[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Notices]
[Pages 15028-15030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04972]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-1072; Docket No. CDC-2023-0017]


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 STD Surveillance Network (SSuN). This information collection 
request is designed to strengthen national and local surveillance 
capacity for incident, new and emerging sexually transmitted diseases 
(STDs) by collecting relevant risk, demographic, and clinical 
information on patients at risk for STDs attending STD-related 
healthcare facilities, and providing more accurate estimates of the 
burden of disease, incidence of STDs, trends and impact of STDs at the 
population level.

DATES: CDC must receive written comments on or before May 9, 2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0017 by either of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     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 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 using 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 STD Surveillance Network (SSuN), (OMB Control No. 0920-1072, 
Exp. 10/31/2023)--Revision--National Center for HIV/AIDS, 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 (NCHHSTP) is requesting revision of the information 
collection entitled, 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 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 purpose of this project is to enhance national capacity for STD 
surveillance and 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 characteristics and to monitor STD

[[Page 15029]]

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 U.S. 
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 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).
    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 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

[[Page 15030]]

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).
    The total estimated annual burden hours for SSuN are 7,407. 
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.

                                        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)
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Data managers at STD clinics    Electronic                    40               6               4             960
 (Strategy A).                   Clinical Record
                                 Abstraction.
General Public, Adults (sample  Patient                    7,000               1           10/60           1,167
 of persons diagnosed and        interviews for
 reported with gonorrhea and/    a random sample
 or syphilis).                   of gonorrhea
                                 and syphilis
                                 cases.
Data Managers: 11 local/state   Data cleaning/                11              12              40           5,280
 health departments.             validation, HIV-
                                 registry
                                 matching, data
                                 transmission.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           7,407
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2023-04972 Filed 3-9-23; 8:45 am]
BILLING CODE 4163-18-P