Cancer Cause and Prevention Research
To identify cancer risks and risk reduction strategies, to identify factors that cause cancer in man, and to discover and develop mechanisms for cancer prevention in man. Research programs include: (1) epidemiology; (2) chemical, physical and molecular carcinogenesis; (3) early detection biomarkers; (4) nutrition and bioactive food components; (5) immunology and vaccines; (6) field studies and statistics; (7) chemoprevention; (8) agent development; and (9) 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.
General information about this opportunity
Last Known Status
Agency: Department of Health and Human Services
Office: National Institutes of Health
Type(s) of Assistance Offered
Cooperative Agreements; Project Grants
Fiscal Year 2014: Competing FY14 RPG actual 343 awards which were 15.2% of applications received.
Competing FY14 SBIR/STTR actual 8 awards which were 12.9% of applications received. Fiscal Year 2015: FY 2015 RPG est. 1,305 total awards. Fiscal Year 2016: FY 2016 RPG est. 1,348 total awards.
Public Health Service Act, Sections 301, 410 and 411, Public Law 78-410, as amended, 42 U.S.C. 241, 42 U.S.C. 285 - 285a-1; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.
Who is eligible to apply/benefit from this assistance?
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 application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
Any nonprofit or for-profit organization, company, or institution engaged in biomedical research on cancer.
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 75. For SBIR and STTR grants, the 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 form SF424(R&R) (Rev. August 2012) is used to apply for SBIR Phase I and Phase II, and STTR Phase I and Phase II. 2 CFR 200, Subpart E - Cost Principles applies to this program.
What is the process for applying and being award this assistance?
Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.
2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. Depending on the grant mechanism, form PHS-398 (Rev. August 2012) or form SF424 (R&R) (Rev. August 2012) is the standard application form. Both forms can be obtained online at http://grants.nih.gov/grants/forms.htm. SBIR and STTR Grant Solicitations and SBIR Contract Solicitations may be obtained electronically through the NIH's Small Business Funding Opportunities home page at http://www.nih.gov/grants/funding/sbir.htm. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms. All competing SBIR and STTR grant applications must be submitted electronically to the NIH via Grants.gov (http://www.grants.gov/).
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.
Contact the headquarters or regional office, as appropriate, for application deadlines.
Approval/Disapproval Decision Time
(Grants) Approximately 10 months. SBIR/STTR: About 7-1/2 months.
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 online through the NIH home page at http://www.grants.nih.gov/grants/guide/notice-files/not97-232.html.
Applications submitted for renewal must be reviewed and selected for funding on a competitive basis.
How are proposals selected?
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.
How may assistance be used?
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.
What are the requirements after being awarded this opportunity?
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. Expenditure reports are not applicable. Performance monitoring is not applicable.
In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503. Grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.
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.
Other 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.
Who do I contact about this opportunity?
Regional or Local Office
None. Not applicable.
Catherine M. Battistone 9609 Medical Center Drive
Seventh Floor, West Tower, 7W532, MSC 9750, Rockville, Maryland 20850 Email: firstname.lastname@example.org
Phone: 240-276-6443 Fax: 240-276-7682
75-0849-0-1-550 - Cancer Causation Research.
(Project Grants (Cooperative Agreements)) FY 14 $611,442,000; FY 15 est $544,308,000; and FY 16 est $614,006,000 - Cancer Causation Research Grants.
Range and Average of Financial Assistance
Range: $5,887 to $5,022,000
Regulations, Guidelines and Literature
42 CFR 52; 45 CFR 75; NIH Grants Policy Statement (10/1/11); Grants will be available under the authority of and administered in accordance with the NIH 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.
Examples of Funded Projects