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

Type of respondent Form name Number of respondents 

Number of 

responses 

per respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Participating Clinic ............................ Baseline data collection variables 

list.

2 1 2 4 

Monthly study report form ................ 2 12 15/60 6 

Participants in prospective study of 

persons without HIV seeking HIV 

testing and/or PrEP services.

Release of information form ............. 850 1 10/60 142 

Study visit survey ............................. 850 1 15/60 213 

Participants in prospective study of 

persons with HIV seeking STI testing.

Release of information form ............. 50 1 10/60 8 

Study visit survey ............................. 50 1 15/60 13 

Participants in RCT of POC NAT or 

Standard of Care for persons with 

HIV.

Release of information form ............. 212 1 10/60 35 

Study visit survey ............................. 212 1 15/60 53 

Participants in survey group examining POC NAT acceptability.POC NAT acceptability survey ........ 500 1 20/60 167 

Participants in cross-sectional comparison of several point-of-care 

NATs.

Release of information form ............. 333 1 10/60 56 

Study visit survey ............................. 333 1 15/60 83 

Participants in the acceptability/feasibility assessment.POC NAT acceptability survey, 

focus group, or interview.

100 1 1 100 

Total ........................................... ........................................................... ........................ ........................ ........................ 880 

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] 

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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices 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. 


lotter on DSK11XQN23PROD with NOTICES1
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. 

SUMMARY: 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: 

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 

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 

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; 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. 


lotter on DSK11XQN23PROD with NOTICES1