National Institutes of Health
Office of Extramural Research
Topics
to Discuss
•
Medical and Health Research Funding
Environment
•
NIH
Small Business Innovation Research &
Small Business Technology Transfer (SBIR
& STTR)
Program Awards
•
Academic Research Enhancement Awards
National Institutes of Health
National Institutes of Health
Office of Extramural Research
Federal Allocations
3 National Institutes of Health...34,829 -14.4% 29,831 0.6% 30,012
Department of Defense (medical research, chemical and biological defense) ...2,667 -12% 2,346 2.8% 2,412
Department of Homeland Security (biodefense) ...2,372 -91.0% 213 9.9% 234
Department of Agriculture (Agricultural Research Service, National Institute of Food and Agri-
culture, Economic Research Service) ...2,188 -19.8% 1,754 11.3% 1,953
National Science Foundation (biological sciences, bioengineering, behavioral sciences,
computer and information science and engineering) ...1,753 0.4% 1,760 17.9% 2,075
Department of Energy (biological and environmental research, advanced scientific computing
research) ...1,037 -3.1% 1,005 1.5% 1,020
Environmental Protection Agency (clean air, clean water, health and human ecosystems,
pesticides and toxics) ...596 -2.3% 582 -2.4% 568
National Institute of Standards and Technology ...588 -9.5% 532 4.7% 557 Department of Veterans Affairs (medical and prosthetic research) ...581 -0.2% 580 0% 580
Agency for Healthcare Research and Quality ...420 -5.2% 398 -1.0% 394 Centers for Disease Control and Prevention (disease control, research and training) ..363 25.9% 457 -10.7% 408
Food and Drug Administration ...248 2.4% 254 59.8% 406 NASA (Human Research Program) ...182 -14.8% 155 1.9% 158
U.S. Agency for International Development...158 0% 158 19.0% 188 Administration for Children and Families (children’s research)...43 -4.7% 41 -75.6% 10
Ctrs. for Medicare & Medicaid Services (health services research, demonstration, evaluation) ..27 33.3% 36 -47.1% 21
Health Resources and Services Administration ...8 42.9% 12 0% 12 Patient Centered Outcomes Research Institute...— — 1 700% 8
National Institutes of Health
Office of Extramural Research
SMALL BUSINESS INNOVATION
RESEARCH (SBIR) PROGRAM
Set-aside program for small business concerns to
engage in Federal R&D – with potential for
commercialization
SMALL BUSINESS TECHNOLOGY
TRANSFER (STTR) PROGRAM
Set-aside program to facilitate cooperative R&D
between small business concerns and U.S. research
institutions – with potential for commercialization
0.40%
2.9%
SBIR/STTR
NCI
NIAID
NHLBI
NIGMS
NIDDK
NINDS
NIMH
NICHD
NIA
NIDA
NEI
NCATS
NIEHS
NIAMS
NHGRI
NIAAA
NIDCD
NIDCR
NIBIB
NIMHD
ORIP
NINR NCCAM
NLM
2.8% SBIR $663M
0.40% STTR $95M
Total FY2014 $758M
FY15 pending
National Institutes of Health
Office of Extramural Research
PHASE II
Full Research/R&D
$1M (SBIR), $1M (STTR) over two years
PHASE IIB
Competing Renewal/R&D
Clinical R&D; Complex Instrumentation/Tools to FDA
Many, but not all, ICs participate
Varies ~$1M/year; 3 years
PHASE III
Commercialization Stage
NIH, generally, not the “customer”
Consider partnering and exit strategy early
PHASE I
Feasibility Study
Budget Guide: $150K (SBIR); $150K (STTR) Total Costs
Project Period: 6 months (SBIR); 1 year (STTR)
NIH SBIR/STTR
3-Phase Program
National Institutes of Health
Office of Extramural Research
Award is always made
to Small Business Concern
SBIR and STTR
Critical Differences
SBIR
STTR
Partnering
Requirement
Permits
partnering
Requires
a non-profit
research institution partner
Principal
Investigator
Primary employment
(>50%)
must
be with the
small business
PI may be employed
by
either
the research institution
partner or small business
Work
Requirement
May outsource up to 33%
(Phase I), 50% (Phase II)
40% Small Business
30% Research
National Institutes of Health
Office of Extramural Research
Success Rates Posted Online:
http://report.nih.gov/success_rates/index.aspx
34.4%
20.3%
39.4%
28.6%
18.7%
26.4%
Fast Track
Phase I
Phase II
2012
2013
STTR
15.9%
15.6%
39.9%
15.7%
13.2%
32.8%
Fast Track
Phase I
Phase II
SBIR
Success Rate of SBIR/STTR
2012 and 2013 by Phase
National Institutes of Health
Office of Extramural Research
•
NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation
Release: January
Standard Due Dates: April 5, August 5,
December 5
(AIDS/AIDS-related: May 7, September 7,
January 7
)
•
SBIR Contract Solicitation (NIH, CDC)
Release: August 15, 2014 November
5, 2014
close date
•
NIH Guide for Grants and Contracts
Release: Weekly Receipt dates specified in each FOA
(
http://grants.nih.gov/grants/guide/index.html
)
“Parent” FOAs:
SBIR:
PA-14-071
STTR:
PA-14-072
National Institutes of Health
Office of Extramural Research
•
Talk to an NIH Program Officer about your
application and
SUBMIT EARLY (days not hours
and minutes)
!
Program Officer contact information found in the NIH
SBIR/STTR Solicitation on
http://sbir.nih.gov
Questions about who to contact? Email
sbir@od.nih.gov
National Institutes of Health
Office of Extramural Research
Michelle M. Timmerman, Ph.D.
Director, AREA Program
National Institutes of Health
INBRE PI/PC Meeting
September 25, 2014
National Institutes of Health
Office of Extramural Research
Key features
• Project period is limited to 3 years
• Direct cost limited to $300,000 over entire
project period
• Multiple PIs are allowed, if all eligible
• Research Strategy limited to 12 pages
• Grants are renewable
• Preliminary data not re
quir
ed but can be
provided
• Can’t be PI on another NIH research grant at
time of award
National Institutes of Health
Office of Extramural Research
PI Eligibility
• Primary appointment at eligible institution
• Not OK:
– Also serve as PI of other NIH research grants
at time of award
– Also serve as Multiple PI on another NIH
research grant at time of award
• OK:
– Be Key Personnel on another grant
– Have a grant from another agency
National Institutes of Health
Office of Extramural Research
Institutional eligibility
•
Can a satellite campus be considered
separately from the flagship?
• Where is degree issued?
– At level of flagship campus = not considered
separately
– At level of satellite campus = considered
separately
National Institutes of Health
Office of Extramural Research
R15 limits consider inflation
FY
DC limit/3 years
Institutional
cap
FY 85
$50 K (2 years)
FY 96
$75 K
$2 million
FY 99
$100 K
$2 million
FY 03
$150 K
$3 million
ARRA (FY10) &
Parent FY11 onward
$300 K
$6 million
15
FY11
• ICs R15 spending doubled compared to FY09
• ~50% increase in # of applications (sustained)
• 200 newly eligible institutions (100 from cap increase)
• 15% of applications
Currently (April 2014 – March 2015)
National Institutes of Health
Office of Extramural Research
unique review criteria
• PA-12-006 & PA-13-313
• Significance
– Strengthen research environment?
– Expose students to research?
• Investigator
– Experience supervising students in research?
• Approach
– Can project stimulate students’ interest so they
consider biomedical/behavioral science career?
• Environment
– Well qualified students available?
– Have or likely will students pursue biomedical/
behavioral science careers?
National Institutes of Health
Office of Extramural Research
Advice for Grants Offices
• Understand the NIH extramural research program
– Know guidelines, deadlines, submission & correction
process, and review criteria
• Make a commitment to establishing an environment
in which research can succeed
– Start up packages for equipment and supplies
– Pilot grants, student research grants
– Credit for student involvement in research
• Consider the importance of collaborative research in
establishing a successful research environment
National Institutes of Health
Office of Extramural Research
More Advice for Grants Offices
• Do not pressure investigators to apply if their
projects are not ready for peer review
– Quality over quantity; submit best application
– “Get some feedback from the reviewers”
• Help investigators with the “Facilities and Other
Resources” section of application
– Profile of student body
– Description of the institution and research environment
– Letter of institutional commitment to research project
National Institutes of Health
Office of Extramural Research
Strategies of Successful PIs
• Include a collaborator with a well-
justified role
if you
don’t have the necessary expertise or resources
• Understand the review criteria and the review
criteria questions
– Each question should be addressed in the
application
• In A1, respond thoroughly and diplomatically to all of
the reviewer comments
• AREA grant is research award, not training award
– Focus on hands-on research not course work
– Describe PI’s role in research & supervision
National Institutes of Health
Office of Extramural Research
More Strategies of Successful PIs
• Address the AREA-specific programmatic goals
in the application
– Support meritorious research
• Research should contribute to the field
• Results should be publishable
– Expose students to research
• Profile of available and former students at the institution
• Experience of the investigator in working with students
• How students will be incorporated into the research project
• How students will benefit from this research experience
– Strengthen the research environment
• The suitability of the institution for an award
• The impact the AREA grant will have on the institution
• Involve freshman & sophomores
National Institutes of Health
Office of Extramural Research
Current Opportunity
FYI - please share this R15 AREA FOA with interested PUI faculty in your INBRE
networks. Thanks,
NIMHD Academic Research Enhancement Award: Enhancing Health Disparities
Research at Undergraduate Institutions (R15)
(RFA-MD-15-002)
National Institute on Minority Health and Health Disparities
Application Receipt Date(s): January 12, 2015
The NIMHD encourages institutions that are eligible to apply for support through
the NIH Academic Research Enhancement Awards (AREA) program to submit
applications for innovative research projects focused on minority health and health
disparities. Awards are intended to support small-scale projects proposed by faculty
members at eligible institutions to expose students to meritorious research and to
strengthen the research environment of participating institutions. This initiative also
seeks to stimulate interest in health disparities research careers among
undergraduate students through hands-on participation in original research. - See
more at:
http://grants.nih.gov/grants/guide/rfa-files/RFA-MD-15-002
.
National Institutes of Health
Office of Extramural Research
