NATIONAL
INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
AUTHORIZATION:
Public
Health Service Act, Sections 301, 410, and 411, Public Law 78-410,
as amended, 42 U.S.C. 241; Public Law 100-607, 42 U.S.C. 285 and
285a; Small Business Research and Development Enhancement Act of
1992, Public Law 102-564.
To
improve screening and early detection strategies and to develop
accurate diagnostic techniques and methods for predicting the course
of disease in cancer patients. Screening and Early Detection research
includes development of strategies to decrease cancer mortality
by finding tumors early when they are more amenable to treatment.
Diagnosis research focuses on methods to determine the presence
of a specific type of cancer and to predict its course and response
to therapy. These methods include diagnostic imaging and direct
analyses of tumor specimens. Support is also provided for establishing
and maintaining resources of human tissue to facilitate research.
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 of socially and economically
disadvantaged small business concerns and women-owned small business
concerns 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
to foster and encourage participation of socially and economically
disadvantaged 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, consultants 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 organization, or a 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 concerns (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 application 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.
Credentials/Documentation:
Costs will be determined in accordance with OMB Circular No. A-87
for State and local governments. For-profit organizations' costs
are determined in accordance with 48 CFR, Subpart 31.2 of the
Federal Acquisition Regulations. For other grantees, costs will
be determined in accordance with HHS Regulations 45 CFR, Part
74, Subpart Q. For SBIR and STTR grants, applicant organization
(small business concern) must present in a research plan an 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) 435-0714. E-mail: grantsinfo@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 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: Telephone:
(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:
Approved 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) 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 Applications: April
15, August 15, and December 15. STTR Grants: April 1, August 1,
and December 1.
Range of Approval/Disapproval
Time: Regular 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 are 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 and a 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 an Electronic Transfer System. 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 the end of the budget period. Special
reports may be requested by DHHS. Terminal reports are required
6 months after the end of the 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
government 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 $185,593,000; FY 02 est $243,411,000; and FY
03 est $248,558,000. For SBIR/STTR: FY 01 est $20,402,000; FY
02 est $25,861,000; and FY 03 est $34,644,000.
Range
and Average of Financial Assistance: Grants: $64,461 to $4,234,939; Average: $439,000.
Competing fiscal year
2001 RPG act 151 awards which were 24.80 percent of applications
received. Competing fiscal year 2001 SBIR/STTR act 74 awards which
were 29.40 percent of applications received. Fiscal year 2002 est
632 total awards and fiscal year 2003 est 669 total awards.
REGULATIONS, GUIDELINES, AND
LITERATURE:
42 CFR 52; 45 CFR 74;
45 CFR 92; PHS Grants Policy Statement, DHHS Publication 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 Institute of
Health for Small Business Technology Transfer (STTR) Grant Applications.
INFORMATION CONTACTS:
Regional or Local
Office: Not applicable.
Headquarters Office:
Program Contact: Dr. Sheila E. Taube, Associate Director, Cancer
Diagnosis Program, Division of Cancer Treatment and Diagnosis,
National Cancer Institute, National Institutes of Health, Department
of Health and Human Services, 6130 Executive Boulevard, EPN-6035A
Bethesda, MD 20892. Telephone: (301) 496- 8639. Grants Management
Contact: Leo F. Buscher, Jr., Grants Management Officer, National
Cancer Institute, National Institutes of Health, Department of
Health and Human Services, EPS-234, Bethesda, MD 20892. Telephone:
(301) 496-7753. Use the same numbers for FTS.
Web Site Address: http://www.nih.gov
EXAMPLES OF FUNDED PROJECTS:
Screening and early detection
research includes development of more sensitive and specific detection
techniques; assessment of availability of, access to, and use of
these techniques in the community; development of community outreach
methods to encourage all segments of the population to take advantage
of available services; and collection of cancer surveillance data
to assess effectiveness of cancer interventions. Cancer diagnosis
and prognosis research depends on interactions among clinicians,
basic researchers, and experts in study design to ensure that new
diagnostic and prognostic techniques are evaluated efficiently and
effectively for more rapid transfer to clinical application. Diagnosis
research includes development and evaluation of better methods for
monitoring the response to therapy and detecting the recurrence
of tumors earlier; utilizing the advances in the development of
sensitive molecular biological techniques; developing tests to identify
individuals with a genetic predisposition to specific cancers; and
developing more sensitive imaging techniques, including the use
of immunodiagnostic reagents.
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.
