[Federal Register Volume 88, Number 146 (Tuesday, August 1, 2023)]
[Notices]
[Pages 50153-50155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16220]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-23-1072]


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 ``STD Surveillance Network (SSuN)'' 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 March 10, 2023 to obtain 
comments from the public and affected agencies. CDC received two 
comments related to the previous notice. 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 www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct 
written 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

    The STD Surveillance Network (SSuN), (OMB Control No. 0920-1072, 
Exp. 10/31/2023)--Revision--National Center for HIV/, Viral Hepatitis, 
STD, TB Prevention (NCHHSTP), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    The National Center for HIV/AIDS, Viral Hepatitis, STD and TB 
Prevention (NCHSTP) is requesting a Revision of the Information 
Collection Request (ICR) titled, The STD Surveillance Network (SSuN). 
Revisions to this submission include addition of mpox-related data 
elements for monitoring mpox risk, vaccination, diagnoses, and 
laboratory testing as part of ongoing surveillance for this emergent 
public health issue. Additionally, this Revision ICR incorporates 
future expansion of SSuN to additional STD clinical facilities, 
addition of several new data elements to sentinel surveillance 
activities in STD clinical facilities related to Pre-Exposure 
Prophylaxis for HIV (PrEP), and enhanced investigations of a random 
sample syphilis cases reported to participating health departments. 
Multiple data elements associated with enhanced gonorrhea case 
investigations and provider reporting forms are also being retired. The 
estimate of annualized burden hours for this revised data collection 
increases from 5,863 hours to 7,487 hours.
    The purpose of this project is to enhance national capacity for STD 
surveillance and to better meet CDC's disease surveillance mandate by: 
(1) addressing gaps in epidemiologically-relevant information by 
providing more complete behavioral and demographic data on reported 
cases of notifiable STDs to enhance the ability of public health 
authorities to interpret trends in case incidence, assess inequalities 
in the burden of disease by population

[[Page 50154]]

characteristics and to monitor STD treatment and selected adverse 
health outcomes of STDs; (2) monitoring STD and HIV co-infection, 
screening, uptake of STD and HIV prevention interventions and health 
care access trends among patients seeking care for, and those diagnosed 
with, STDs in specialty clinical settings; and (3) providing a robust 
sentinel monitoring system for newly emergent and/or re-emergent health 
threats such as mpox.
    Routine STD case surveillance activities are ongoing in all US 
jurisdictions. Cases diagnosed in U.S. jurisdictions are voluntarily 
reported to CDC through the National Notifiable Diseases Surveillance 
System (NNDSS) and case data are collaboratively defined in cooperation 
with the Council of State and Territorial Epidemiologists (CSTE). 
However, case data received by CDC through NNDSS are increasingly 
missing required patient demographics and are extremely limited in 
scope with respect to risk behaviors, treatments prescribed, co-
infection with other infections, preventive services, and sexual 
network characteristics. These data are needed to monitor incidence and 
prevalence and to inform prevention and control efforts.
    Additionally, clinical information on patients seeking STD-specific 
care in specialty STD clinics is not available through any other 
national medical record abstracts or data sources. These data are 
critical to detecting emergent STD-related sequela or reemergence of 
mpox, appropriately informing local disease control activities and to 
inform analyses of national trends in the epidemiology of STD 
incidence. These data are also useful to monitor care services in 
essential safety-net STD clinics and evaluate local and national STD 
prevention and control measures. SSuN is the only surveillance 
infrastructure providing such comprehensive, representative information 
on patient and sex-partner characteristics, clinical presentation, STD 
screenings, uptake of HIV testing, screening for and uptake of mpox 
vaccine in STD clinics, curative and preventive treatment patterns, 
provider compliance with treatment recommendations, HIV co-infection 
among persons diagnosed with STDs and uptake of STD and HIV prevention 
interventions such as pre-exposure prophylaxis for HIV (PrEP) and/or 
Post-Exposure Prophylaxis (PEP) for bacterial STDs. These measures are 
key elements of the U.S. national strategy to End the HIV Epidemic 
(EHE) and support the Sexually Transmitted Infections, National 
Strategic Plan for the United States.
    The STD Surveillance Network was established in 2005 as a network 
of six initially funded state and local public health agencies 
providing more comprehensive STD case-level and clinical facility 
information. In 2008, SSuN was expanded to 12 recipients to add 
important geographic diversity and to include visit-level data on a 
full census of patients being seen in categorical STD clinics. The 
network's activities were continued in a third funding cycle in 2013, 
with 10 recipients conducting core data collection activities in STD 
clinics and among a random sample of reported cases.
    The current project, SSuN Cycle 4 (2019-2024), comprises 11 U.S. 
local/state health departments, including Baltimore City Health 
Department, California Department of Public Health, City of Columbus 
Public Health Department, Florida Department of Health, Indiana 
Department of Public Health, Multnomah County Health Department, New 
York City Department of Health & Mental Hygiene, Philadelphia 
Department of Public Health, San Francisco Department of Public Health, 
Utah Department of Public Health and Washington State Department of 
Health.
    SSuN Cycle 4 continues to provide critical information addressing 
CDC's Division of Sexually Transmitted Disease (DSTDP) priorities as 
articulated in the STI National Strategic Plan, including contributing 
data to CDC's annual STD Surveillance Report, CDC's quarterly progress 
indicators and contributing to the body of literature related to STDs. 
Trend data across multiple cycles of SSuN are frequently used to inform 
policy discussions on prevention and treatment recommendations for 
common bacterial STDs. Of particular importance, SSuN provides data on 
use of pre- and post-exposure prophylaxis to prevent STDs and HIV 
infection (PEP and PrEP). SSuN also provides documentation of critical 
changes in clinical services provided by specialty STD clinics, and on 
the proportion of cases treated with appropriate antimicrobial 
regimens, an essential indicator of compliance with CDC treatment 
recommendations to combat the emergence of antimicrobial resistance 
(AMR). More recently, SSuN data have also been invaluable in assessing 
COVID-19 and mpox impacts on reported case incidence and patient access 
and care-seeking patterns and provides a reliable monitoring 
infrastructure for mpox re-emergence. STD clinics were the front-line 
provider of choice for persons suspecting mpox infection or seeking 
preventive services such as mpox vaccination.
    Data collection components of SSuN are grouped into two primary 
strategies, reflecting different sentinel and enhanced population-based 
surveillance methods and activities. Strategy A includes sentinel 
surveillance in STD clinics to monitor patient care, screening and 
diagnostic practices, HIV co-infection, treatment and STD-related HIV 
prevention services delivered to patients. In collaboration with 
participating local/state health departments and their clinical 
partners, SSuN implements consensus protocols to collect demographic, 
clinical and risk behavior data on patients presenting for care in 
selected specialty STD clinics. Records for patients presenting for 
care are also matched to the jurisdiction's HIV surveillance registry, 
providing data on HIV co-infection not currently available from any 
other multi-jurisdictional source. Data for these activities are 
abstracted from existing electronic medical records at participating 
STD clinics, leveraging information that is already collected in the 
provision of routine STD clinical care. All records are fully de-
identified by collaborating facilities or health departments and 
transmitted to CDC through secure file transport mechanisms six times 
annually. The estimated time for the clinic data managers to abstract/
recode data is four hours every two months. The current Revision 
anticipates expansion of this activity from the current 15 clinics to 
up to 40 STD clinics beginning in 2024 with a resulting burden of 960 
hours (40 x 4 hours x 6 times/year). Previously approved clinic patient 
survey is no longer required and will only be implemented by clinics on 
a local use/need basis; number of responses are reduced to 1,000 with a 
corresponding reduction in burden hours.
    The second core data collection activity, Strategy B, currently 
includes: (1) abstraction recoding and reporting of all gonorrhea and 
syphilis cases reported in the collaborating jurisdiction; (2) enhanced 
investigations on a random sample of all persons diagnosed with 
gonorrhea or syphilis; and (3) health department abstraction and 
registry matching for a complete census of reported gonorrhea and 
syphilis cases. For the first activity, a random sample of all 
gonorrhea cases diagnosed and reported to health departments within the 
participating jurisdictions are selected for enhanced investigations. 
Beginning in 2024, these investigations will be expanded to include a 
random sample of reported syphilis cases, include abstracting

[[Page 50155]]

clinical data from diagnosing providers, matching cases with existing 
health department disease registries and brief patient demographic and 
behavioral interviews (10 minutes per response). The population of 
interest includes all persons diagnosed and reported with gonorrhea and 
syphilis; existing case records are matched to other health department 
disease registries to determine co-infections and to document 
laboratory and treatment information known by the health department 
through routine case investigations and local laboratory reporting. In 
the proposed Revision, syphilis cases will also be selected for 
enhanced provider and patient investigations utilizing the same 
consensus protocols used for enhanced gonorrhea case investigations. 
Considering recent increases in syphilis cases in the U.S., especially 
congenital syphilis, these data are critical to informing local and 
national syphilis prevention and control activities. SSuN recipients 
implement protocols providing uniformly coded data on demographic 
characteristics, behavioral risk factors, clinical care, laboratory 
data and health care seeking behaviors that are combined into a 
national dataset following data quality assurance at CDC.
    In 2021, there were 211,791 cases of gonorrhea diagnosed and 
reported across the 11 current recipients of SSuN. Approximately 7.4%, 
or 15,715 cases were randomly sampled for enhanced investigation; full 
enhanced investigations were completed for 6,186 (39.4%). During the 
COVID-19 public health emergency, a slightly larger proportion of cases 
were lost to follow-up than in prior years due to local staffing 
shortages, issues with timely laboratory and case reporting, and higher 
than average patient refusals. No additional burden is anticipated from 
the future inclusion of early syphilis cases in Strategy B because of 
the decrease in gonorrhea case investigations.
    Data managers at each of the local/state health departments or 
clinical facilities receiving funding are responsible for transmitting 
validated datasets for these activities to CDC every other month. This 
reflects 5,280 burden hours for Strategy A and B data management (11 
respondents x 12 data transmissions x 40 hours per data transmission), 
which includes automated HIV registry matching which was previously 
included as a separate activity; burden for this previously approved 
component as a separate activity is reduced to zero.
    The total estimated annual burden hours are 7,487 for SSuN. 
Respondents from local/state health departments and/or clinical 
facilities receive federal funds to participate in this project. There 
are no costs to patients or respondents other than their time and no 
risk or penalty for non-participation.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of
          Type of respondent                    Form name            Number of     responses per   Average hours
                                                                    respondents     respondent     per response
----------------------------------------------------------------------------------------------------------------
Data managers at sentinel STD clinics.  Electronic Clinical                   40               6               4
                                         Record Abstraction.
General Public--Adults (persons         Patient interviews for a           7,000               1           10/60
 diagnosed with gonorrhea).              random sample of
                                         gonorrhea and syphilis
                                         cases.
Data Managers: local/state health       Data cleaning/                        11               6              40
 departments (strategy A).               validation, HIV
                                         registry matching and
                                         data transmissions for
                                         all activity components.
Data Managers: local/state health       Data cleaning/                        11               6              40
 departments (strategy B).               validation, HIV
                                         registry matching and
                                         data transmissions for
                                         all activity components.
General Public--Adults (persons         Clinic waiting room                 1000               1            5/60
 presenting for care in STD Clinics).    surveys.
----------------------------------------------------------------------------------------------------------------


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. 2023-16220 Filed 7-31-23; 8:45 am]
BILLING CODE 4163-18-P