[Federal Register: June 4, 1999 (Volume 64, Number 107)]
[Notices]               
[Page 30040-30041]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04jn99-77]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-1540]

 
Draft Guidance for Reviewers on Evaluation of Human Pregnancy 
Outcome Data; 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availability of a draft guidance for reviewers entitled ``Evaluation of 
Human Pregnancy Outcome Data.'' The draft guidance is intended to 
provide the FDA clinical reviewer with factors to consider when 
systematically evaluating pregnancy outcome data related to maternal 
drug exposure. The draft guidance will be discussed during the June 3, 
1999, meeting of the Subcommittee of the Advisory Committee for 
Reproductive Health Drugs.

DATES: Written comments on the draft guidance document may be submitted 
by September 2, 1999. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Copies of this draft guidance for reviewers are available on 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written requests for single copies of the draft guidance to the Drug 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. 
Submit written comments on the draft guidance to the Dockets Management 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; or the Office of Communication, Training and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448; ``http://www.fda.gov/cber/guidelines.htm'' ; FAX: 1-888-
CBERFAX or 301-827-3844; Mail: the Voice Information System at 800-835-
4709 or 301-827-1800.

FOR FURTHER INFORMATION CONTACT: 
    Rose E. Cunningham, Center for Drug Evaluation and Research (HFD-
6), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-5468; or
    Toni M. Stifano, Center for Biologics Evaluation and Research (HFM-
602), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-3028, or via e-mail at ``stifano@cber.fda.gov''.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for reviewers entitled ``Evaluation of Human Pregnancy 
Outcome Data.''
    As part of its evaluation of pregnancy labeling, in September 1997 
the agency held a 21 CFR part 15 hearing on the current category 
requirements for pregnancy labeling (see 62 FR 41061, July 31, 1997). 
The agency sought comment on the practical utility, effects, and 
limitations of the pregnancy categories. The agency sought input on 
ways to address problems, including possible alternatives to the 
categories for communicating information on reproductive and 
developmental toxicity.
    Subsequently, the agency has been working on the development of 
various

[[Page 30041]]

draft guidance documents, including the draft guidance for reviewers on 
``Evaluation of Human Pregnancy Outcome Data.'' This draft guidance 
document will be discussed during the June 3, 1999, meeting of the 
Subcommittee of the Advisory Committee for Reproductive Health Drugs 
(64 FR 23340, April 30, 1999).
    This Level 1 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 the evaluation of 
human pregnancy outcome data. 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 written comments on the draft 
guidance to the Dockets Managements 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 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: May 28, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-14149 Filed 6-3-99; 8:45 am]
BILLING CODE 4160-01-F