[Federal Register Volume 61, Number 217 (Thursday, November 7, 1996)]
[Notices]
[Pages 57687-57688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28682]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94P-0429]
Additional Data Regarding the Composition of Conjugated
Estrogens; Availability; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
additional materials have been submitted to Docket No. 94P-0429, the
docket established for a citizen petition filed on November 30, 1994,
on behalf of Wyeth-Ayerst Laboratories, Division of American Home
Products Corp. These materials include amendments to the petition and
data supporting the petition submitted by Wyeth-Ayerst as well as data
submitted to the docket by FDA and other interested persons. Among the
documents submitted to the docket by FDA is a document entitled
``Preliminary Analysis of Scientific Data on the Composition of
Conjugated Estrogens.'' The agency is requesting comments on this
document as well as on the citizen petition, amendments to the
petition, and other materials in the docket.
DATES: Written comments by December 9, 1996.
ADDRESSES: Submit written requests for single copies of the document
entitled ``Preliminary Analysis of Scientific Data on the Composition
of Conjugated Estrogens'' to the Drug Information Branch, Division of
Communications Management (HFD-210), Center for Drug Evaluation and
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857. Send two self-addressed adhesive labels to assist that office
in processing your requests. Submit written comments on the materials
submitted to the docket to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville,
MD 20857. Two copies of any comments are to be submitted, except that
individuals may submit one. Requests and comments should be identified
with the docket number found in brackets in the heading of this
document. Materials related to the Wyeth-Ayerst citizen petition on
conjugated estrogens are available for public examination in the
Dockets Management Branch (address above) between 9 a.m. and 4 p.m.,
Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Diane Sullivan-Ford, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 7500
Standish
[[Page 57688]]
Pl., Rockville, MD 20855, 301-594-2041.
SUPPLEMENTARY INFORMATION: On November 30, 1994, a citizen petition was
filed on behalf of Wyeth-Ayerst Laboratories, Division of American Home
Products Corp. The petition was amended on December 2, 1994; September
26, 1995; November 6, 1995; March 8, 1996; March 15, 1996; and June 27,
1996. The citizen petition requests, among other things, that FDA: (1)
Determine that sodium delta 8,9-dehydroestrone sulfate (delta 8,9-DHES)
is a concomitant component in conjugated estrogens tablets; (2)
officially recommend that the United States Pharmacopeial Convention
amend the United States Pharmacopeia (USP) monograph for conjugated
estrogens and conjugated estrogens tablets to include delta 8,9-DHES as
a concomitant component comprising at least 2 percent but not more than
6 percent of the estrogens in these products; and (3) not accept for
filing or receive or approve any new drug application (NDA) or
abbreviated new drug application (ANDA) for a conjugated estrogens
product in which delta 8,9-DHES does not comprise at least 2 percent
but not more than 6 percent of its estrogens. Amendments to the
petition raised issues concerning the contribution of delta 8,9-DHES to
the clinical effect of Premarin. FDA is inviting comments on this as
well as any other issues raised in the citizen petition and amendments
as well as on issues raised in comments received on the petition.
In addition, FDA has placed in the docket a document entitled
``Preliminary Analysis of Scientific Data on the Composition of
Conjugated Estrogens'' which addresses some of the issues and data
submitted in the citizen petition and amendments. This document
presents the agency's preliminary analysis of certain currently
available data relating to the contribution of estrone sulfate, equilin
sulfate, and delta 8,9-DHES to the clinical effects of Premarin,
including effects on bone mineral density. The document does not
respond to the citizen petition nor does it announce any action with
regard to any pending application or accepting any future application
for a conjugated estrogens drug product or indication for use of such a
product.
Interested persons may, on or before December 9, 1996, submit to
the Dockets Management Branch (address above) written comments
regarding materials submitted to the docket. 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. Materials related to the Wyeth-Ayerst
citizen petition on conjugated estrogens and received comments may be
seen in the office above between a.m. and 4 p.m., Monday through
Friday. Comments submitted after December 9, 1996 may not be considered
by the agency.
Dated: October 31, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-28682 Filed 11-04-96; 3:24 pm]
BILLING CODE 4160-01-F