[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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