[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]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Bioresearch; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
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