SMALL BUSINESS INNOVATION RESEARCH PROGRAM 

NIH GUIDE, Volume 26, Number 28, August 22, 1997

 

P.T. 34



Keywords:

  Biomedical Research, Multidiscipl 

 

National Institutes of Health

Centers for Disease Control and Prevention

 

Contract Proposal Receipt Date:  November 5, 1997

 

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 which 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 CONTRACT PROPOSALS (PHS 98-1) with a due date for

receipt of SBIR CONTRACT proposals of November 5, 1997; 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.  The SBIR

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 research or R&D budgets for

an SBIR program.  The PHS SBIR set-aside requirement for FY 1998 is

estimated to be $260-$270 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, one-third of

the Phase I budget may be spent on consultant and/or subcontractual

costs, and 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~ 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, normally, 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~ 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 IX,

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 IX 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 R&D 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 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

CONTRACT PROPOSALS (PHS 98-1) for the contract proposal receipt date

of November 5, 1997:

 

NATIONAL INSTITUTES OF HEALTH

 

 NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA)

o Development of Psychometric Techniques Tailored for the Alocohol

Field (DBE)

o Portable Miniaturized Alcohol Monitoring Device (DBR)

o Development of Methodology for Measuring Compliance for Medications

(DCPR)

o Medications Development (DCPR)

o Evaluation of Alcohol Abuse and AIDS Prevention Programs (DCPR)

o Performance Indicators of Quality of Care for Alcohol Treatment

(DCPR)

 

NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

(NIAMS)

o  Markers of Osteoarthritis

 

NATIONAL CANCER INSTITUTE (NCI)

o Innovative Approaches to Clinical Trials Informatics

 

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  Acute Renal Failure

o  New Noninvasive Body Iron Test

o  Mechanical Approaches to Achieving Euglycemia

o  Chronic Renal Failure

 

NATIONAL INSTITUTE ON DRUG ABUSE (NIDA)

o  Drug Supply Services Support

o  Chemical Libraries for Drug Development

o  Analytical Techniques Program

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

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

o  Development of a Computerized Neuropsychological Testing Program

o  Internet-based Research Support for Drug Abuse Researchers

o  Development of a Management Information System on Ethnic Specific

Factors in the Etiology of Drug Abuse Among Minority Populations

o  Develop Prevention Research Dissemination

o  Design and Construction of a Multi-Environment, Multi-Choice

Rodent Testing Apparatus

 

NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS):

o  Development of a Transgenic Teleost Animal Model for Assessing

Mutagenesis

o  Commercialization of Laboratory Methods for Assessing the Genetic

Responses to Chemicals

o  Methods for Assessing the Estrogenicity and Other Endocrine

Activity of Environmental Chemicals

o  Rapid Mutational Analysis of Rodent DNA Samples

o  High Kd Fluorescent Calcium Indicators

o  Development of Assay Systems for Determining the Formation of

Mutagens by Prostaglandin H Synthase-2

o  Development of Applications of Human Breath Analysis for Metabolic

Phenotyping of Individuals

o  Development of an EIA Kit for Determination of 2,3-Dinor-5,6-

dihydroprostaglandin F2~

o  Development of an Enzyme Immunoassay for Arachidonic Acid Epoxides

and Diols

o  Detection of Mutations in Stem Cell Spermatogonia from Transgenic

Mice with Integrated PhiX Vector

o  Development of Oligoarrays for Genotyping Human Polymorphisms

Associated with Cancer Risk

o  Development of Embryonic Stem Cells for Experimental Studies

o  Development and Evaluation of Transgenic Mouse/Rat Models for

Problems in Environmental Toxicology and Carcinogenesis

 

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI)

o  Computer Algorithm for the Identification of Unknown Proteins

After Peptide Sequencing

o  Atherosclerosis Gene Discovery Program

 

NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS)

o  Development of Non-Pharmacological Therapy of Epilepsy

o  Anti-epileptic Drug Delivery Systems and Formulations

o  Portable Devices For Sleep Disorder Screening/Monitoring

o  Non Pharmacological Therapy of Sleep Disorders

o  Models for Screening Antiepileptic and Antiepileptogenic Therapy

o  Alertness Measures

o  Improved EEG/ICU/OR Interface

o  Improving Magnetic Resonance Imaging to Evaluate the Central

Nervous System of Critically-ill Neonates

o  Inducible Knockout Technology

o  Genome Scanning

o  Direct Gene Transfer

 

NATIONAL CENTER FOR RESEARCH RESOURCES (NCRR)

o  General Software Tools for Biomedical Research

o  Enhancement and Support of the SAAM II Software

 

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

 

NATIONAL IMMUNIZATION PROGRAM (NIP)

o Means to Decrease Trauma Associated with Children Receiving

Parenteral Injections

o Assay to Detect Minimal Infectious Dose of HBsAg or Blood Surrogate

o Safe, Needle-free, Liquid Jet Injector for Routine Immunization

Clinics

o Needle-free, Fast, Liquid Jet Injector for Mass Immunization

Campaigns

o Needle-less Device to Deliver Powdered Measles Vaccine into Skin or

Mucosa

 

PUBLIC HEALTH PRACTICE PROGRAM OFFICE (PHPPO)

o Improving Public Health Through Geographic Information Systems

 

NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH PROMOTION

(NCCDPHP)

o Development of New Methods to Quantify Lipoprotein Subfractions

 

INQUIRIES

 

Eligibility requirements, definitions, submission procedures, review

considerations, contract proposal forms and instructions, and other

pertinent information, including the ~Fast-Track~ Initiative, are

contained in the SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL

BUSINESS INNOVATION RESEARCH CONTRACT PROPOSALS (PHS 98-1) for the

proposal receipt date of November 5, 1997.  This PHS SBIR Contract

Solicitation is available electronically by accessing 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 PHS SBIR Contract Solicitation

is produced.  Subject to availability, they may be obtained from:

 

PHS SBIR/STTR Solicitation Office

13687 Baltimore Avenue

Laurel, MD  20707-5096

Phone:  (301) 206-9385

Fax:  (301) 206-9722

E-mail:  a2y@cu.nih.gov

 

Those interested in the PHS SBIR GRANT program may access

electronically, at the same http address above, the OMNIBUS

SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS

INNOVATION RESEARCH GRANT APPLICATIONS (PHS 97-2) for the calendar

year 1997 grant application receipt dates of April 15, August 15, and

December 15 (same dates each year).  The ~Fast-Track~ review option

is an initiative for SBIR grant applications also.  Hard copies of

the PHS SBIR GRANT Solicitation may be obtained also from the

Solicitation Office identified above.

 

.


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