[Federal Register Volume 59, Number 123 (Tuesday, June 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15605]
[Federal Register: June 28, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 86D-0334]
Estrogen Drug Product Labeling; Labeling Guidance Texts;
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 informal labeling guidance texts for professional and
patient labeling for estrogen drug products that were last revised in
1992. The texts provide information to assist manufacturers and other
persons in preparing supplemental applications to meet labeling
requirements. The revisions reflect updated scientific information.
DATES: Written comments on the labeling may be submitted at any time.
ADDRESSES: Submit written requests for a copy of the labeling guidance
texts to Philip A. Corfman, Division of Metabolism and Endocrine Drug
Products (HFD-510), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-3510. Send two self-addressed adhesive
labels to assist that office in processing your requests. Submit
written comments on the labeling guidance texts to the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857. Requests and comments should
be identified with the docket number found in brackets in the heading
of this document. The labeling guidance texts and received comments are
available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Deborah A. Wolf, Center for Drug
Evaluation and Research (HFD-362), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1046.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of the
1992 revised informal labeling guidance texts for professional and
patient labeling for estrogen drug products. The 1992 revisions reflect
updated scientific information, particularly pertaining to the
relationship between estrogen replacement therapy and reduction of
cardiovascular risk. Although, the agency has distributed copies of the
1992 labeling guidance on a case-by-case basis, it is announcing its
availability now to ensure more widespread distribution.
Under 21 CFR 314.70(c), a holder of an approved application for a
new drug is required to submit a supplemental application to obtain
approval for the following changes, among others, in the text of
professional or patient labeling: to add or strengthen
contraindications, warnings, precautions, or adverse reactions, or to
add or strengthen dosage and administration instructions to increase
the safe use of the product. Manufacturers and other persons can refer
to the labeling guidance texts for assistance in preparing supplemental
applications to meet the labeling requirements of 21 CFR 310.515 for
estrogen drug products and 21 CFR 201.56, 201.57, and 201.100 for
professional labeling of prescription drug products.
In the Federal Register of May 4, 1990 (55 FR 18761), the agency
announced the revocation of guideline texts of professional and patient
labeling for estrogen drug products. The agency determined that the
time period to finalize and announce revised guidelines prevented the
agency from providing the most current medical information to
manufacturers and others. Therefore, in place of guidelines, the agency
announced that it would provide assistance in meeting labeling
requirements in the form of informal labeling guidance texts.
Labeling guidance texts are informal documents. They do not bind or
otherwise obligate the agency or a person referring to them and are not
formal agency opinions. The agency does not require manufacturers
printing professional and patient package inserts to follow the
labeling guidance texts. Manufacturers and others are free to use an
alternative or modified approach, although they are encouraged to
consult with the Division of Metabolism and Endocrine Drug Products
(address above) before drafting alternative labeling so that any
differences can be resolved prior to the submission of a supplemental
application, if such an application is required under 21 CFR 314.70.
Interested persons may submit written comments concerning the
informal labeling guidance texts 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. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
Dated: June 21, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-15605 Filed 6-27-94; 8:45 am]
BILLING CODE 4160-01-F
