[Federal Register Volume 65, Number 132 (Monday, July 10, 2000)]
[Notices]
[Page 42387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17278]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1350]


Draft Guidance for Industry on Combined Oral Contraceptives--
Labeling for Healthcare Providers and Patients; 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availability of a draft guidance for industry entitled ``Combined Oral 
Contraceptives--Labeling for Healthcare Providers and Patients.'' FDA's 
Center for Drug Evaluation and Research is issuing this draft guidance 
for drug products in the combined oral contraceptives class. When 
finalized, the guidance should result in uniform labeling among 
combined oral contraceptive products. Uniform labeling is important to 
physicians and patients when they read and try to understand efficacy 
claims and safety risks associated with drug products in this class. In 
addition, this draft guidance is intended to provide sponsors of new 
combined oral contraceptive drug products with a labeling template.

DATES: Submit written comments on the draft guidance by September 8, 
2000. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at http://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written requests for single copies of the draft guidance to the Drug 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 guidance to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Combined Oral Contraceptives--
Labeling for Healthcare Providers and Patients.'' The draft guidance is 
intended to produce uniform labeling among combined oral contraceptive 
products. Uniform labeling is important to physicians and patients in 
understanding efficacy claims and safety risks associated with drug 
products in this class. The draft guidance, which outlines 
recommendations for the physician insert, also includes a labeling 
template for physician labeling and instructions for use that can be 
used for new drug applications and abbreviated new drug applications. 
Among the labeling recommendations is a black box warning explaining 
the increased risk of serious cardiovascular side effects associated 
with the concomitant use of cigarettes and combined oral 
contraceptives. Once the draft guidance is finalized, the recommended 
text should be included in all approved, pending, and future 
applications. This labeling guidance is intended to supersede the 
``Labeling Guidance for Combination Oral Contraceptives, Physician and 
Patient Labeling,'' revised in August 1994.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). The draft guidance 
represents the agency's current thinking on combined oral contraceptive 
labeling for healthcare providers and patients. 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 statute, regulations, or 
both.
    Interested persons may 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 are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 28, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-17278 Filed 7-7-00; 8:45 am]
BILLING CODE 4160-01-F