SMALL BUSINESS INNOVATION RESEARCH AND SMALL BUSINESS TECHNOLOGY TRANSFER 
GRANT PROGRAMS

Release Date:  January 12, 2000

NOTICE:  OD-00-012

National Institutes of Health
Centers for Disease Control and Prevention
Food and Drug Administration

Annual SBIR/STTR Grant Application Receipt Dates:  

National Institutes of Health (SBIR and STTR)
April 1, 2000, August 1, 2000, and December 1, 2000

Centers for Disease Control and Prevention (SBIR only)
December 1, 2000

Food and Drug Administration (SBIR only)
April 1, 2000, August 1, 2000, and December 1, 2000

Innovative technologies and methodologies fuel progress in biomedical 
and behavioral research and represent an increasingly important area of 
the economy.  The Small Business Innovation Research (SBIR) program and 
the Small Business Technology Transfer (STTR) program provide support 
for research and development (R&D) of new technologies and 
methodologies which have the potential to succeed as commercial 
products.

The SBIR and STTR programs stimulate technological innovation in the 
private sector by strengthening the role of small business concerns in 
meeting Federal research and development needs, increasing the 
commercial application of federally supported research results, and 
fostering and encouraging participation by socially and economically 
disadvantaged persons and women-owned small businesses in technological 
innovation. The STTR program further expands the goals through 
cooperative research and development carried out between small business 
concerns and research institutions.

The purpose of this notice is to inform the public about the special 
opportunities that the SBIR/STTR programs offer to small business 
concerns as well as to scientists at research institutions, including 
colleges and universities.

The National Institutes of Health (NIH), Centers for Disease Control 
and Prevention (CDC), and Food and Drug Administration (FDA) invite 
eligible small business concerns to submit Phase I applications for the 
Calendar Year (CY) 2000 Small Business Innovation Research (SBIR) 
program and, applicable to NIH only, for the CY 2000 Small Business 
Technology Transfer (STTR) program. 

In the past, NIH has issued separate SBIR and STTR Grant Solicitations.  
Because of the similarities between the two solicitations, both in 
research topics that may be of interest to small businesses and in 
application instructions, a single Omnibus Solicitation of the NIH, 
CDC, and FDA for SBIR/STTR Grant Applications will be issued for 
coincident CY 2000 grant application receipt dates of April 1, August 1 
and December 1.  

The significant difference between the SBIR and STTR programs is that 
the STTR requires researchers at universities and other non-profit 
research institutions to have a formal collaboration with the small 
business concern and play a significant intellectual role in the 
conduct of each STTR project. 

The SBIR or STTR applicant organization must be a small business 
concern, and, under the SBIR Program, the primary employment of the 
principal investigator must be with the small business at the time of 
award and during the conduct of the proposed project. Under the STTR 
program, the Principal Investigator may be from the small business 
concern or the research institution.  In addition, a Principal 
Investigator from the research institution is not required to be 
employed by the small business concern. 

In accord with the intent of the SBIR program to increase private 
sector commercialization of innovations derived from federal R&D, 
scientists at research institutions can play an important role in an 
SBIR project by serving as consultants and/or subcontractors to the 
small business concern.  Normally, up to one-third of the Phase I 
budget may be spent on consultant and/or contractual costs, and up to 
one-half of the Phase II budget may be spent on such costs.  In this 
manner, a small business concern with limited expertise and/or research 
facilities may benefit from teaming with a scientist at a research 
institution, for the scientist at a research institution, this team 
effort provides support for R&D not otherwise obtained.

The Small Business Innovation Research (SBIR) program was established 
by the Small Business Research and Development Enhancement Act of 1992.  
Current legislation (Public Law 102-564, signed October 28, 1992) 
requires the National Institutes of Health (NIH), the Centers for 
Disease Control and Prevention (CDC), and the Food and Drug 
Administration (FDA), Public Health Service (PHS), Department of Health 
and Human Services, and certain other federal agencies, to set-aside 
2.5 percent of their extramural budgets for an SBIR program each year 
through fiscal year 2000. Under this program, agencies of the Public 
Health Service (PHS), Department of Health and Human Services (HHS), 
and certain other Federal agencies are required to reserve 2.5% of 
their current fiscal year extramural budgets for small companies to 
conduct research or research and development (R/R&D). 

The Small Business Technology Transfer (STTR) program, currently in 
five Federal agencies, was established by the Small Business Technology 
Transfer Act of 1992 (Public Law 102-564, Title II). Under this 
program, 0.15% of a Federal agency"s extramural R/R&D effort is 
reserved for awards to small business concerns and their non-profit 
research institution partners for cooperative research and development 
efforts.

The SBIR and STTR programs consist of three phases:

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 Phase I awards normally may not exceed $100,000 total 
costs (direct costs, indirect costs, and negotiated fixed fee) for a 
period normally not to exceed 6 months. STTR Phase I awards normally 
may not exceed $100,000 total costs for a period of 1 year. For SBIR 
projects, the total amount of all contractual costs and consultant fees 
normally may not exceed 33% of the total costs requested.  

The objective of Phase II is to continue the research or R&D efforts 
initiated in Phase I. Funding shall be based on the results of Phase I, 
scientific and technical merit, and commercial potential of the Phase 
II application. SBIR Phase II awards normally may not exceed $750,000 
in total costs (direct costs, indirect costs, and negotiated fixed fee) 
for a period normally not to exceed 2 years. STTR Phase II awards 
normally may not exceed $500,000 total costs (direct costs, indirect 
costs, and negotiated fixed 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. 
Phase II applications may be submitted either before or after 
expiration of the Phase I budget period, except for those applicants 
electing to concurrently submit Phase I and Phase II applications under 
the Fast-Track procedures. (See “Phase I/Phase II Fast-Track Review 
Option” below.)

Note: The Phase I and Phase II award levels and project periods are 
statutory guidelines.  Therefore, applicants are encouraged to propose 
a budget and project period that is appropriate for completion of the 
research project.  Deviations from the guidelines must be well 
justified.  IN ADDITION, UNDER SPECIAL CIRCUMSTANCES, REQUESTS FOR 
SUPPLEMENTAL FUNDS TO EXISTING PHASE I GRANTS OR REQUESTS FOR AN 
EXTENSION OF THE PERIOD OF SUPPORT WITH FUNDS, WILL BE CONSIDERED.  
(The above applies to NIH ONLY, as CDC and FDA do NOT make awards 
greater than the stated guidelines.)

The objective of Phase III, where appropriate, 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.

Both Phase I and Phase II grant applications -- initial and revised -- 
will be accepted on the application receipt dates identified above.  
However, the NIH will accept no more than two revised (amended) 
applications within a time period of two years from the receipt date of 
the initial, unamended application.

INQUIRIES

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

Eligibility requirements, definitions, application procedures, review 
considerations, application forms and instructions, and other pertinent 
information are contained in the “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.”   

This solicitation, including application forms, is available 
electronically from the NIH"s "Small Business Funding Opportunities" 
home page at http://grants.nih.gov/grants/funding/sbir.htm  on the 
World Wide Web.

A limited number of hard copies of the solicitation for calendar year 
2000 will be produced.  Subject to availability, they may be obtained 
from:

SBIR/STTR Solicitation Office
13687 Baltimore Avenue
Laurel, MD  20707-5096
Telephone:  (301) 206-9385
FAX:  (301) 206-9722
Email:  a2y@cu.nih.gov

Phase I/Phase II Fast-Track Review Option (APPLICABLE TO NIH ONLY)
The SBIR/STTR “Fast-Track” procedures described below are designed to 
expedite the decision and award of Phase II funding for scientifically 
meritorious applications for projects that have a high potential for 
commercialization. Fast-Track is a parallel review option available to 
those small business concerns (applicant organizations) whose 
applications satisfy additional criteria that enhance the probability 
of the project’s commercial success.  Applications that do not meet 
these criteria may be redirected for review through the standard review 
procedures described above.
Fast-Track offers two major advantages:

Concurrent submission and peer review of both Phase I and Phase II 
projects.

Minimal or no funding gap between Phase I and Phase II.

Fast-Track Phase II applications that are recommended for approval may 
be funded following submission of the Phase I progress report and other 
documents necessary for continuation.  Phase II applications will be 
selected for funding based on the project’s scientific and technical 
merit, the awarding component’s assessment of the Phase I progress 
report and determination that the Phase I goals were achieved, an 
update and verification of the Product Development Plan and any 
commitment(s) for funds and/or resources from an investor or partner 
organization, as described below, the project’s potential for meeting 
the mission of the awarding component and for commercial success, and 
the availability of funds.

SBIR/STTR Fast-Track Application Eligibility Criteria and Process 

Identify the application as Fast-Track, by typing the words “Fast-
Track” in Item 2 on the Face Page of the Phase I application.

Prepare and submit both a Phase I and Phase II SBIR/STTR application 
together for concurrent initial peer review and evaluation. (Phase I 
and Phase II application forms and instructions are available 
electronically on the “NIH"s Small Business Funding Opportunities” home 
page found at http://grants.nih.gov/grants/funding/sbir.htm.)

Specify in the Phase I application clear, measurable goals (milestones) 
that should be achieved prior to initiating Phase II.  Failure to 
provide clear, measurable goals may be sufficient reason for the 
scientific peer review group to exclude the Phase II application from 
Fast-Track review.  The scientific peer review group will evaluate the 
goals and may suggest other milestones that should be achieved prior to 
Phase II funding. The Phase I and Phase II applications will receive a 
single rating.  Following the initial peer review, Fast-Track 
applications will receive secondary review by the advisory council or 
board of the NIH awarding component that is the potential funding 
component. 

Submit a concise Product Development Plan (limited to ten pages).  
Label this section clearly and include it as an Appendix to the Phase 
II application addressing each of the following areas:

1. Company information: including size, specialization area(s), 
products with significant sales, and history of previous Federal 
and non-Federal funding, regulatory experience, and subsequent 
commercialization (see Section III of this solicitation for 
definition of “commercialization”).
2. Value of SBIR/STTR project, including lay description of key 
technology objectives, current competition, and advantages 
compared to competing products or services.
3. Commercialization plans, milestones, target dates, market 
analyses of market size, and estimated market share after first 
year sales and after five years.
4. Patent status or other protection of project intellectual 
property.

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.  

BEFORE SUBMITTING APPLICATIONS UNDER THE FAST-TRACK INITIATIVE, 
APPLICANT SMALL BUSINESS CONCERNS AND INVESTIGATORS ARE STRONGLY 
ENCOURAGED TO CONSULT WITH THE NIH PROGRAM STAFF NAMED BELOW FOR 
SPECIFIC DETAILS RELEVANT TO THAT AWARDING COMPONENT.

National Institute on Aging
http://www.nia.nih.gov/
Dr. Miriam F. Kelty
Phone: 301-496-9322
Fax:  301-402-2945
Email: mk46u@nih.gov

National Institute on Alcohol Abuse and Alcoholism
http://www.niaaa.nih.gov
Dr. Michael Eckardt
Phone: 301-443-6107
Fax: 301-443-6077
Email: me25t@nih.gov

National Institute of Allergy and Infectious Diseases
http://www.niaid.nih.gov
Mr. Vincent Thomas
Phone: 301-435-8563
Fax: 301-402-0369
Email: vt5e@nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases
http://www.nih.gov/niams
Dr. Steven J. Hausman 
Phone: 301-594-2463
Fax: 301-480-4543
Email: sh41g@nih.gov

National Cancer Institute
http://www.nci.nih.gov
Dr. Jay George
Phone: 301-496-1550
Fax: 301-496-7807
Email: jg249o@nih.gov

National Institute of Child Health and Human Development
http://www.nichd.nih.gov
Dr. Louis A. Quatrano
Phone: 301-402-2242
Fax: 301-402-0832
Email: lq2n@nih.gov

National Institute on Drug Abuse
http://www.nida.nih.gov
Dr. Cathrine Sasek
Phone: 301-443-1056
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: lh99s@nih.gov

National Institute of Dental and Craniofacial Research
http://www.nidr.nih.gov/
Dr. Joyce Reese
Phone: 301-594-2088
Fax: 301-480-8318
Email: jr55r@nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases
http://www.niddk.nih.gov
Dr. Judith Podskalny
Phone: 301-594-8876
Fax: 301-480-8300
Email: jp53s@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: jh190f@nih.gov

National Eye Institute
http://www.nei.nih.gov
Dr. Ralph Helmsen
Phone: 301-496-5301
Fax: 301-402-0528
Email: rh27v@nih.gov

National Institute of General Medical Sciences
http://www.nigms.nih.gov/
 Dr. Peter Preusch
Phone: 301-594-1832
Fax: 301-480-2802
Email: pp27g@nih.gov

National Heart, Lung, and Blood Institute
http://www.nhlbi.nih.gov
Dr. John T. Watson
Phone: 301-435-0513
Fax: 301-480-1336
Email: jw53f@nih.gov

National Human Genome Research Institute
http://www.nhgri.nih.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: 301-443-5625
Fax: 301-443-1731
Email: mh38f@nih.gov

National Institute of Neurological Disorders and Stroke
http://www.ninds.nih.gov
Dr. Joseph S. Drage
Phone: 301-496-4188
Fax: 301-402-4370
Email: jd66x@nih.gov

National Institute of Nursing Research
http://www.ninr.nih.gov
Dr. Hilary Sigmon
Phone: 301-594-5970
Fax: 301-480-8260
Email: hs38k@nih.gov

National Center for Research Resources
http://www.ncrr.nih.gov
Dr. Louise E. Ramm
Phone: 301-496-6023
Fax: 301-402-0006
Email: lr34m@nih.gov

National Center for Complementary and Alternative Medicine
http://nccam.nih.gov
Dr. Richard Nahin
Phone: 301-496-4792
Fax: 301-402-4741
Email: rn8p@nih.gov

National Library of Medicine
http://www.nlm.nih.gov
Mr. Peter Clepper
Phone: 301-496-4621
Fax: 301-402-0421
Email: pc49n@nih.gov

Centers for Disease Control and Prevention (CDC)
http://www.cdc.gov
Ms. Nina Waters
Phone: 770-488-2805
Fax: 770-488-2847
Email: jvw0@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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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