Proposed Data Collection Submitted for Public Comment and Recommendations

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Published

June 16, 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 proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Global Action in Healthcare Network Antimicrobial Resistance Module (GAIHN-AR). This project supports planning and management of antimicrobial resistance prevention, detection, and response activities associated with the GAIHN-AR network.

Full Text

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<title>Federal Register, Volume 90 Issue 114 (Monday, June 16, 2025)</title>
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[Federal Register Volume 90, Number 114 (Monday, June 16, 2025)]
[Notices]
[Pages 25290-25292]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10901]

[[Page 25290]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-25-0015; Docket No. CDC-2025-0011]

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 proposed information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Global Action in Healthcare Network Antimicrobial Resistance
Module (GAIHN-AR). This project supports planning and management of
antimicrobial resistance prevention, detection, and response activities
associated with the GAIHN-AR network.

DATES: CDC must receive written comments on or before August 15, 2025.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0011 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#56393b341635323578313920"><span class="__cf_email__" data-cfemail="432c2e21032027206d242c35">[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

Global Action in Healthcare Network Antimicrobial Resistance Module
(GAIHN-AR)--New--National Center for Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

This is a request for a three-year OMB approval of a New
Information Collection Request (ICR). Antimicrobial resistance (AR) is
a growing global public health threat that does not respect borders and
was estimated to kill at least 1.27 million people in 2019--more than
HIV/AIDS or malaria. If no actions are taken, these numbers will grow
up to an estimated two million deaths attributable to AR and eight
million deaths associated with AR by 2050. The U.S. Centers for Disease
Control and Prevention (CDC) works globally to detect and control
emerging AR threats at the source before they cross borders and spread
to other countries, including the United States.
The United States National Action Plan for Combating Antibiotic
Resistant Bacteria Sub-Objective 2.5.3 describes the creation of a
global network for ``detection and containing new and critical
antibiotic-resistant threats,'' to ``identify innovative and effective
strategies for stopping the spread of antibiotic resistant pathogens in
low- and middle-income countries,'' and to ``improve standardization of
laboratory methodologies and data collection to improve the quality,
reliability, and utility of data to facilitate global comparisons of
antibiotic resistance.''
CDC has established this network, and it is called the Global
Action in Healthcare Network--Antimicrobial Resistance Module (GAIHN-
AR). GAIHN-AR aims to help prevent and reduce the spread of AR threats
before they reach the United States through coordinated laboratory
detection, communication, and infection prevention and control (IPC)
actions in healthcare. The initial focus is carbapenemase-producing
carbapenem-resistant Enterobacterales (CP-CRE), an AR threat recognized
as requiring urgent action by both CDC and the World Health
Organization (<a href="https://www.cdc.gov/antimicrobial-resistance/media/pdfs/2019-ar-threats-report-508.pdf">https://www.cdc.gov/antimicrobial-resistance/media/pdfs/2019-ar-threats-report-508.pdf</a> and <a href="https://iris.who.int/bitstream/handle/10665/376776/9789240093461-eng.pdf?sequence=1">https://iris.who.int/bitstream/handle/10665/376776/9789240093461-eng.pdf?sequence=1</a>). Partners may
also optionally include other epidemiologically important
carbapenemase-producing organisms such as Acinetobacter spp. and
Pseudomonas aeruginosa.
This network is implemented by the Department of Health and Human
Services, CDC in response to the Executive Order 13676 of September 18,
2014, the National Strategy of September 2014, and to implement
Subobjective 2.5.3 of the United States National Action Plan for
Combating Antibiotic Resistant Bacteria of October 2020. Data collected
throughout this network is also authorized by Section 301 of the Public
Health Service Act (42 U.S.C. 241).
GAIHN-AR is currently composed of healthcare facilities and
laboratories in Argentina, Chile, Ethiopia, Greece, India and the
United States, and additional healthcare facilities and laboratories in
Costa Rica, Ecuador, Ukraine, and Cambodia are in the planning stages
of implementation. These sites are supported by CDC, CDC's funded
partners, and in some countries,

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Ministries of Health. The current participants are supported through
CDC's CK21-2104, CK18-1801, GH21-2174, GH23-0048, GH0056, GH00-2375 and
GH20-2110 Cooperative Agreements. Laboratories in the participating
healthcare facilities and their supporting reference laboratories
identify and characterize CP-CRE with known and novel mechanisms of
resistance from clinical cultures and colonization screening specimens.
Laboratories communicate detection events immediately to healthcare
personnel at the participating healthcare facilities and relevant
public health authorities for immediate action. IPC personnel within
the participating healthcare facilities: (1) work with units that are
at high risk for spreading CP-CRE to proactively strengthen IPC with a
focus on hand washing, use of personal protective equipment, patient
placement strategies, and cleaning of the healthcare environment even
before CP-CRE is detected; and (2) rapidly respond to detection of
patients with CP-CRE to identify, prevent and contain further spread.
Participating healthcare facilities and laboratories use a shared
framework with harmonized methods and standardized data collection to
improve and innovate prevention, detection, and rapid response
strategies. Lessons learned are then shared with key partners such as
Ministries of Health who can voluntarily translate the findings into
national initiatives.
Funded CDC partners or Ministries of Health supporting the network
healthcare facilities and laboratories will report the following
information to the Program Office at CDC--Division of Healthcare
Quality Promotion (DHQP):
1. Site demographics and qualitative challenges and successes
encountered during implementation are reported yearly
2. Quantitative impact measures (e.g., number of carbapenem-
resistant and carbapenemase-producing organisms detected, IPC practice
auditing and compliance rates, rates of carbapenemase-producing
organism transmission) are reported on a monthly basis
3. Key implementation milestones (e.g., performance of IPC practice
assessments, creation of action plans), changes in laboratory methods,
trainings, and containment responses are reported on an event-based
frequency.
All data are based on data routinely collected in the healthcare
facilities and laboratories as part of their normal operations and
based on best practices for laboratory and IPC. The data described
above may be shared with CDC in one of two ways: (1) funded CDC
partners or Ministries of Health receive the data in secure
intermediate databases that they host and own, and then the data is
entered into CDC's secure online web portal or (2) participating
healthcare facilities and laboratories enter the data directly into
CDC's secure online web portal. CDC's web portal is based in the
District Health Information System 2 (DHIS2) platform, which is an
open-source tool for collection, validation, analysis, and
visualization of aggregate data that is used globally in more than 40
countries in Africa, Asia, and Latin America.
The data collected through GAIHN-AR is used to: (1) monitor
progress toward core network activity implementation; (2) measure the
impact, inform resource needs, and demonstrate return on investment for
those activities over time; (3) provide data to the participating
healthcare facilities, laboratories, and Ministries of Health to set
priorities and support continuous improvement of prevention, detection,
and response activities in the participating sites and at the national
level within the country; and (4) facilitate collaboration with CDC on
the improvement activities described in (3).
CDC requests OMB approval for a total estimated 1,491 annualized
burden across GAIHN-AR is 1491 hours. There are no additional costs to
respondents other than their time.

Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
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CDC-funded Partner/Ministry of Annual Country 9 1 45/60 7
Health. Successes and
Challenges.
Healthcare facility........... Annual Facility 30 1 5/60 3
Demographics.
CDC-funded Partner/Ministry of Annual Facility 9 4 5/60 3
Health. Demographics.
Healthcare facility........... Annual Unit 30 2 10/60 10
Demographics.
CDC-funded Partner/Ministry of Annual Unit 9 7 5/60 6
Health. Demographics
(Attachment 3c).
Laboratory.................... Annual 43 1 15/60 11
Laboratory
Demographics.
CDC-funded Partner/Ministry of Annual 9 5 10/60 8
Health. Laboratory
Demographics.
Healthcare facility........... Monthly Unit 30 24 20/60 240
Prevention
Measures.
CDC-funded Partner/Ministry of Monthly Unit 9 79 10/60 119
Health. Prevention
Measures.
Laboratory.................... Monthly 43 12 60/60 516
Laboratory
Detection
Measures.
CDC-funded Partner/Ministry of Monthly 9 58 60/60 522
Health. Laboratory
Detection
Measures.
CDC-funded Partner/Ministry of Event-based 9 15 5/60 12
Health. Trainings Form.
Healthcare facility........... Event-based 30 0.5 10/60 3
Facility
Response
Measures.
CDC-funded Partner/Ministry of Event-based 9 2 20/60 6
Health. Facility
Response
Measures.
CDC-funded Partner/Ministry of Event-based Unit 9 27 5/60 21
Health. Prevention
Measures.
CDC-funded Partner/Ministry of Event-based 9 5 5/60 4
Health. Laboratory
Measures.
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Total..................... ................ .............. .............. .............. 1491
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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. 2025-10901 Filed 6-13-25; 8:45 am]
BILLING CODE 4163-18-P

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