Notice2023-16220
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 1, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 146 (Tuesday, August 1, 2023)</title>
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[Federal Register Volume 88, Number 146 (Tuesday, August 1, 2023)]
[Notices]
[Pages 50153-50155]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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Number of
Type of respondent Form name Number of responses per Average hours
respondents respondent per response
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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.
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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. 2023-16220 Filed 7-31-23; 8:45 am]
BILLING CODE 4163-18-P
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