NIH GUIDE, Volume 25, Number 7, March 8, 1996


P.T. 34


  Grants Administration/Policy+ 


National Institutes of Health

Centers for Disease Control and Prevention

Food and Drug Administration


Application Receipt Dates:  April 15, August 15, December 15, 1995

(same dates each calendar year)


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.


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),

Department of Health and Human Services, and certain other federal

agencies, to reserve a specified amount of their extramural research

or R&D budgets for an SBIR program.  In fiscal year 1996, 2.0 percent

of the extramural budget is reserved for the SBIR program, amounting

to nearly $184 million at NIH alone; in fiscal years 1997 and beyond,

the SBIR set aside requirement becomes 2.5 percent of the extramural



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" PILOT



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"



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.


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


PHASE I:  Awards should not exceed $100,000 for direct costs,

indirect costs, and negotiated fixed fee for a period normally not to

exceed six months.


PHASE II:  Awards should not exceed $750,000 for direct costs,

indirect costs, and negotiated fixed fee for a period normally not to

exceed two years, that is, generally, a 2-year project should not

cost more than $750,000 for that project.  A Phase I award must have

been received in order to obtain a Phase II award.




Eligibility requirements, definitions, application procedures, review

considerations, application forms and instructions, and other

pertinent information are contained in the OMNIBUS SOLICITATION OF






MTL, Inc.

13687 Baltimore Avenue

Laurel, MD  20707-5096

Telephone:  (301) 206-9385

FAX:  (301) 206-9722



The Omnibus Solicitation will be available through the NIH Home Page

( in the near future.


The Omnibus Solicitation contains numerous staff contact points for

discussion of research program interests pertaining to the NIH, CDC,

and FDA awarding components participating in the SBIR grant program.




The following NIH awarding components are inaugurating a Fast-Track

pilot initiative to expedite the decision and award of SBIR Phase II

funding for scientifically meritorious applications for projects that

have a high potential for commercialization:


National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Cancer Institute (NCI)

National Institute of Child Health and Human Development (NICHD)

National Institute of Diabetes and Digestive and Kidney Diseases


National Institute of Environmental Health Sciences (NIEHS)

National Institute of General Medical Sciences (NIGMS)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Mental Health (NIMH)

National Center for Human Genome Research (NCHGR)


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 priority score.  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 named above.


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 (priority

score); 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



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



Before submitting applications under the Fast-Track pilot initiative,

applicant organizations and investigators are strongly encouraged to

consult with the program staff named below for specific details

relevant to the particular NIH awarding component.


Dr. Laurie Foudin

National Institute on Alcohol Abuse and Alcoholism

Willco Building, MSC 7003

6000 Executive Boulevard, Suite 402

Bethesda, MD  20892-7003

Telephone:  (301)  443-4224

FAX:  (301)  594-0673



Dr. Gregory Milman

Division of Acquired Immunodeficiency Syndrome

National Institute of Allergy and Infectious Diseases

Solar Building, Room 2C06 - MSC 7620

Bethesda, MD  20892-7620

Telephone:  (301) 496-8378

FAX:  (301) 402-3211



Ms. Jo Anne Goodnight

Division of Cancer Biology

National Cancer Institute

6130 Executive Boulevard, Room 500 - MSC 7380

Bethesda, MD  20892-7380

Telephone:  (301) 496-5307

FAX:  (301) 496-8656



Dr. Danuta Krotoski

National Center for Medical Rehabilitation Research

National Institute of Child Health and Human  Development

6100 Executive Boulevard, Room 2A03 - MSC 7510

Bethesda, MD  20892-7510

Telephone:  (301) 402-2242

FAX:  (301) 402-0832



Mr. John R. Garthune

Division of Extramural Activities

National Institute of Diabetes and Digestive and Kidney Diseases

Building 45, Room 6AS49E - MSC 6600

Bethesda, MD  20892-6600

Telephone:  (301) 594-8842

FAX:  (301) 480-3504



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



Dr. Michael R. Martin

National Institute of General Medical Sciences

Building 45, Room 2AN-32K

45 Center Drive - MSC 6200

Bethesda, MD  20892-6200

Telephone:  (301) 594-3910

FAX:  (301) 480-1852



Dr. John T. Watson

Division of Heart and Vascular Diseases

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, Room 9178 - MSC 7940

Bethesda, MD  20892-7940

Telephone:  (301) 435-0513

FAX:  (301) 480-1336



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



Dr. Carol Dahl

Sequencing Technology Branch

National Center for Human Genome Research

Building 38A, Room 604 - MSC 6050

Bethesda, MD  20892-6050

Telephone:  (301) 496-7531

FAX:  (301) 480-2770




Return to 1996 Index

Return to NIH Guide Main Index

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.