[Federal Register: October 15, 1998 (Volume 63, Number 199)]
[Notices]               
[Page 55399-55400]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15oc98-93]

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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Draft Guidance for Industry on Non-Contraceptive Estrogen Class 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing 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availability of a draft guidance for industry entitled ``Labeling 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 The draft guidance is intended to serve as a 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. Once finalized, this draft guidance will replace the 
``Labeling Guidance for Estrogen Drug Products, Physician Labeling'' 
and ``Labeling Guidance for Estrogen Drug Products, Patient Package 
Insert,'' both of which were revised and published in August 1992.

DATES: Written comments on the draft guidance document may be submitted 
by December 14, 1998. General comments on the agency guidance documents 
are welcome at any time.

ADDRESSES: Copies of this draft guidance for industry can be obtained 
on the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit 
written requests for single copies of ``Labeling Guidance for Estrogen 
Drug Products; Physician and Patient labeling'' 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 Submit written comments on the draft guidance to the Dockets 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.

FOR FURTHER INFORMATION CONTACT: John C. Markow, 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: FDA is announcing the availability of a 
draft guidance for industry entitled ``Labeling Guidance for Non-
Contraceptive Estrogen Drug Products; Physician and Patient Labeling.'' 
Once it has been finalized, the guidance will replace two existing 
guidance documents: (1) ``Labeling Guidance for Estrogen Drug Products, 
Physician Labeling'' and (2) ``Labeling Guidance for Estrogen Drug 
Products, Patient Package Insert,'' both of which were revised and 
published in August 1992. The draft guidance provides a template for 
both physician and patient labeling for estrogen class drug products, 
which sponsors should use with new drug applications and abbreviated 
new drug applications.
    The draft guidance outlines the recommended language for the 
physician insert and the patient package insert. Included are black box 
warnings explaining the increased risk of cancer of the uterus 
associated with the use of estrogens. Once finalized, the 
recommendations in this draft guidance should be followed for all 
approved, pending, and future applications.
    This draft guidance is a level 1 guidance consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). It represents 
the agency's current thinking on estrogen class labeling. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirement of the applicable statute, 
regulations, or both.
    Interested persons may submit written comments on the draft 
guidance to the Dockets Management Branch (address above). 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. The draft guidance and

[[Page 55400]]

received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 5, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-27583 Filed 10-14-98; 8:45 am]
BILLING CODE 4160-01-F