[Federal Register Volume 59, Number 197 (Thursday, October 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25298]
[[Page Unknown]]
[Federal Register: October 13, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Conference on FDA-Regulated Products and Pregnant Women; Notice
of Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
Office of Women's Health, FDA, in cooperation with the Office on
Women's Health, Public Health Service; the National Institute of Child
Health and Human Development, and the Office of Research on Women's
Health, National Institutes of Health; and the Centers for Disease
Control and Prevention, is sponsoring a public meeting to gather
consumers and representatives from academia, industry, and government
to discuss the scientific, legal, and ethical issues associated with
testing FDA-regulated products in pregnant women.
DATES: The public meeting will be held on Monday, November 7 and
Tuesday, November 8, 1994, from 8 a.m. to 5:30 p.m. Registration is
recommended by October 26, 1994. An opportunity for public comment is
planned on November 7, 1994, from 1:30 p.m. to 2:30 p.m. Submit written
notices of participation by October 31, 1994.
ADDRESSES: The public meeting will be held at the Hyatt Regency Crystal
City Hotel, 2799 Jefferson Davis Hwy., Arlington, VA 22202, 703-418-
1234. Those persons interested in attending the conference should
return registration forms by mail to Michelle Priester, KRA Corp., 1010
Wayne Ave., suite 850, Silver Spring, MD 20910, 301-495-1591, FAX 301-
495-9410. Participants who wish to speak during the public comment
session should send name, affiliation, address, and phone number to the
contact person listed below.
FOR FURTHER INFORMATION CONTACT: Mary C. Gross or Elyse I. Summers,
Food and Drug Administration, Office of External Affairs (HF-24), 5600
Fishers Lane, Rockville, MD 20857, 301-443-3390.
SUPPLEMENTARY INFORMATION: The meeting will include discussions on: (1)
The scope of the use of and the need for medical intervention in
pregnancy, (2) the extent to which the physiologic changes of pregnancy
alter the metabolism of drugs in pregnant women, (3) the application of
scientific, legal, and ethical concepts that apply to clinical trials
in pregnant women, and (4) strategies to promote research and
collection of information on the use of drugs, biologics, and devices
in pregnant women and their effects on the fetus.
Dated: October 6, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-25298 Filed 10-12-94; 8:45 am]
BILLING CODE 4160-01-F
