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Catalog of Federal Domestic Assistance

Program Descriptions

93.859:  Pharmacology, Physiology, and Biological Chemistry Research

Objectives:  To support research in the areas of chemistry, biochemistry, pharmacology, physiology, and biotechnology including research on pharmacogenetics and complex systems. The research ranges from fundamental studies in chemistry to the elucidation of biochemical and cellular mechanisms that may serve as new targets for drug design. Grantees are investigating chemical and biotechnological methods for synthesizing new drugs, the biochemical pathways involved in cellular functioning, the genetic and metabolic factors affecting drug action in humans, the body's response to trauma and burn injury, and the molecular mechanisms of action of local and general anesthetics. The results of these studies improve our understanding of how the body works and pave the way for the discovery and development of new drugs. Small Business Innovation Research (SBIR) grants are made 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 the participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. Small Business Technology Transfer (STTR) grants are made 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 the participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.

PROGRAM AND AWARD	FINANCIAL AND INFORMATION CONTACTS
ELIGIBILITY REQUIREMENTS	FINANCIAL AND ADMINISTRATIVE INFO.
APPLICATION AND AWARD PROCESS	INFORMATION CONTACTS
RELATED PROGRAMS	ASSISTANCE CONSIDERATIONS
PROGRAM ACCOMPLISHMENTS	POST ASSISTANCE REQUIREMENTS

93.859 ELIGIBILITY REQUIREMENTS:

Applicant Eligibility:  Research projects: Awards can be made to any public or private, for-profit or nonprofit university, college, hospital, laboratory, or other institution, including State and local units of government, qualifying small businesses, and individuals. To be eligible for funding, a proposal must be approved for scientific merit and program relevance by a scientific review committee and a national advisory council. 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. or its possessions. To be eligible for funding, an SBIR 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) that "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. Nonfederal public and private nonprofit domestic organizations may apply for an institutional National Research Service Award. Individual National Research Service awardees must be nominated and sponsored by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program. All awardees must be citizens or no citizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence. Protectoral awardees must have completed the baccalaureate degree, and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Scud., Den., or equivalent domestic or foreign degree). Applicants to the SBIR and STTR Programs must meet special requirements for small businesses, as defined by the Small Business Administration.

Beneficiary Eligibility:  Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.

Credentials/Documentation:  Each applicant for research projects must present a research plan and furnish evidence that scientific competence, facilities, equipment, and supplies are appropriate to carry out the plan. Use grant application Form PHS 398 (Rev. 4/98) provided by the Division of Extramural Outreach and Information Resources, National Institutes of Health, Bethesda, MD 20892. 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 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. For applicants for National Research Service Awards, the academic record, research experience, citizenship, institutional sponsorship, and the proposed area and plan of training must be included in the application. The applicant institution must show the objectives, methodology, and resources for the research training program; the qualifications and experience of directing staff; the criteria to be used in selecting individuals for the award; and a detailed budget and justification for the grant funds requested. 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 C.

93.859 APPLICATION AND AWARD PROCESS:

Preapplication Coordination:  Not applicable. This program is excluded from coverage under E.O. 12372.

Application Procedure:  Application forms (and information concerning the areas of science being supported) may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, Bethesda, MD 20892, and must be submitted to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892 for assessment by a scientific review committee. 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, "Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Nonprofit Organizations," as appropriate. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the Nil's "Small Business Funding Opportunities" home page at grants.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:  All accepted applications for project grants, SBIR/STTR grants, and institutional National Research Service Awards are reviewed for scientific merit by an appropriate initial review group and by a national advisory council. (NRSA applications for the support of individual fellows are not reviewed by the council.) All approved applications compete for available funds on the basis of scientific merit and program emphasis.

Deadlines:  New Research Projects: February 1, June 1, and October 1. Renewals: March 1, July 1, and November 1. NRSA (institutional): January 10, May 10, and September 10. NRSA (individual): April 5, August 5, and December 5. SBIR: April 15, August 15, and December 15. STTR: April 1, August 1, and December 1.

Range of Approval/Disapproval Time:  Project Grants: About 9 months. NRSA: (institutional) 9 to 12 months, (individual) 6 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 grants.nih.gov/grants/guide/notice-files/not97-232.html.

Renewals:  Renewal grants are generally made prior to the expiration of any current award.

Criteria for Selecting Proposals:  Research Grants: 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 safeguarding human or animal subjects and/or protecting against or minimizing any adverse effect on the environment.

Examples of Funded Projects:  (1) "Determinants of Individual Responsiveness to Drugs"; (2) "Regulation of Cyclic Nucleotide Metabolism"; (3) "Mechanisms of Anesthetic Action on Signal Transudation"; (4) "Enzymes Mechanisms and Enzymes Inhibitors"; (5) "Biochemical Mechanisms of Cellular Injury in Trauma"; and (6) "Synthesis of Biologically Active Natural Products."

Range and Average of Financial Assistance:  The range is from $35,000 to $716,000; $193,902. Average SBIR Phase I awards are for about $100,000; Phase II awards may be made for amounts up to $750,000. Average STTR Phase I awards are for about $100,000; Phase II awards may be made for amounts up to $500,000.

93.859 RELATED PROGRAMS:

• 93.862 Genetics and Developmental Biology Research;
• 93.821 Cell Biology and Biophysics Research.

93.859 PROGRAM ACCOMPLISHMENTS:

93.859 FINANCIAL AND ADMINISTRATIVE INFO:

Federal Agency:  NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

Type of Assistance:  Project Grants.

Obligations:  (Grants) FY 99 $330,762,000; FY 00 est $372,762,000; and FY 01 est $396,832,000.

Budget Account Number:  75-0851-0-1-552.

Authorization:  Public Health Service Act, Sections 301, 461, and 487, as amended; Public Laws 78-410 and 99-158; 42 U.S.C. 241, as amended; 42 U.S.C. 285k; 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992; Public Law 102-564.

Regulations, Guidelines, and Literature:  42 CFR 52; 45 CFR 66; 45 CFR 74; 45 CFR 92; NIH Extramural Programs brochure; miscellaneous program literature from Headquarters Office. 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.

93.859 INFO CONTACTS:

Regional or Local Office:  Not applicable.

Headquarters Office:  Program Contact: Dr. Michael Rogers, Director, Division of Pharmacology, Physiology, and Biological Chemistry, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive MSC 6200, Bethesda, MD 20892-6200. Phone: 301) 594-3827. SBIR/STTR Contact: Dr. Michael Martin, Deputy Associate Director for Extramural Activities, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive MSC 6200, Bethesda, MD 20892-6200. Phone: (301) 594-3910. Grants Management Contact: Ms. Carol Tipper, Chief Grants Management Officer, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive MSC 6200, Bethesda, MD 20892-6200. Phone: (301) 594-5135. Use the same numbers for FTS.

(See Appendix IV for more contact info.)

93.859 ASSISTANCE CONSIDERATIONS:

Formula and Matching Requirements:  This program has no statutory formula or matching requirements.

Length and Time Phasing of Assistance:  All awards are made for at least 1 year, with additional support (up to 4 years) depending on the recommendation of the scientific review group, the national advisory council, successful annual performance, and availability of funds. A description of the NIH Peer Review Appeal procedures is available on the NIH home page at grants.nih.gov/grants/guide/notice-files/not97-232.html.

Uses and Use Restrictions:  The research project grant is awarded to an eligible institution on behalf of a principal investigator to support a discrete project or group of related projects representing the investigator's area of interest and competence. Funds are used for reasonable costs of the research activity, as well as for salaries, equipment, supplies, travel, and other related expenses. National Research Service Awards are made directly to individuals for research training leading to a Ph.D. or combined professional degree Ph.D. in the scientific areas covered by the division. In addition, grants may be made to institutions to enable them to make National Research Service Awards to individuals selected by them. Responsibilities of grantees and restrictions on use of funds are set forth in the Public Health Service policy statement on grants for research projects, which is available on request from the Division of Extramural Outreach and Information Resources, NIH, Bethesda, MD 20892. SBIR Phase I grants (of about 6 months' duration) are to establish the scientific and 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 research initiated in Phase I that is 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's duration) are to determine the scientific, technical, and commercial merit and feasibility of proposed cooperative effort that has potential for commercial application. Phase II funding is based on the results of research initiated in Phase I.

93.859 POST ASSISTANCE REQUIREMENTS:

Reports:  Annual progress and selected financial status reports for continuing projects and final reports on all projects upon conclusion are required. Recipients of National Research Service Awards are required to file termination reports to ascertain compliance with the service and payback provisions.

Audits:  For most grant recipients, audits are to be carried out in accordance with the provisions set forth in OMB Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal 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.