[Federal Register Volume 67, Number 184 (Monday, September 23, 2002)]
[Notices]
[Page 59528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24037]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0388]


Guidance for Industry on Establishing Pregnancy Exposure 
Registries; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration is announcing the 
availability of a final guidance entitled ``Establishing Pregnancy 
Exposure Registries.'' The guidance is intended to provide sponsors 
with guidance on how to establish pregnancy exposure registries to 
monitor the outcomes of pregnancies exposed to specific medical 
products.

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Office Drug Information (HFD-240), Center for Drug Evaluation 
and Research, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, or the Office of Communication, Training, and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-
addressed adhesive label to assist that office in processing your 
requests. The guidance document may also be obtained by mail by calling 
the CBER Voice Information System at 1-800-835-4709 or 301-827-1800. 
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. See the SUPPLEMENTARY INFORMATIONsection for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Dianne L. Kennedy, Center for Drug 
Evaluation and Research (HFD-970), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2364, [email protected]; 
or Toni M. Stifano, Center for Biologics Evaluation and Research (HFM-
600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-6190, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Establishing Pregnancy Exposure Registries.'' Pregnancy 
exposure registries are recognized as one method of obtaining 
information on risks associated with exposure to medical products 
during pregnancy. The guidance is intended to provide sponsors with 
recommendations on how to establish pregnancy exposure registries, to 
help ensure the quality and integrity of registry data, and to help 
ensure the adequacy of document registry research methods.
    In June 1999, FDA announced the availability of a draft guidance 
entitled ``Establishing Pregnancy Registries'' (64 FR 30041, June 4, 
1999). Comments received on the draft guidance revealed that several 
general areas of the guidance needed revision and/or clarification.
    Based on the comments received and on discussions with FDA's 
Pregnancy Labeling Subcommittee of the Advisory Committee for 
Reproductive Health Drugs on June 3, 1999 (64 FR 23340) and March 28 to 
29, 2000 (65 FR 10811), the agency revised and/or clarified several 
sections of the guidance, including (1) When it is recommended that a 
registry be conducted, (2) use of comparison groups, (3) promotion of a 
registry and (4) regulatory reporting requirements. In addition, the 
name of the guidance was changed from ``Pregnancy Registries'' to 
``Pregnancy Exposure Registries'' to more accurately reflect the nature 
of these types of studies and to differentiate them from more classic 
retrospective registries (e.g., cancer registries and birth defect 
registries).
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on pregnancy exposure registries. 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, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). 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 guidance document and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/guidelines.htm. To obtain the guidance document by fax 
call the FAX Information System at 1-888-CBER-FAX or 301-827-3844.

    Dated: September 16, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-24037 Filed 9-20-02; 8:45 am]
BILLING CODE 4160-01-S