Cancer Cause and Prevention Research (93.393)

Program

93.393 Cancer Cause and Prevention Research

Federal Agency

Agency: Department of Health and Human Services
Office: National Institutes of Health

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.

Program Number

93.393

Last Known Status

Active

Objectives

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, chemoprevention and organ site studies. 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

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. OMB Circular No. A-87 applies to this program.

Application and Award Process

Preapplication Coordination

Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.

Application Procedure

This program is excluded from coverage under OMB Circular No. A-102. OMB Circular No. A-110 applies to this program. 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. Phone (301)435-1714, 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. 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

Contact the headquarters or regional office, as appropriate, for application deadlines.

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.

This program has no matching requirements.

MOE requirements are not applicable to this program.

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. Method of awarding/releasing assistance: by letter of credit.

Post Assistance Requirements

Reports

No program reports are required. No cash reports are required. 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. No expenditure reports are required. No performance monitoring is required.

Audits

No audits are required for this program.

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.

Program Accomplishments

Fiscal Year 2008: Competing fiscal year 2008 RPG act. 428 awards which were 23.4 percent of applications received. Competing FY 2008 SBIR/STTR act. 24 awards which were 31.6 percent of applications received. Fiscal Year 2009: Fiscal year 2009 est. 1,639 total awards. Fiscal Year 2010: FY 2010 est. 1,716 total awards.

Financial Information

Account Identification

75-0849-0-1-550 - Cancer Causation Research.

Obligations

(Project Grants (Cooperative Agreements)) FY 08 $646,537,000; FY 09 est $659,933,000; FY 10 est $684,564,000 - (Grants) For RPG: FY 08 $646,537,000; FY 09 est $659,933,000; and FY 10 est $684,564,000. For SBIR/STTR: FY 08 $8,549,000; FY 09 est $8,251,000; and FY 10 est $8,986,000.

Range and Average of Financial Assistance

Range: $6,961 to $5,456,051.
Average: $384,157.

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.

Related Programs

93.394 Cancer Detection and Diagnosis Research; 93.395 Cancer Treatment Research; 93.396 Cancer Biology Research; 93.399 Cancer Control

Information Contacts

Regional or Local Office

None. Not applicable.

Headquarters Office

Catherine M. Battistone 6116 Executive Blvd., Rm. 8044, Rockville, Maryland 20852 Email: battistc@mail.nih.gov Phone: 3015941088

Web Site Address

http://www.nih.gov; http://cancer.gov; http://cancercontrol.cancer.gov; http://prevention.cancer.gov.

Examples of Funded Projects

Fiscal Year 2008: Cancer Cause and Prevention Research focuses on research programs in epidemiology, chemical and physical carcinogenesis, biological carcinogenesis, nutrition, chemoprevention and organ site studies. 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; (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; (10) a phase III chemoprevention clinical trial for prostate cancer (SELECT); (11) Epidemiology and Consortia and (12) Genome-Wide Association Studies (GWAS). Fiscal Year 2009: No Current Data Available Fiscal Year 2010: No Current Data Available

Criteria for Selecting Proposals

Not Applicable.