FEDERAL AGENCY:

NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

AUTHORIZATION:

Public Health Service Act, Sections 301, 410, and 411, Public Law 78-410, 42 U.S.C. 241, as amended, Public Law 100-607, 42 U.S.C 285(a); Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

OBJECTIVES:

To develop the means to cure as many cancer patients as possible and to control the disease in those patients who are not cured. Cancer Treatment Research includes the development and evaluation of improved methods of cancer treatment through the support and performance of both fundamental and applied laboratory and clinical research. Research is supported in the discovery, development, and clinical testing of all modes of therapy including: surgery, radiotherapy, chemotherapy, and biological therapy, both individually and in combination. In addition, research is carried out in areas of nutritional support, stem cell and bone marrow transplantation, studies to reduce toxicity of cytotoxic therapies, and other methods of supportive care that may supplement and enhance primary treatment. 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 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 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 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:   For-profit organizations' cost are determined in accordance with 48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. Costs will be determined in accordance with 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 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 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. 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:   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 remainder of 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 if they are recommended for further consideration, 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 Grants: April 1, August 1, and December 1.

Range of Approval/Disapproval Time:   Approximately 10 months. SBIR Applications: 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 with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page http//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, maximum of 5 years. Renewals may be awarded for additional periods of up to 5 years based on competitive peer review. Funds are 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 the 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 $443,348,000; FY 02 est $506,396,000; and FY 03 est $564,559.000. For SBIR/STTR: FY 01 est $32,981,000; FY 02 est $37,531,000; and FY 03 est $40,709,000.

Range and Average of Financial Assistance:  
Range: $12,996 to $13,134, Average: $438,068.

Competing fiscal year 2001 RPG act 330 awards which were 27.50 percent of applications received. Competing fiscal year 2001 SBIR/STTR act 112 awards which were 26.90 percent of applications received. Fiscal year 2002 est 1339 total awards and fiscal year 2003 est 1378 total awards.

REGULATIONS, GUIDELINES, AND LITERATURE:

42 CFR 52; 45 CFR 74; 45 CFR 92. 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 USC 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:   Catherine M. Battistone 9609 Medical Center Drive Seventh Floor, West Tower, Room 7W532, MSC 9750, Rockville, Maryland 20850 Email: battistc@mail.nih.gov Phone: 240-276-6443 Fax: 240-276-7682

Web Site Address:  
http://www.cancer.gov/cancertopics/treatment

EXAMPLES OF FUNDED PROJECTS:

Fundamental research projects on problems of anticancer drug discovery and development, preclinical biochemistry, pharmacology, cell and molecular biology of cancer treatment, and the clinical development and evaluation of all modalities of treatment, both alone and in combination. These include surgery, radiotherapy, chemotherapy, immunotherapy, cellular therapy, vaccines, liposomes, antisense therapy, gene therapy, and supportive approaches including: nutritional support and blood component replacement; clinical trials after drugs undergo screening, toxicology, and pharmacology testing; and the provision of research animals, compounds, and formulated drugs.

CRITERIA FOR SELECTING PROPOSALS:

The major elements in evaluating applications 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.