[Federal Register Volume 70, Number 25 (Tuesday, February 8, 2005)]
[Notices]
[Page 6697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2416]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0030]


Draft Guidance for Industry on Clinical Lactation Studies--Study 
Design, Data Analysis, and Recommendations for Labeling; 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availability of a draft guidance for industry entitled ``Clinical 
Lactation Studies--Study Design, Data Analysis, and Recommendations for 
Labeling.'' This guidance discusses agency recommendations on how and 
when to conduct clinical lactation studies and how to assess the 
influence of drugs or biologic products on lactation. The goals of this 
guidance are to provide the basic framework for designing, conducting, 
and analyzing clinical lactation studies and to stimulate further study 
and research to assist in rational therapeutics for lactating patients.

DATES:  Submit written or electronic comments on the draft guidance by 
April 11, 2005. 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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, or the Office of Communications, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research (CBER), 1401 Rockville Pike, Rockville, MD 20852-1448. 
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 Submit written comments on the draft guidance 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. The 
guidance may also be obtained from CBER by mail by calling 1-800-835-
4709 or 301-827-1800. 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electronic access to the draft guidance document.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: Kathleen Uhl, Center for Drug 
Evaluation and Research (HFD-020), Food and Drug Administration, 5515 
Security Lane, Rockville, MD 20852, 301-443-5157, or Toni M. Stifano, 
Center for Biologics Evaluation and Research (HFM-600), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6190.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Clinical Lactation Studies--Study Design, Data Analysis, and 
Recommendations for Labeling.'' This guidance is intended to provide 
recommendations to sponsors and investigators on how to design, 
conduct, and assess studies investigating the influence of lactation on 
maternal pharmacokinetics (PK), and where appropriate, the 
pharmacodynamics of drugs or biologic products, the extent of drug 
transfer into breast milk, and the effects of drugs on milk production 
and composition. Clinical lactation studies are usually not conducted 
during the development of most products and lactating women are 
actively excluded from trials. Consequently, at the time of a drug's 
initial marketing, there are seldom meaningful human data on the 
appropriate dosage and frequency of administration during lactation. 
Even after years of marketing, data in product labels regarding 
lactation rarely provide more information for appropriate prescribing 
in lactation than what was available at the time of initial marketing.
    The information in this guidance is intended to promote an increase 
in the amount of useful data concerning how drug kinetics are affected 
by lactation, the extent of drug transfer into breast milk, and the 
effects of drugs on milk production and composition. Topics covered 
include study design, data analysis, labeling, and considerations for 
future research. The agency recommends using this guidance in 
conjunction with other pharmacological and clinical literature on the 
design, conduct, and interpretation of PK studies. Because the conduct 
of studies in lactating women and their breast-fed infants requires 
specialized knowledge in a variety of areas, investigators designing 
such studies are encouraged to obtain advice from experts in fields 
including obstetrics, pediatrics, pharmacology, clinical pharmacology, 
pharmacometrics, statistics, and other applicable disciplines.
    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 this topic. 
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. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper 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 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2416 Filed 2-7-05; 8:45 am]
BILLING CODE 4160-01-S