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

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when they are more amenable to treatment.

Diagnosis research focuses on methods to determine the presence of a specific type of cancer; to predict its course and response to therapy, both a particular therapy or a class of agents; and to monitor the effect of the therapy and the appearance of disease recurrence.

These methods include diagnostic imaging and direct analyses of specimens from tumor or other tissues.

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.

Competing FY 2007 RPG actual 203 awards which were 16.2 percent of applications received. Competing FY 2007 SBIR/STTR actual 56 awards which were 20.4 percent of applications received. Fiscal year 2008 est. 797 total awards and FY 2009 est. 796 total awards.

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.

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Eligibility Requirements

Applicant Eligibility

The awardee will be a university, college, hospital, public agency, nonprofit research institution or organization, unit of tribal government, 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.

Aplication and Award Process

Preapplication Coordination

None.

This program is excluded from coverage under E.O.

12372.

Application Procedures

The NIH is in the process of a transition to fully electronic grant submission through Grants.gov (see http://era.nih.gov/ElectronicReceipt for details). Depending on the grant mechanism, either form PHS-398 (Rev. September 2004) or form SF424(R&R) (October 2005) is the standard form. Both can be obtained at http://grants1.nih.gov/grants/forms.htm. 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, as appropriate. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" home page at www.nih.gov/grants/funding/sbir.htm on the World Wide Web. 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 via Grants.gov The following is a website address for NIH electronic submission of grant application information: http://era.nih.gov/ElectronicReceipt/index.htm.

Award Procedures

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 5, June 5, and October 5. Renewals and supplements: March 5, July 5, and November 5. These deadlines apply to the most frequently used grant mechanism. Other deadlines may apply; these will be specified in the Funding Opportunity Announcement on Grants.gov. Cooperative Agreements are usually submitted in response to a Request for Applications (RFA). The receipt date is stipulated in the RFA. SBIR and STTR Applications: April 5, August 5, and December 5.

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.

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 27, 2003), "Audits of States, Local Governments, and Nonprofit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 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

75-0849-0-1-550.

Obigations

(Grants) (RPG) FY 07 $237,161,000; FY 08 est $244,279,000; and FY 09 est $240,131,000. For SBIR/STTR: FY 07 $44,743,000; FY 08 est $42,054,000; and FY 09 est $38,779,000.

Range and Average of Financial Assistance

$54,315 to $10,637,601; $371,726.

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. Tracy G. Lively, 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) 496-1591. 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.

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.