanasia of the American Veterinary Medical Association”.
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Be aware that if you choose not to address these five points, your application
may be considered incomplete and therefore removed from its scheduled round of
peer review. Alternatively, your impact/priority score could be negatively affected.
If you are unsure whether your research will require the use of vertebrate animals,
you must still complete this additional document. Include an explanation, and
indicate when you anticipate you will use animals. If your grant is awarded, you
must submit to the awarding office detailed information covering the five points
above and verify approval by your IACUC — all before you may involve animals
in your research.
What About the Use of “Select Agents”?
As in the case of using human or animal test subjects, you must create
additional documentation — which you will upload as a separate document — if
your research involves using “Select Agents.” These are hazardous biological
agents and toxins that the U.S. Department of Health and Human Services (HHS)
and Department of Agriculture (USDA) identify as having the potential to pose a
severe threat to public health and safety, to animal and plant health, or to animal
and plant products. You can find a list of these agents, at the National Select Agent
Registry website (http://www.selectagents.gov/SelectAgentsandToxinsList.html).
Direct from NIH:
Select Agents are hazardous biological agents and toxins that have been
identified by DHHS or USDA as having the potential to pose a severe threat
to public health and safety, to animal and plant health, or to animal and plant
products. CDC maintains a list of these agents. See http://www.selectagents.gov/
SelectAgentsandToxinsList.html
If the activities proposed in the application involve only the use of a strain(s)
of Select Agents which has been excluded from the list of select agents and toxins
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as per 42 CFR 73.3, the Select Agent requirements do not apply. Use this section to
identify the strain(s) of the Select Agent that will be used and note that it has been
excluded from this list. The CDC maintains a list of exclusions at
http://www.selectagents.gov/SelectAgentsandToxinsExclusions.html
If the strain(s) is not currently excluded from the list of select agents and toxins
but you have applied or intend to apply to DHHS for an exclusion from the list,
use this section to indicate the status of your request or your intent to apply for an
exclusion and provide a brief justification for the exclusion.
If any of the activities proposed in your application involve the use of Select
Agents at any time during the proposed project period, either at the applicant
organization or at any other performance site, address the following three points for
each site at which Select Agent research will take place. Although no specific page
limitation applies to this section, be succinct.
1. Identify the Select Agent(s) to be used in the proposed research.
2. Provide the registration status of all entities* where Select Agent(s) will be
used.
• If the performance site(s) is a foreign institution, provide the name(s)
of the country or countries where Select Agent research will be
performed. *An “entity” is defined in 42 CFR 73.1 as “any government
agency (Federal, State, or local), academic institution, corporation,
company, partnership, society, association, firm, sole proprietorship, or
other legal entity.”
3. Provide a description of all facilities where the Select Agent(s) will be used.
• Describe the procedures that will be used to monitor possession, use and
transfer of the Select Agent(s).
• Describe plans for appropriate biosafety, biocontainment, and security
of the Select Agent(s).
• Describe the biocontainment resources available at all performance
sites.
• If you are responding to a specific funding opportunity announcement
(e.g., PA or RFA), address any requirements specified by the FOA.
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Reviewers will assess the information provided in this Section, and any
questions associated with Select Agent research will need to be addressed prior to
award.
What it means:
Check this document to see if what you plan to use is on the excluded list. If
so, this section does not apply to you, so you do not need to provide the requested
information. The exclusions list can be found at: http://www.selectagents.gov/
SelectAgentsandToxinsExclusions.html. If the strain(s) is not currently excluded
from the Select Agent list but you have applied or intend to apply to HHS for an
exclusion from the list, use this document to indicate your request’s status or your
intent to apply for an exclusion and provide a brief justification for the exclusion.
If Select Agents are going to be used at any time during execution of the project,
by your lab or in a contractors lab, you must address the following three points for
each research site where Select Agent research will take place:
1. Identify the Select Agent(s) planned for use.
2. Provide the registration status of all entities — which the agency defines
as “any government agency (Federal, State, or local), academic institution,
corporation, company, partnership, society, association, firm, sole
proprietorship, or other legal entity” — where you will use Select Agent(s).
Even if the performance site(s) is a foreign institution, provide the name(s)
of the country(ies) where Select Agent research will be performed.
3. Provide a description of all facilities where the Select Agent(s) will be used,
including:
• Procedures for monitoring Select Agent(s) possession, use and transfer.
• Your plans for biosafety, biocontainment and Select Agent(s) security.
• The available biocontainment resources at all performance sites.
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Here is an example of a select agent section from a successful grant application
(Developing small molecule therapeutics for Ebola hemorrhagic fever virus):
Select Agent
Select Agent to be used:
In vitro:
Ebola Zaire Mayinga
Ebola Sudan Boniface
Marburg
Angola
In vivo:
Mouse Adapted
Ebola
Zaire
Guinea Pig Adapted Ebola Zaire
Organization Name registration status:
Number and expiration date: XXXXXXXXX-XXXX expiration XX/X/XX
The foundation is a select agent registered entity with Health and Human
Services, Centers for Disease Control and Prevention (CDC) and U.S. Department
of Agriculture, Animal Plant Health Inspection Service, National Select Agent
Program. The foundation has been inspected by the CDC National Select Agent
Program for use of HHS Select Agents and Toxins, Overlap Select Agents and
Toxins and USDA Select Agents and Toxins. Per the requirements of 42 CFR 73,
is approved for use of select agents at BioSafety Level 2, 3, and 4 and Animal
Biosafety Level 3 and 4.
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Description of Facilities:
Procedures used to monitor possession, use and transfer of Select Agent(s) The
foundation maintains an experienced and trained staff of scientists, veterinarians,
research technicians and veterinary technicians available to perform studies at high
biocontainment and maximum containment. These individuals have demonstrated
proficiency at conducting nonhuman primate studies with the agents identified
in the proposal. The BSL3, ABSL3 and BSL4 Operations and Safety Manuals
specify policies, procedures, and standard operating procedures (SOP) for the safe
handling of biological materials in biosafety laboratories. The policies, procedures,
and SOPs comply with application federal, state, and municipal regulations and
with the guidelines “Biosafety in Microbiological and Biomedical Laboratories”
issued by the Centers for Disease Control and Prevention (CDC) and the National
Institutes of Health (NIH). Employees are trained from these manuals on each
facility’s mechanical systems, biosafety, biocontainment and security. Employees
are also trained according to project specific and departmental standard operating
procedures.
These procedures apply to all foundation employees and visitors that use,
generate, store, or dispose of potentially infectious materials in foundation
biosafety laboratories and to persons who must enter those laboratories to perform
services. Prior to conducting experiments in the foundation biosafety laboratories,
staff members must read and be trained in the requirements outlined in this manual
and applicable task-specific safety plans.
At the present time, the director is the CDC designated Responsible Official
(RO). Select agent use, transfer or possession is forbidden without the permission
of the Responsible Official or Alternate Responsible Official, the required forms
filed, and written approval received from the CDC Select Agent Program.
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Upon approval, the BSK-3/4 Committee will consider select agents proposals
for work in the BSL-3/4 laboratory. BSL-3/4-qualified investigators desiring
to work on a BSL4 project must also submit a Biohazard Application to the
Biohazards and Safety committee. The foundation Biosafety Committee has a key
role in the foundation’s overall biosafety program. The committee is responsible
for evaluating the foundation’s facility, equipment, and staff capabilities for
performing work in a safe manner. The committee is also responsible for:
• Reviewing protocols and risk assessments submitted by principal
investigators for work involving biological materials or toxins.
• Meeting with PIs prior to the implementation of projects involving
biological materials or biological-derived toxins.
• Evaluating the foundation’s staff, facility and equipment for their ability to
provide the appropriate containment for handling biological materials.
• Assessing the foundation’s compliance with existing federal, state and
localenvironmental regulations.
Committee membership consists of representatives from technical departments,
management, and administrative staff, among others. The committee communicates
by e-mail with face-to-face meetings at least quarterly and/or more frequently if
necessary.
Plans for appropriate biosafety, biocontainment, and security of the Select
Agent(s)
Infectious cultures, inventory stocks or toxic materials are stored inside the
BSL4 laboratory in refrigerators, incubators or freezers that are marked with the
universal biohazard sign. Principal investigators maintain inventories of infectious
agents stocks. A master list of select agents is securely kept by Virology and
Immunology in the BSL4 Scientific Manager’s office. A computerize and bar
code inventory system has been selected for the select agent inventory. All issues
relating to select agent inventory or tracking must be directed to the Responsible
Official.
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All infectious or toxic materials stored in refrigerators or freezers are properly
labeled and stored in containers capable of withstanding thermal shock of freezing
and thawing. Each container is labeled with the identity of the infectious agents,
the date of the preparation, the initials or name of the responsible laboratorian
and a reference number that links the material to the more inclusive information
contained in the inventory database.
When work is completed, all infectious cultures and toxins are removed
from workbenches and cabinets and stored in a designated refrigerator or freezer.
Materials to be discarded are placed in a sealable container filled with a suitable
disinfectant. The container is placed in a discard pan containing the disinfectant.
Discard pans are placed in a cart and transported to the autoclave. Labware
containing infectious liquids are stored and transported in leak-proof containers
large enough to contain the fluid in case of leakage.
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CONCLUSION
The agency will need you to provide additional specific information if you plan
on using human subjects, vertebrate animals, and/or select agents. This information
will focus on need and safety. This information will be uploaded as part of your
SBIR application. But remember you cannot use these documents to bypass the
Research Strategy page limitation. n
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Chapter 6: Your Proposal’s Budget
Chapter 6:
Your Proposal’s Budget
In addition to a description of your research and development project, your
SBIR application also needs to have a projection of the amount of money needed to
successfully perform the work. The budget and associated justifications that you provide
are very important in conveying to the reviewer what your plan is for the funds they
are investing. Reviewers will consider whether the budget and the requested period of
support are fully justified and reasonable in relation to the proposed research.
The NIH has two types of budget formats they will accept:
1. Modular Budget
2. Detailed Budgets
For SBIR (and STTR, for that matter) applications, the modular format was excluded
beginning with the 2005 Omnibus Solicitation (2006 Solicitation available at
(http://grants.nih.gov/grants/funding/sbirsttr1/2006-2_SBIR-STTR-topics.pdf). So, you
have no choice but to submit the Detailed Budgets — also called Research and Related
(R&R) Budgets. This involves filling out three separate data entry screens, comprised of
REMEMBER:
Reviewers will
consider whether
the budget and the
requested period
of support are fully
justified and reasonable in relation
to the proposed
research.
11 different sections as part of the application process. Also, a separate detailed budget
is required. Be forewarned — this will take you some time to complete. The justification
documents will detail where you propose to spend your award money and why you are
spending it in this manner.
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The Difference Between Direct and Indirect Costs
According to the NIH:
Direct Costs are those that can be identified specifically with a particular
sponsored project, an instructional activity, or any other institutional activity, or
that can be directly assigned to such activities relatively easily with a high degree
TIP:
Unless previously
negotiated, do not
propose an F&A
rate above 40%
of the total direct
costs.
of accuracy.
Indirect Costs include Facilities and Administrative (F&A) Costs that are
incurred by a grantee for common or joint objectives and cannot be identified
specifically with a particular project or program.
When putting your detailed budget together, include both direct and indirect
costs. It is customary for a company to have previously established a single,
negotiated contracted percentage rate to represent F&A costs for all SBIR grants
received. For Phase I applicants who do not have a negotiated rate with a Federal
agency, you should not propose an estimated rate above 40% of the total direct
costs. If you have a subcontract or consulting agreements, any associated costs are
considered “direct,” including the subcontracted organization’s indirect costs.
What is the “Fee”?
SBIR awardees are permitted to charge a fee for performing the work, which is
explained this way by the NIH:
A reasonable fee, not to exceed 7% of total costs (direct and indirect) for each
project, is available to small businesses receiving awards under the SBIR/STTR
program. The fee is intended to be a reasonable profit factor available to for-profit
organizations, consistent with normal profit margins provided to profit-making
firms for research and development work. The amount requested for the fee should
be based on the following guidelines:
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(1) it must be consistent with that paid under contracts by the PHS for similar
research conducted under similar conditions of risk;
(2) it must take into account the complexity and innovativeness of the research
to be conducted under the SBIR/STTR project; and
(3) it must recognize the extent of the expenditures for the grant project for
equipment and for performance by other than the grantee organization
through consultant and subaward agreements.
The fee is not a direct or indirect “cost” item and may be used by the small
business concern for any purpose, including additional effort under the SBIR/STTR
award. The fee applies solely to the small business concern receiving the award and
not to any other participant in the project. However, the grantee may pay a profit/
fee to a contractor providing routine goods or services in accordance with normal
commercial practice.
How About “Program Income”?
As a commercial entity, your small business may have an opportunity to
generate some cash under the awarded program. The agency will certainly allow
this, but they ask that you provide an estimate of the amount of income you
foresee. According to the SF424 (R&R) SBIR/STTR Application Guide for NIH
and Other PHS Agencies:
NIH policy requires applicants for research grants to include in their grant
applications an estimate of the amount and source of program income (defined
below) expected to be generated as a result of the project for which funding is
being sought. The specific policies that govern the treatment of program income
under research grants are set forth in the NIH Grants Policy Statement
(http://grants.nih.gov/grants/policy/policy.htm#gps).
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Program Income is defined as gross income earned by the applicant
organization that is directly generated by a supported activity or earned as a result
of the award. The PHS Grants Policy Statement or NIH Grants Policy Statement
contains a detailed explanation of program income, the ways in which it may be
generated and accounted for, and the various options for its use and disposition.
Examples of program income include:
• Fees earned from services performed under the grant, such as those
resulting from laboratory drug testing;
• Rental or usage fees, such as those earned from fees charged for use of
computer equipment purchased with grant funds;
• Third party patient reimbursement for hospital or other medical services,
such as insurance payments for patients when such reimbursement occurs
because of the grant-supported activity;
• Funds generated by the sale of commodities, such as tissue cultures, cell
lines, or research animals;
• Patent or copyright royalties (exempt from reporting requirements); and
• Registration fees generated from grant-supported conferences.
What this means:
If your company earns income under the award of the program, such income
can be added to the grant account and used to further the objectives of the research
project under the expanded authorities stated in the Notice of Award.
Fees generated from services provided under the award or from the sale of
commodities as described above are real possibilities under a Phase I award given
the focus of the program on technology development. If so, report your best
estimate in the application. If you do not expect to have any program income,
indicate this also.
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Budget Limits
Unlike R01 and other types of NIH grants, the SBIR program has limits to
the budget that you may request in your application. The agency states that SBIR
Phase I awards may not exceed $150,000 in total costs (direct costs, facilities and
administrative (F&A/indirect costs, and fee) for a period typically not to exceed six
months. Can you submit a larger budget and ask for a longer award period, say, up
to one year? Absolutely. According to the SF424 (R&R) SBIR/STTR Application
Guide for NIH and Other PHS Agencies:
Deviations from the indicated statutory award amount and project period
guidelines are acceptable, but must be well justified and should be discussed with
NIH Program Staff prior to submission of the application. (CDC, FDA, and ACF
do not make awards greater than the stated guidelines.) The budgets of SBIR and
STTR applications will be evaluated to assess the appropriateness of the budget
to the timeliness of the research goals and may be reduced on a case-by-case basis
as recommended by peer reviewers, Institute/Center Advisory Board/Council, or
program staff. When making awards, NIH reserves the right to withhold or reduce
grant funding on applications at any ranking based on program priority.
The Application guide goes on to say:
According to statutory guidelines, total funding support (direct costs, indirect
costs, and fee) normally may not exceed $150,000 for Phase I awards and
$1,000,000 for Phase II awards. With appropriate justification from the applicant,
Congress will allow awards to exceed these amounts by up to 50% ($225,000
for Phase I and $1,500,000 for Phase II, a hard cap). As written in the statute and
under appropriate circumstances, NIH can apply for a waiver from SBA to issue
an award exceeding $225,000 for Phase I or $1,500,000 for Phase II, if this hard
cap will interfere with NIH‘s ability to meet its mission. Award waivers from the
TIP:
You can
negotiate funding
support exceeding
the $150,000 limit
for Phase I awards.
SBA are not guaranteed and may delay the release of funds. Applicants are strongly
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encouraged to contact NIH program officials prior to submitting any award in
excess of the guidelines. In all cases, applicants should propose a budget that is
reasonable and appropriate for completion of the research project.
What this means:
With appropriate justification on your part, Congress will allow awards to
exceed this amount by up to 50% ($225,000 for Phase I). Consult the appropriate
Institute’s or Center’s topic section for additional budget guidance. Also,
you should first contact program officials prior to submitting any application.
Regardless of your budget or award length requests, propose a budget and time
line that is both reasonable and appropriate for completion of the research and
development project.
One additional observation – regardless of the amount of funding requested,
many Phase I applications request an award length of one year. This observation
suggests that many applicants feel six months is too short a time frame to complete
the project or to get it to a place where they can confidently apply for a Phase II
SBIR award.
Budget Strategy
Without a doubt, the more complete your budget justification is, the better your
application will be viewed. Also, there are parameters for what is appropriate to be
charged to a grant. The NIH provides the following guidance:
An allowable cost is one which is:
1. reasonable for the performance of the award, meaning any fiscally
responsible person would do so under the circumstances when the decision
to spend the funds was made
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2. allocable, meaning that the cost was incurred for work performed under the
award
3. in conformance with any limitations or exclusions set forth in the Federal
cost principles applicable to the organization incurring the cost or in the
Notice of Award (NoA) as to the type or amount of cost;
4. consistent with regulations, policies, and procedures of the recipient that
are applied uniformly to both federally supported and other activities of the
organization;
5. accorded consistent treatment as a direct or indirect cost;
6. determined in accordance with generally accepted accounting principles;
and
7. not included as a cost in any other federally supported award (unless
specifically authorized by statute).
What this means:
As the PI, you are responsible to make sure all costs are assigned appropriately
and consistently. Although seldom actually occur, be confident that your project
cost assignments can pass an accounting audit by the agency if need be.
What Else Should You Consider Before Actually Creating Your
Budget?
Given the budget limitations of the SBIR award program, many budgets will
focus their requests on salary for personnel to perform the work, and money
for goods and services to fulfill the specific aims. Be careful with requests for
equipment purchases; large pieces are just not realistic for a Phase I. Small
equipment can seem reasonable at first, but at the expense of personnel or goods
and services, this may jeopardize your ability to accomplish the proposed aims.
Reviewers will be looking for reasonable costs and form opinions based on how
TIP:
Be careful with
requests for equipment purchases;
large pieces are just
not realistic for
a Phase I.
well the Specific Aims and Methods support your request. As a check to make
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sure you have included everything in your financial plan that you should, have a
colleague review it to search for anything that you may have missed.
Although your budget is not one of the five scored review criteria, the reality
STRATEGY:
is that reviewers will look at your budget and it will play a role in their scoring of
Asking for too
little funding will be
perceived as lack
of experience and
misjudgment on
your part for what
it will take to actually get the project
completed, which
can lower enthusiasm and be reflected in your overall
score.
these other five sections. Make sure that you ask for the correct amount of funding
to get the job done; overinflating the budget is not advised. Asking for too little
funding will be perceived as lack of experience and misjudgment on your part for
what it will take to actually get the project completed, which can lower enthusiasm
and be reflected in your overall score, thus putting you out of award range.
Budget Creation
As mentioned above, SBIR applicants must follow the Detailed Budget format,
using the R&R budget component forms (Application Sections A-K). From the
SF424 (R&R) SBIR/STTR Application Guide for NIH and Other PHS Agencies:
The R&R Budget form includes three separate data entry screens: (1) Sections
A and B; (2) Sections C through E; and (3) Sections F through K. To navigate
between the various screens, use the Previous and Next buttons at the top of the
form or use the scroll bar on the side of the screen. Complete the R&R Budget
form following the instructions provided. You must complete a separate detailed
budget for each year of support requested. The form will generate a cumulative
budget for the total project period. You must complete all the required information
(i.e., those fields that are highlighted in yellow, outlined in red and noted with an
“*”) before the Next Period button is activated. If no funds are requested for a
required field, enter “0.”
While the dollar fields allow cents to be entered, all dollar fields should be
presented in whole numbers. Please round to the nearest whole number.
NIH and other PHS agencies use the concept of person months as a metric for
determining percent of effort. To assist applicants unfamiliar with this concept,
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resources are available on the web at: http://grants.nih.gov/grants/policy/person_
months_faqs.htm. Frequently asked questions and a conversion calculator are
available.
What this means:
These are the sections that must be filled out:
• A: Senior/Key Person
• B: Other Personnel
• C: Equipment Description
• D: Travel
• E: Participant/Trainee Support Costs
• F: Other Direct Costs
• G: Total Direct Costs (A through F)
• H: Indirect Costs
• I: Total Direct and Indirect Institutional Costs (G+H)
• J: Fee
• K: Budget Justification
Start With Personnel
From the SF424 (R&R) SBIR/STTR Application Guide for NIH and Other
PHS Agencies:
Senior/Key Person
This section should include the names of all senior/key persons at the applicant
organization who are involved on the project in a particular budget year. Include
all collaborating investigators, and other individuals meeting the senior/key person
definition if they are from the applicant organization. Details of collaborators at
other institutions will be provided in the Subaward budget for each subaward/
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consortium organization. Personnel listed as Other Significant Contributors who
are not committing any specific measurable effort to the project should not be
included in the Personnel section of the budget since no associated salary and/or
fringe benefits should be requested for their contribution. Consultants designated
as senior/key persons in the Senior/Key Person Profile Form can be included in
Budget Section A only if they are also employees of the applicant organization.
Otherwise, consultant costs should be included in F.3 Consultant Services.
What this means:
There are a series of data fields for each Senior/Key Person which needs to be
populated:
• First, middle and last name, along with any prefixes or suffixes
• Project role — identify each Senior/Key Person, including Project
Directors/ Principal Investigators, Postdoctoral Associates and other
professionals
• Base salary — enter the annual compensation paid by the employer
• Calendar, Academic or Summer months — indicate the number of
person months devoted to the project for each individual (based upon the
appropriate calendar, academic or summer designations)
• Requested salary — regardless of the number of months each Senior/Key
Person devotes to the project, you must identify only the salary amount you
are requesting for this budget period
• Fringe benefits — enter the cash value of any applicable fringe benefits for
each person (This is a rate based upon your institution’s policy, and NIH
states these are “allowable as part of overall compensation to employees
in proportion to the amount of time or effort employees devote to the
grant-supported project, provided such costs are incurred under formally
established and consistently applied policies of the organization.”)
• Funds requested — here, note the requested salary and fringe benefits.
• Total Funds requested for all senior/key persons in the attached file - enter
total funds requested for all senior/key persons. This is required information
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• Total Senior/Key Persons - enter total funds requested for all senior/key
persons.
For Section B (Other Personnel), you will identify only the number of people in
each project role, not their names. Section B includes the following data fields for
each role:
• Number of personnel — identify the number of people you are proposing
for each project role category
• Project role — the form already lists Post-Doctoral Associates, Graduate
Students, Undergraduate Students and Secretarial/Clerical, and you should
count only those not already listed in Section A. You can list additional
project roles in the additional data fields provided.
• Calendar, Academic or Summer months — indicate the number of person
months devoted to the project for each project role category (based upon the
calendar, academic or summer designations)
• Requested salary — show the amount of salary/wages you are requesting
for each project role
• Fringe benefits — enter the cash value of any applicable fringe benefits for
each project role
• Funds requested — note the requested salary and fringe benefits for each
project role
• Total Number of Other Personnel - This total will auto-calculate. Total
Salary, Wages and Fringe Benefits (A+B).
• Total Other Personnel - Total funds requested for all other Personnel
Equipment
Section C is where you will separately list any equipment costing more than
$5,000. NIH defines equipment as “an item of property that has an acquisition cost
of $5,000 or more (unless the organization has established lower levels) and an
expected service life of more than one year.” The agency will allow items limited
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to research and development equipment and apparati that is not currently available
to you for conducting the work. General-use equipment such as lap top computers
are not allowed, unless they are used exclusively or primarily for conducting your
proposed project. You need to list the estimated cost of each equipment item,
including shipping and any maintenance costs and agreements.
Travel:
In Section D, you have an opportunity to outline your travel costs. Separate
data fields exist for domestic and foreign travel, which NIH breaks down as
follows:
• Domestic travel — total requested funds for travel within the United States,
Canada, Mexico and U.S. possessions.
• Foreign travel —total requested funds for travel outside of North America
and U.S. possessions.
Make sure that you describe in your budget justification section the purpose,
destination, anticipated travel dates (if possible) and number of individuals for
each trip. If you are not certain when the travel will take place, make sure that you
estimate the duration of the trip (i.e. five days).
Participant/ Trainee Support Costs
NIH states the following:
Unless specifically stated otherwise in an announcement, NIH and other PHS
agencies applicants should leave blank Section E. Note: Tuition remission for
graduate students should continue to be included in Section F. Other Direct Costs
when applicable.
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In the unlikely event that you do need to fill out this section, the SF424 (R&R)
SBIR/STTR Application Guide for NIH and Other PHS Agencies provides a list of
what information is needed (i.e. Tuition/Fees/Health Insurance, stipends, travel, to
name just a few of the categories).
Other Direct Costs
Section F is where you will request Other Direct Costs:
• Materials and supplies — List general categories, unless the category is
under $1,000
• Publication costs
• Consultant services
• Computer services
• Subawards/consortium/contractual costs
• Equipment or facility rental/user fees
• Alterations and renovations
• Other, which might include technical assistance
Total Direct Costs
In Section G, the project’s Total Direct Costs, you add the totals for Sections
A-F and report this number.
Indirect Costs
Section H is the place to provide Indirect Costs information, grouping by type,
such as salaries and wages.
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Total Direct and Indirect Costs
For Section I, Total Direct and Indirect Costs, add the totals for Sections G and
H and record this number.
Fees
Remember, the fee is neither a direct or indirect “cost” item and may be
used by the small business concern for any purpose. Note: The electronic system
automatically rounds up. If you get an error “The fee must be less than 7%,” try
using 6.99% as the rate.
Budget Justification
Direct from NIH:
Use the budget justification to provide the additional information requested
in each budget category identified above and any other information the applicant
wishes to submit to support the budget request. The following budget categories
must be justified, where applicable: equipment, travel, participant/trainee support
and other direct cost categories. Only one file may be attached.
Use this section to list the names, role (e.g., PostDoc or Graduate Student),
associated months, salary and fringe benefits for all Postdoctoral Associates and
Graduate Students included in Budget Section B. Other Personnel.
Include a justification for any significant increases or decreases from the initial
year budget. Justify budgets with more than a standard escalation from the initial to
the future year(s) of support. Also use this section to explain any exclusions applied
to the F&A base calculation.
If the application includes a subaward/consortium budget, a separate budget
justification is submitted for that budget. See Section 4.7 Special Instructions for
Preparing Applications with a Subaward/Consortium.
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What this means:
Section K is where you will upload your justification to support the need for
the requested funds detailed in Sections A-J. Remember to address each cost
individually. The budget justification section is your chance to show the reviewers
that your project is well thought-out. With this in mind, make certain that there is
nothing in the budget that was not mentioned previously in the research strategy
section. For example, funds requested for microarray analysis in the budget section,
when this was not described a part of your research and development work in the
research strategy section.
Here is a sample of Section K, which was combined from two successful SBIR
Phase I grants. The reason for the combination is that each grant alone did not
illustrate all of the sections needed to be justified.
REMEMBER:
The budget justification section
is your chance to
show the reviewers
that your project is
well thought-out.
Senior/Key personnel
[AB], Ph.D., will serve as Co-PI on this new Phase I SBIR proposal. He
will devote 10% of his effort to the execution, oversight, and coordination of
all components of the study and will be responsible coordinating outside feefor-service efforts. He will be responsible for the design and organization of all
experiments and analysis of their outcomes in coordination with Dr. [AK].
[AK], PhD, Co-PI will be responsible for setting the experimental strategies,
interacting with collaborators and consultants, will oversee the project, manage
the laboratory personnel, and evaluate data. He will also lead the writing of
manuscripts for publication and progress reports. He will devote 12 calendar
months to this effort coordinating efforts with Dr. [AB].
[MP], PhD, Senior Scientist will be responsible for purchasing reagents,
execution of the experiments, data evaluation, and preparation of visual and written
presentation of obtained results. Dr. [MP] will devote 12 calendar months to this
work.
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Other Significant Contributors
[DI], Ph.D., consultant, will provide support to this project as a population
scientist. Dr. [DI] is an epidemiologist with extensive training in basic science
that is required for this interdisciplinary project. She has been instrumental
for the development of this proposal. The proposed study is a next step in our
collaboration Dr. [DI] on studying individual responses to low-dose ionizing
radiation. She will participate in meetings twice a month and will conduct
statistical analysis.
[SS], PhD, consultant. Dr. [SS] is an expert in the field of vascular biology and
angiogenesis with for more than 20 years of experience. He has special interest
in neovascularization of bioengineered and regenerating tissues using angiogenic
growth factors and vascular cells, including endothelial progenitor cells. Dr. [SS]
will participate in monthly meeting and in the discussion of the results.
[RS], PhD, consultant on toxicological risk assessment. Dr. [RS] has
the perspective and expertise and will consult on the issues of integration of
toxicological testing with population based approach. The proposed project is an
extension of our collaboration. Dr. [RS] will participate in monthly meeting and in
the discussion of the results.
[GT], Ph.D., consultant. Dr. [GT] is an expert in biology of circulating
endothelial colony forming cells. Our previous work was conducted in
collaboration with Dr. [GT]. The proposed project is a logical extension of our
collaboration. Dr. [GT] will participate in monthly meeting and in the discussion of
the results.
[EH], PhD, consultant. Dr. [EH] is a highly reputed toxicologist. He is an
expert in xenobiotic metabolism and particularly in human xenobiotic metabolism
in human hepatocytes. We are collaborating with Dr. [EH] on metabolic and
toxicological aspects of our model. Dr. [EH] will participate in monthly meeting
and in the discussion of the results.
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Consultant Costs
Name
Dr. [DI]
Dr. [SS]
Dr. [RS]
Dr. [EH]
Dr. [GT]
Project
Role
Consultant
Consultant
Consultant
Consultant
Consultant
Rate/hr. ($)
50
50
50
50
50
Hrs./
month
8
2
2
1
1
Number of
months
12
12
12
12
12
Total
hrs.
96
24
24
12
12
Total
Total
Cost ($)
4,800
1,200
1,200
600
600
8,400
Equipment
xCELLigence RTCA-SP (ACEA Biosciences, Inc.) monthly lease including
warranty $1,500.00/months x 6 months = $9,000.00
Infinite-M200-PRO (Tecan) monthly lease including warranty – $1,000.00/months
x 10 months = $10,000.00
Total___________________________________________________ $19,000.00
Materials and Supplies:
The cost estimate of $2,750.00 per month for supplies is derived from costs
we currently experience in cell isolation, culture and performing cell based assays.
The broad areas covered in this part of the budget are cell cultureware and other
disposables, media and serum, growth factors and reagents, waste disposal,
antibodies, and the purchase of cell lines and primary cells. The budget estimate
for supplies is a conservative estimate and could be much more depending on a
number of factors, including the number of compounds tested in the screening
assays. The company is prepared for this eventuality and will pay any supply costs
beyond those requested. Category cost estimates below are for the entire grant
period of 12 months.
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Lab disposables – It is expected that the cost of these supplies will be
approximately $6,000.00. This category includes an extensive amount of
serological pipets, gloves, gowns, tips, and other items necessary for the
performance of the outlined work.
Cell isolation and culture reagents –These items such as culture ware,
media and serum, enzymes, and biohazardous waste disposal are needed for the
experiments conducted during the performance of the grant. The estimated cost for
this is $17,000.00
Antibodies, growth factors, cells and reagents – This category includes items
such as assay reagents, phospho-specific antibodies, ELISAs, growth factors, and
radiolabeled reagents (and their disposal). We anticipate that the cost of these items
will be $10,000.00
Tissue Procurement - These funds consist entirely of tissue procurement
expenses. As with our established visceral adipose tissue procurement, we will
utilize at least two medical institutions requiring approximately $1,000 per location
for IRB maintenance fees. We expect to procure up to 8 samples, at a cost of
approximately $400.00 per sample. This cost breaks down to $50.00 in shipping
costs and the remainder in compensation for nurse or physician time consenting the
patient, physician time obtaining the sample during normal surgery, and nurse time
involved in packaging and recording appropriate patient information. The total cost
for these items is expected to be approximately $4,200.00
Travel
Funds are requested to cover travel for the principal investigators to attend
meetings with consultants and to major conference to present results. Funds for this
purpose are to cover airfare, conference registration fees, room and board, and any
taxi and parking costs.
Total___________________________________________________ $2,000.00
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Indirect rate
[Company] is requesting a 40% indirect rate.
Fee
[Company] is requesting the standard 7% fee.
Special Instructions for Preparing Applications with a Subaward/
Consortium
In most circumstances, a minimum of two-thirds or 67% of the research or
analytical effort must be carried out by the small business awarded a Phase I SBIR.
That leaves a maximum of 33% of the total award (direct, F&A/indirect, and fee)
which can go towards all third party consultant and contractual arrangements for
portions of the scientific and technical effort.
According to NIH:
If the application is selected for an award, the Authorized Organization
Representative (AOR) will need to certify that the applicant and all proposed
consortium participants understand and agree to the following statement: The
appropriate programmatic and administrative personnel of each organization
involved in this grant application are aware of the NIH consortium agreement
policy and are prepared to establish the necessary inter-organizational agreement(s)
consistent with that policy.
What this means:
You, as the awardee organization, will make sure that 67% or more of the work
will be performed by the award recipient, and no more than 33% will be performed
by outside entities.
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Complete subaward/consortium budget form (including the budget justification
section) will need to be completed by each consortium grantee organization.
Remember that separate budgets are required only for subawardee/consortium
REMEMBER:
organizations that perform a substantive portion of the project.
As the awardee
organization, 67%
or more of the work
must be performed
by the award recipient, and no more
than 33% can be
performed by outside entities.
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CONCLUSION
Although your budget is not one of the reviewer’s five scored sections, what
they think of your budget will influence their opinion of your proposal. Detailed
budgets require careful planning and can take up a considerable amount of time to
prepare. Whether you will have sufficient financial support to successfully achieve
your project’s research and development goals will depend on your budget. n
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Chapter 7: Application Submission
Chapter 7:
Application Submission
Now that you have come this far along in the process, take some time just
prior to submission to review your finished product. Your proposal must read like
a single, cohesive, flowing document as opposed to individual parts that were
cobbled together. Make sure your message comes through loud and clear - that
this research and development project deserves to be funded, you are the best
person to do the work, and your company is the only place where this work can be
successfully accomplished. Ensure all of the sections communicate this message.
Here again, if you can have some of your colleagues also give it the once-over
and provide their feedback, you will be ahead of the game. Don’t discount the
possibility of enlisting the services of a professional editor; they may be a nonexpert, but they can make sure the proposal reads as one integrated unit and that
your message comes through.
You also need to compose a cover letter to introduce your proposal. This is
part of the NIH’s application upload process, and the agency encourages you to do
so. If you are submitting a changed or corrected application, a cover letter is mandatory. Make sure to include all attachments and that the attachments comply with
agency requirements. If you upload all of your materials at least two days prior to
the deadline, the agency will allow you two days to make any changes. After the
deadline, this ‘grace period’ is not available. The best advice is to have everything
checked and get it uploaded right the first time.
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Make Sure Everything is Attached and Submitted
Incomplete submissions will not be reviewed. “Incomplete” may include parts
REMEMBER:
Incomplete
submissions will
not be reviewed.
Period.
or attachments that are missing, or do not conform to the guidelines for submission.
Certain components are mandatory for all SBIR applicants, and others are required
only under certain circumstances.
Direct from NIH:
A completed application includes data in the following components:
Required Components
• SF424 (R&R) (Cover component)
• Research & Related Project/Performance Site Locations
• Research & Related Other Project Information
• Research & Related Senior/Key Person
• PHS398 Cover Page Supplement
• PHS398 Research Plan
• PHS398 Checklist
• PHS398 Research & Related Budget
Optional Components
• PHS398 Cover Letter File
• Research & Related Subaward Budget Attachment(s) Form
• Planned enrollment report
• PHS 398 Cumulative Inclusion Enrollment Report
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Applications With More than One PI
An SBIR application may have more than one PD/PI, or multiple PDs/PIs,
designated on the application for projects that require a “team science” approach
that clearly does not fit the single-PD/PI model. To do so, each PD/PI must have
a PD/PI role and a leadership plan must be included in the application package.
The plan needs to explain your rationale for having multiple PIs in addition to the
leadership team’s organizational structure. Include communication plans, decision-making processes for scientific direction and conflict resolution procedures.
If you have planned budget allocation, you should describe how resources will be
distributed to the project’s specific components or individual PIs. In addition, all
PDs/PIs must be registered in the NIH eRA Commons prior to the submission of
the application. The individual who serves as the contact PD/PI must be from the
small business that was awarded the grant and he/she must meet the primary
employment requirement. In contrast, other PDs/PIs need not meet this requirement.
The contact PD/PI is responsible for all communication, for assembling the
application materials and for coordinating progress reports for the NIH. At the
REMEMBER:
For applications with
more than one PI,
all must be registered in the NIH
eRA Commons prior
to the submission of
the application.
same time, this PI may not have other special roles or responsibilities within the
project team. The contact’s information should be entered on the SF424 (R&R)
cover component. All other PIs should be listed in the research and related senior/
key person component as PIs. The commons login ID of each PI must be included
in the credential field of the research and related senior/key person component.
Failure to do so will result in your application being rejected.
References Cited
The agency does not require that you comply with a specific format. They do
want you to make sure that your bibliography includes all references cited in the
research plan, and that references are arranged in the same sequence as they
appear in the document. Include the names of all authors, the article and journal
title or the book title, the volume number, page numbers and year of publication.
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Facilities and Other Resources
Only describe those relevant to your work and identify them as laboratory, animal, computer, office, clinical and other. Where appropriate, indicate their capacities, applicable capabilities, proximity and availability to the project.
Consortium/Contractual Arrangements
Be sure to detail the programmatic, fiscal and administrative arrangements between the applicant organization and the consortium organization(s).
Letters of Support (e.g. Consultants)
Direct from NIH:
Attach all appropriate letters of support necessary to demonstrate the support of
consortium participants and collaborators such as Senior/Key Personnel and Other
Significant Contributors included in the grant application. Letters should state expectations for co-authorship, and whether cell lines, samples or other resources
agreed to in the letter are also available to other investigators in the scientific community or will be provided to the particular investigators only.
For consultants, letters should include rate/charge for consulting services
and level of effort/number of hours per year anticipated. Consultant biographical
sketches should be in the Biographical Sketch section.
Involvement of consultants and collaborators in the planning and research
stages of the project is permitted. Include with the application letters from each individual and/or collaborator confirming their role(s) in the project.
Following is guidance for such documentation:
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• The letter(s) should be prepared on the consultant or collaborator’s letterhead and addressed to the small business. A single page is recommended.
• Minimally, each consultant and collaborator letter should:
1. verify their commitment to the project;
2. refer to the specific project by name, acknowledging the PD/PI as
the lead on the project; and
3. specify what services /tasks the consultant or collaborator will
contribute (e.g. expertise, number of hours/ percent of effort,
summary of tasks to be completed).
• For consultants, the letter should also include the rate/charge for consulting
services. Also include biographical sketches for each consultant.
• Letters of interest from potential commercial partners or investors and letters of commitment of funds or other resources that will enhance the likelihood of commercialization should be placed following the letters of support
for consultants and collaborators.
What this means:
Letters of support are very important to include in your application. Be sure to
attach letters from all consultants that corroborate their project roles. Letters from
key opinion leaders (KOLs) are especially helpful. The letter should start with the
title of the application and the submission date. The KOL should next describe
their relevant background information, as a means to establish their credentials.
Next, the KOL should state something to the effect that “This is a valuable and
innovative product…(and explain why it is valuable and innovative)” The letter
REMEMBER:
Letters of support
from big-names in
your field can help
your application
a lot.
should conclude with a strong statement of desire to try the product once it
becomes available.
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Chapter 7: Application Submission
The Cover Letter
All SBIR grant applicants are encouraged to include a cover letter with their
application. While the agency makes the final decision as to where your application
is assigned, what you say in your cover letter may help the agency decide to assign
it to where you feel it would be best.
Direct from NIH:
The cover letter is only for internal use and will not be shared with peer reviewers. The letter should contain any of the following information that applies to the
application:
1. Application title.
2. Funding Opportunity (PA or RFA) title of the NIH initiative.
3. Request of an assignment (referral) to a particular awarding component(s)
or Scientific Review Group (SRG). The PHS makes the final determination.
4. List of individuals (e.g., competitors) who should not review your
application and why.
5. Disciplines involved, if multidisciplinary.
6. For late applications (see Late Application policy in Section 2.14) include
specific information about the timing and nature of the cause of the delay.
7. When submitting a Changed/Corrected Application after the submission
date, a cover letter is required explaining the reason for the Changed/
Corrected Application. If you already submitted a cover letter with a
previous submission and are now submitting a Changed/Corrected
Application, you must include all previous cover letter text in the revised
cover letter attachment. The system does not retain any previously
submitted cover letters until after an application is verified; therefore, you
must repeat all information previously submitted in the cover letter as well
as any additional information.
8. Explanation of any subaward budget forms that are not active for all periods
of the proposed grant.
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9. Statement that you have attached any required agency approval documentation for the type of application submitted. This may include approval for applications $500,000 or more, approval for Conference Grant or Cooperative
Agreement (R13 or U13), etc.
There are study sections dedicated to reviewing SBIR and STTR applications.
They can be found at http://public.csr.nih.gov/StudySections/SmallBusinessTechnologyTransfer/Pages/default.aspx. These study sections have more representation
from industry than standard study sections.
When requesting peer-review assignment, please adhere to the following
format:
• A single request per line.
• The institute/center and SRG review requests need to be on separate lines.
• Positive and negative requests are placed on separate lines.
• Include the name of the institute/center or SRG, followed by a dash and the
acronym. Do not use parentheses.
• Explain each request in a separate paragraph
Tips When Making Peer Review Suggestions
There are tips you should keep in mind when making your peer review suggestions:
• It is never appropriate to request individual reviewers by name
• It is always appropriate to request reviewers having specific area(s) of expertise
• Make suggestions of study sections or funding agencies most applicable to
your proposal
• Be sure to emphasize your application’s disciplinary/multidisciplinary focus
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• Think about including a list of disciplines important for understanding your
proposal i.e. if it is as combination therapeutic product you are researching
and developing, disciplines would include cell biology and biomaterials
engineering.
REMEMBER:
Be mindful of the
language you use
when making peer
review suggestions
and for any individuals you would like
to be excluded from
reviewing your
application.
Take advantage of the http://era.nih.gov/roster/ website to read up on the
reviewers who make up the various SRGs. It is inappropriate to correspond with
them, and they will inform the SROs if you do try or succeed in communicating
with them.
What About Conflict of Interest?
Suppose you request a specific study section in your cover letter, but there
happens to be a direct competitor of your company who is a member of that study
section? It is appropriate in this situation for you to request that this reviewer be
excluded from evaluation of your proposal. To do so, you will need to:
• Name the individual in the cover letter.
• Explain why this person should be excluded from reviewing your
application.
The following template is offered by the agency as a guide for crafting your
cover letter.
Application title.
Funding Opportunity Announcement number:
Please assign this application to the following: Please note the outline of
indentations.
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Institutes/Centers
National Cancer Institute - NCI
National Institute for Dental and Craniofacial Research - NIDCR
Scientific Review Groups
Molecular Oncogenesis Study Section - MONC
Cancer Etiology Study Section - CE
Please do not assign this application to the following:
Scientific Review Groups
Cancer Genetics Study Section - CG
The reasons for this request are [provide a narrative explanation for the
request(s)]. List of individuals (e.g., competitors) who should not review the
application and why.
Disciplines involved, if multidisciplinary.
Statement that required NIH approval documents are included. (e.g., budget
over $500K/year; approval for conference grant; cooperative agreement, etc.) For
late applications, if applicable, include explanation of the delay as part of the letter.
Go Over Your Proposal One More Time for Content
You have now come to the point where all of the proposal components are
assembled, required attachments are in place, and the cover letter is crafted. Now,
it’s time to review your entire proposal’s content. To repeat what was stated in the
respective previous chapters of this manual, make certain:
• that your abstract is convincing
• your budget is aligned with your research and development strategy
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• your specific aims are clear and focused
• you’ve compellingly described your project’s significance, innovation and
approach
Common Problems with SBIR Applications
From a slide show presented by Rosemarie Hunziker, Program Director,
National Institute of Biomedical Imaging and Bioengineering (NIBIB):
Common Problems with SBIR/STTR Applications
Low/No significance
• Unimportant problem
• Unconvincing case for commercial potential or societal impact
• Irrelevant, inconsistent, or insufficient reference to published work
Lack of innovation, evolutionary rather than revolutionary
Weak PD/PI/Research team
• Insufficient experience with essential methodologies
• Poor environment; weakly documented institutional support
Questionable reasoning in experimental approach
• Errors in design = FATAL FLAW
• Failure to consider potential pitfalls and alternatives
Diffuse, superficial, or unfocused research plan
• Lack of sufficient experimental detail
• Unrealistically large amount of work proposed
Inadequately defined Phase I feasibility test / milestones
Serious/unresolvable human or animal subjects concerns
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Chapter 7: Application Submission
While going over your proposal one more time for content, be sure to address
any of these common problems.
Application Submission
The authorized organization representative (AOR) is usually the person who
will submit all of you application materials. As the PI, you can submit materials
with the approval of the AOR, but the agency will not accept any materials that
have not been approved. To begin the process, go to the grants.gov login page and
enter your username and password. Once logged in, the application package will
be automatically uploaded to the website. A confirmation screen appears once the
upload is complete, and a grants.gov tracking number is provided. Be sure and
retain this number for your records.
If everything is in order and there are no glaring issues, no further action on
your part is needed. From this point your application will automatically move to
the Division of Receipt and Referral in the Center for Scientific Review for
processing.
If for some reason there is an issue, for example there was a glitch in the
document transfer process, the AOR can reject it and submit a changed/ corrected
application. In this instance, you should contact the eRA help desk to ensure the
issues are addressed and corrected. Once you have rejected the proposal, follow the
instructions for correcting errors, including the requirement for cover letters on late
applications.
You can also use the reject feature if you determine that the warnings you
receive regarding your application are applicable and need to be handled now.
Warnings alone will not stop the application process. If a submission receives
TIP:
While some things
may be out of your
control, for those
that you do control,
make sure everything is in place to
get your application
uploaded correctly
the first time.
warnings only, but no errors, it will automatically move forward after two weekdays. Work with your AOR to determine if or when the reject feature is appropriate.
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After the submission deadline, the SRO is under no obligation to accept
corrective materials. Should you need to submit such materials, send them to the
SRO in a PDF format via an e-mail, making sure that you have the consent of your
AOR and that he/she is copied on any emails sent to the SRO.
Application Withdrawal
Direct from NIH:
There are two ways to stop the application from moving forward for peer
review. You can withdraw it or you can simply reject the application image. Your
application will undergo peer review as is unless your scientific review officer
[SRO] allows you to send additional information or you have withdrawn it. You
should consider withdrawing your application in the following circumstances:
• You feel the application is not up to snuff.
• You’ve run out of time for corrections and can’t send additional data.
Remember that your goal is to impress your reviewers with the best possible
application. Balance the severity of the problems with the amount of time you have
left to correct them in the same review cycle. Compare that with the time lost if you
wait for the next due date. To withdraw your application from consideration, ask
your organization to fax a signed letter to the Center for Scientific Review’s Division of Receipt and Referral at 301-480-1987. Provide your NIH accession number.
If you plan to withdraw the application and resubmit for the same deadline, be
careful. Once you no longer have an active application in the system, you will have
the same disadvantages as anyone else who applies at the last minute. Allow at
least two days to get your corrected application into the system.
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CONCLUSION
Congratulations on your submission. You made the application deadline and
there were no errors that could sidetrack your proposal’s advancement towards
review. Since you planned and executed the writing of your proposal well in
advance, and are comfortable and confident on its content, there should be no
reason for you to withdraw your application. n
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Chapter 8: Application Review Process
Chapter 8:
Application Review Process
Brief Overview
Once submitted, your SBIR undergoes a superficial review by the Center
for Scientific Review to make sure there are no errors which will automatically
disqualify your submission. Assuming there are no red-flags here, the proposal
is then reviewed by the Integrated Review Groups (IRG). Each IRG represents
a cluster of study sections around a general scientific area. From here, your
submission goes to a Scientific Review Group (SRG), usually referred to as the
study section. SRGs for SBIR and STTR applications have more representation
from industry on them than standard study sections; however academicians still
occupy the largest part of the panel positions. The SRG is composed of mostly a
dozen or more non-federal scientists, who have expertise in relevant disciplines
and current research areas. The scientific review officer (SRO) however is an NIH
staff member. Their job is to lead the group and designate a few key reviewers to
analyze your proposal in detail. The other members of the study section will skim
over your application, reading only certain sections in any detail. The study section
votes and scores your application on the five review criteria discussed previously:
• Significance
• Innovation
• Approach
• Investigator(s)
• Environment.
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The group also evaluates your proposal’s Overall Impact. Once completed, the
SRO will compile a summary statement, including your application’s scores as well
as a more detailed critique. After assessment by the SRG, the application will go to
the institute/center national advisory councils for review. Council recommendations
are based on considerations of scientific merit (assessed by the SRGs) and
relevance of the proposed study to an Institute/Center’s mission, programs and
priorities. Your application is only eligible for funding if both the study section and
the institute/ center advisory council recommend it.
Reviewers also have another option they can use to streamline their review
process and reduce the panel workload. If an application is unanimously judged
by the peer review committee to be less competitive, it will not be discussed at the
peer review meeting. These applications do not receive a numerical impact score,
nor do they receive individual criterion scores. In short, these applications are not
considered any further for funding.
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What Does the CSR Look for During Their Check of Your
Application?
The staff on the CSR makes sure that your application follows all
administrative and formatting requirements. Failure to do so may result in the
agency returning your application without further review. Common failures
include:
• Late submission
TIP:
Make sure your
submission is
correctly formatted.
• Improper format such as font size and margins
• Did not meet requirements of the agency announcement
• Company did not qualify as a small business
The take home message here is to follow the agency instructions to the letter.
Application Number Assignment
Your application will receive a unique identification number from the CSR. The
format is as follows: 1 R43 ES023527-01.
What this means (from the NIH):
• The first number is the application type. A new application is Type 1.
This indicates to the agency whether your application is a new, renewal,
noncompeting or other type of application.
• The activity code comes next. This is the type of grant mechanism you
have applied for. In the example above, an R43 designates an SBIR Phase I
research grant.
REMEMBER:
This unique identifying number is
how you will track
your application.
• The two-letter abbreviation is the institute code. In this example, the
National Institute of Environmental and Health Sciences code is ES.
• Next is the unique serial number the CSR assigns.
• The number after the hyphen shows the support year for the grant.
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When accessing the eRA Commons, the website where you submit your
application (https://commons.era.nih.gov/commons/), you’ll see this assignment
number. Agency staff will typically refer to your application using this assignment
number.
Assignment to an IRG, SRG, and Institute/Center
While you can request review assignments in your cover letter, it is up to the
discretion of the CSR whether to honor your request or not. It may make different
assignments based on NIH referral guidelines and workload factors.
Direct from NIH:
Your assignment should appear in the eRA Commons within 3 weeks after
submission. Be sure to log into eCommons and verify. Call the NIH Referral
Office at 301-435-0715 if you do not see it there.
Your requested study section may not be there yet, but the IRG should be.
Updates will take place over the next several days, at which time your SRG will
show up. What should you do if your application is assignment is not agreeable to
you? You can request a change, and be prepared to justify why you are requesting
the change. The CSR will try to accommodate your request, but remember that they
are balancing referral guidelines and workloads, and that their decision is final. You
may always withdraw the application from this round of review if you feel that this
may be in the best interest of your application’s chances for future success.
After the funding agency receives your application, it is assigned to a program
division using internal referral guidelines. The program officer, grants management
specialist and SRO fields will initially be blank in the eRA Commons.
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Steps to Follow if You Want to Request a Reassignment
Direct from NIH:
1. Inform your SRO of the problem well in advance of the initial peer review
beginning. An appropriate justification for such a request would be a
committee member having conflict of interest, working for a competitor’s
company, or, in your opinion, the panel doesn’t have adequate expertise to
review your research and development project.
2. Be sure to suggest an alternative, after checking the study section rosters.
3. Discuss the alternative you prefer with the chief of the IRG for your
assigned study section. You can get his contact information from your SRO.
4. Fax a letter to the center at 301-480-1987 detailing your reasons for
requesting a change. Here is an example of an acceptable request and an
unacceptable one:
• Acceptable: “Study section A seems to focus more on the contribution
of the cells is the therapeutic function of regenerative medicine
products. Since my application proposes to develop a combination
product consisting of both cells and a biodegradable scaffold material,
the bioengineering expertise of reviewers on study section B is critical
to appreciate the approaches I have taken.”
• Not acceptable: “Study section A lacks the required expertise to
evaluate my proposal, so please move my application to study section
B”.
5. If your concerns are still not resolved, you may appeal to the Center for
Scientific Review’s director of receipt and referral by calling 301-435-0715.
6. Make sure to keep your program officer informed about your situation.
It may be better to withdraw you application and wait until the next receipt
date rather than having it reviewed by an inappropriate study section. You also
have grounds for an appeal if the group doesn’t have the expertise required for an
effective peer review and, as a result, the assessment turns out poorly.
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Submitting Additional Information
The agency will allow you to add certain types of information to your
submitted application prior to review. However, there are restrictions on what
TIP:
You will have an
opportunity to
submit additional
information – use
it wisely.
can be added, how it needs to be added, and a deadline of up to 30 calendar days
before the peer review meeting. Use this opportunity if you change companies
and can take the funding with you, or if there was a catastrophic event such as the
lab you were going to perform the work is for some reason inaccessible. Other
good examples are; letters of support if you add a consultant or a biosketch if
a key person leaves and is replaced by someone else. The SRO will determine
whether your additional information will be included with your application. Postsubmission materials that the NIH will not accept include; changing specific aims
or research approach, nor will they accept new data.
To Submit Additional Information
1. Make sure to have the signature of the signing official at your company.
The agency will not accept what you send them unless you have it.
2. Follow the guidelines for the pages you’re submitting. If what you are
sending has a form page (e.g. Biographical Sketch), be sure to use it. If a
form page is not needed, such a letter of support from a new consultant,
limit it to a single page. Remember to always follow NIH policies regarding
margins, paper size and font size.
3. Describe the material you’re submitting in a note.
4. Send the material to the SRO. Sending the information electronically as a
PDF, in a single e-mail, is the preferred method. Be sure to include:
• A brief note describing your attachment
• Why you are submitting it (1-2 sentences at the most)
• The grant application number and full title
If accepted, your additional material will be uploaded to eRA Commons, under
the “Additions for Review” section of your application.
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Peer Review
Direct from NIH:
Your application’s most significant test is initial peer review. Your peers —
successful scientists in your field and related ones — use the information in your
application to assess the merit of the science you’ve proposed and your ability
to get the work done. Peer review results in a numerical value indicating the
reviewers’ judgment of the likelihood that your project will have a powerful impact
on its area of science. That number is the most important factor in determining your
application’s success.
The agency goes on to say:
Your SRO does an initial check of your application to make sure the key parts
are there. If you’re responding to a request for applications, program staff will
TIP:
The fate of your
proposal depends
on how well three
individual reviewers
on the study
section like
your proposal.
check to ensure it is responsive to the request for application.
Before sending your application to reviewers, SROs look at it more thoroughly
to make sure it’s complete, and they may contact you if anything is missing. If this
happens, send in the information quickly so reviewers receive it well before the
review.
At least three reviewers will be selected by the SRO to examine each proposal
and report on it to the rest of the study section. They were selected based on their
degree of familiarity with your area of research and development. Sometimes, if
none of the members have the necessary expertise, the SRO will find at least one ad
hoc reviewer with the appropriate credentials. How well these three individuals like
your proposal will determine how well the SRG grades your application.
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SBIR/STTR Study Sections
These study sections are centered around general areas, such as orthopedic and
skeletal biology, sensory technologies, and basic and integrative bioengineering, just
to name a few. The reviewers are going to be experts in the discipline, but not all are
going to be experts in your particular area. Each study section meeting may have 50100 applications to review.
Successful SBIR grants generate enthusiasm for the project, even though they
may be high-risk but the applicant makes it clear what the end-point measurements
will be for success and failure. While it should go without saying that the best SBIR
proposals have good science, they also have a defined product goal with scenarios for
use.
REMEMBER:
The reality is that
2-3 weeks before study section
meets is when your
proposal may actually receive a fast
read for the first
time, focusing on
the specific aims,
biographical sketch,
and the company.
It is at this time in
which a general impression is formed.
195 The Review Process
Approximately 1-2 months before the study section meets, reviewers receive the
grant application on a CD. Each reviewer receives 4-7 grants to review. This may not
seem like much time to do a thorough review, and the reality is that 2-3 weeks before
the study section meets is when your proposal may actually receive a fast read for the
first time, focusing on the specific aims, biographical sketch, and the company. It is at
this time in which a general impression is formed. The SRA will send each reviewer
a reminder that written reviews are due in one week; this is when they generally go
back and finish their review, scoring each section and giving their assessment of
impact. Based on the preliminary scores an order of review is made. Best preliminary
score to worst preliminary score. Only the top 40-60% are scheduled to be discussed
by the group. The remainder are deemed noncompetitive and undergo what is called
a ‘’streamlined review”.
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Direct from NIH:
NIH uses a process called “streamlining” so reviewers can focus on
applications that have a chance of being funded. Review committees don’t review
any application the group unanimously feels is roughly in the bottom half of
applications being reviewed at the meeting. That percentage varies by grant type as
well as by study section. Because no institute funds 50% of applications assigned
to it, there’s no need to review the bottom half. Here is how streamlining works:
• One week before the study section meets, SROs ask members for a list of
applications they feel should not be reviewed and prepare a combined list.
• If any reviewer disagrees with a call, the group will review that application.
What this means:
Your application is not discussed during the study section meeting. As
such they do not receive a numerical impact/priority score, but they do receive
individual criterion scores. One of the more common reasons for this approach is
that the application lacked significant and substantial merit.
For the competitive applications, the five criteria discussed in previous chapters
(Significance, Investigator(s), Innovation, Approach, and Environment) determine
the score. The reviewers will assign scores to these criteria based on their opinion
of your proposal’s scientific and technical merit. The scores are based on the 1-to-9
scale. Your application does not necessarily need to be strong in all categories to
be judged likely to have major scientific impact. For instance, a project that is not
necessarily innovative may be essential to advance a particular scientific field.
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Direct from NIH:
Impact
High
Score
1
2
Medium
3
4
5
Descriptor
Exceptional
Outstanding
Additional Guidance on Strengths/Weaknesses
Exceptionally strong with essentially no weaknesses
Extremely strong with negligible weaknesses
Excellent
Very good
Good
Very strong with only some minor weaknesses
Strong but with numerous minor weaknesses
Strong but with at least one moderate weakness
6
Satisfactory
Some strengths but also some moderate weaknesses
7
Fair
Some strengths but at least one major weakness
8
Marginal
A few strengths and a few major weaknesses
Low
9
Poor
Very few strengths and numerous major weaknesses
Minor weakness — An easily addressable weakness that does not substantially lessen impact
Moderate weakness — A weakness that lessens impact
Major weakness — A weakness that severely limits impact
As part of NIH’s effort to enhance peer review a new scoring system took effect
starting with Sept 2009 council (FY2010). Please refer to NOT-OD-09-024. This
scoring system was designed to encourage more reliable scoring of applications.
Highly rating all applications greatly diminishes the ability of a reviewer or
study section to communicate the scientific impact of an application. Therefore,
reviewers who carefully consider the rating guidance provided in determining
their scores improve not only the reliability of their scores, but also improve their
ability to communicate the scientific impact of the applications reviewed. The new
scoring system uses a 9-point rating scale (1 = exceptional; 9 = poor). The overall
impact score for each discussed application will be determined by calculating
the mean score from all the eligible members’ impact scores, and multiplying the
average by 10; the overall impact score will be reported on the summary statement.
Thus, the overall impact scores will range from 10 - 90. Overall impact scores will
not be reported for applications that are not discussed.
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Summary Statements
Direct from NIH:
Your summary statement is an official document with a short synopsis of peer
reviewer critiques scores, codes indicating various concerns, and budget.
Summary Statements include:
•Resume and summary of the main points discussed during the review meeting
and major strengths and weaknesses
•Reviewer critiques containing more information about the strengths and
weaknesses detected by peer reviewers
•Codes and budget information
• Meeting Roster
TIP:
View your
Summary
Statement like a
report card.
• Contact information for the Program Official (PO) to whom the grant is
assigned
Within approximately 30 days, your summary statement will be available via
your NIH Commons account.
The information on your summary statement is not intended to be allinclusive; there may be additional concerns that are not reflected in the statement.
Nonetheless, you should use this information if you decide to resubmit.
Institute/Council Review
Once the SRG has evaluated your application, the institute/center’s advisory
council or board will conduct a second review. These groups are comprised of
scientists from the extramural research community and public representatives who
are approved by the U.S. Department of Health and Human Services. During this
review process, agency staff will examine applications, Overall Impact scores, and
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summary statements. They provide the advisory council with a grant-funding plan.
The council considers the institute/center’s goals before advising the director, and
the director makes the final funding decision.
In the event that your application did not make the payline, yet is still in line
REMEMBER:
You may still
get awarded if
there are funds
remaining at the
end of the
funding cycle.
with the agency’s priorities, you may be placed on the “select pay” list. What this
means is, if there is money remaining at the end of the funding cycle, selected
applications will be funded in the order they are listed.
If you are fortunate enough to win an award, you will be working closely with
the institute/center program officer on scientific and programmatic matters and a
grants management officer to make sure that all budgetary or administrative issues
are addressed to the agency’s satisfaction. Your scores will be available in the
eRA Commons three business days after the review is complete. Your summary
statement should appear there within three weeks.
Tracking Your Application
Direct from NIH:
The eRA Commons provides a valuable resource for applicants and PIs to track
an application throughout various phases of the grants process. Within the eRA
Commons , the Status tab is where most of the tracking information is found.
1)Use eRA Commons to track status. eRA Commons provides the status
of your grant application and allows you to review detailed information
associated with your applications/grants.
a)Log in to eRA Commons with your user name and password
b)Click the Status tab on the blue navigation bar across the top of the screen
c)Find the application/grant of interest d)Click on the application ID.
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The Status screen contains the most current status and relevant documents
for that application/grant.
2)Watch for email notifications. Email notices are sent to notify the PI and/or
signing official to check the eRA Commons for a change in status.
3)Tracking during Peer Review phase.
a)Score and percentile. Following the review group meeting, any available
score and percentile information can be found in the application
information section of the Status screen.
b)Summary statement. Approximately three weeks after the review meeting
a full summary statement is available in the other relevant documents
section.
4)Tracking during Pre-Award and Award phase.
a)Just-in-time (JIT). Some application information (other support,
institutional review board and/or Institutional Animal Care and Use
Committee approval dates and human subjects education information) is
requested just prior to a final award decision. If needed, NIH will send a
request for this information.
b)Notice of award (NoA). The NoA is the official grant award document
notifying the grantee and others that an award has been made and stating
the terms and conditions of the award. You will find a link to the NoA
under the other relevant documents section of the Status screen. NoAs can
also be automatically emailed to the grantee organization. Organizational
officials can maintain an NoA email address in the eRA Commons
institutional profile.
5)Tracking during Post-Award Management phase. Several post-award tasks
can be managed through the eRA Commons..
a)Electronic Streamlined Non-Competing Award Process (eSNAP). eSNAP
allows extramural grantee institutions to submit an electronic version
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of a PHS 2590 progress report. This information is needed to receive a
non-competing award. An eSNAP link is available under actions in your
Status list of grants.
b)Closeout. Electronically submit required closeout documents including
Final Status Report (FSR), Final Progress Report and Final Invention
Statement. At the appropriate time, a Requires Closeout link is available
under actions in your Status list of grants.
c)No-cost extension. You can extend the final budget period of the project
one time for up to 12 months beyond the original expiration date on your
NoA as long as no cost or scope change is involved. At the appropriate
time, an Extension link is available under actions in your Status list of
grants. This may be completed electronically up to one day prior to the
end of the project period.
New Program Certifications Required for SBIR and STTR
Awards-2013
Notice Number NOT-OD-13-116, released September 17, 2013 by the NIH, the
purpose of which is to announce that the agency is implementing new SBIR/STTR
program-specific certifications based on the SBIR/STTR Reauthorization Act of
2011 and the Small Business Administration’s (SBA) SBIR and STTR Policy
Directives. There has been a revision in the certifications required prior to award
and there has been an added requirement that small businesses certify they are
meeting the program’s requirements during the life cycle of the funding agreement.
The agency will replace the pre-award small business concern “Verification
Statement” form with a revised “Funding Agreement Certification”. The agency
will also introduce a post-award “Life Cycle Certification” form consistent with the
SBIR and STTR Policy Directives.
Direct from NIH:
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Implementation
Revised Certification: Effective October 1, 2013, NIH will require
completion of a SBIR Funding Agreement Certification by all SBIR applicants
for new or renewal grants prior to award of a new award (grant or contract) or
a competing renewal award (grant or contract). Likewise, a STTR Funding
Agreement Certification will be required of applicants for all new and competing
renewal STTR grants. Submission of these Funding Agreement Certifications for
grants will be implemented using NIH’s Just-in-Time pre-award procedures for
SBIR/STTR grants. The SBIR and STTR Funding Agreement Certifications are
revised and re-named versions of the Verification Statements formerly used at the
pre-award stage. They are being implemented to mirror the content and format
contained in the current SBIR and STTR Policy Directives. These certifications
are necessary to assure that the applicant meets the SBA size criteria, and that the
organization will comply with other program-specific requirements such as all
work must be conducted in the United States and that a minimum amount of work
be performed by its own employees within its own facilities, before NIH to can
issue an award.
As done previously, if the funding agreement officer (for grants this is the
Grants Management Officer) believes that the business may not meet certain
eligibility requirements at the time of award, they may request a size determination
from the SBA, who will determine eligibility. At that time, SBA will request
further clarification and supporting documentation from the applicant small
business concern in order to assist in the verification of any of the information
provided as part of the determination request.
New Certification: Effective October 1, 2013, NIH also will require that all
recipients of new or continuing SBIR and STTR awards complete a “Life Cycle
Certification” once certain milestones are reached during the project period. Grant
awardees are not required to submit this certification directly to NIH, but must
instead complete a certification and maintain it on file in accordance with the
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records retention policy in Section 8.4.2 of the NIH Grants Policy Statement. A
certification is required at the following times:
• For SBIR and STTR Phase II Awardees: prior to receiving more than 50%
of the total award amount and prior to final payment or disbursement from
the Payment Management System (PMS).
• For SBIR and STTR Phase I Awardees: At the time of receiving final
payment or disbursement from the Payment Management System
In addition, SBIR and STTR awardees indicate compliance with these
certification requirements by drawing or requesting funds from PMS. The “Life
REMEMBER:
Revised and New
certifications
are required for
SBIR awardees
beginning in 2013.
Cycle Certification” is intended to ensure the ongoing compliance of the awardee
with the assurances it provided in the Funding Agreement Certification prior to
award.
If the Grants Management Officer believes, after award, that the business is not
meeting certain funding agreement requirements, the agency may request further
clarification and supporting documentation in order to assist in the verification of
any of the information provided.
The Funding Agreement Certification and Life Cycle Certification forms are
now available for SBIR and STTR applicants and awardees in fillable format
at: http://grants.nih.gov/grants/forms.htm#sbir. Applicants and awardees are
encouraged to carefully review each form prior to apply for or accepting an award.
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Just-in-Time Procedures
Just-in-Time means just that; the information requested will be just-in-time
should the agency need it to make you an award.
Direct from NIH:
NIH uses Just-in-Time procedures for certain programs and award mechanisms
(each FOA will include specific guidance on the use). These procedures allow
certain elements of an application to be submitted later in the application process,
after review when the application is under consideration for funding. The standard
application elements include other support information (both active and pending)
for senior/key personnel; certification of IRB approval of the project’s proposed
use of human subjects; verification of IACUC approval of the project’s proposed
use of live vertebrate animals; and evidence of compliance with the education in
the protection of human research participants requirement. Other program-specific
information may also be requested using this procedure. (Applications in response
to RFAs also may be subject to these procedures. The RFA will specify the timing
and nature of required submissions.)
Applicants will be notified (primarily by e-mail) when Just-in-Time information
is needed. This notification is not a Notice of Award nor should it be construed to
be an indicator of possible funding. Applicants should only submit this information
when requested. Information must be submitted electronically using the Just-inTime feature in the eRA Commons. In some circumstances the GMO may ask for
information in addition to the descriptions below, e.g., if the application involves
hESCs and the applicant did not identified a hESC from the NIH Registry in the
application.
The requirement for applicants to verify the accuracy and validity of all
administrative, fiscal, and programmatic information extends to information
submitted through the Just-in-Time process. Applicants are responsible for
promptly notifying NIH of any substantive changes to previously submitted
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Just-in-Time information up to the time of award. This includes items such as
Other Support changes that could lead to budgetary overlap, scientific overlap,
or commitment of effort greater than 12 person-months for the PD/PI(s) or any
Senior/Key Personnel; or any changes in the use or approval of vertebrate animals
or human subjects. Similar to the NIH public policy requirements, applicants are
responsible for establishing and maintaining the necessary processes to monitor
its compliance and informing NIH of any problems or concerns. Failure to
address changes to Just-in-Time submissions prior to award does not diminish
the applicant’s responsibility to address changes post-award by submitting a prior
approval request to NIH in accord with Administrative Requirements—Changes in
Project and Budget—NIH Standard Terms of Award.
Other Support. Information on other active and pending support will be
requested as part of the Just-in-Time procedures. Other support includes all
financial resources, whether Federal, non-Federal, commercial or institutional,
available in direct support of an individual’s research endeavors, including but not
limited to research grants, cooperative agreements, contracts, and/or institutional
awards. Training awards, prizes or gifts are not included. Other support is requested
for all individuals designated in an application as senior/key personnel—those
devoting measurable effort to a project. Information on Other Support is not
specifically requested for Program Directors, training faculty, and other individuals
involved in the oversight of training grants since applicable information is
collected in other sections of a training grant application. It is also not requested for
individuals categorized as Other Significant Contributors.
IC scientific program and grants management staff will review this information
before award to ensure the following:
• Sufficient levels of effort are committed to the project.
• There is no scientific, budgetary, or commitment overlap.
o Scientific overlap occurs when (1) substantially the same research
is proposed in more than one application or is submitted to two or
more funding sources for review and funding consideration or (2) a
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specific research objective and the research design for
accomplishing the objective are the same or closely related in two or
more applications or awards, regardless of the funding source.
o Budgetary overlap occurs when duplicate or equivalent budgetary
items (e.g., equipment, salaries) are requested in an application but
already are provided by another source.
o Commitment overlap occurs when an individual’s time commitment
exceeds 100 percent (i.e., 12 person months), whether or not salary
support is requested in the application.
o Overlap, whether scientific, budgetary, or commitment of an
individual’s effort greater than 100 percent, is not permitted. Any
overlap will be resolved by the IC with the applicant and the PD/PI
at the time of award.
• Only funds necessary to the approved project are included in the award.
Certification of IRB Approval. If the proposed project involves human
subjects research, the certification date of IRB review and approval must be
submitted. Pending or out-of-date approvals are not acceptable. See Public Policy
Requirements/Human Subjects for additional information.
Verification of IACUC Approval. If the proposed project involves research
with live vertebrate animals, verification of the date of IACUC approval of those
sections of the application that involve use of vertebrate animals along with any
IACUC-imposed changes must be submitted. Pending or out-of-date approvals
are not acceptable. See Public Policy Requirements/Animal Welfare for additional
information.
Human Subjects Education Requirement. If the proposed project involves
human subjects research, certification that any person identified as senior/key
personnel involved in human subjects research has completed an education
program in the protection of human subjects must be submitted. See Public Policy
Requirements/Human Subjects/Education in the Protection of Human Research
Participants for additional information.
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Human Embryonic Stem Cells (hESCs). If the proposed project involves
hESCs and the applicant did not identify a hESC line from the NIH Human
Embryonic Stem Cell Registry in the application, the line(s) should be included in
the Just-in-Time submission.
Other Information Requested by the Awarding IC. NIH IC’s may also request
additional Just-in-Time information on a case-by-case basis, such as revised
budgets or changes to the human subjects or vertebrate animal sections of the
application.
Reasons for Rejection
“Multiple and varied” sums up the reasons for SBIR application rejection.
Most of the time, however, the reasons focus on lack of enthusiasm for the research
and development problem the proposal addresses, the investigator’s ability to get
the work done, the company setting, naive budget requests, and/or poor project
presentation.
Reviewer Comments
Now, of what value are the reviewer’s comments if the application is not
funded? First off, addressing these comments in a resubmission (A1) of the same
request is expected. Sufficiently putting to rest the reviewer’s concerns are your
best chance of having the proposal awarded the next time around. The one caveat
here, however, is that if your resubmission doesn’t have the same reviewers, you
may still not be funded owing to different concerns by the different reviewers. The
agency tries to avoid this inconsistency in reviewing, but it does still occur. While
there are many reasons for not funding an application, including technical, not
falling within the agency’s mission, failure to write persuasively, and poor scientific
design, it is important to discern between those that can be addressed and those that
cannot.
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Resubmission (A1) or New Application (A0)
Nearly every PI who submits a proposal to the NIH is denied the first time out.
In fact, the estimated first-time rejection rate is 75 percent or more. Fortunately,
the NIH does allow resubmissions for SBIR proposals.
From 2009 to 2014 the NIH only allowed one resubmission (A1) and if the
resubmitted proposal was rejected your only choice was to develop an entirely new
scope for your project or revised to be submitted through another mechanism or
Institute/Center. Applicants now have another option of submitting the rejected
proposal as a new application (A0).
Tips for Resubmitting
Provide sufficient evidence to justify your project. Include specific
background data. Highlight compelling new data you gathered while waiting
for the initial response, and cite newly published research papers. Ensure your
outcomes/objectives are measurable, obtainable and specific. And create a clear
budget narrative.
Focus on your writing. Create a strong introduction that keeps reviewers
engaged and sets your proposal’s tone. Be sure to label the progression of ideas,
and keep your narrative concise by writing in short sentences and paragraphs.
Familiarize yourself with review process changes. Take note of new
requirements like page limit reductions, and adhere to them.
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TIP:
If space permits,
your resubmitted
application should
include a reply to
each comment,
and highlight your
explanations and
changes.
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NIH Policy Change on Resubmitting Applications
The NIH still allows only one resubmission of an unfunded application
REMEMBER:
It is important to
read the initial
RFA or program
announcement
you applied under
carefully to see if
there are any
special rules
regarding A1
resubmissions.
(see NOT-OD-09-016 at http://grants.nih.gov/grants/guide/notice-files/NOTOD-09-016.html), which must be submitted within 37 months of the new (A0)
application (see NOT-OD-10-140 at http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-10-140.html). If the resubmission is not funded, the previous policy
stated that the application had to substantially differ in both content and scope
in order to be eligible for submission as a new application. However, for all
application due dates after April 16, 2014, if your resubmission application (A1)
was unsuccessful at receiving funding, you may now submit the same idea as a
new (A0) application for the next appropriate new application due date (see NOTOD-14-074 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-074.
html). This change in resubmission policy applies to applications submitted to all
grant and cooperative agreement funding opportunities that allow resubmissions,
including all fellowship, training, and career development awards.
Direct from NIH:
http://grants.nih.gov/grants/policy/amendedapps.htm
Per NOT-OD-14-074 (see http://grants.nih.gov/grants/guide/notice-files/NOTOD-14-074.html), for application due dates after April 16, 2014:
TIP:
The revised proposal
requires a one page
introduction that
explains how the
investigator has
revised the grant.
209 •
following an unsuccessful resubmission (A1) application, applicants may
submit the same idea as a new (A0) application for the next appropriate due
date.
NIH will not assess the similarity of the science in the new (A0) application to
any previously reviewed submission when accepting an application for review.
This policy applies to all NIH Funding Opportunity Announcements (FOAs) that
allow resubmissions, including FOAs for research grants, the NIH Small Business
Innovation Research (SBIR) and Small Business Technology Transfer (STTR)
programs, Career Development Awards, Individual Fellowships, Institutional
Training Grants, Resource Grants, Program Projects, and Center Grants.
.
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Chapter 8: Application Review Process
NIH’s policy for accepting overlapping applications remains in effect (see NOTOD-09-100 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-100.html).
The NIH will not accept duplicate or highly overlapping applications under review
at the same time. This means that the NIH will not review:
• a new (A0) application that is submitted before issuance of the summary
statement from the review of an overlapping new (A0) or resubmission
(A1) application.
• a resubmission (A1) application that is submitted before issuance of the
summary statement from the review of the previous new (A0) application.
• an application that has substantial overlap with another application pending
appeal of initial peer review (see NOT-OD-11-101 at http://grants.nih.gov/
REMEMBER:
Not counting the
introduction, a
revised proposal
must keep to the
same page limits as
other proposals.
grants/guide/notice-files/NOT-OD-11-101.html).
NIH will not accept a resubmission (A1) application that is submitted later than
37 months after submission of the new (A0) application that it follows (see NOTOD-12-128 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-128.
html and NOT-OD-10-140 at http://grants.nih.gov/grants/guide/notice-files/NOTOD-10-140.html).
Applicants should check the individual FOA to determine whether
resubmission applications are allowed. Resubmissions normally are not permitted
for applications received in response to a Request for Applications (RFA) unless
it is specified in the FOA, in which case only one resubmission will be permitted.
Since an RFA often has special considerations of eligibility, scientific scope,
and review criteria, unfunded applications to an RFA must be submitted as new
applications to another FOA, using that FOA’s target due date for new applications.
Similarly, a change of grant activity code (e.g., from an R01 to an R21 or from
an R03 to an R01) usually involves a change of eligibility criteria, application
characteristics, dollar limits, time limits, or review criteria. These applications also
MUST be prepared as new applications. More information on these policies can be
found in the NOT-OD-03-019 (see http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-03-019.html).
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The Purpose of this Policy Change
The new policy allows for ideas that were unsuccessfully submitted as
a resubmission to be presented in a new grant application without having to
substantially redesign the content and scope of the project. This policy change from
the requirement that previously reviewed applications be substantially redesigned
in order to be accepted as a new application is in response to researcher’s concerns
that changing the scope to be accepted as new resulted in many meritorious
research ideas being deemed ineligible for resubmission. It was argued that this
previous policy was especially hard on new investigators, since finding new
research directions can be quite difficult during this phase of their career. Likewise,
established investigators expressed concern about the need to redirect the research
focus of productive labs in order to submit future NIH applications.
Resubmission of an idea as new means that the application will be considered
without a connection to a previous submission. As such, the applicant will not
provide an introduction to describe how this application has changed or specifically
respond to previous reviewer critiques. During review, the reviewers will be
TIP:
If you had an
unsuccessful
resubmission before
this new policy
was issued, this
previously rejected
A1 is now eligible
for submission as a
new A0 application.
instructed to evaluate the submission as a new idea, even if they have seen this
project in prior cycles. While there may not be major changes to the research
direction of these previously reviewed ideas, the NIH does expect that applicants
will still take advantage of previous comments to bolster the application for each
submission. Also, if you had an unsuccessful resubmission before this new policy
was issued, this previously rejected A1 is now eligible for submission as a new A0
application.
What Does This Mean in Practice?
• You may now submit a new A0 following an unsuccessful new A0
• Unless you would like the opportunity to address reviewer comments
directly, you do not have to resubmit as an A1
• The new resubmission policy does not limit the number of times an
application may be submitted as new
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• Following an unsuccessful A1, you can submit as an A0 having the same
title if you wish; it is not a requirement that you change the title
• As a new submission, it will receive a new grant number
• You still need to have received your summary statement before you can
submit an unsuccessful A1 as an A0
Keep in mind, these rules refer to grants submitted through a general program
announcement, not necessarily requests for applications (RFA). Most RFAs, which
are one time competitions to meet a specific need, do not allow resubmissions. If
an investigator wants to resubmit an RFA with revisions under a regular program
announcement, that would be considered a new proposal.
Direct from NIH:
How does NIH’s current resubmission policy affect SBIR/STTR Applicants?
Please review the four case studies for Phase I, Phase II/Phase IIB, Fast-Track,
and Direct Phase II to understand how the current NIH resubmission policy relates
to SBIR/STTR applicants.
Phase I
A Phase I application is a “Type 1” or “New” application. When the applicant
submits a New Phase I application (A0) and it is not funded, the applicant can
address reviewer comments and submit as a Resubmission A1 for the next
appropriate application due date, or they can submit a New application (A0).
Fast-Track
A Fast-track application is also a “Type 1” or “New” application and follows the
same rules as a Phase I. If a New Fast-track (A0) is not funded, the applicant can
address reviewer comments and submit as a Resubmission Fast-track A1, or they
can submit a New Fast-track (A0) for the next appropriate application due date.
If the Fast-track (A0 or A1) was not funded, the applicant can also revise down
the scope of their application and submit as a New Phase I (A0).
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Phase II/Phase IIB
A Phase II and Phase IIB are considered “Type 2” or “Renewal” applications.
If an applicant does not get funded on the first submission (A0), they can re-submit
an A1 for a Phase II/IIB.
If a Phase II or Phase II resubmission (Type 2, A1) is not funded, the applicant
may submit a New Phase I, Fast-track, or SBIR Direct Phase II (Type 1, A0).
However, the project will lose any association with the previously funded grant,
and the New project must be substantially different than the previous project to
avoid duplicative funding. If the applicant decides to submit a SBIR Direct Phase
II, they must also have previously completed the Phase I equivalent work without
any SBIR/STTR funds.
Direct Phase II
A Direct Phase II application is considered a “Type 1” or “New” application,
but in order to be eligible for a Direct Phase II, the small business applicant must
demonstrate the Phase I equivalence of their preliminary data in their Direct Phase
II application. If a New SBIR Direct Phase II (A0) is not funded, the applicant can
address reviewer comments and submit as a Resubmission SBIR Direct Phase II
A1, or they can submit a SBIR New Direct Phase II (A0) for the next appropriate
application due date. The small business applicant is not able to apply for a new
Phase I or Fast-track (A0) unless they substantially change their project scope to
prevent funding for a Phase I-like work already completed by the applicant.
For more information, please read the NIH Policy on Resubmission
Applications (http://grants.nih.gov/grants/policy/amendedapps.htm) and check out
the Resubmissions of NIH Applications FAQs (http://grants.nih.gov/grants/policy/
resubmission_q&a.htm). General questions concerning this policy may be directed
to the Division of Receipt and Referral at the Center for Scientific Review, 301435-0715.
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CONCLUSION
This final chapter describes the review process, from receipt of your application
by the NIH to ‘just in time’ procedures in the event that an award may be made
to you. The information that you can expect to receive, as well as the timing of
when to anticipate this information becoming available, is also described. The
NIH realizes that you spend a lot of time getting to this point and they strive to
keep you up-to-date with you application’s progress. Remember that the majority
of applications received by the NIH are not awarded. So, if your application is not
funded the first time around, shake off the initial disappointment, heed the reviewer
comments, and submit again. n
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Appendix A
Appendix A:
A Few Words Regarding Phase II SBIR Awards
Phase I awards cannot be renewed; applying for a Phase II is in effect asking
for a renewal or a continuation of your research and development project, since you
cannot apply for a Phase II unless you have been awarded a Phase I.
All of the information in the previous chapters of this manual is directly
applicable to applying for a Phase II SBIR. The main things to keep in mind for
Phase II are:
• Phase II is an extension of the Phase I.
• You must build the Phase II project from where the Phase I left off.
• If results for Phase I were insufficient, the Phase II application may not receive
a score in the peer review process.
• Phase II must still demonstrate feasibility, scientific, technical merit, and
commercial potential.
• You must include a commercialization plan in Phase II (12 page limit)
• Phase II applications may be submitted either before or after expiration of the
Phase I budget period.
• Phase II grant applications should be submitted no later than the first six
submission dates following expiration of the Phase I budget period.
Direct from NIH:
Funding shall be based on the results of Phase I and the scientific and technical
merit and commercial potential of the Phase II application. Part I: Instructions for
Preparing and Submitting an Application I-4 SBIR/STTR SF424 (R&R) Adobe
Forms Version B Application Guide.
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All Phase II applications must include a succinct Commercialization Plan.
Specific details for preparing this section are described in Section 5.6 of this
Application Guide.
SBIR Phase II awards normally may not exceed $1,000,000 total (direct costs,
F&A/indirect costs, and fee) for a period normally not to exceed 2 years. STTR
Phase II awards normally may not exceed $1,000,000 total (direct costs, F&A/
indirect costs, and fee) for a period normally not to exceed 2 years.
According to statutory guidelines, total funding support (direct costs, indirect
costs, and fee) normally may not exceed $150,000 for Phase I awards and
$1,000,000 for Phase II awards. With appropriate justification from the applicant,
Congress will allow awards to exceed these amounts by up to 50% ($225,000
for Phase I and $1,500,000 for Phase II, a hard cap). As written in the statute and
under appropriate circumstances, NIH can apply for a waiver from SBA to issue
an award exceeding $225,000 for Phase I or $1,500,000 for Phase II, if this hard
cap will interfere with NIH‘s ability to meet its mission. Award waivers from the
SBA are not guaranteed and may delay the release of funds. Applicants are strongly
encouraged to contact NIH program officials prior to submitting any award in
excess of the guidelines. In all cases, applicants should propose a budget that is
reasonable and appropriate for completion of the research project.
Only Phase I awardees are eligible to apply for and obtain Phase II funding
at this time. Awardees identified via a “successor-in-interest” or “novated” or
similarly-revised funding agreement, or those that have reorganized with the
same key staff, regardless of whether they have been assigned a different tax
identification number, are eligible to apply for Phase II funding. Agencies may
require the original awardee to relinquish its rights and interests in an SBIR/STTR
project in favor of another applicant as a condition for that applicant’s eligibility to
participate in the SBIR/STTR program for that project.
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Only one new Phase II award may be made for a single SBIR/ STTR project.
You may submit a Phase II application either before or after expiration of the
Phase I budget period, unless you elect to submit a Phase I and Phase II application
concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase
II support, a Phase I grantee organization should submit a Phase II application
within the first six receipt dates following the expiration of the Phase I budget.
Commercialization Plan
From the agency:
Commercialization Plan
(Applicable to all Phase II and Phase IIB Applications and Phase I/Phase II
Fast-Track Applications.)
If you are submitting a Phase II, Phase IIB or Phase I/Phase II Fast-Track
application, include a Commercialization Plan in accordance with the agency
announcement and/or agency-specific instructions. To attach a Commercialization
Plan file, click the Add Attachment button to the right of this field, browse to where
you saved the file, select the file, and then click Open.
All Phase II, Phase IIB and Fast-Track applications must include a succinct
Commercialization Plan. The Commercialization Plan is limited to 12 pages. Be
succinct. There is no requirement for applicants to use the maximum allowable
pages allotted to the Commercialization Plan.
Create a document entitled, “Commercialization Plan,” and provide a
description in each of the following areas:
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a. Value of the SBIR/STTR Project, Expected Outcomes, and Impact.
Describe, in layperson’s terms, the proposed project and its key technology
objectives. State the product, process, or service to be developed in Phase III.
Clarify the need addressed, specifying weaknesses in the current approaches to
meet this need. In addition, describe the commercial applications of the research
and the innovation inherent in this application. Be sure to also specify the potential
societal, educational, and scientific benefits of this work. Explain the noncommercial impacts to the overall significance of the project. Explain how the
SBIR/STTR project integrates with the overall business plan of the company.
b. Company. Give a brief description of your company including corporate
objectives, core competencies, present size (annual sales level and number
and types of employees), history of previous Federal and non-Federal funding,
regulatory experience, and subsequent commercialization, and any current
products/services that have significant sales. Include a short description of the
origins of the company. Indicate your vision for the future, how you will grow/
maintain a sustainable business entity, and how you will meet critical management
functions as your company evolves from a small technology R&D business to a
successful commercial entity.
c. Market, Customer, and Competition. Describe the market and/or market
segments you are targeting and provide a brief profile of the potential customer.
Tell what significant advantages your innovation will bring to the market, e.g.,
better performance, lower cost, faster, more efficient or effective, new capability.
Explain the hurdles you will have to overcome in order to gain market/customer
acceptance of your innovation.
Describe any strategic alliances, partnerships, or licensing agreements you have
in place to get FDA approval (if required) and to market and sell your product.
Briefly describe your marketing and sales strategy. Give an overview of the
current competitive landscape and any potential competitors over the next several
years. (It is very important that you understand and know the competition.)
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d. Intellectual Property (IP) Protection. Describe how you are going to protect
the IP that results from your innovation. Also note other actions you may consider
taking that will constitute at least a temporal barrier to others aiming to provide a
solution similar to yours.
e. Finance Plan. Describe the necessary financing you will require to
commercialize the product, process, or service, and when it will be required.
Describe your plans to raise the requisite financing to launch your innovation
into Phase III and begin the revenue stream. Plans for this financing stage may be
demonstrated in one or more of the following ways:
Letter of commitment of funding.
• Letter of intent or evidence of negotiations to provide funding, should the
Phase II project be successful and the market need still exist.
• Letter of support for the project and/or some in-kind commitment, e.g., to
test or evaluate the innovation.
• Specific steps you are going to take to secure Phase III funding.
f. Production and Marketing Plan. Describe how the production of your
product/process/service will occur (e.g., in-house manufacturing, contract
manufacturing). Describe the steps you will take to market and sell your product/
process/service. For example, explain plans for licensing, Internet sales, etc.
g. Revenue Stream. Explain how you plan to generate a revenue stream for
your company should this project be a success. Examples of revenue stream
generation include, but are not limited to, manufacture and direct sales, sales
through value added resellers or other distributors, joint venture, licensing, service.
Describe how your staffing will change to meet your revenue expectations.
Applicants are encouraged to seek commitment(s) of funds and/or resources
from an investor or partner organization for commercialization of the product(s)
or service(s) resulting from the SBIR/STTR grant. Place relevant letters following
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letters from consultants and collaborators in Item 14, Letters of Support in the PHS
398 Research Plan Form.
Your Phase III funding may be from any of a number of different sources
including, but not limited to: SBIR/STTR firm itself; private investors or “angels”;
venture capital firms; investment companies; joint ventures; R&D limited
partnerships; strategic alliances; research contracts; sales of prototypes (built as
part of this project); public offering; state finance programs; non SBIR-funded
R&D or production commitments from a Federal agency with the intention that the
results will be used by the United States government; or other industrial firms.
What this means:
A. Value proposition of project
• Define the opportunity. What need will you address addressed? Why are
current solutions not sufficient?
• State expected outcomes, impact. How will the success of your research
and development project make a difference?
B.Company
• Overview: origins, number of employees, annual sales, previous or
current SBIR support
• Corporate objectives: vision, mission, plans for growth and expansion
• Core competencies
• Commercialization experience
C.Market
• Customer and competition/competitive landscape
D. Intellectual Property (IP) Protection
• Your patent position and plans moving forward
• Freedom to operate
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E. Finance Plan
• Milestone-based
• Diversified
• Documented
F. Production and Marketing plan
• Manufacturing in-house, contracted, or licensed?
• Marketing out-sourced?
G. Revenue Stream
• Sales
• Services
• Royalties
• Other
The Commercialization Plan is perhaps the most critical section of the
Phase II proposal. It is your best opportunity to describe the strategy that your
company will use to generate revenue from the proposed research and development
innovation. The plan must clearly spell out the business opportunity enabled
by the innovation. The plan also needs to communicate the current status of the
innovation, as well as describing your company’s strategy for advancement and
how the innovation fits into the future market. Your Commercialization Plan
should:
• Cover a specific product, service, or technology
• Define the route to market
• Identify milestones and risks related to the product, service, or technology
commercialization
• Provide financial information (i.e. – cost, price, sales projections, margin)
related to the product, service, or technology.
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Appendix B: Index
Appendix B:
Index
TermPages
Abstract����������������������������������������������������������������34-40,46-49,119,182
Appendix��������������������������������������������������������������58, 72,120
Approach��������������������������������������������������������������35, 38, 41, 74-75, 92-94, 98, 100107, 108-118, 183, 188, 193, 208
Attachments���������������������������������������������������������94, 174-175, 182
Bibliography��������������������������������������������������������98, 119-120, 176
Biographical Sketch���������������������������������������������46, 56-58, 72-73, 177, 193, 195
Biohazards������������������������������������������������������������81-82, 85, 148
Budget������������������������������������������������������������������152-176, 179, 182, 198, 201
Budget justification����������������������������������������������157, 160, 163, 165-171
Children, inclusion of�������������������������������������������128-130, 134-137
Citations���������������������������������������������������������������58-59, 119-120
Cover letter�����������������������������������������������������������174-175, 179-181, 191
Detailed budget����������������������������������������������������152-153, 159
Direct costs�����������������������������������������������������������28-29, 58-59, 65, 86, 153, 156,
160, 163-164, 211
Environment���������������������������������������������������������80-82, 84, 92, 102-104, 116-117,
126, 183, 188, 196
Equipment������������������������������������������������������������28, 31, 80, 82-85, 90, 111, 148,
154-155, 158, 160, 162-165, 168,
206
Facilities and other resources�������������������������������35, 71, 75, 80-85, 90, 144-147,
153, 156, 177, 202
Feasibility studies������������������������������������������������34-35
Foreign organizations�������������������������������������������144-145
Genome-wide association studies (GWAS)���������86, 89
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Appendix B: Index
Human subjects����������������������������������������������������27, 75, 84, 111, 124-130, 134-138,
150
Hypothesis�����������������������������������������������������������8, 33-35, 41, 43-44, 102, 117-118
Inclusion Enrollment Report��������������������������������175
Indirect costs��������������������������������������������������������28, 153, 156, 160, 164-165, 211
Innovation������������������������������������������������������������92-94, 98-100, 103-104, 107-108,
110, 116, 118, 183, 188, 196, 213214, 216
Institute/Center Advisory Board/Council������������40-41, 156, 198-199
Integrated Review Group (IRG)��������������������������188, 191-192
Intellectual property���������������������������������������������15, 30-31, 50, 60, 76, 78, 81-82,
85, 87-88, 214-215
Just-in-time information���������������������������������������200, 202, 204-207
Letters of support ������������������������������������������������46, 72, 74, 177-178, 193, 215
Minorities, inclusion of����������������������������������������128-129, 134, 137-138
Modular budget����������������������������������������������������152
Multiple institutions/sites�������������������������������������84
Multiple principal investigators���������������������������74-75, 176
Overall Impact�����������������������������������������������������33, 92-94, 102-105, 116-119, 139,
143, 189, 194-198, 213, 215
Peer review�����������������������������������������������������������23, 62, 70, 139, 143, 180-181,
185, 189, 192-194, 197, 200, 210
Personal Statement�����������������������������������������������46, 57-61
Positions and honors��������������������������������������������46, 58-59, 62
Preliminary data���������������������������������������������������100, 102, 108-109, 111-115
Project Narrative��������������������������������������������������54-55, 119
Project Summary �������������������������������������������������See Abstract
Qualifications�������������������������������������������������������46, 57-59, 65, 82
References �����������������������������������������������������������See Bibliography Research Strategy�������������������������������������������������92, 98-100, 108, 110, 139-140,
150, 166
Research support��������������������������������������������������46, 58-59, 70-72
Resource sharing��������������������������������������������������See Sharing plans
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Appendix B: Index
Resubmission�������������������������������������������������������36, 207-208, 212
Review process����������������������������������������������������188-208
Revision application���������������������������������������������36
Scientific Review Group (SRG)/study section����23, 48, 179-180, 188-189, 191,
194, 198
Scientific Review Officer (SRO)�������������������������185, 188-189, 191-194
Scoring your application��������������������������������������197
Select agents���������������������������������������������������������81, 99, 109, 143-146, 148, 150
Sharing model organisms�������������������������������������86, 89
Sharing plans��������������������������������������������������������85-89, 99
Significance����������������������������������������������������������49, 51-53, 61, 92, 98-104, 106,
116-118, 183, 188, 196, 213
Specific Aims�������������������������������������������������������32, 34-37, 41-43, 47, 50-53, 75,
92-100, 108-111, 114, 119, 158,
183, 193, 195, 208
Submitting the application�����������������������������������26, 37, 41-42, 74, 78, 157, 174,
179, 210-212
Summary Statements�������������������������������������������189, 197-200, 208
Title of project �����������������������������������������������������8, 34, 36-44
Tracking your application������������������������������������199
Vertebrate animals������������������������������������������������83, 124-125, 139-140, 143, 150,
204-207
When to apply������������������������������������������������������40
Withdrawing your application�����������������������������185
Women, inclusion of��������������������������������������������128-129, 134-138
Writing schedule��������������������������������������������������47
225 Principal Investigators Association | www.principalinvestigators.org
NIH SBIR Grant Application Mentor: An Educational How-to Manual — 1st Edition
About the Author —
John W. Ludlow, Ph.D
Dr. Ludlow began his academic faculty career at the
University of Rochester (NY) in 1991, with appointments
in the department of biochemistry at the medical school
and the university’s cancer research center. During this time
he maintained an independently funded research laboratory
training graduate students and post doctoral fellows in the
area of tumor suppressor gene expression, protein structure,
and function. Funding for his laboratory came from a variety of sources, including
the NIH, the American Cancer Society, and private foundations. Dr. Ludlow
began working in the commercial biotechnology sector in 2000, developing and
managing research and pre-clinical programs for cell therapy and tissue engineered
products, where he has continued to compete in, and advise on, multiple NIH
award programs.
Principal Investigators Association | www.principalinvestigators.org
226
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