[Federal Register Volume 69, Number 44 (Friday, March 5, 2004)]
[Notices]
[Pages 10457-10458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4886]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2000D-1350]


Draft Guidance for Industry on Labeling for Combined Oral 
Contraceptives; 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availability of a draft guidance for industry entitled ``Labeling for 
Combined Oral Contraceptives.'' The draft guidance contains recommended 
labeling for combined oral contraceptives. This is the second draft of 
a guidance being issued on this topic.

DATES:  Submit written or electronic comments on the draft guidance by 
May 4, 2004. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Margaret Kober, Center for Drug 
Evaluation and Research (HFD-580), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4260.

SUPPLEMENTARY INFORMATION:

[[Page 10458]]

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Labeling for Combined Oral Contraceptives.'' The draft 
guidance describes the recommended labeling for health care providers 
and patient instructions for use for new drug applications (NDAs) and 
abbreviated new drug applications (ANDAs) for combined oral 
contraceptives (those that contain estrogen and progestin). This draft 
guidance incorporates changes in response to public comments on the 
previous draft guidance that was published in the Federal Register on 
July 10, 2000 (65 FR 42387). Because of the many changes resulting from 
comments on the 2000 draft, this guidance is being issued in draft 
again to allow for additional public input. Once comments on this 
second draft have been received and considered, the agency will 
finalize the guidance.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on labeling for 
combined oral contraceptives. 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 
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Two copies of mailed 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 Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: February 25, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-4886 Filed 3-4-04; 8:45 am]
BILLING CODE 4160-01-S