Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Programs

Notice Number: NOT-OD-05-027 (See addendum, NOT-OD-05-031)

Key Dates
Release Date: January 14, 2005

Issued by
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, 2005
August 1, 2005
December 1, 2005

AIDS and AIDS-related SBIR/STTR Grant Application Submission Dates:
May 1, 2005
September 1, 2005
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) 2005 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 2005-2 are noted above.

Eligibility requirements, definitions, application procedures, review considerations, application forms and instructions, and other pertinent information are contained in the PHS 2005-2 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

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 2005 are estimated to be $630 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.


Applicants are strongly encouraged to contact NIH staff listed in the Awarding Component/Agency Contact Information Table (PDF or MS Word) prior to submitting an SBIR/STTR grant application for information regarding research topics.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.