[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Draft Guidance for Industry on Noncontraceptive Estrogen Class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availability of a draft guidance for industry entitled ``Labeling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 The draft
guidance is intended to serve as a template for sponsors of estrogen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of availability of an earlier version of this draft guidance in the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 As a result, the original draft guidance was revised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DATES: Written comments on the draft guidance document may be submitted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ADDRESSES: Copies of the draft guidance for industry can be obtained on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 Submit written comments on the draft guidance to the Dockets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draft guidance for industry entitled ``Labeling Guidance for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
