Notice2025-22009

Proposed Data Collection Submitted for Public Comment and Recommendations

Primary source

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Published
December 5, 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 STI Surveillance Network (SSuN). This information collection request is designed to strengthen national and local surveillance capacity for incident, new, and emerging sexually transmitted infections (STIs) by collecting information on patients at risk for STIs and providing more accurate estimates of the burden of disease, incidence of STIs, trends and impact of STIs at the population level.

Full Text

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<title>Federal Register, Volume 90 Issue 232 (Friday, December 5, 2025)</title>
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[Federal Register Volume 90, Number 232 (Friday, December 5, 2025)]
[Notices]
[Pages 56152-56153]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22009]



[[Page 56152]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-26-1072; Docket No. CDC-2025-0752]


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 STI Surveillance Network (SSuN). This information collection 
request is designed to strengthen national and local surveillance 
capacity for incident, new, and emerging sexually transmitted 
infections (STIs) by collecting information on patients at risk for 
STIs and providing more accurate estimates of the burden of disease, 
incidence of STIs, trends and impact of STIs at the population level.

DATES: CDC must receive written comments on or before February 3, 2026.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0752 by either of the following methods:
    [ssquf] Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow the 
instructions for submitting comments.
    [ssquf] 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#214e4c43614245420f464e57"><span class="__cf_email__" data-cfemail="7d12101f3d1e191e531a120b">[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

    The STI Surveillance Network (SSuN), (OMB Control No. 0920-1072, 
Exp. 09/30/2026)--Revision--National Center for HIV, Viral Hepatitis, 
STD, TB Prevention (NCHHSTP), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    The CDC is requesting a Revision of a currently approved 
information collection request (ICR) titled The STI Surveillance 
Network (SSuN) for a period of three years. The Revision submitted for 
this ICR reflects changes to the title of the currently approved ICR, 
inclusion of Doxycycline Post-exposure Prophylaxis (Doxy PEP) data 
elements, deletion of multiple data elements no longer required, and an 
updated anonymous patient clinic survey.
    The purpose of the STI Surveillance Network (SSuN) is to enhance 
national capacity for STI surveillance. While U.S. jurisdictions 
voluntarily report STI cases to the CDC via the National Notifiable 
Diseases Surveillance System (NNDSS), these reports often lack 
essential patient demographics and detailed information on risk 
behaviors, treatment, co-infections, preventive services, and sexual 
networks.
    SSuN enhances CDC's STI surveillance efforts by:
    1. Providing comprehensive behavioral and demographic data on STI 
cases not available from standard case-based surveillance.
    2. Monitoring trends in STI and HIV co-infection, screening, 
prevention interventions, and healthcare access among patients with 
gonorrhea or other STIs.
    3. Providing an additional sentinel monitoring system for emerging 
health threats like mpox.
    These data help public health authorities better understand STI 
trends, assess disease burden inequalities, and monitor treatment 
outcomes and adverse health effects among STI patients.
    Data will be transmitted through CDC's Secure Access Management 
System (SAMS) by the 15 state and local health jurisdictions (eight 
jurisdictions funded for both Strategy A and B, four Strategy A only 
jurisdictions, and three Strategy B only jurisdictions) funded to 
conduct SSuN activities.
    The revised project, SSuN Cycle 5 (2024-2029), comprises 15 US 
local/state health departments. SSuN recipients are funded to conduct 
either or both of the two core SSuN Strategies: Sentinel surveillance 
in specialty sexual health clinics (Strategy A) and Enhanced 
population-based surveillance for persons diagnosed with gonorrhea and 
adult syphilis (Strategy B). In Strategy A, data is abstracted from 
existing electronic medical records at 16 participating STI clinics 
across 12 funded jurisdictions, utilizing information already collected 
during routine clinical care. This reflects a total of 384 burden 
hours. These data are sent to the 12 funded health jurisdictions, where 
they are formatted and deduplicated by data managers into standardized 
formats. Records are also matched with the jurisdiction's HIV 
surveillance registry, providing data on HIV co-infection not available 
from

[[Page 56153]]

other multi-jurisdictional sources. All patient records are fully de-
identified and securely transmitted to the CDC six times a year. Data 
managers at each of the 16 clinical facilities across 12 jurisdictions 
receiving funding are responsible for transmitting validated datasets 
for these activities to CDC every other month. This reflects 2,880 
burden hours for Strategy A Health Department data management. 
Participating Strategy A clinics are also required to administer a one-
time clinic patient survey between years 2-5 of the cycle. Clinic 
patient surveys will be conducted with approximately 3,000 patients 
across all funded sites for a total of five minutes each, resulting in 
250 burden hours.
    The second core data collection activity, Strategy B, includes: (1) 
abstraction, recoding, and reporting of all gonorrhea and syphilis 
cases in the collaborating jurisdiction; (2) enhanced investigations of 
a random sample of diagnosed individuals; and (3) Health Department 
abstraction and registry matching for a complete census of reported 
cases. Enhanced investigations include clinical data abstraction from 
providers, registry matching, and brief demographic and behavioral 
interviews. SSuN recipients implement data collection protocols that 
provide uniformly coded data on demographics, risk factors, clinical 
care, laboratory data, and healthcare-seeking behaviors, which are 
compiled into a national dataset after quality assurance at the CDC. 
For Activity 1, data managers at participating health jurisdictions are 
responsible for transmitting validated datasets case datasets to CDC 
every other month, resulting in 2,640 burden hours. In 2023, there were 
187,833 cases of gonorrhea diagnosed and reported across the 11 
Strategy B SSuN jurisdictions. Approximately 7%, or 13,148 gonorrhea 
cases were randomly sampled for enhanced investigation. Over past 
cycles, approximately 50% of patients contacted for investigations 
responded; we estimate this will result in 1,083 burden hours for 
patients with gonorrhea.
    The estimated burden hours for this revised collection decreases 
from the previously approved 7,510 to 7,237 due to decreases in the 
number of participating clinical sites and expected number of 
interviews conducted by funded jurisdictions, a result of declines in 
reported gonorrhea cases. CDC requests OMB approval for an estimated 
7,237 annual burden hours. There are no additional costs to respondents 
other than their time to participate.

                                                            Estimated Annualized Burden Hours
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                                                                                                        Number of
             Type of respondent                             Form name                  Number of      responses per     Average hours    Total response
                                                                                      respondents      respondent       per response     burden (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data managers at sentinel STI clinics.......  Electronic Clinical Record                        16                 6                 4               384
                                               Abstraction.
General Public--Adults (persons diagnosed     Patient interviews for a random                6,500                 1             10/60             1,083
 with gonorrhea).                              sample of gonorrhea cases.
Data Managers: local/state health             Data cleaning/validation, HIV                     12                 6                40             2,880
 departments (strategy A).                     registry matching and data
                                               transmissions for all activity
                                               components.
Data Managers: local/state health             Data cleaning/validation, HIV                     11                 6                40             2,640
 departments (strategy B).                     registry matching and data
                                               transmissions for all activity
                                               components.
General Public--Adults (persons presenting    Clinic patient surveys..............           3,000                 1              5/60               250
 for care in STI Clinics).
                                                                                                   -----------------------------------------------------
    Total...................................  ....................................  ..............  ................  ................             7,237
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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. 2025-22009 Filed 12-4-25; 8:45 am]
BILLING CODE 4163-18-P


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