NATIONAL
INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
AUTHORIZATION:
Public
Health Service Act, Sections 301 (c) and 410, Public Law 78-410,
as amended, 42 U.S.C. 241; Small Business Research and Development
Enhancement Act of 1992, Public Law 102-564.
To
identify those factors that cause cancer in man; and to develop
mechanisms for preventing cancer in man. The following research
programs are included: epidemiology, chemical and physical carcinogenesis,
biological carcinogenesis, nutrition, immunology, field studies
and statistics, and organ site. Small Business Innovation Research
(SBIR) program: To expand and improve the SBIR program; to increase
private sector commercialization of innovations derived from Federal
research and development; to increase small business participation
in Federal research and development; and to foster and encourage
participation on socially and economically disadvantaged small business
concern and women-owned small business concern in technological
innovation. Small Business Technology Transfer (STTR) program: To
stimulate and foster scientific and technological innovation through
cooperative research and development carried out between small business
concerns and research institutions; to foster technology transfer
between small business concerns and research institutions; to increase
private sector commercialization of innovations derived from Federal
research and development and economically disadvantage small business
concerns and women-owned small business concerns in technological
innovation.
TYPES
OF ASSISTANCE:
Project Grants. Place Cursor Here for Definition
USES
AND USE RESTRICTIONS:
Grants and cooperative
agreements may be made to eligible institutions for the support
of cancer research projects. The grants and cooperative agreements
may be used for personnel, consultant costs, equipment, supplies,
travel, patient costs, animals, alterations and renovations, miscellaneous
items, and indirect costs. SBIR Phase I grants (of approximately
6-months' duration) are to establish the technical merit and feasibility
of a proposed research effort that may lead to a commercial product
or process. Phase II grants are for the continuation of the research
initiated in Phase I, and that are likely to result in commercial
products or processes. Only Phase I awardees are eligible to receive
Phase II support. STTR Phase I grants (normally of 1-year duration)
are to determine the scientific, technical, and commercial merit
and feasibility of the proposed cooperative effort that has potential
for commercial application. Phase II funding is based on results
of research initiated in Phase I and scientific and technical merit
and commercial potential of Phase II application. The SBIR Fast-Track
Initiative provides additional assistance to applicants by expediting
the decision and award of SBIR Phase II funding for scientifically
meritorious applications for projects that have a high potential
for commercialization. Fast-Track is a parallel review option whereby
Phase I and Phase II projects are reviewed concurrently with the
aim of reducing or eliminating the funding gap between Phase I and
Phase II.
ELIGIBILITY REQUIREMENTS:
Applicant Eligibility:
The awardee will be a university, college, hospital, public agency,
nonprofit research institution or for-profit organization that submits
an application and receives a grant or cooperative agreement for
support of research by a named principal investigator. SBIR grants
can be awarded only to domestic small businesses (entities that
are independently owned and operated for profit, are not dominant
in the field in which research is proposed, and have no more than
500 employees). Primary employment (more than one- half time) of
the principal investigator must be with the small business at the
time of award and during the conduct of the proposed project. In
both Phase I and Phase II, the research must be performed in the
U.S. and its possessions. To be eligible for funding, a grant application
must be approved for scientific merit and program relevance by a
scientific review group and a national advisory council. STTR grants
can be awarded only to domestic small business concern (entities
that are independently owned and operated for profit, are not dominant
in the field in which research is proposed and have no more than
500 employees) which "partner" with a research institution in cooperative
research and development. At least 40 percent of the project is
to be performed by the small business concern and at least 30 percent
by the research institution. In both Phase I and Phase II, the research
must be performed in the U.S. and its possessions. To be eligible
for funding, a grant applicant must be approved for scientific merit
and program relevance by a scientific review group and a national
advisory council.
Beneficiary Eligibility:
Any nonprofit or for-profit organization, company, or institution
engaged in biomedical research on cancer.
Credentials/Documentation:
Costs will be determined by OMB Circular No. A-87 for State and
local governments. For other grantees, costs will be determined
in accordance with HHS Regulations 45 CFR, Part 74, Subpart Q.
For-profit organizations' costs are determined in accordance with
48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. For
SBIR and STTR grants, applicant organization (small business concern)
must present in a research plan and idea that has potential for
commercialization and furnish evidence that scientific competence,
experimental methods, facilities, equipment, and funds requested
are appropriate to carry out the plan. Grant forms PHS 6246-1
and PHS 6246-2 are used to apply for SBIR Phase I and Phase II,
respectively. Grant forms PHS 6246-3 and PHS 6246-4 are used to
apply for STTR Phase I and Phase II, respectively.
Pre-application
Coordination: Not applicable. This program is
excluded from coverage under E.O. 12372.
Application Procedure:
Application form PHS-398 (Rev. May 2001) is the standard form
which can be obtained from the Division of Extramural Outreach
and Information Resources, National Institutes of Health, 6701
Rockledge Drive, MSC-7910, Bethesda, MD 20892-7910. Telephone
(301)435-1714, email: ASKNIH@odrockml.od.nih. gov. The standard
application forms, as furnished by PHS and required by 45 CFR,
Part 92 for State and local governments, must be used for this
program. This program is subject to the provisions of 45 CFR,
Part 92 for State and local governments and OMB Circular No. A-110
for nonprofit organizations. SBIR and STTR Grant Solicitations
and SBIR Contract Solicitation may be obtained electronically
through the NIH's "Small Business Funding Opportunities" home
page at http://www.nih.gov/grants/funding/sbir.htm on the World
Wide Web. A limited number of hard copies of these publications
are produced. Subject to availability, they may be obtained by
contacting the NIH support services contractor: phone: (301) 206-9385;
fax: (301) 206-9722; e-mail: a2y@cu.nih.gov. The Solicitations
include submission procedures, review considerations, and grant
application or contract proposal forms. SBIR and STTR grant applications
should be submitted to the Center for Scientific Review, 6701
Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710.
Award Procedure:
Grants and cooperative agreements are funded based on scientific
merit, program relevance and program balance and are made annually.
Initial award provides funds for the first budget period (usually
12 months) and Notice of Grant Award (Form PHS 1533-2) indicates
support recommended for the remainder of the project period, allocation
of Federal funds by budget categories, and special conditions,
if any. All accepted SBIR/STTR applications are evaluated for
scientific and technical merit by an appropriate scientific peer
review panel and by a national advisory council or board. All
applications receiving a priority score compete for available
SBIR/STTR set-aside funds on the basis of scientific and technical
merit and commercial potential of the proposed research, program
relevance, and program balance among the areas of research.
Deadlines:
New Grants: February 1, June 1, and October 1. Renewals and supplements:
March 1, July 1, and November 1. Cooperative Agreements are usually
submitted in response to a Request for Applications (RFA). The
receipt date is stipulated in the RFA. SBIR: April 15, August
15, and December 15. STTR: April 1, August 1, and December 1.
Range of Approval/Disapproval
Time: Grants: Approximately 10 months. SBIR/STTR:
About 7-1/2 months.
Appeals:
A principal investigator (P.I.) may question the substantive or
procedural aspects of the review of his/her application by communicating
with the staff of the Institute. A description of the NIH Peer
Review Appeal procedures is available on the NIH home page www.nih.gov/grants/guide/1997/97.11.21/n2.html.
Renewals:
Applications submitted for renewal must be reviewed and selected
for funding on a competitive basis.
ASSISTANCE CONSIDERATIONS:
Formula and Matching
Requirements: This program has no statutory
formula or matching requirements.
Length and Time Phasing
of Assistance: Grants and Cooperative Agreements:
Average 3 to 4 years, maximum of 5 years. Renewals may be awarded
for additional periods of up to 5 years based on competitive peer
review. Funding is provided through Monthly Demand Payment System
or Letter of Credit. SBIR: Normally, Phase I awards are for 6
months; normally, Phase II awards are for 2 years. STTR: Normally,
Phase I awards are for 1 year; normally, Phase II awards are for
2 years.
POST ASSISTANCE REQUIREMENTS:
Reports:
Progress reports are required each year. Annual financial status
report is required 90 days after end of budget period. Special reports
may be requested by DHHS. Terminal reports are required 6 months
after the end of a project.
Audits:
In accordance with the provisions of OMB Circular No. A- 133 (Revised,
June 24, 1997), "Audits of States, Local Governments, and Nonprofit
Organizations," nonfederal entities that expend financial assistance
of $300,000 or more in Federal awards will have a single or a
program-specific audit conducted for that year. Nonfederal entities
that expend less than $300,000 a year in Federal awards are exempt
from Federal audit requirements for that year, except as noted
in Circular No. A-133. In addition, grants and cooperative agreements
are subject to inspection and audits by DHHS and other Federal
officials.
Records:
Expenditures and other financial records must be retained for
3 years from the day on which the grantee submits the last financial
status report for the report period.
FINANCIAL INFORMATION:
Account Identification:
75-0849-0-1-552.
Obligations:
(Grants) FY 01 est $534,280,000; FY 02 est $599,474,000; and FY
03 est $630,018,000. For SBIR/STTR: FY 01 est $15,166,000; FY
02 est $19,420,000; and FY 03 est $22,365.
Range
and Average of Financial Assistance:
Grants: $24,327 to $4,320,915; Average: $394,000.
Competing fiscal year
2001 RPG act 360 awards which were 28.00 percent of applications
received. Competing fiscal year 2001 SBIR/STTR act 39 awards which
were 31.20 percent of applications received. Fiscal year 2002 est
1,514 total awards and fiscal year 2003 est 1,580 total awards.
REGULATIONS, GUIDELINES, AND
LITERATURE:
42 CFR 52; 42 CFR 74;
45 CFR 92; PHS Grants Policy Statement. No. (OASH) 94-50,000, (Rev.)
April 1, 1994; Grants will be available under the authority of and
administered in accordance with the PHS Grants Policy Statement
and Federal regulations at 42 CFR 52 and 42 U.S.C. 241; Omnibus
Solicitation of the Public Health Service for Small Business Innovation
Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus
Solicitation of the National Institutes of Health for Small Business
Technology Transfer (STTR) Grant Applications.
INFORMATION CONTACTS:
Regional or Local
Office: Not applicable.
Headquarters Office:
Program Contact: For epidemiological and nutrition studies, field
studies, and statistics; Dr. Deborah Winn, Acting Associate Director,
Epidemiology and Genetics Research Program, Division of Cancer
Control and Population Sciences, National Cancer Institute, National
Institutes of Health, Public Health Service, Department of Health
and Human Services, 6130 Executive Blvd., EPN 5113B, Bethesda,
MD 20892. Telephone: (301) 496-9600.
Web Site Address: http://www.nih.gov http://cancer.gov http://cancercontrol.cancer.gov
EXAMPLES OF FUNDED PROJECTS:
Cancer Cause and Prevention
Research focuses on research programs in epidemiology, chemical
and physical carcinogenesis, biological carcinogenesis, and nutrition.
Examples of funded projects include the following: (1) A epidemiologic
study of lung cancer and wood dust; 2) prostate cancer in relation
to vasectomy; (3) mechanism of estrogen-induced breast carcinogenesis;
(4) dietary fat, calories, and two-stage tumorigenesis; (5) mechanisms
of radiation, chemical and/or biological carcinogenesis; (6) effects
of radiation or chemical carcinogens on genetic material; (7) studies
leading to development of vaccines against human cancer viruses;
(8) role of the P53 tumor suppressor gene in human cancers of viral
etiology; and (9) investigations of HIV and their related viruses
as etiologic factors or cofactors in the malignant sequelae of AIDS,
including Kaposi's sarcoma and AIDS-associated lymphomas.
CRITERIA FOR SELECTING PROPOSALS:
The major elements in
evaluating proposals include assessments of: (1) The scientific
merit and general significance of the proposed study and its objectives;
2) the technical adequacy of the experimental design and approach;
(3) the competency of the proposed investigator or group to successfully
pursue the project; (4) the adequacy of the available and proposed
facilities and resources; (5) the necessity of the budget components
requested in relation to the proposed project; and (6) the relevance
and importance to announced program objectives. The following criteria
will be used in considering the scientific and technical merit of
SBIR/STTR Phase I grant applications: (1) The soundness and technical
merit of the proposed approach; (2) the qualifications of the proposed
principal investigator, supporting staff, and consultants; (3) the
technological innovation of the proposed research; (4) the potential
of the proposed research for commercial application; (5) the appropriateness
of the budget requested; (6) the adequacy and suitability of the
facilities and research environment; and (7) where applicable, the
adequacy of assurances detailing the proposed means for (a) safeguarding
human or animal subjects, and/or (b) protecting against or minimizing
any adverse effect on the environment. Phase II grant applications
will be reviewed based upon the following criteria: (1) The degree
to which the Phase I objectives were met and feasibility demonstrated;
(2) the scientific and technical merit of the proposed approach
for achieving the Phase II objectives; (3) the qualifications of
the proposed principal investigator, supporting staff, and consultants;
(4) the technological innovation, originality, or societal importance
of the proposed research; (5) the potential of the proposed research
for commercial application; (6) the reasonableness of the budget
requested for the work proposed; (7) the adequacy and suitability
of the facilities and research environment; and (8) where applicable,
the adequacy of assurances detailing the proposed means for a) safeguarding
human or animal subjects, and/or (b) protecting against or minimizing
any adverse effect on the environment.
