Notice2025-00164
Proposed Data Collection Submitted for Public Comment and Recommendations
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
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 proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Combating Antimicrobial Resistant Gonorrhea and Other STIs (CARGOS). CARGOS is a comprehensive strategy designed to streamline and improve the coordination of Antimicrobial Resistance (AR) surveillance and preparedness and response activities focused on Neisseria gonorrhoeae (GC) and expand capacity to include other STIs with emerging AR in the United States.
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 1493-1495]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-00164]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-25CH; Docket No. CDC-2024-0102]
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 Combating Antimicrobial Resistant Gonorrhea and Other STIs
(CARGOS). CARGOS is a comprehensive strategy designed to streamline and
improve the coordination of Antimicrobial Resistance (AR) surveillance
and preparedness and response activities focused on Neisseria
gonorrhoeae (GC) and expand capacity to include other STIs with
emerging AR in the United States.
DATES: CDC must receive written comments on or before March 10, 2025.
ADDRESSES: You may submit comments identified by Docket No. CDC-2024-
0102 by either of the following methods:
[squ] Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow the
instructions for submitting comments.
[squ] 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: 404-639-7118;
Email: <a href="/cdn-cgi/l/email-protection#204f4d42604344430e474f56"><span class="__cf_email__" data-cfemail="eb848689ab888f88c58c849d">[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 the 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 collecting information on those to
respond, including using appropriate automated, electronic, mechanical,
or other technological collection techniques or other forms of
information technology, e.g., permitting electronic responses; and
5. Assess information collection costs.
Proposed Project
Combating Antimicrobial Resistant Gonorrhea and Other STIs
(CARGOS)--New--National Center for HIV, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The purpose of the proposed Combating Antimicrobial Resistant
[[Page 1494]]
Gonorrhea and Other STIs (CARGOS) data collection is to: (1) strengthen
local epidemiologic capacity to detect, monitor, and respond to AR in
STIs; (2) improve coordination of AR in STI preparedness and outbreak
response activities; (3) enhance local laboratory testing for
surveillance, reporting, and response; and (4) enhance coordination
between epi-lab-health information technology for public health action.
This information collection is important because: (1) effective
treatment of gonorrhea is critical to gonorrhea control and prevention;
(2) untreated or inadequately treated gonorrhea can cause serious
reproductive health complications, such as infertility; (3) Neisseria
gonorrhoeae (the bacterium that causes gonorrhea) has consistently
demonstrated the ability to develop resistance to the antibiotics used
for treatment and may be developing resistance to the last remaining
treatment option recommended by CDC; and (4) antibiotic-resistant
gonorrhea is extremely difficult to detect without enhanced
surveillance and public health activities, such as CARGOS, because
healthcare providers rarely perform or have access to resistance
testing for individual patients. CARGOS will support rapid detection of
resistant gonorrhea, get actionable information into the hands of
healthcare providers (to support appropriate treatment of individual
patients) and local health departments (to support rapid public health
response to slow the spread of resistant infections in the community),
and support multiple national public health strategies including the
2020-2025 National Action Plan for Combating Antibiotic-Resistant
Bacteria (CARB) and STI National Strategic Plan for the United States
2021-2025.
Jurisdictions participating in CARGOS applied as part of a
competitive process and will participate voluntarily. As an overview of
CARGOS, healthcare providers at participating clinics will collect
specimens for N. gonorrhoeae culture testing from men and women seeking
care for gonorrhea. Specimens that demonstrate N. gonorrhoeae (called
``isolates'') will undergo antibiotic resistance testing at the local
public health laboratory. Detection of resistance is rapidly
communicated by the laboratory staff to the healthcare provider and
health department to initiate a field investigation. The patient (from
whom the resistant specimen was taken) will be interviewed to obtain
demographics, clinical and risk factor information. For cases of
gonorrhea of public health significance, recent sexual contacts of
those cases will be interviewed by the health department and tested for
gonorrhea. The participating health departments will collect and
transmit to CDC demographic and clinical data about persons tested for
and diagnosed with gonorrhea in the participating clinics, results of
local antibiotic resistance testing, and information about field
investigations. None of the data transmitted to CDC will contain any
personally identifiable information. These data will be used by CDC to
monitor and improve understanding of resistance and identify scalable,
effective approaches to prevent the spread of resistance. Data will be
transmitted through CDC's Secure Access Management Services (SAMS).
SAMS is an approved federal information technology system that provides
authorized and validated users secure and encrypted access to CDC file
transfer applications. The encrypted data will be stored in a secure
CDC server with strictly controlled and restricted access rights.
Isolates will be shipped each month to one of four Antibiotic
Resistance Regional Laboratory Network (ARLN) laboratories for
confirmatory antibiotic susceptibility testing and molecular
characterization.
Under the CARGOS protocol, local CARGOS data managers from each of
the funded jurisdictions will abstract STD clinic data for patients
tested for gonorrhea, receive resistance testing laboratory results
from local public health laboratories, abstract data about field
investigations, and will merge the data. Every month, the local CARGOS
data manager will clean the data, remove personally identifiable
information, and transmit the data to CDC. CDC estimates these data
processes will take eight hours every month. Annually, the local CARGOS
data manager will send a final cumulative data file for a total of 12
data transmissions/responses.
Microbiologists at public health laboratories from each funded
jurisdictions will conduct antibiotic resistance testing on all N.
gonorrhoeae isolates on approximately 700 isolates each year (600
clinical isolates and 100 control strains; each test is approximately
10 minutes). Every month, a laboratory data manager will abstract test
results and securely send the datafile to the local CARGOS data
manager. We estimate that laboratory data managers will spend
approximately one hour each time they abstract, clean, and transmit
project data.
Health department staff will interview any person diagnosed with
antibiotic-resistant gonorrhea or have a case of gonorrhea of public
health significance (index case) and his/her sexual contacts. On
average, two drug-resistant isolates are identified annually. These
isolates will spur field investigations, which will result in two
additional interviews each month. CDC estimates a total of 48
interviews will occur annually at each site, for a total of 960
interviews each year across the funded sites. Each interview will take
approximately 30 minutes.
CDC requests OMB approval for an estimated 3,875 annual burden
hours. Respondents receive federal funds to participate in this
project. There are no additional costs to respondents other than their
time.
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Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (hours) hours
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Public Health Laboratory Attachment 3A... 19 700 10/60 2,217
Microbiologist.
Public Health Laboratory Data Attachment 3A... 19 6 1 114
Manager.
Local CARGOS data manager/ Attachments 3A, 19 7 8 1,064
epidemiologist. 3B, 3C.
Gonorrhea Patients and Sexual Attachment 3C... 960 1 0.5 480
Contacts.
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Total..................... ................ .............. .............. .............. 3,875
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[[Page 1495]]
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. 2025-00164 Filed 1-7-25; 8:45 am]
BILLING CODE 4163-18-P
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