Catalog of Federal Domestic Assistance

Formula and Matching Requirements:

This program has no statutory formula.
This program has no matching requirements.
This program does not have MOE requirements.

Length and Time Phasing of Assistance:

All programs except for RFIP: 1 to 5 years. An Electronic Transfer System is used for transferring funds. RFIP: Construction must be completed within the time specified in grant award. The initial budget period is usually 2 years in length, although extensions may be requested. All funds must be obligated within 5 years from the date of award. See the following for information on how assistance is awarded/released: All programs except for RFIP: 1 to 5 years. An Electronic Transfer System is used for transferring funds. RFIP: Construction must be completed within the time specified in grant award. The initial budget period is usually 2 years in length, although extensions may be requested. All funds must be obligated within 5 years from the date of award. Reports:

No program reports are required. No cash reports are required. Annual progress and financial status reports are required for all grants. Final performance and financial reports are required 90 days following the end of the project period. Reports are required after termination of NRSA to ascertain compliance with the service and payback provisions. RFIP: The grantee is responsible for performance of the contractor. The contractor must be covered by performance and payment bonds. Annual progress and financial status reports are required for all grants. Final performance and financial reports are required 90 days following the end of the project period. Reports are required after termination of NRSA to ascertain compliance with the service and payback provisions. RFIP: The grantee is responsible for performance of the contractor. The contractor must be covered by performance and payment bonds. No performance monitoring is required.

Audits:

In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit 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 accordance with 45 Code of Federal Regulations, Part 74.26, for-profit (commercial) organizations are subject to audit requirements for a non-Federal audit if, during it s fiscal year, it expended $500,000 or more under HHS awards and at least one award is a HHS grant or subgrant. The regulation incorporates the thresholds and deadlines of OMB Circular No. A-133, but provides for profit organizations with two options for the type of audit that will satisfy the audit requirement: 1. a financial related audit of the HHS awards in accordance with Government Auditing Standards, or 2. an audit that meets the requirements of OMB Circular No. A-133. In accordance with NIH grants policy, Foreign grantees are subject to the same audit requirements as for-profit (commercial) organizations.

Records:

Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual FSR is submitted. For awards under SNAP (other than those to foreign organizations and Federal institutions), the 3-year retention period will be calculated from the date the FSR for the entire competitive segment is submitted. Those grantees must retain the records pertinent to the entire competitive segment for 3 years from the date the FSR is submitted to NIH. Foreign organizations and Federal institutions must retain records for 3 years from the date of submission of the annual FSR to NIH. See 45 CFR 74.53 and 92.42 for exceptions and qualifications to the 3-year retention requirement (e.g., if any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken). Those sections also specify the retention period for other types of grant-related records, including F&A cost proposals and property records. See 45 CFR 74.48 and 92.36 for record retention and access requirements for contracts under grants. In accordance

with 45 Code of Federal Regulations, Part 74.53(e), the HHS Inspector General, the U.S. Comptroller General, or any of their duly authorized representatives have the right of timely and unrestricted access to any books, documents, papers, or other records of recipients that are pertinent to awards in order to make audits, examinations, excerpts, transcripts, and copies of such documents. This right also includes timely and reasonable access to a recipients personnel for the purpose of interview and discussion related to such documents. The rights of access are not limited to the required retention period, but shall last as long as records are retained. Account Identification:

75-0848-0-1-552.

Obligations:

(Project Grants) FY 08 $381,726,000; FY 09 est $412,754,000; FY 10 est $398,101,000 - Clinical Research Resources (includes General Clinical Research Centers and Clinical and Translational Science Awards). (Project Grants) FY 08 $0; FY 09 est $0; FY 10 est $0 - Construction. (Project Grants) FY 08 $75,928,000; FY 09 est $75,973,000; FY 10 est $75,973,000 Biomedical Technology Research Centers. (Project Grants) FY 08 $376,265,000; FY 09 est $421,748,000; FY 10 est $441,748,000 - General Clinical Research Centers/Clinical and Translational Science Awards. (Project Grants) FY 08 $52,511,000; FY 09 est $56,707,000; FY 10 est $57,857,000 Research Centers in Minority Institutions. (Project Grants) FY 08 $32,867,000; FY 09 est $33,185,000; FY 10 est $37,542,000 - Research Project Grants. (Project Grants) FY 08 $117,226,000; FY 09 est $128,008,000; FY 10 est $130,065,000 - Comparative Medicine Centers. (Project Grants) FY 08 $223,546,000; FY 09 est $223,720,000; FY 10 est $228,533,000 - Special Comprehensive Centers. (Project Grants) FY 08 $151,176,000; FY 09 est $161,367,000; FY 10 est $186,774,000 - Other Research. (Project Grants (Capacity Building and Complaint Processing, Training)) FY 08 $5,612,000; FY 09 est $5,254,000; FY 10 est $5,307,000 - Research Training. (Project Grants (Contracts)) FY 08 $53,477,000; FY 09 est $61,932,000; FY 10 est $63,223,000 - Research & Development Contracts.

Range and Average of Financial Assistance:

In fiscal year 2008, there were 106 Research Project Grants; In FY 2009, it is estimated that there will be 116 and in FY 2010, 132. There were 75 Clinical Research Resource Center Awards in 2008 (includes General Clinical Research Centers and Clinical and Translational Science Awards). It is estimated that there will be 68 in FY 2009 and 61 in FY 2010. There were 26 General Clinical Research Centers in FY 2008 and it is estimated that there will be 19 in FY 2009 and 11 in FY 2010. There were 38 Clinical and Translational Science Awards in FY 2008 and it is estimated that there will be 46 in FY 2009 and 48 in FY 2010. There were 51 Biomedical Technology Resource Centers in FY 2008 and it is estimated there will be 51 in FY 2009 and FY 2010. There were 99 Specialized Comprehensive Centers in FY 2008 and it is estimated that there will be 99 in FY 2009 and 101 in FY 2010. There were 50 Comparative Medicine Centers in FY 2008. It is estimated that there will be 59 in FY2009 and 60 in FY 2010. There were 22 Research Centers in Minority Institutions in FY 2008 and it is estimated that there will be the same number in FY 2009 & FY 2010. There were 371 Other Research Grants in FY 2008. It is estimated that there will be 400 in FY 2009 & 385 in FY 2010. There were 117 Full Time Training positions in FY 2008. Its estimated that there will be 112 in FY 2009 & FY 2010. There were 86 Research and Development Contracts in FY 2008. It is estimated that there will be 69 in FY 2009 & 70 in FY 2010. PROGRAM ACCOMPLISHMENTS:

Not Applicable.

REGULATIONS, GUIDELINES, AND LITERATURE:

BT: OMB Circular No. A-21, "Cost Principles for Educational Institutions." Reference: 44 FR 12368, March 6, 1979; Rev. No. 1, 47 FR 33658, August 3, 1982; Rev. No. 2, 51 FR 20908, June 9, 1986. OMB Circular No. A-110, "Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Nonprofit Organizations." Reference: 41 FR 32016, July 30, 1976. OMB Circular No. A-122, "Cost Principles for Nonprofit Organizations." OMB Circular No. A-128, "Audits of State and Local Governments"; Reference: Public Law 98-502, the Single Audit Act of 1984. OMB Circular No. A-87, "Cost Principles Applicable to Grants and Contracts with State and Local Governments"; Reference: 34 CFR 255. 45 CFR 92. Reference: 42 FR 45828.

OMB Circular No. A-122, "Cost Principles for Nonprofit Organizations." Reference: 45 FR 46022, July 8, 1980. 45 CFR 74; 42 CFR 52h. 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. Department Staff Manual "Grants Administration"; Indirect Cost Register, DHHS; PHS Grants Policy Statement, DHHS Publications No. (OASH) 94-50,000, (Rev.) April 1, 1994; "NIH Grants Policy Guide," Office for Protection from Research Risks, NIH; "A Guide to Grant and Award Programs of the NIH"; and miscellaneous program literature from Headquarters Office. Regional or Local Office:

None.

Headquarters Office:

Patricia Newman, 6701 Democracy Boulevard, Room 994-MSC4874, Bethesda, Maryland 20892-4874 Email: pnewman@mail.nih.gov Phone: (301) 435-0864.

Website Address:

http://www.ncrr.nih.gov.

RELATED PROGRAMS:

Not Applicable.

EXAMPLES OF FUNDED PROJECTS:

Not Applicable.

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. RFIP: Factors considered in making awards include the merit of the proposal, the needs of the institution, with special consideration for institutions designated as centers of excellence, the commitment of the institution, the availability of funds, and the overall program priorities.

93.393 CANCER CAUSE AND PREVENTION RESEARCH FEDERAL AGENCY:

National Institutes of Health, Department of Health and Human Services 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.

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.

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.

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:

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.

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.

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.

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.

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.

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.

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

Website Address:

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

RELATED PROGRAMS:

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

93.394 CANCER DETECTION AND DIAGNOSIS RESEARCH

Cancer Detection and Diagnosis Research

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, 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.

OBJECTIVES:

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 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.

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, 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.

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 form SF424 is used to apply for SBIR Phase I and Phase II, respectively. Grant form SF424 is also used to apply for STTR Phase I and Phase II, respectively. See the website for more information on electronic submission of grants.

http://grants.nih.gov/grants/funding/424/index.htm. OMB Circular No. A-87

applies to this program.

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:

This program is excluded from coverage under OMB Circular No. A-102. OMB Circular No. A-110 applies to this program. 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 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 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:

Not Applicable.

Range of Approval/Disapproval Time:

(Regular Grants) Approximately 10 months. SBIR/STTR: About 7-1/2 months. See website: http://grants 1.nih.gov/grants/funding/submissionschedule.htm. Appeals:

http://grants.nih.gov/grants/guide/notice-files/not97-232.html.

Renewals:

Applications submitted for renewal are reviewed and selected for funding on a competitive basis.

Formula and Matching Requirements:

This program has no statutory formula.

This program has no matching requirements. This program has no statutory formula or 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 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. Method of awarding/releasing assistance: by letter of credit. 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 the budget period. Special reports may be requested by DHHS. Terminal reports are required 6 months after the end of the project. No expenditure reports are required. Performance monitoring is not applicable. Audits:

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.

Account Identification:

75-0849-0-1-550 - Detection and Diagnosis Research. Obligations:

(Project Grants (Cooperative Agreements)) FY 08 $234,889,000; FY 09 est $237,736,000; FY 10 est $241,532,000 - (Grants) (RPG) FY 08 $237,889,000; FY 09 est $237,736,000; and FY 10 est $241,532,000. For SBIR/STTR: FY 08 $44,612,000; FY 09 est $39,481,000; and FY 10 est $39,870,000. Range and Average of Financial Assistance:

Ramge: $4,368 to $9,101,961

Average: $364,302.

PROGRAM ACCOMPLISHMENTS:

Fiscal Year 2008: Competing FY 2008 RPG actual 192 awards which were 17.4 percent of applications received. Competing FY 2008 SBIR/STTR actual 86 awards which were 32.3 percent of applications received. Fiscal Year 2009: Fiscal year 2009 est. 750 total awards. Fiscal Year 2010: FY 2010 est. 799 total awards.

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.

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 Fax: 3014020275 Website Address:

http://www.cancer.gov; http://cancerdiagnosis.nci.nih.gov; http://imaging.cancer.gov.

RELATED PROGRAMS:

Not Applicable.

EXAMPLES OF FUNDED PROJECTS:

Not Applicable.

CRITERIA FOR SELECTING PROPOSALS: Not Applicable.

93.395 CANCER TREATMENT RESEARCH
Cancer Treatment Research
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 including molecularly targeted therapies, both individually and in combination. In addition, research is carried out in areas of nutritional support, stem cell and bone marrow transplantation, image guided therapies and 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.

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Books

Catalog of Federal Domestic Assistance, Volume 2