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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 [www.gpo.gov]
[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: www.regulations.gov. 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 www.regulations.gov. Please note: Submit all comments through the 
Federal eRulemaking portal (www.regulations.gov) 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: [email protected].

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.
                                                 ---------------------------------------------------------------
    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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