Notice2025-00166
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
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Published
January 8, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 5 (Wednesday, January 8, 2025)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#6c03010e2c0f080f420b031a"><span class="__cf_email__" data-cfemail="610e0c03210205024f060e17">[email protected]</span></a>.
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.
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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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