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[Federal Register Volume 90, Number 5 (Wednesday, January 8, 2025)]
[Notices]
[Pages 1501-1502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00166]

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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.

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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: [email protected].

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-of-
Care 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 Point-of-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

[[Page 1502]]

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 real-world 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
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of    responses  per   per  response   Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Participating Clinic..........  Baseline data                  2               1               2               4
                                 collection
                                 variables list.
                                Monthly study                  2              12           15/60               6
                                 report form.
Participants in prospective     Release of                   850               1           10/60             142
 study of persons without HIV    information
 seeking HIV testing and/or      form.
 PrEP services.
                                Study visit                  850               1           15/60             213
                                 survey.
Participants in prospective     Release of                    50               1           10/60               8
 study of persons with HIV       information
 seeking STI testing.            form.
                                Study visit                   50               1           15/60              13
                                 survey.
Participants in RCT of POC NAT  Release of                   212               1           10/60              35
 or Standard of Care for         information
 persons with HIV.               form.
                                Study visit                  212               1           15/60              53
                                 survey.
Participants in survey group    POC NAT                      500               1           20/60             167
 examining POC NAT               acceptability
 acceptability.                  survey.
Participants in cross-          Release of                   333               1           10/60              56
 sectional comparison of         information
 several point-of-care NATs.     form.
                                Study visit                  333               1           15/60              83
                                 survey.
Participants in the             POC NAT                      100               1               1             100
 acceptability/feasibility       acceptability
 assessment.                     survey, focus
                                 group, or
                                 interview.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             880
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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
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