Notice2023-04972
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
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Published
March 10, 2023
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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 47 (Friday, March 10, 2023)</title>
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[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Notices]
[Pages 15028-15030]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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#4e21232c0e2d2a2d60292138"><span class="__cf_email__" data-cfemail="1e71737c5e7d7a7d30797168">[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 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
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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.
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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
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