Proposed Data Collection Submitted for Public Comment and Recommendations

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Published

September 30, 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 National HIV Surveillance System (NHSS). The NHSS collects comprehensive population-based data on persons living with HIV in the U.S. and its territories, utilizing standard reporting from laboratories and healthcare providers to monitor trends, estimate incidence and prevalence, analyze drug resistance, detect and monitor clusters, and inform public health planning and resource allocation at federal, state and local levels and by HIV prevention and care partners.

Full Text

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<title>Federal Register, Volume 90 Issue 187 (Tuesday, September 30, 2025)</title>
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[Federal Register Volume 90, Number 187 (Tuesday, September 30, 2025)]
[Notices]
[Pages 46891-46893]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18904]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-25-0573; Docket No. CDC-2025-0519]

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 National HIV Surveillance System (NHSS). The NHSS collects
comprehensive population-based data on persons living with HIV in the
U.S. and its territories, utilizing standard reporting from
laboratories and healthcare providers to monitor trends, estimate
incidence and prevalence, analyze drug resistance, detect and monitor
clusters, and inform public health planning and resource allocation at
federal, state and local levels and by HIV prevention and care
partners.

DATES: CDC must receive written comments on or before December 1, 2025.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0519 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#3a5557587a595e59145d554c"><span class="__cf_email__" data-cfemail="82edefe0c2e1e6e1ace5edf4">[email&#160;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

National HIV Surveillance System (NHSS) (OMB Control No. 0920-0573,
Exp. 2/28/2026)--Extension--National Center for HIV, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and
Prevention (CDC).

Background and Brief Description

CDC is authorized under Sections 304 and 306 of the Public Health
Service Act (42 U.S.C. 242b and 242k) to collect information on cases
of human immunodeficiency virus (HIV) and indicators of HIV disease and
HIV disease progression including AIDS. Data collected as part of the
National HIV Surveillance System (NHSS) are the primary data used to
monitor the extent and characteristics of the HIV burden in the United
States. HIV surveillance data are used to describe trends in HIV
incidence, prevalence and characteristics of persons diagnosed with HIV
infection and used widely at the federal, state, and local levels for
planning and evaluating prevention programs and health-care services,
allocating funding for prevention and care, and monitoring progress
toward achieving national prevention goals. NHSS data collection
activities are currently supported through cooperative agreements with
health departments

[[Page 46892]]

under CDC Notice of Funding Opportunity PS24--0047: High-Impact HIV
Prevention and Surveillance Programs for Health Departments CDC-RFA-PS-
24-0047 and Accelerating the Prevention and Control of HIV, Viral
Hepatitis, STDs, and TB in the U.S. Affiliated Pacific Islands CDC-RFA-
PS23-2302. The activities funded under these announcements promote and
support improving health outcomes for persons living with HIV through
achieving and sustaining viral suppression, by using quality, timely,
and complete surveillance, and program data to guide HIV prevention
efforts toward reducing new HIV infections and ending the HIV epidemic
in the United States.
The Division of HIV Prevention (DHP), National Center for HIV,
Viral Hepatitis, STD, and TB Prevention (NCHHSTP), CDC in collaboration
with health departments in the states, the District of Columbia, and
U.S. territories and freely associated states, conducts national
surveillance for cases of HIV infection that includes critical data
reported across the spectrum of HIV disease stages from HIV diagnosis
to death. The systematic data collection provides the essential data
used to calculate population-based HIV case counts, HIV incidence
estimates, describe the geographic distribution of disease, monitor HIV
transmission and drug resistance patterns and genetic diversity of HIV
among infected persons, detect and respond to HIV clusters of recent
and rapid transmission, and monitor perinatal exposures. NHSS data are
also used locally to identify persons with HIV who are not in medical
care and linking them to care and needed services. NHSS data continue
to be collected, maintained, and reported using standard case
definitions, report forms and software. The system is periodically
updated as needed to keep pace with changes in testing technology and
advances in HIV care and treatment, as well as changing prevention
program monitoring and evaluation needs.
CDC receives adult and pediatric HIV case reports from 59 areas.
Additional information on perinatal exposures is also reported in a
subset of jurisdictions when reportable using the same pediatric case
report form used to monitor progress toward perinatal HIV elimination
goals. Health department staff compile information from laboratories,
physicians, hospitals, clinics, and other health care providers to
complete the HIV adult and pediatric case reports. CDC estimates that
approximately 789 adult HIV case reports and 57 perinatal exposure and
pediatric case reports are processed by each health department
annually.
These data are recorded using standard case report forms either on
paper or electronically and entered into the electronic reporting
system. Updates to case reports are also entered into the reporting
system by health departments as additional information may be received
from laboratories, vital statistics, or additional providers.
Evaluations are also conducted by health departments on a subset of
case reports (e.g. re-abstraction, validation). CDC estimates that on
average approximately 85 evaluations of case reports, 2519 updates to
case reports and 10130 updates of electronic laboratory test data will
be processed by each of the 59 health departments annually. In
addition, 59 health departments will conduct routine deduplication
activities for new diagnoses and cumulative case reports. CDC estimates
that health departments on average will follow up on 3032 reports as
part of deduplication activities annually. Case report information
compiled over time by health departments is then de-identified and
forwarded to CDC monthly to become part of the national HIV
surveillance database.
Additional information will be reported by health departments for
monitoring and evaluation of health department investigations including
activities identifying persons who are not in HIV medical care and
linking them to HIV medical care (e.g., Data-to-Care activities) and
other services and identifying and responding to clusters. CDC
estimates health departments will on average process 929 responses
related to investigation reporting and monitoring annually.
Clusters of HIV are groups of persons related by recent, rapid
transmission, for which rapid response is needed to intervene and
interrupt ongoing transmission and prevent future HIV infections.
Health departments may detect clusters through multiple means,
including through routine analyses of Surveillance data and other data
reported to the NHSS. Summary data on clusters of recent and rapid HIV
transmission in the United States are collected to monitor situations
necessitating public health intervention, assess health department
response, and evaluate outcomes of intervention activities. Health
departments complete an Initial Cluster Report Form when a cluster is
first identified, a Follow-up Cluster Report Form each quarter when
response activities are ongoing, and an Annual/Closeout Cluster Report
Form depending on the state of cluster response. CDC estimates on
average health departments will provide information for 2.5 Initial
Cluster Report Forms, 5 Follow-up Cluster Report Forms, and 2.5 Annual/
Closeout Cluster Report Forms annually.
The Standards Evaluation Report (SER) is used by CDC and Health
Departments to improve data quality, interpretation, usefulness, and
surveillance system efficiency, as well as to monitor progress toward
meeting surveillance program objectives. The information collected for
the SER includes a brief set of questions about evaluation outcomes and
the collection of laboratory data that will be reported one time a year
by each of the 59 health departments.
There are no revisions to data collection or changes in burden
requested in this Extension. The total estimated annualized burden is
60,731 hours.

Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total
Type of respondent Form name respondents responses per response burden (in
respondent (in hours) hours)
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Health Departments................ Adult HIV Case 59 789 20/60 15,517
Report (ACRF).
Health Departments................ Perinatal Exposure 59 57 35/60 1,962
and Pediatric HIV
Case Report (PCRF).
Health Departments................ Case Report 59 85 20/60 1,672
Evaluations.
Health Departments................ Case Report Updates. 59 2519 2/60 4,954
Health Departments................ Laboratory Updates.. 59 10130 0.5/60 4,981
Health Departments................ Deduplication 59 3032 10/60 29,815
Activities.
Health Departments................ Investigation 59 929 1/60 914
Reporting and
Evaluation.

[[Page 46893]]

Health Departments................ Initial Cluster 59 2.5 1 148
Report Form.
Health Departments................ Follow-up Cluster 59 5.0 0.5 148
Report Form.
Health Departments................ Annual/Closeout 59 2.5 1 148
Cluster Report Form.
Health Departments................ Annual Reporting: 59 1.0 8 472
Standards
Evaluation Report
(SER).
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Total......................... .................... ............ .............. ........... 60,731
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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. 2025-18904 Filed 9-29-25; 8:45 am]
BILLING CODE 4163-18-P

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