Content provided by the Catalog of Federal Domestic Assistance
93.396 Cancer Biology Research
NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service Act, Section 301, 410, and 411, Public Law 78-410, 42 U.S.C. 241, as amended; Public Law 100-607, 42 U.S.C. 285 and 285a; Small Business Research and Development Enhancement Act of 1992, as amended, Public Law 102-564.
To provide fundamental information on the cause and nature of cancer in man, with the expectation that this will result in better methods of prevention, detection and diagnosis, and treatment of neoplastic diseases. Cancer Biology Research includes the following research programs: nutrition, tumor biology, genetics and immunology. Small Business Innovation Research (SBIR) program: To expand and improve the SBIR program; to increase private sector commercialization of innovations derived from Federal 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 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:
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 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 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 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.
Pre-application Coordination: Not applicable. This program is excluded from coverage under E.O. 12372.
Formula and Matching Requirements: This program has no statutory formula or matching requirements.
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 a project.
Account Identification: 75-0849-0-1-552.
Competing fiscal year 2001 RPGs, 331 awards, which were 27.50 percent of applications received. Competing fiscal year 2001 SBIR/STTRs, 11 awards, which were 19.30 percent of applications received. Fiscal year 2002 est 1,461 total awards and fiscal year 2003 est 1,526 total awards.
REGULATIONS, GUIDELINES, AND LITERATURE:
42 CFR 52; 45 CFR 74; 45 CFR 92; 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; 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: Not applicable.
EXAMPLES OF FUNDED PROJECTS:
(1) Studies of the properties of the membranes of malignant cells; (2) studies of the molecular genetics of oncogenes and tumor suppressor genes and the proteins they encode; (3) studies of the mechanism of action of growth factors and other growth modifiers and differentiation agents; (4) studies of the regulation of the biology of tumor cells by their micro environment; (5) studies of the synthesis, structure, and function of humoral factors that participate in, activate, and/or regulate the immune response to tumors, including interferons, interleukins, growth factors, helper factors, suppressor factors, etc., as they are involved in immune responses to tumors; (6) studies of the immunobiology of lymphocytes, macrophages, and other cells that may participate in immune surveillance responses (e.g., natural killer cells and cytotoxic T cells); (7) studies of the immune mechanisms involved in effective immunotherapy in animal models and humans, including studies on the development vaccine approaches to cancer therapy or prevention; (8) studies of bone marrow transplantation in humans and animals as a treatment for cancer when the emphasis is on immunologic problems such as immune reconstitution, sensitization and graft-versus-host disease.
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.