SMALL BUSINESS INNOVATION RESEARCH PROGRAM 

NIH GUIDE, Volume 25, Number 30, September 6, 1996

 

P.T. 34



Keywords:

  Biomedical Research, Multidiscipl 

 

National Institutes of Health

Centers for Disease Control and Prevention

 

Contract Proposal Receipt Date:  November 5, 1996

 

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 or

improved technologies and methodologies that have the potential to

succeed as commercial products.

 

The purpose of this notice is to (1) announce the issuance of the

"Solicitation of the Public Health Service for Small Business

Innovation Research (SBIR) Contract Proposals (PHS 97-1)" with a due

date for receipt of proposals of November 5, 1996; and (2) inform the

public about the opportunities that the SBIR program offers to small

business concerns as well as to scientists at research institutions,

including colleges and universities.  Beginning October 1, 1996 (FY

1997) through FY 2000, Public Law 102-564, dated October 28, 1992,

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 research or R&D budgets for an SBIR

program.  The PHS SBIR set-aside requirement for FY 1997 is estimated

to be $230-$240 million.

 

The offeror organization must be a small business concern, and the

PRIMARY EMPLOYMENT of the principal investigator MUST be with the

small business concern 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

subcontractual 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(s) at a research institution; for the

scientist(s) at a research institution, this team effort provides

support for R&D not otherwise obtained.

 

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 research or R&D efforts and the

quality of performance of the small business concern, before

consideration of further Federal support in Phase II.

 

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 proposal.  Only Phase I

contractors are eligible to apply for Phase II funding, and Phase II

proposals may be submitted upon the request of the Contracting

Officer ONLY.  (However, see ~Fast-Track~ Pilot 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.

 

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

 

PHASE I:  Normally, awards may not exceed $100,000 for direct costs,

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

exceed six months.

 

PHASE II: Normally, awards may 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 two-year Phase II project may

not cost more than $750,000 for that project.  Only one Phase II

award may be made for any SBIR project.

 

"FAST-TRACK" PILOT INITIATIVE (Applicable only to proposals submitted

to National Institutes of Health [NIH])

 

Fast-Track is a parallel review option available to those small

business concerns (offeror organizations) whose proposals satisfy

additional criteria which enhance the probability of the project's

commercial success.  Proposals that do not meet these criteria may be

redirected for review through the standard review procedures

described in the PHS SBIR Contract Solicitation under section VIII,

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 proposals for both Phase I and Phase II must be

submitted together for concurrent initial peer review and evaluation.

To Identify the proposals as Fast-Track, check the box marked "Yes"

next to the words "Fast-Track Proposal" shown on the Phase I Proposal

Cover Sheet (Appendix A).  The Phase I proposal 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 proposal from Fast-Track review, retaining it for Phase I

consideration only.  The peer review committee will evaluate the

goals and may suggest other milestones that should be achieved prior

to the Phase II award.  The Phase I and Phase II proposals will be

scored individually and the scores for both phases totaled.

Following the initial peer review, Fast-Track proposals may receive

secondary review by the program staff of the respective NIH awarding

component.

 

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

 

Fast-Track Phase II proposals may be funded following submission of

the Phase I progress report and other documents necessary for

continuation.  Phase II proposals will be selected for award based on

the project's scientific and technical merit of the proposed Phase II

research; the awarding component's assessment of the Phase I progress

report and determination that the Phase I objectives were met and

feasibility demonstrated; the potential of the proposed research for

technological innovation; and the availability of funds.  (See

section VIII of the PHS SBIR Contract Solicitation for discussion of

the Technical Evaluation Criteria.)

 

SBIR contract proposals submitted to the NIH are eligible for the

Fast-Track review process upon meeting the following criteria:

 

1.  The Phase II proposal 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 contract.  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 proposal.

 

2.  The COMMITMENT APPENDIX must specify the amount of funds and/or

the 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 II 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 proposal 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 proposal 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.

 

Following are the research topics contained in the SOLICITATION OF

THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH

(SBIR) CONTRACT PROPOSALS (PHS 97-1) for the proposal receipt date of

November 5, 1996:

 

NATIONAL INSTITUTES OF HEALTH

 

NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA)

o  Antibodies to peptides and proteins mediating alcohol-related

behaviors (from DBR);

 

NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

(NIAMS)

o  Markers of Osteoarthritis

 

NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

(NIDDK)

o  Assays for Identification of High Risk Individuals for the

Development of Insulin Dependent Diabetes (IDDM)

o  Transplantation of Human Islets or Beta Cells

o  Improved Methods for Production of Clinical Gene Therapy Vectors

for Diseases of Interest to NIDDK

o  Development of Materials for Screening and Recruitment of Clinical

Trial Participants

o  Self-study Materials for Achieving Intensive Management of

Glycemic Levels

o  Methods to Detect and Quantify Kidney Damage

o  Acute Renal Failure

o  New Noninvasive Body Iron Test

 

NATIONAL INSTITUTE ON DRUG ABUSE (NIDA)

o  Drug Supply Services Support

o  Develop Animal Model(s) with Compromised Immune Function Induced

by Abused Drug(s) to  Screen Potential HIV/AIDS Medicating Agents

o  Develop Animal Models to Assess the Potential for Genetic

Predisposition or Increased Sensitivity to Cardiovascular

Complications Associated with Abused Substance(s)

o  Computerized Neuropsychological Testing Software

o  Development of a Computerized Problem Oriented Screening

Instrument for Teenagers (Posit)

o  Development of Improved HIV Risk Reduction Questionnaire and

Interview

o  Questionnaires or Brief Interviews for Assessment of Drug Abuse in

Individuals Seen in Primary Health Care Settings

o  Handbook for Conducting Drug Abuse Research with Ethnic/Racial

Minority Populations

o  International Drug Abuse Epidemiology Data Bank

 

NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS):

o  Development of a Transgenic Teleost Animal Model for Assessing

Mutagenesis

o  Better Nitrone Spin Traps for Oxygen-Centered Radicals

o  Commercialization of Laboratory Methods for Assessing the Genetic

Responses to Chemicals

o  Device/Capability for Quantitative Assessment of Bone Strength in

Rodents

o  Methods for Assessing the Estrogenicity and Other Endocrine

Activity of Environmental Chemicals

o  Development of Device and Procedure for Collecting DNA by Mail

with a Cheek Swab

 

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI)

o  Stage- and Tissue-Specific Animal Models of Hemophilia

o  Radio-frequency Coils for High Field MRI

o  ECG Monitoring in MRI to Detect Cardiac Ischemia

 

NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS)

o  Animal Models

o  Models for Screening Antiepileptic and Antiepileptogenic Therapy

o  Alertness Measures

o  Improved EEG/ICU/OR Interface

o  Medication Dispensing Monitor

o  Improving Magnetic Resonance Imaging to Evaluate the Central

Nervous System of Critically-ill Neonates

o  Development of Neuronal Pluripotential Neuronal Stem Cells

o  Quantitative Tremor Measurement

o  Inducible Knockout Technology

o  Genome Scanning

o  Direct Gene Transfer

 

NATIONAL CENTER FOR RESEARCH RESOURCES (NCRR)

o  General Software Tools for Biomedical Research

 

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

 

NATIONAL CENTER FOR HEALTH STATISTICS (NCHS)

 

o  Electronic Death Registration System Prototype

 

NATIONAL IMMUNIZATION PROGRAM (NIP)

o  Design a Multi-channel, Needleless Injector Device to Administer

Vaccines

 

PUBLIC HEALTH PRACTICE PROGRAM OFFICE (PHPPO)

o  Distance Learning (DL) Support Technology.

 

INQUIRIES

 

Eligibility requirements, definitions, submission procedures, review

considerations, contract proposal forms and instructions, and other

pertinent information, including the "Fast-Track" Pilot Initiative,

are contained in the Solicitation of the PHS for SBIR Contract

Proposals for the proposal receipt date of November 5, 1996, which

will be available electronically on or about September 6, 1996,

through the NIH Home Page at: HTTP://WWW.NIH.GOV.

 

A limited number of hard copies of the Solicitation will be available

on or about September 13, 1996, from:

 

PHS SBIR/STTR Solicitation Office

13687 Baltimore Avenue

Laurel, MD  20707-5096

Telephone:  (301) 206-9385

FAX:  (301) 206-9722

Email:  a2y@cu.nih.gov

 

Those interested in the PHS SBIR GRANT program may access --

electronically -- the OMNIBUS SOLICITATION OF THE PUBLIC HEALTH

SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) GRANT

APPLICATIONS for the calendar year 1996 receipt dates of April 15,

August 15, and December 15 (same dates each year) at:

HTTP://WWW.NIH.GOV:80/GRANTS/OEP/SBIR/SBIR962.HTM.  The "Fast-Track"

review option is a pilot initiative for SBIR grant applications also.

 

Hard copies of the PHS SBIR GRANT Solicitation may be obtained from

the PHS SBIR/STTR Solicitation Office at the address above.  See also

the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 25, Number 7, March 8,

1996.

 

.


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