[Federal Register Volume 67, Number 175 (Tuesday, September 10, 2002)]
[Notices]
[Page 57432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22900]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0834]


Withdrawal of Guidances on Estrogen and Estrogen/Progestin-
Containing Drug Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of two guidances: A draft entitled``Labeling Guidance for 
Noncontraceptive Estrogen Drug Products--Prescibing Information for 
Healthcare Providers and Patient Labeling'' and a final ``Guidance for 
Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug 
Products Used for Hormone Replacement Therapy of Postmenopausal 
Women.'' These guidances are under agency review for change.

DATES: General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Submit written requests for the guidance to the 
Division of Drug Information (HFD-240), Center for Drug Evaluation and 
Research (CDER), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857. See the Supplementary Information section for 
electronic access to agency guidance documents.

FOR FURTHER INFORMATION CONTACT: Dan Shames, Center for Drug Evaluation 
and Research (HFD-580), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-4260

SUPPLEMENTARY INFORMATION: FDA is announcing the withdrawal of two 
guidances on estrogen and estrogen/progestin drug products. The two 
guidances being withdrawn are the draft guidance ``Labeling Guidance 
for Noncontraceptive Estrogen Drug Products--Prescibing Information for 
Healthcare Providers and Patient Labeling'' (labeling guidance) and the 
final ``Guidance for Clinical Evaluation of Combination Estrogen/
Progestin-Containing Drug Products Used for Hormone Replacement Therapy 
of Postmenopausal Women'' (combination guidance). The draft labeling 
guidance was made available for comment in the Federal Register of 
September 27, 1999 (64 FR 52100); the final combination guidance was 
made available in March 1995. Both guidances are undergoing review for 
change as a result of the results from the National Institutes of 
Health (NIH) Women's Health Initiative trial.\1\
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    \1\ The results of the NIH Women's Health Initiative trial were 
reported in the Journal of the American Medical Association, 
2002;288:321-333.
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    Interested persons may submit written or electronic comments to the 
Dockets Management Branch (see ADDRESSES). Two copies of any comments 
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. Received comments are available for 
public examination in the Dockets Management Branch between 9 a.m. and 
4 p.m., Monday through Friday.
    Persons with access to the Internet may obtain CDER guidance 
documents at http://www.fda.gov/cder/guidance/index.htm.

    Dated: August 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-22900 Filed 9-9-02; 8:45 am]
BILLING CODE 4160-01-S