Notice2025-10620
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 11, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 90 Issue 111 (Wednesday, June 11, 2025)</title>
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[Federal Register Volume 90, Number 111 (Wednesday, June 11, 2025)]
[Notices]
[Pages 24613-24615]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10620]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-25-0573]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``National HIV Surveillance System (NHSS)''
to the Office of Management and Budget (OMB) for review and approval.
CDC previously published a ``Proposed Data Collection Submitted for
Public Comment and Recommendations'' notice on April 1, 2022 to obtain
comments from the public and affected agencies. CDC received two
comments related to the previous notice. No changes were made to the
information collection plan. This notice serves to allow an additional
30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written
[[Page 24614]]
comments and/or suggestions regarding the items contained in this
notice to the Attention: CDC Desk Officer, Office of Management and
Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
National HIV Surveillance System (NHSS) (OMB Control No 0920-0573,
Exp, 02/28/2026)--Revision--National Center for HIV, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Collected with authorization under Sections 304 and 306 of the
Public Health Service Act (42 U.S.C. 242b and 242k), the National HIV
Surveillance System (NHSS) data 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 infected persons and used widely at
the federal, state, and local levels for planning and evaluating
prevention programs and healthcare services, to allocate funding for
prevention and care, and to monitor progress toward achieving national
prevention goals of the Ending the HIV Epidemic in the U.S initiative.
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. dependent areas, 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. NHSS data
collection activities are currently supported through cooperative
agreements with health departments 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 systematic data collection in NHSS provides the essential data
used to calculate population-based 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. Describing geographic
distribution allows CDC to assess social determinants of health in the
context of HIV which allows identification health inequities, and
guides steps to address and monitor the health equity over time moving
forward. NHSS data continue to be collected, maintained, and reported
using standard case definitions, report forms and software. The system
is periodically updated to keep pace with changes in testing technology
and advances in HIV care and treatment, as well as changing prevention
program monitoring, evaluation and response needs.
The changes requested in this Revision include program-initiated
modifications to currently collected data elements and forms including
changes to the Initial, Follow-up, and Annual/Closeout Cluster Report
Forms (CRFs). Changes are being made to better address the current
challenges and implementation of cluster response. There is no change
to the purpose, use, or methods of data collection, as outlined in the
previously submitted Supporting Statement Parts A and B. These
modifications of questions will add depth and result in more accurate
and complete responses. Revisions were made to simplify data collection
and entry for health departments, to collect more relevant data that
would help health departments track progress in responding to HIV
clusters, and to help health departments better communicate their
progress and challenges to CDC so that CDC can provide more effective
technical assistance and other support for responding to clusters and
outbreaks.
Revisions were guided by discussions with health departments. In
2024, CDC hosted three webinars about changes to the forms that were
open to all health departments expected to submit CRFs. CDC also sent
draft revised CRFs to health departments to solicit written feedback on
the changes. CRFs were streamlined by removing data elements felt by
health departments to be particularly difficult to populate, or which
were no longer needed. Some were replaced with data elements that will
capture the information more accurately and in a way that providers
health departments more flexibility about which data elements to
report, depending on the context of the cluster. Some questions and
instructions within the form were modified to improve the quality of
data collected, based on experience and data gathered since the last
ICR submission.
This Revision also standardizes questions across the three CRFs
(initial, follow-up, and annual/closeout) to make it a more consistent
experience for health departments to complete the forms. The Revision
removes a rigid set of outcome questions related to three specific
activities (testing partners of cluster members for HIV, linking
cluster members to treatment, and referring partners of cluster members
to pre- or post-exposure prophylaxis) that were included in the initial
and annual/closeout CRFs and instead substitutes more open-ended
outcome questions representing the full range of potential response
activities in just the annual/closeout CRFs. This Revision will allow
health departments more flexibility in reporting outcomes for the
activities that they felt were most important to implement in the
cluster response.
The number of questions answered varies due to skip patterns and
optional questions that health departments may elect to answer or skip,
and has been reduced in each of the three CRFs, as shown below.
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Currently Proposed
Form approved revision
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Initial....................................... Total questions................. 57 32
Required questions.............. 21-43 13-25
Follow-up..................................... Total questions................. 25 20
Required questions.............. 20 4-17
Annual/Closeout............................... Total questions................. 39-42 39
Required questions.............. 28 21-32
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[[Page 24615]]
Cluster report forms will be captured via REDCap, a secure web
application for building and managing online surveys and databases.
REDCap allows for auto-population of several fields and reduces burden
on health departments, who previously needed to encrypt and upload
Excel files.
There will be no increase or decrease in the number of respondents
for the CRFs. The overall number of required questions will be reduced
though the overall burden will remain the same, as additional detail
will be asked in some of the remaining questions. OMB approval is
requested for three years. The total estimated annualized burden is
60,731 hours for NHSS, including the CRFs. There are no costs to the
respondents other than time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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Health Departments.................... Adult HIV Case Report 59 789 20/60
(ACRF).
Health Departments.................... Perinatal Exposure and 59 57 35/60
Pediatric HIV Case
Report (PCRF).
Health Departments.................... Case Report Evaluations. 59 85 20/60
Health Departments.................... Case Report Updates..... 59 2519 2/60
Health Departments.................... Laboratory Updates...... 59 10,130 0.5/60
Health Departments.................... Deduplication Activities 59 3,032 10/60
Health Departments.................... Investigation Reporting 59 929 1/60
and Evaluation.
Health Departments.................... Initial Cluster Report 59 2.5 1
Form.
Health Departments.................... Follow-Up Cluster Report 59 5 0.5
Form.
Health Departments.................... Annual/Closeout Cluster 59 2.5 1
Report Form.
Health Departments.................... Annual Reporting 59 1 8
Standards Evaluation
Report (SER).
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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. 2025-10620 Filed 6-10-25; 8:45 am]
BILLING CODE 4163-18-P
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