[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for Weight Reduction; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Obesity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 This draft guidance provides recommendations to industry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 This draft guidance revises and replaces the
draft guidance for industry ``Developing Products for Weight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DATES: Submit either electronic or written comments on the draft
guidance by April 8, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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
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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]
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