[Federal Register Volume 64, Number 186 (Monday, September 27, 1999)]
[Notices]
[Pages 52100-52101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24981]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Draft Guidance for Industry on Noncontraceptive Estrogen Class 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availability of a draft guidance for industry entitled ``Labeling 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 Noncontraceptive Estrogen Drug Products--Prescribing 
Information for Healthcare Providers 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 The draft 
guidance is intended to serve as a template for sponsors of estrogen 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 health 
care provider and patient labeling information. FDA published a notice 
of availability of an earlier version of this draft guidance in the 
Federal Register of October 15, 1998 (63 FR 55399). The agency received 
numerous comments. As a result, the original draft guidance was revised 
substantially and is being issued in draft for a second time.

DATES: Written comments on the draft guidance document may be submitted 
by November 26, 1999. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Copies of the draft guidance for industry can be obtained on 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 
Noncontraceptive Estrogen Drug Products--Prescribing Information for 
Healthcare Providers 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 Submit written comments on the draft guidance to the Dockets 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: 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: FDA is announcing the availability of a 
draft guidance for industry entitled ``Labeling Guidance for 
Noncontraceptive Estrogen Drug Products--Prescribing Information for 
Healthcare Providers 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 health care 
provider 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

[[Page 52101]]

Insert,'' both of which were revised and published in August 1992.
    The draft guidance outlines recommended language for the 
prescribing information for the health care provider and the patient 
package inserts. 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.
    In the Federal Register of October 15, 1998 (63 FR 55399), FDA 
announced the availability of an earlier version of this draft 
guidance. The agency received numerous comments. As a result, the 
original draft guidance was revised substantially and is being issued 
in draft for a second time.
    This Level 1 draft guidance is being issued 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 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 17, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-24981 Filed 9-24-99; 8:45 am]
BILLING CODE 4160-01-F