SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY 
TRANSFER (STTR) GRANT PROGRAMS

RELEASE DATE:  January 6, 2004

NOTICE:  NOT-OD-04-016

National Institutes of Health (NIH)
Centers for Disease Control and Prevention (CDC)
Food and Drug Administration (FDA)

SBIR/STTR Grant Application Submission Dates: 
April 1, 2004
August 1, 2004
December 1, 2004

AIDS and AIDS-related SBIR/STTR Grant Application Submission Dates: 
May 1, 2004
September 1, 2004
January 2, 2005

The purpose of this notice is to (1) announce the issuance of the 
SOLICITATION of THE NATIONAL INSTITUTES OF HEALTH (NIH), CENTERS for 
DISEASE CONTROL AND PREVENTION (CDC), and FOOD AND DRUG ADMINISTRATION 
FDA) for SMALL BUSINESS INNOVATION RESEARCH (SBIR) and SMALL BUSINESS 
TECHNOLOGY TRANSFER STTR) GRANT APPLICATIONS (PHS 2004-2) and (2) 
inform the public about the opportunities that the SBIR/STTR programs 
offer to small business concerns. The NIH, CDC, and FDA invite eligible 
small business concerns to submit Phase I grant applications for the 
Calendar Year (CY) 2004 SBIR program and, applicable to NIH only, for 
the STTR program. 

United States small business concerns that have the research 
capabilities and technological expertise to contribute to the research 
or research and development (R/R&D;) mission(s) of the NIH, CDC and the 
FDA awarding components identified in this solicitation are encouraged 
to submit SBIR/STTR grant applications in response to identified 
topics. Applicants may also consider “other” areas of research within 
the mission of an Institute/Center (IC) and submit an investigator-
initiated SBIR/STTR application.

The submission dates for grant applications in response to the PHS 
2004-2 are noted above. Effective with the release of the PHS 2004-2 
Solicitation, CDC will accept SBIR applications for the SAME THREE 
dates as NIH and FDA: April 1, August 1, and December 1.

Eligibility requirements, definitions, application procedures, review 
considerations, application forms and instructions, and other pertinent 
information are contained in the PHS 2004-2 OMNIBUS SOLICITATION of the 
NATIONAL INSTITUTES of HEALTH, CENTERS for DISEASE CONTROL and 
PREVENTION, and FOOD AND DRUG ADMINISTRATION for SMALL BUSINESS 
INNOVATION RESEARCH (SBIR) and SMALL BUSINESS TECHNOLOGY TRANSFER 
(STTR) GRANT APPLICATIONS.   

The solicitation, including application forms, is available 
electronically from the NIH "Small Business Funding Opportunities" home 
page. See http://grants.nih.gov/grants/funding/sbir.htm.
The SBIR and STTR legislation requires the Public Health Service (PHS), 
Department of Health and Human Services, and certain other federal 
agencies to reserve 2.5 percent of their extramural R/R&D; budgets for 
an SBIR program and 0.3% of their extramural R/R&D; budgets for an STTR 
program. The PHS SBIR and STTR set-aside requirements for FY 2004 are 
estimated to be $600 million.

The goals of the SBIR and STTR programs are to stimulate technological 
innovation in the private sector, strengthen the role of small business 
concerns in meeting Federal research and development needs, increase 
the commercial application of federally supported research results, and 
foster and encourage participation by socially and economically 
disadvantaged persons and women-owned small businesses in technological 
innovation. The STTR program further expands the goals through 
cooperative R/R&D; carried out between small business concerns and 
research institutions. Innovative technologies and methodologies fuel 
progress in biomedical and behavioral research and represent an 
increasingly important area of the economy.  The SBIR and STTR programs 
provide support for R/R&D; of new technologies and methodologies that 
have the potential to succeed as commercial products, processes or 
services.

The SBIR and STTR programs consist of three phases:

PHASE I: The objective of Phase I is to establish the technical merit 
and feasibility of the proposed R/R&D; efforts and to determine the 
quality of performance of the small business grantee organization prior 
to providing further Federal support in Phase II. Preliminary data is 
not required.  SBIR/STTR Phase I awards normally may not exceed 
$100,000 total costs (direct costs, Facilities & Administrative [F&A;] 
costs, and fee) for a period normally not to exceed 6 months (SBIR) or 
one year (STTR). For SBIR projects, the total amount of all contractual 
costs and consultant fees normally may not exceed 33% of the total 
costs requested. For STTR projects, the small business must perform a 
minimum of 40% of the R/R&D; and the single partnering U.S. research 
institution must perform a minimum of 30% of the R/R&D.;  

PHASE II: The objective of Phase II is to continue the R/R&D; efforts 
initiated in Phase I. Funding shall be based on several factors 
including the feasibility results of Phase I, scientific and technical 
merit, and commercial potential of the Phase II application. SBIR/STTR 
Phase II awards normally may not exceed $750,000 in total costs (direct 
costs, F&A; costs, and fee) for a period normally not to exceed 2 years. 
Only Phase I grantees are eligible to obtain Phase II funding, and only 
one Phase II award may be made for a single SBIR/STTR project. 

Not all types of biomedical and behavioral research can be completed 
within the statutory award amounts for Phase I ($100,000) or Phase II 
($750,000) and statutory project periods (six months for Phase I; two 
years for Phase II). Applicants are encouraged to propose a budget and 
project period that is reasonable and appropriate for completion of the 
research project.  Deviations from the statutory guidelines MUST be 
well justified and must be discussed with appropriate NIH staff listed 
below. Note: CDC and FDA do NOT make awards greater than the stated 
guidelines.)

PHASE III: The objective of Phase III is for the small business concern 
to pursue with non-SBIR/STTR funds (either Federal or non-Federal) the 
commercialization objectives resulting from the results of the research 
or R&D; funded in Phases I and II. In some Federal agencies, Phase III 
may involve follow-on, non-SBIR/STTR funded R&D;, or production 
contracts for products or processes intended for use by the U.S. 
Government.

INQUIRIES

Applicants are strongly encouraged to contact NIH program staff named 
below prior to submitting an SBIR/STTR grant application for 
information regarding research topics. 

National Institute on Aging
http://www.nia.nih.gov
Dr. Michael-David A.R.R. Kerns 
Phone: 301-496-9322 
Fax:   301-402-2945 
Email: mk417e@nih.gov

National Institute on Alcohol Abuse and Alcoholism
http://www.niaaa.nih.gov 
Dr. Karen Peterson 
Phone: 301-451-3883 
Fax:   301-443-6077 
Email: kpeterso@mail.nih.gov

National Institute of Allergy and Infectious Diseases
http://www.niaid.nih.gov
Dr. Gregory Milman 
Phone: 301-496-8666 
Fax:   301-402-0369 
Email: gmilman@niaid.nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases
http://www.niams.nih.gov/
Dr. Cheryl Kitt  
Phone: 301-594-2463 
Fax:   301-480-4543 
Email: kittc@mail.nih.gov

National Institute of Biomedical Imaging and Bioengineering
http://www.nibib.nih.gov/
Mr. Todd Merchak 
Phone: 301-496-8592 
Fax:   301-480-1614 
Email: merchakt@mail.nih.gov

National Cancer Institute
http://www.nci.nih.gov
Ms. Connie Dresser 
Phone: 301-435-2846 
Fax:   301-480-2087 
Email: cd34b@nih.gov  

National Institute of Child Health and Human Development
http://www.nichd.nih.gov
Dr. Louis A. Quatrano 
Phone: 301-402-4221 
Fax:   301-402-0832 
Email: lq2n@nih.gov

National Institute on Drug Abuse
http://www.nida.nih.gov
Dr. Cathrine Sasek 
Phone: 301-443-6071 
Fax:   301-443-6277 
Email: csasek@nih.gov

National Institute on Deafness and Other Communication Disorders
http://www.nidcd.nih.gov
Dr. Lynn E. Luethke 
Phone: 301-402-3458 
Fax:   301-402-6251 
Email: luethkel@nidcd.nih.gov

National Institute of Dental and Craniofacial Research
http://www.nidcr.nih.gov
Dr. Eleni Kousvelari 
Phone: 301-594-2427 
Fax:   301-480-8318 
Email: kousvelari@de45.nidr.nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases
http://www.niddk.nih.gov
Dr. Sanford A. Garfield 
Phone: 301-594-8803 
Fax:   301-402-6271 
Email: sg50o@nih.gov

National Institute of Environmental Health Sciences
http://www.niehs.nih.gov
Dr. Jerrold Heindel 
Phone: 919-541-0781 
Fax:   919-541-5064 
Email: heindelj@niehs.nih.gov

National Eye Institute
http://www.nei.nih.gov
Dr. Ralph Helmsen 
Phone: 301-451-2020 
Fax:   301-402-0528 
Email: rjh@nei.nih.gov 

National Institute of General Medical Sciences
http://www.nigms.nih.gov/
Dr. Peter Preusch 
Phone: 301-594-5938 
Fax:   301-480-2802 
Email: preuschp@nigms.nih.gov

National Heart, Lung, and Blood Institute
http://www.nhlbi.nih.gov
Ms. Susan Pucie 
Phone: 301-435-0079 
Fax:   301-480-0867 
Email: sp34j@nih.gov

National Human Genome Research Institute
http://www.genome.gov 
Dr. Bettie J. Graham 
Phone: 301-496-7531 
Fax:   301-480-2770 
Email: bg30t@nih.gov

National Institute of Mental Health
http://www.nimh.nih.gov
Dr. Michael F. Huerta 
Phone: 301-443-3563 
Fax:   301-443-1731 
Email: mhuert1@mail.nih.gov

National Institute of Neurological Disorders and Stroke
http://www.ninds.nih.gov
Dr. Thomas Miller 
Phone: 301-496-1779 
Fax:   301-402-1501 
Email: tm208y@nih.gov

National Institute of Nursing Research
http://www.nih.gov/ninr
Dr. Yvonne Bryan 
Phone: 301-594-6908 
Fax:   301-480-8260 
Email: yb5y@nih.gov

National Center for Research Resources
http://www.ncrr.nih.gov
Dr. Louise E. Ramm 
Phone: 301-435-0879 
Fax:   301-480-3658 
Email: lr34m@nih.gov 

National Center for Complementary and Alternative Medicine
http://nccam.nih.gov
Dr. Shan Wong 
Phone: 301-496-7498 
Fax:   301-480-3621 
Email: sw196c@nih.gov

National Center on Minority Health and Health Disparities
http://www.ncmhd.nih.gov
Mr. Vincent Thomas, MSW, MPA 
Phone: 301-402-2516 
Fax:   301-480-4049 
Email: vt5e@nih.gov

National Library of Medicine
http://www.nlm.nih.gov
Dr. Milton Corn 
Phone: 301-496-4621 
Fax:   301-402-2952 
Email: cornm@mail.nlm.nih.gov

Centers for Disease Control and Prevention (CDC)
http://www.cdc.gov
Mr. Curtis L. Bryant  
Phone: 770-488-2806 
Fax:   770-488-2828 
Email: ckb9@cdc.gov

Food and Drug Administration (FDA)
http://www.fda.gov
Ms. Rosemary Springer 
Phone: 301-827-7182 
Fax:   301-827-7106 
Email: rspringe@oc.fda.gov


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