Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices 1501 

case, cluster, and outbreak prevention 

and control strategies. CRF data 

elements and the CRF were designed for 

administration via telephone interviews 

with individuals ill with 

cryptosporidiosis, or their designated 

proxy. 

CDC requests OMB approval for an 

estimated 125 annual burden hours. 

Providing information is voluntary, and 

there are no costs to respondents other 

than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondents Form name Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Individuals ill with cryptosporidiosis, or their 

designated proxy.

CryptoNet Case Report Form ........................ 500 1 15/60 

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. 2025–00162 Filed 1–7–25; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–25–1357; Docket No. CDC–2024– 

0104] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other federal 

agencies the opportunity to comment on 

a continuing information collection, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on a proposed information 

collection project titled The Greater 

Access and Impact with NAT (GAIN) 

Study: Improving HIV Diagnosis, 

Linkage to Care, and Prevention 

Services with HIV Point-of-Care Nucleic 

Acid Tests (NATs). This study will 

identify facilitators and barriers with 

implementation of HIV point-of-care 

(POC) nucleic acid tests (NATs) in 

clinical settings, estimate the sensitivity 

and specificity of the HIV POC NAT, 

and assess the impact of the test in 

decreased time to receipt of HIV 

prevention and care. 

DATES: CDC must receive written 

comments on or before March 10, 2025. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2024– 

0104 by either of the following methods: 

• Federal eRulemaking Portal: 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS H21–8, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

www.regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(www.regulations.gov) or by U.S. mail to 

the address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Jeffrey M. Zirger, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road, NE, MS 

H21–8, Atlanta, Georgia 30329; 

Telephone: 404–639–7570; Email: omb@

cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses; and 

5. Assess information collection costs. 

Proposed Project 

The Greater Access and Impact with 

NAT (GAIN) Study: Improving HIV 

Diagnosis, Linkage to Care, and 

Prevention Services with HIV Point-ofCare Nucleic Acid Tests (NATs) (OMB 

Control No. 0920–1357, Exp. 12/31/ 

2024)—Reinstatement—National Center 

for HIV, Viral Hepatitis, STD, and TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC) 

Background and Brief Description 

HIV prevention and care services can 

be improved by the availability of Pointof-care (POC) HIV viral RNA testing in 

clinical settings. Viral RNA tests are the 

most sensitive HIV tests for the 

detection of early infection. The 

purpose of this data collection is to 

develop feasible and effective models to 

integrate HIV POC nucleic acid tests 

(NATs) in HIV prevention and treatment 

services. The HIV POC NAT can be used 

to test persons at high-risk of acquiring 

HIV infection to reduce the time 


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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 


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