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Catalog of Federal Domestic Assistance

Program Descriptions

93.948:  Pilot Clinical Pharmacology Training

Objectives:  To assist in the establishment of a clinical pharmacology training and research demonstration program at domestic medical schools.

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

93.948 ELIGIBILITY REQUIREMENTS:

Applicant Eligibility:  Domestic medical schools may apply.

Beneficiary Eligibility:  Colleges, universities, and the public health will benefit.

Credentials/Documentation:  Grant applicants must present a plan and furnish evidence that faculty, facilities and equipment are appropriate to carry out the plan. Costs will be determined by Department of Health and Human Services (DHHS) Regulations 45 CFR Part 74, Subpart Q, and OMB Circular No. A-110 for nonprofit private organizations.

93.948 APPLICATION AND AWARD PROCESS:

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

Application Procedure:  Consultation of program staff is available by contacting the Headquarters Office listed below. The standard application forms, as furnished by the Food and Drug Administration (FDA), must be used for this program. Applications in response to Federal Register Announcements shall be sent to the address listed below. Information can be obtained by contacting the Headquarters Office. All application kits may be obtained from the FDA office listed below. This program is subject to the provisions of 45 CFR Part 74 and OMB Circular No. A-110 for nonprofit organizations.

Award Procedure:  All accepted grant applications are evaluated under objective review procedures. If sufficient funds are available the successful application will be issued a Notice of Grant Award by the FDA.

Deadlines:  Contact Headquarters Office listed below for solicited application deadlines.

Range of Approval/Disapproval Time:  About 6 months.

Appeals:  None.

Renewals:  Not applicable.

Criteria for Selecting Proposals:  The major elements in evaluating application include the assessment of: (1) Post-doctoral training and research studies should be proposed on one or more of the six clinical pharmacology and biopharmaceutics objectives listed in the RFA under section II: Research Goals and Objectives; 2) Whether the proposed study is within the budget and costs have been adequately justified and fully documented; 3) Soundness of the rationale for the proposed study and appropriateness of the study design to address the objectives of the RFA; 4) Availability and adequacy of laboratory and associated clinical pharmacology and biopharmaceutics resources; 5) Availability and adequacy of support services, e.g., biostatistics, computers, etc.; and 6) Research experience, training, and competence of the Principal Investigator and support staff.

Examples of Funded Projects:  Not applicable.

Range and Average of Financial Assistance:  The range is from $300,000 to $750,000.

93.948 RELATED PROGRAMS:

93.948 PROGRAM ACCOMPLISHMENTS:

93.948 FINANCIAL AND ADMINISTRATIVE INFO:

Federal Agency:  FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

Type of Assistance:  Project Grants.

Obligations:  (Grants) under old program FY 99 $500,000; FY 00 est $459,992; and FY 01 est $460,000.

Budget Account Number:  75-0600-0-1-550.

Authorization:  Section 2(a), Public Law 102-222.

Regulations, Guidelines, and Literature:  PHS Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000, (Rev.), April 1, 1994.

93.948 INFO CONTACTS:

Regional or Local Office:  Not applicable.

Headquarters Office:  Grants Management Contact: Rosemary Springer, Grants Management Specialist, Division of Contracts and Procurement Management, OFACS, Food and Drug Administration, Public Health Service, HFA-520, Room 2129, 5630 Fishers Lane, Rockville, MD 20852. Phone: (301) 827-7182. Use the same number for FTS. FAX: (301) 827-7106. E-MAIL: rspringe@oc.fda.gov.

(See Appendix IV for more contact info.)

93.948 ASSISTANCE CONSIDERATIONS:

Formula and Matching Requirements:  This program has no statutory formula or matching requirements. Cost participation is not required but is encouraged.

Length and Time Phasing of Assistance:  It is anticipated that four to 10 awards will be made for 1 year with additional support (up to 3 years) depending on the recommendation of the review group, successful annual performance and availability of funds.

Uses and Use Restrictions:  Funds are to be used for salaries and wages, equipment, supplies, travel, and other costs directly required to carry out the project.

93.948 POST ASSISTANCE REQUIREMENTS:

Reports:  Annual program progress reports and financial status reports are required for continuation at the end of each budget period and final performance and financial status reports and invention statements must be submitted upon completion.

Audits:  In accordance with the provisions of OMB Circular No. A-133 (Revised, June 24, 1997), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that receive financial assistance of $300,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $300,000 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:  Progress reports, expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the final financial status report for the project period.