NIH Guide: SMALL BUSINESS INNOVATION RESEARCH PROGRAM

SMALL BUSINESS INNOVATION RESEARCH PROGRAM

Release Date:  February 12, 1998

P.T.

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

Annual Grant Application Receipt Dates:  April 15, August 15, and December 15

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 provides
support for research and development (R&D) of new technologies and
methodologies which have the potential to succeed as commercial products.

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

The applicant organization must be a small business concern, and 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.  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.

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.  In fiscal year 1998, a total
of $268.5 million has been reserved for the SBIR program by these PHS
agencies: NIH - $264.7 million; CDC - $3.3 million; and FDA - $0.5 million.

The SBIR program consists of the following three phases:

PHASE I:  The objective of this phase is to determine the scientific and
technical merit and feasibility and potential for commercialization of the
proposed project and the quality of performance of the small business concern,
before consideration of further federal support in Phase II.  (SEE "FAST-
TRACK" INITIATIVE BELOW.)

PHASE II:  The objective of this phase is to continue the research or R&D
efforts initiated in Phase I.  Funding shall be based on the results of Phase
I and the scientific and technical merit and commercial potential of the Phase
II application.  (SEE "FAST-TRACK" INITIATIVE BELOW.)

PHASE III:  The objective of this phase, where appropriate, is for the small
business concern to pursue, with non-SBIR funds, the commercialization of the
results of the research or R&D funded in Phases I and II.

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.

The amount and period of support for SBIR awards are as follows:

PHASE I:  Normally, the award period for Phase I is for six months and the
statutory guideline is $100,000 for direct costs, indirect costs, and fixed
fee.  However, these award levels are guidelines and NOT ceilings.  Therefore,
APPLICANTS MAY PROPOSE LONGER PERIODS OF TIME AND GREATER AMOUNTS OF FUNDS
NECESSARY FOR COMPLETION OF THE RESEARCH PROJECT.  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.)

PHASE II:   Normally, Phase II is for two years and the statutory guideline is
$750,000 for direct costs, indirect costs, and fixed fee.  However, these
award levels are guidelines and NOT ceilings.  Therefore, APPLICANTS MAY
PROPOSE LONGER PERIODS OF TIME AND GREATER AMOUNTS OF FUNDS NECESSARY FOR
COMPLETION OF THE RESEARCH PROJECT.  IN ADDITION, UNDER SPECIAL CIRCUMSTANCES,
REQUESTS FOR SUPPLEMENTAL FUNDS TO EXISTING PHASE II 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.)

INQUIRIES

Eligibility requirements, definitions, application procedures, review
considerations, application forms and instructions, and other pertinent
information are contained in the "OMNIBUS SOLICITATION OF THE PUBLIC HEALTH
SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH GRANT APPLICATIONS."  This
solicitation, including application forms, is available electronically from
the NIH's "Small Business Funding Opportunities" home page at 
https://grants.nih.gov/grants/funding/sbir.htm  on the World Wide Web.

A limited number of hard copies of the solicitation for calendar year 1998
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:  [email protected]

"FAST-TRACK" INITIATIVE (NIH ONLY)

Fast-Track is a parallel review option available to those small business
concerns (applicant organizations) whose applications satisfy additional
criteria which 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 in the Omnibus Solicitation
under section VII, Method of Selection and Evaluation Criteria.

Fast-Track offers two major advantages:

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

Fast-Track SBIR applications for both Phase I and Phase II must be submitted
together for concurrent initial peer review and evaluation.  In order to
identify the applications as such, the words "Fast-Track" must be shown in
item 2 on the face page of the Phase I application.  The Phase I application
must specify 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 peer review committee to exclude the Phase II
application from Fast-Track review.  The peer review committee 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 respective advisory council or board of the
respective NIH awarding component that is the potential funding component.

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

Fast-Track Phase II applications 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 Commitment and Product Development Plans 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 applications are eligible for the Fast-Track review process upon meeting
the following criteria:

1.  The Phase II application must be accompanied by a commitment(s) for funds
and/or resources for commercialization of the product(s) or service(s)
resulting from the SBIR grant.  Although a specific level of commitment is not
specified, funds or resources matching or greater than the Phase II award are
encouraged.  Any commitment(s) from an investor or partner organization must
be described in a letter of agreement or contract signed by an official of the
investor or partner organization with the authority to legally bind the
organization.  Details of the commitment(s) must be included in a Commitment
Appendix to the Phase II application.

2.  The Commitment Appendix must specify the amount of funds and/or nature of
resources that will be dedicated to activities directly related to the SBIR
project and must describe those activities.  Non-federal commitments may
support additional research and development on the project or activities that
are beyond the scope of federal SBIR funding, such as market research.  The
activities supported by the commitment(s) should begin in Phase II and provide
for a smooth transition into Phase III commercialization.

3.  Because of the risk involved, the commitment(s) may be contingent upon the
small business concern receiving the Phase II award, achieving technical
objectives, and the technology continuing to be scientifically and
economically viable in the marketplace.  Details of commitment contingencies
must be described in the Commitment Appendix.  Withdrawal of the commitment(s)
may be considered sufficient reason by the participating awarding component to
remove the Phase II application from consideration under Fast-Track or
withhold further Phase II support.

4.  The small business concern must submit a concise Product Development Plan
(limited to five pages) as a Product Development Plan Appendix to the Phase II
application addressing each of the following areas:

a.  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.

b.  Value of SBIR project, including lay description of key technology
objectives; current competition; and advantages to competing products or
services.

c.  Commercialization plans, milestones, target dates, market analyses of
market size, and estimated market share after first year sales and after five
years.

d.  Patent status or other protection of project intellectual property.

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.

Dr. Miriam F. Kelty
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C218
Bethesda, MD  20892-9205
Telephone:  (301) 496-9322
FAX:  (301) 402-2945
Email:  [email protected]

Dr. Michael Eckardt
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 402
Bethesda, MD  20892-7003
Telephone:  (301) 443-4224
FAX:  (301) 594-0673
Email: [email protected]

Dr. Gregory Milman
National Institute of Allergy and Infectious Diseases
Solar Building, Room 2C06
Bethesda, MD  20892-7620
Telephone:  (301) 496-8378
FAX:  (301) 402-3211
Email:  [email protected]

Dr. Steven J. Hausman
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Building 31, Room 4C32
Bethesda, MD  20892-2350
Telephone:  (301) 402-1691
FAX:  (301) 480-6069
Email:  [email protected]

Ms. Jo Anne Goodnight
National Cancer Institute
6130 Executive Boulevard, Room 500
Bethesda, MD  20892-7380
Telephone:  (301) 496-5307
FAX:  (301) 496-8656
Email:  [email protected]

Dr. Louis A. Quatrano
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03
Bethesda, MD  20892-7510
Telephone:  (301) 402-2242
FAX:  (301) 402-0832
Email:  [email protected]

Ms. Jeanne Borger
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A-55
Rockville, MD  20857
Telephone:  (301) 443-1056
FAX:  (301) 443-6277
Email:  [email protected]

Dr. Lynn E. Huerta
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C
Bethesda, MD  20892-7180
Telephone:  (301) 402-3458
FAX:  (301) 402-6251
Email:  [email protected]

Dr. Joyce Reese
National Institute of Dental Research
Building 45, Room 4AN-32K
Bethesda, MD  20892-6402
Telephone:  (301) 594-2088
FAX:  (301) 480-8318
Email:  [email protected]

Mr. John R. Garthune
National Institute of Diabetes and Digestive and Kidney Diseases
Building 45, Room 6AS49E
Bethesda, MD  20892-6600
Telephone:  (301) 594-8842
FAX:  (301) 480-3504
Email:  [email protected]

Dr. Michael Galvin
National Institute of Environmental Health Sciences
P.O. Box 12233, MD 3-03, North Campus
Research Triangle Park, NC  27709
Telephone:  (919) 541-7825
FAX:  (919) 541-3843
Email:  [email protected]

Dr. Ralph Helmsen
National Eye Institute
6120 Executive Boulevard, Suite 350
Bethesda, MD  20892-7164
Telephone:  (301) 496-5301
FAX:  (301) 402-0528
Email:  [email protected]

Dr. Michael R. Martin
National Institute of General Medical Sciences
Building 45, Room 2AN-32K
Bethesda, MD  20892-6200
Telephone:  (301) 594-3910
FAX:  (301) 480-1852
Email:  [email protected]

Dr. John T. Watson
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9178
Bethesda, MD  20892-7940
Telephone:  (301) 435-0513
FAX:  (301) 480-1336
Email:  [email protected]

Dr. Bettie J. Graham
National Human Genome Research Institute
Building 38A, Room 613
Bethesda, MD  20892-6050
Telephone:  (301) 496-7531
FAX:  (301) 480-2770
Email:  [email protected]

Dr. Michael F. Huerta
National Institute of Mental Health
5600 Fishers Lane, Room 11-103
Rockville, MD  20857
Telephone:  (301) 443-5625
FAX:  (301) 443-1731
Email:  [email protected]

Dr. Joseph S. Drage
National Institute of Neurological Disorders and Stroke
Federal Building, Room 1016
Bethesda, MD  20892-9190
Telephone:  (301) 496-4188
FAX: (301) 402-4370
Email:  [email protected]

Dr. Mary W. Leveck
National Institute of Nursing Research
Building 45, Room 3AN-12
Bethesda, MD  20892-6300
Telephone:  (301) 594-5968
FAX:  (301) 480-8260
Email:  [email protected]

Dr. Louise E. Ramm
National Center for Research Resources
Building 12A, Room 4009
Bethesda, MD  20892-5662
Telephone:  (301) 496-6023
FAX:  (301) 402-0006
Email:  [email protected]

Mr. Peter Clepper
National Library of Medicine
Building 38A, Room 5S518
Bethesda, MD  20894
Telephone:  (301) 496-4621
FAX:  (301) 402-0421
Email:  [email protected]
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