[Federal Register Volume 72, Number 31 (Thursday, February 15, 2007)]
[Notices]
[Pages 7441-7442]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0040]


Draft Guidance for Industry on Developing Products for Weight 
Management; 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availability of a draft guidance for industry entitled ``Developing 
Products for Weight Management.'' FDA is interested in updating the 
September 1996 draft guidance entitled ``Guidance for the Clinical 
Evaluation of Weight-Control Drugs'' by incorporating the latest 
scientific and clinical advances in the drug development field of 
obesity, including recommendations on the development of products for 
weight management in pediatric patients and in patients with 
medication-induced weight gain, and recommendations on the development 
of combinations of weight-management products. This action is expected 
to provide clear and consistent advice to those in industry who are 
interested in developing weight-management products.

DATES:  Submit written or electronic comments on the draft guidance by

[[Page 7442]]

April 16, 2007. 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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access to the draft guidance document.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: Eric Colman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 3340, Silver Spring, MD 20993-0002, 301-
796-1190.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Developing Products for Weight Management,'' which revises 
the September 1996 draft guidance entitled ``Guidance for the Clinical 
Evaluation of Weight-Control Drugs.''
    In 1996, following input from an expert advisory panel, FDA issued 
the September 1996 draft guidance. The September 1996 draft guidance 
provides general recommendations on the development of drugs for the 
long-term treatment of obesity. Important areas discussed in that 
guidance include patient-selection criteria, size and duration of phase 
3 trials, and definitions of efficacy of a weight-control drug.
    On January 26, 2004, FDA issued a notice in the Federal Register 
requesting public comment on the September 1996 draft guidance for the 
purpose of incorporating the latest scientific and clinical advances in 
weight-management drug development (69 FR 3588). In September 2004, FDA 
convened an advisory committee meeting to discuss the public comments 
received and to identify specific scientific, clinical, and regulatory 
issues that should be incorporated into an updated guidance document.
    As a result, this revised draft guidance discusses several key 
areas of interest that are not covered in the September 1996 draft 
guidance. These areas include recommendations on the development of 
products for weight management in pediatric patients and in patients 
with medication-induced weight gain, and recommendations on the 
development of combinations of weight-management products.
    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 developing 
products for weight management. 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 regarding this document. 
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. Received comments may be seen 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 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2581 Filed 2-14-07; 8:45 am]
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