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[Federal Register Volume 90, Number 5 (Wednesday, January 8, 2025)]
[Notices]
[Pages 1502-1504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00237]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0435]

Obesity and Overweight: Developing Drugs and Biological Products 
for Weight Reduction; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Obesity 
and Overweight: Developing Drugs and Biological Products for Weight 
Reduction.'' This draft guidance provides recommendations to industry 
regarding the development of drugs and biological products regulated 
within the Center for Drug Evaluation and Research intended for 
reduction and long-term maintenance of body weight in patients with 
obesity or overweight. This draft guidance revises and replaces the 
draft guidance for industry ``Developing Products for Weight 
Management'' issued in February 2007.

DATES: Submit either electronic or written comments on the draft 
guidance by April 8, 2025 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your

[[Page 1503]]

comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2007-D-0435 for ``Obesity and Overweight: Developing Drugs and 
Biological Products for Weight Reduction.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: John Sharretts, Center for Drug 
Evaluation and Research (HFD-510), Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-4678.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Obesity and Overweight: Developing Drugs and Biological 
Products for Weight Reduction.'' This draft guidance is intended to 
provide recommendations to industry regarding the development of drugs 
and biological products regulated within the Center for Drug Evaluation 
and Research in FDA intended for reduction and long-term maintenance of 
body weight in patients with either obesity or who are classified as 
overweight based on body mass index and also have weight-related 
medical problems. This draft guidance revises and replaces the draft 
guidance for industry ``Developing Products for Weight Management'' 
issued on February 15, 2007 (72 FR 7441), which no longer reflects our 
current state of knowledge and the state of medical product 
development.
    This draft guidance focuses on the design of trials to demonstrate 
sustained medical weight loss in individuals with obesity and those 
with body mass index classified as overweight who also have weight-
related comorbidities. Medical weight loss is defined within the draft 
guidance as a long-term reduction in excess body fat with a goal of 
reduced morbidity and mortality. The weight reduction indication 
comprises the concepts of both initial weight loss and weight 
maintenance (i.e., prevention of weight regain) for a minimum of 1 
year.
    Major topics in this draft guidance include discussion of 
appropriate adult and pediatric participants to enroll in clinical 
trials for chronic weight management, principles of phase 1 and phase 2 
trials, and detailed discussion of phase 3 trials, including trial 
design, size, and duration; efficacy endpoints; safety evaluation; and 
statistical principles. Special topics include trial considerations for 
patients with diabetes mellitus, assessment of weight management 
products in combination, and trial considerations for assessment of 
pediatric patients.
    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 current thinking of FDA on ``Obesity and 
Overweight: Developing Drugs and Biological Products for Weight 
Reduction.'' It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). This guidance refers to 
collections of information from ``individuals under treatment or 
clinical examination in connection with research,'' which are not 
subject to review by OMB under 5 CFR 1320.3(h)(5). The collections of 
information in 21 CFR part 312 for investigational new drug 
applications have been approved under OMB control number 0910-0014. The 
collections of information in 21 CFR part 314 for new drug 
applications, including formal meetings between FDA and sponsors or 
applicants have been approved under OMB control number 0910-0001. The 
collections of information in 21 CFR part 58, Good Laboratory Practice 
for Nonclinical Studies, has been approved under OMB control number 
0910-0119.

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III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 30, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-00237 Filed 1-7-25; 8:45 am]
BILLING CODE 4164-01-P
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