Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction; Draft Guidance for Industry; Availability, 1502-1504 [2025-00237]
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<![CDATA[
1502
Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices
between testing in community-based
and clinical-based settings and linkage
to HIV care, ART initiation, and viral
suppression.
Data will be used to compare an HIV
RNA POC NAT to standard lab-based
HIV testing. The data will be analyzed
and disseminated to describe the realworld performance and clinical
usefulness of HIV RNA POC NAT
technology. Data will be gathered
through: clinical site extraction of
electronic medical records for use as a
retrospective baseline comparator after
study implementation; a longitudinal,
prospective study of persons without
HIV seeking HIV testing or PrEP
services; a longitudinal, prospective
study of persons with HIV seeking STI
testing; a randomized clinical trial of
HIV POC NAT or standard of care for
persons with HIV; a survey, interviews,
and focus groups to understand HIV
POC NAT acceptability among persons
without HIV and persons with HIV; an
assessment of the performance of an
HIV POC NAT among persons with HIV;
and an acceptability/feasibility
assessment among clinical and
community providers and costing
analyses.
CDC is requesting OMB approval for
estimated 880 annual burden hours.
There are no costs to respondents other
than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Participating Clinic ............................
Baseline data collection variables
list.
Monthly study report form ................
Release of information form .............
2
1
2
4
2
850
12
1
15/60
10/60
6
142
Study visit survey .............................
Release of information form .............
850
50
1
1
15/60
10/60
213
8
Study visit survey .............................
Release of information form .............
50
212
1
1
15/60
10/60
13
35
Study visit survey .............................
POC NAT acceptability survey ........
212
500
1
1
15/60
20/60
53
167
Release of information form .............
333
1
10/60
56
Participants in the acceptability/feasibility assessment.
Study visit survey .............................
POC NAT acceptability survey,
focus group, or interview.
333
100
1
1
15/60
1
83
100
Total ...........................................
...........................................................
........................
........................
........................
880
Participants in prospective study of
persons without HIV seeking HIV
testing and/or PrEP services.
Participants in prospective study of
persons with HIV seeking STI testing.
Participants in RCT of POC NAT or
Standard of Care for persons with
HIV.
Participants in survey group examining POC NAT acceptability.
Participants in cross-sectional comparison of several point-of-care
NATs.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2025–00166 Filed 1–7–25; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0435]
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses
per respondent
Number of respondents
Type of respondent
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.
VerDate Sep<11>2014
17:50 Jan 07, 2025
Jkt 265001
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.
You may submit comments
on any guidance at any time as follows:
SUMMARY:
ADDRESSES:
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.
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
DATES:
PO 00000
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08JAN1
Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
17:50 Jan 07, 2025
Jkt 265001
1503
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/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:
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.
I. Background
II. Paperwork Reduction Act of 1995
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
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.
PO 00000
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E:\FR\FM\08JAN1.SGM
08JAN1
1504
Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–3780]
Developing Drugs for Optical Imaging;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Developing Drugs for Optical
Imaging.’’ The purpose of this guidance
is to provide recommendations to
sponsors regarding clinical trial design
features that support development and
approval of optical imaging drugs that
are used in conjunction with imaging
devices and intended as intraoperative
aids for the detection of pathology such
as tumors or to enhance the conspicuity
of normal anatomical structures.
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:
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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
VerDate Sep<11>2014
17:50 Jan 07, 2025
Jkt 265001
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
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–
2024–D–3780 for ‘‘Developing Drugs for
Optical Imaging.’’ 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
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
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-201509-18/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; or the Office of Policy, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431,
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:
Libero Marzella, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–2050; or Erica Takai,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5456, Silver Spring, MD 20993–
0002, 301–796–6353.
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Developing Drugs for Optical
Imaging.’’ The purpose of this guidance
is to provide recommendations to
sponsors regarding clinical trial design
features that support development and
approval of optical imaging drugs that
are used in conjunction with imaging
devices and intended as intraoperative
aids for detection of pathology such as
tumors or to enhance the conspicuity of
normal anatomical structures.
E:\FR\FM\08JAN1.SGM
08JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
[[Page 1504]]
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
