[Federal Register Volume 64, Number 5 (Friday, January 8, 1999)] [Notices] [Pages 1208-1209] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-379] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98D-0834] Draft Guidance for Industry on Non-Contraceptive Estrogen Class Labeling; Availability; Reopening of Comment Period
Agency
Food and Drug Administration, HHS.
Action
Notice; reopening of comment period.
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Summary
The Food and Drug Administration (FDA) is reopening until February 13, 1999, the comment period on the draft guidance for industry entitled ``Labeling Guidance for Non-Contraceptive Estrogen Drug Products--Physician and Patient Labeling.'' FDA published a notice of availability of the draft guidance in the Federal Register of October 15, 1998. FDA is taking this action in response to a request to extend the comment period.
Dates
Written comments may be submitted by February 13, 1999. General comments on agency guidance documents are welcome at any time.
Addresses
Copies of the draft guidance are available on the Internet at ``www.fda.gov/cder/guidance/index.htm''. Submit written requests for single copies of the draft guidance to the Drug Information Branch (HFD-210), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.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 Submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments are to be identified with the docket number found in brackets in the heading of this document.
www.fda.gov/cder/guidance/index.htmFor 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
In the Federal Register of October 15, 1998 (63 FR 55399), FDA announced the availability of a draft guidance for industry entitled ``Labeling Guidance for Non-Contraceptive Estrogen Drug Products--Physician and Patient Labeling.'' The draft guidance is intended to serve as a template for sponsors of estrogen class drug products to ensure that such products contain uniform physician and patient labeling information. On November 11, 1998, FDA received a letter from Regulatory Affairs, Wyeth-Ayerst Research requesting that the agency extend the comment period on the draft guidance 60 days. The agency has decided to reopen and extend the comment period to February 13, 1999. Interested persons may, on or before February 13, 1999, submit to the Dockets Management Branch (address above) written comments on the draft guidance. 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 may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: January 4, 1999. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 99-379 Filed 1-7-99; 8:45 am] BILLING CODE 4160-01-F