[Federal Register Volume 62, Number 225 (Friday, November 21, 1997)]
[Notices]
[Pages 62322-62323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30561]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0289]


Content and Format of Labeling for Human Prescription Drugs; 
Pregnancy Labeling; Public Hearing; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period following its September 12, 1997, public hearing until 
January 12, 1998. This public hearing, which was announced in the 
Federal Register of July 31, 1997 (62 FR 41061), focused on 
requirements for the content and format of the pregnancy subsection of 
labeling for human prescription drugs. The comment period closed on 
November 12, 1997. This action is being taken in response to the 
request of the Pharmaceutical Research and Manufacturers of America for 
additional time to prepare comments because of the complexity and 
importance of the issues raised by pregnancy labeling.

DATES: Written comments by January 12, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug

[[Page 62323]]

Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Rose E. Cunningham, Center for Drug 
Evaluation and Research (HFD-6), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-6779.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 31, 1997 (62 
FR 41061), FDA announced that it would be holding a public hearing on 
September 12, 1997, concerning the requirements for the content and 
format of the pregnancy subsection of labeling for human prescription 
drugs. The public hearing was intended to elicit comments on the 
practical utility, effects, and limitations of the current pregnancy 
labeling categories in order to help the agency identify the range of 
problems associated with the categories and to identify and evaluate 
options that might address identified problems. Interested persons were 
given until November 12, 1997, to submit written comments on these 
issues. Because of the complexity and importance of the issues raised 
by pregnancy labeling, the Pharmaceutical Research and Manufacturers of 
America has requested an additional 60 days to prepare comments.
     Interested persons may, on or before January 12, 1998, submit to 
the Dockets Management Branch (address above) written comments on this 
subject. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with 
Docket No. 97N-0289. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 13, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-30561 Filed 11-20-97; 8:45 am]
BILLING CODE 4160-01-F