To reduce cancer risk, incidence, morbidity, and mortality and enhance quality of life in cancer survivors through an orderly sequence from research on interventions and their impact in defined populations to the broad, systematic application of the research results through dissemination and diffusion

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strategies.

Primary emphasis is on the inclusion of cancer prevention and control intervention(s) in any proposed study.

Cancer Prevention and Cancer Control research studies are classified into one of five phases: (1) Hypothesis development; (2) methods development and testing; (3) controlled intervention trials to establish cause-and-effect relationships; (4) research in defined populations; and (5) demonstration and implementation studies.

Primary interests are in research on cancer control interventions in Phases 2 through 5, and on cancer prevention research in all phases.

Cancer Prevention and Control programs include those in the following areas: (1) chemoprevention; (2) cancer communications; (3) nutrition, diet, and physical activity; (4) screening and early detection, including biomarker discovery, development and validation; (5) biobehavioral mechanisms; (6) tobacco control; (7) health disparities research; (8) supportive care and survivorship; (9) health services and outcomes research; and (10) surveillance research.

Cancer Control uses Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs to engage domestic small business concerns in federal research and development that has potential for commercialization.

The goals of the SBIR & STTR Programs are to stimulate technological innovation, increase private-sector commercialization of federal research and development, increase small business participation in federally funded research and development, and foster participation by socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.

The STTR Program requires the small business concern to formally collaborate with a research institution in Phase I and Phase II of the program.

Selected Recipients for this Program

Fiscal Year 2016: It is estimated that 0 awards were made in FY2016. Fiscal Year 2017: It is estimated that 0 awards will be made in FY2017. Fiscal Year 2018: It is estimated that 0 awards will be made in FY2018.

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.

Restrictions are imposed against the use of funds for entertainment, foreign travel (unless specifically authorized), office equipment, and other items not normally necessary for the effective prosecution of such research.

SBIR Phase I grants (of approximately 6-months' duration) are to establish the technical merit, feasibility and commercial potential of a proposed research effort and to determine the quality of performance of the awardee.

Phase II grants are for the continuation of the research initiated in Phase I, and are likely to result in commercial products or processes.

Only SBIR 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 the scientific and technical merit and commercial potential of the proposed Phase II project.

Only STTR Phase I awardees are eligible to receive Phase II support.

The NIH Fast-Track mechanism provides additional assistance to applicants by expediting the decision and award of funding for scientifically meritorious applications for projects that have a high potential for commercialization.

The mechanism allows small businesses to submit applications for both Phase I and Phase II together for review as one application, with the aim of reducing or eliminating the funding gap between Phase I and Phase II.

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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 for the duration of the project period.

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, technical 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.

The Principal Investigator may be primarily employed by either the small business concern or the collaborating research institution at the time of award and for the duration of the project period.

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, technical merit and program relevance by a scientific review group and a national advisory council.

Beneficiary Eligibility

University, college, hospital, public agency, nonprofit research institutions or for-profit organizations will benefit.

Credentials/Documentation

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) (version as specified in the FOA) 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.

Aplication 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 Procedures

2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. Depending on the grant mechanism, either form PHS-398 (Rev. March 2016) or form SF424(R&R) (Version as specified in the FOA) is the standard application form. Both forms can be obtained online at http://grants.nih.gov/grants/forms.htm. The standard application forms, as furnished by DHHS. SBIR and STTR Grant Solicitations and SBIR Contract Solicitations may be obtained electronically through the NIH Small Business Funding Opportunities home page at https://sbir.nih.gov/funding. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms. All competing SBIR and STTR grant applications should be submitted electronically to the NIH via Grants.gov (http://www.grants.gov/).

Award Procedures

Grants and cooperative agreements are funded based on scientific merit, program relevance, and program balance and are made annually. Initial award provides funds for 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 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.

Authorization

Public Health Service Act, Sections 301, 410 and 412, Public Law 78-410, as amended, Public Law 99-500, Public Law 100-607, 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.

Range of Approval/Disapproval Time

Regular Grants: Approximately 10 months. SBIR/STTR: About 7-l/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 online through the NIH home page at https://grants.nih.gov/grants/peer-review.htm.

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. Matching requirements are not applicable to this program. MOE requirements are not applicable to this program.

Length and Time Phasing of Assistance

Grants and cooperative agreements average from 3 to 4 years, up to 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. 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 the end of a 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.

Audits

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 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

75-0849-0-1-550 - Cancer Control.

Obigations

(Project Grants) FY 16 $0; FY 17 est $0; and FY 18 est $0 - Cancer Control Grants.

Range and Average of Financial Assistance

Range 0 to 0 Average:: 0.

Regulations, Guidelines, and Literature

Grants: 42 CFR 52; 45 CFR 75 and NIH Grants Policy Statement

Information Contacts

Regional or Local Office

None.

Headquarters Office

Catherine M. Battistone 9609 Medical Center Drive Seventh Floor, West Tower, 7W532, MSC 9750 , Rockville, Maryland 20850 Email: battistc@mail.nih.gov Phone: 240-276-6443 Fax: 240-276-7682

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.