[Federal Register Volume 64, Number 5 (Friday, January 8, 1999)]
[Notices]
[Pages 1208-1209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-379]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0834]


Draft Guidance for Industry on Non-Contraceptive Estrogen Class 
Labeling; Availability; 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 until 
February 13, 1999, the comment period on the draft guidance for 
industry entitled ``Labeling Guidance for Non-Contraceptive Estrogen 
Drug Products--Physician and Patient Labeling.'' FDA published a notice 
of availability of the draft guidance in the Federal Register of 
October 15, 1998. FDA is taking this action in response to a request to 
extend the comment period.

DATES:  Written comments may be submitted by February 13, 1999. General 
comments on agency guidance documents are welcome at any time.

ADDRESSES:  Copies of the draft guidance are available on the Internet 
at ``http://www.fda.gov/cder/guidance/index.htm''. Submit written 
requests for single copies of the draft guidance to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. Submit written comments on the draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document.
FOR FURTHER INFORMATION CONTACT:  Lana L. Pauls, Reproductive and 
Urologic Drug Products, Center for Drug Evaluation and Research (HFD-
580), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-4260.

SUPPLEMENTARY INFORMATION:  In the Federal Register of October 15, 1998 
(63 FR 55399), FDA announced the availability of a draft guidance for 
industry entitled ``Labeling Guidance for Non-Contraceptive Estrogen 
Drug Products--Physician and Patient Labeling.'' The draft guidance is 
intended to serve as a template for sponsors of estrogen class drug 
products to ensure that such products contain uniform physician and 
patient labeling information.
    On November 11, 1998, FDA received a letter from Regulatory 
Affairs, Wyeth-Ayerst Research requesting that the agency extend the 
comment period on the draft guidance 60 days. The agency has decided to 
reopen and extend the comment period to February 13, 1999.
    Interested persons may, on or before February 13, 1999, submit to 
the Dockets Management Branch (address above) written comments on the 
draft guidance. Two copies of any comments

[[Page 1209]]

are to be submitted, except that individuals may submit one copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The draft guidance and received 
comments may be seen in the office above between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: January 4, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-379 Filed 1-7-99; 8:45 am]
BILLING CODE 4160-01-F