[Federal Register Volume 61, Number 172 (Wednesday, September 4, 1996)]
[Notices]
[Page 46653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22442]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Bioresearch; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) (Office of Regulatory 
Affairs, Nashville District Office, and the Center for Drug Evaluation 
and Research) is announcing a free public workshop on FDA regulatory 
requirements for the bioresearch industry. The workshop is designed to 
assist the industry in complying with regulations for clinical 
investigators, institutional review boards, and sponsor-monitors.

DATES: The public workshop will be held on Tuesday, September 24, 1996, 
from 8:45 a.m. to 4:45 p.m.

ADDRESSES: The public workshop will be held at the University of 
Alabama--Birmingham, University Hospital, 620 South 19th St., Spain 
Wallace Bldg., Margaret Cameron Spain Auditorium, rm. S100, Birmingham, 
AL.

FOR FURTHER INFORMATION CONTACT: William H. Oates, FDA's Nashville 
District Office, 296 Plus Park Blvd., Nashville, TN 37217, 615-781-5374 
ext. 118, FAX 615-781-5391.
    Those persons interested in attending this meeting should FAX their 
registration, including name(s), firm name, address, telephone and FAX 
numbers, and any specific questions to William H. Oates (address above) 
by September 13, 1996. There is no registration fee for this workshop. 
Space is limited, therefore, interested parties are encouraged to 
register early.
SUPPLEMENTARY INFORMATION: FDA's survey of the bioresearch industry 
shows that many of these firms are either unaware of applicable 
regulations and guidelines or not in compliance with applicable 
requirements. This workshop is designed to assist the bioresearch 
industry in complying with applicable regulations.

    Dated: August 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-22442 Filed 9-3-96; 8:45 am]
BILLING CODE 4160-01-F