[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21237-21239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07975]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-20-1072]
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 ``The Enhanced 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 Friday,
October 25, 2019, to obtain comments from the public and affected
agencies. CDC did not receive 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 Enhanced STD surveillance Network (SSuN), (OMB Control No.
0920-1072 Exp. 09/30/2021)--Revision--National Center for HIV/AIDS,
Viral Hepatitis, STD, and 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 ``Enhanced STD Surveillance Network (SSuN)''.
Revisions to this submission include adding reported adult syphilis
cases to enhanced case-based surveillance records, addition of 87 new
data elements, removal of 115 data elements associated with a
discontinued neurosyphilis surveillance activity and revision of
methods to include Health Department surveillance HIV registry matching
activities for patients presenting for care in STD clinical facilities.
This revision also includes changes to the number and identity of
collaborating jurisdictions from 10 to 11 sites as a result of a recent
notice of funding opportunity. The estimate of annualized burden hours
for this data collection increases modestly from 4,134 hours to 6,303
hours for the revised project as a result of revisions and expanding
the project from 10 to 11 awardees for the current data collection
cycle.
The purpose of this project is to enhance capacity for STD
surveillance and better meet CDC's disease surveillance mandate by; (1)
providing more comprehensive information 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 treatment
and selected adverse health outcomes of STDs, and, (2) to monitor STD
and HIV co-infection, screening, uptake of high-impact HIV prevention
and health care access trends among patients seeking care and those
diagnosed with STDs in specific clinical settings.
Routine STD surveillance activities are ongoing in all US states
and jurisdictions, and cases are reported to CDC through the National
Notifiable Disease Surveillance System (NNDSS). However, case reports
are often missing critical patient demographics and are of limited
scope with respect to risk behavior, provider and clinical information,
treatment, co-infection and partner characteristics--data that are
needed to appropriately direct disease control activities. Enhanced
SSuN is the only current surveillance infrastructure providing
information on patient and partner characteristics, clinical
presentation, screening and uptake of HIV testing, treatment patterns,
provider compliance with treatment recommendations, HIV co-infection
among persons diagnosed with STDs
[[Page 21238]]
and use of high impact STD-related HIV prevention interventions such as
pre-exposure prophylaxis.
The precursor to Enhanced SSuN was the STD Surveillance Network
(SSuN), which was established in 2005 as a network of six collaborating
state and local public health agencies providing more comprehensive STD
case-level and clinical facility information. In 2008, SSuN was
expanded to 12 awardees to add important geographic diversity and to
include visit-level data on a full census of patients being seen in
categorical STD clinics. Activities of the previously funded SSuN were
subsumed under the network's scope in establishing enhanced SSuN in
2013, which funded 10 awardees to conduct core data collection
activities.
The revised project, SSuN Cycle 4, 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.
Subsequent to reinstatement of OMB approval in 2018, enhanced SSuN
continues to provide ongoing data addressing CDC's Division of Sexually
Transmitted Disease and Prevention priorities (DSTDP), including
contributing to CDC's annual STD surveillance report, CDC's quarterly
and annual progress indicators, and has informed policy discussions on
expedited partner therapy, pre-exposure prophylaxis to prevent HIV
infection (PrEP), documented critical clinical services provided by
categorical STD clinics, and provided information on the proportion of
cases treated with appropriate antimicrobial regimens, which is an
essential indicator of compliance with CDC treatment recommendations
and critical for addressing the emergence of antimicrobial resistance.
The major data collection components of the network are grouped into
two primary strategies, reflecting different sentinel and enhanced
population-based surveillance methods.
The first, Strategy A, includes sentinel surveillance in STD
clinics to monitor patient care, screening and diagnostic practices,
HIV co-infection, treatment and assess the delivery of high impact,
STD-related HIV prevention services. Participating local/state health
departments are implementing common protocols to abstract demographic,
clinical, risk behaviors from existing health records for patients
presenting for care in 15 selected local STD Clinics. Data for this
strategy is abstracted from existing electronic medical records at the
participating STD clinics, leveraging information that is routinely
collected in the provision of clinical care. A brief 10-item de-
identified survey will be administered at registration to 350 patients
presenting consecutively to the clinics once annually to assess
demographics not collected in the course of routine patient care. All
survey and medical records are fully de-identified by collaborating
health departments and transmitted to CDC through secure file transport
mechanisms six times annually (every two months). The estimated time
for the STD clinic data managers to abstract data from electronic
health records and process patient surveys is four hours every two
months.
The second surveillance activity in SSuN Cycle 4, Strategy B,
includes abstraction of all reported gonorrhea and adult syphilis cases
from the jurisdiction's routine STD surveillance data management
system, recoding case data to conform with common protocols and
performance of a registry match with the jurisdictions HIV case
surveillance system. A random sample of gonorrhea cases is selected,
and enhanced investigations conducted on the gonorrhea cases selected
in the random sample. Enhanced investigations include clinical data
collection from reporting providers, searching existing health
department disease and laboratory registries for additional diagnostic
and laboratory data and attempting to obtain brief patient behavioral
and demographic interviews on patients selected in the random sample.
Estimated time for patients to complete these interviews is 10 minutes
or less depending on skip patterns. For these activities, jurisdictions
follow consensus protocols for all data collection to provide uniformly
coded data on demographic characteristics, behavioral risk factors,
clinical care, laboratory data and health care seeking behaviors. There
were 164,177 cases of gonorrhea diagnosed and reported across the 10
participating enhanced SSuN jurisdictions funded in 2018. Approximately
10.6%, or 17,512 cases were randomly sampled for enhanced investigation
and full enhanced investigations were completed for 7,132 (40.7%). The
remaining cases were lost to follow-up due to insufficient contact
information, or the patient failed to respond to multiple contact
attempts. Similar performance is anticipated in the revised project,
which includes 11 jurisdictions which reported 173,605 gonorrhea cases
in 2017. Approximately 17,360 cases will be sampled and 7,380 completed
patient investigations are anticipated.
Data managers at each of the 11 local/state health departments are
responsible for transmitting validated datasets to CDC every month,
alternating between strategies A and B each month. This reflects 3,168
burden hours for data management (11 respondents x 12 data
transmissions x 24 hours). Data managers will also be responsible for
conducting HIV registry matching bimonthly; registry matches are
estimated to take 20 hours for matching, cleaning and recoding records
into approved data formats. Across all 11 jurisdictions, this
represents an additional data management burden of 1,320 hours (11
sites x 6 annual matches x 20 hours).
The total estimated annual burden hours for data management staff
in funded jurisdiction is 4,488 hours (3,168 + 1,320) for the revised
information collection. Respondents from local/state health departments
receive federal funds to participate in this project. Participation of
patients and of facility staff is voluntary. There are no additional
costs or benefits accrued to respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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Data managers at sentinel STD clinics. Electronic Clinical 11 6 4
Record Abstraction.
[[Page 21239]]
General Public--Adults (persons Patient interviews for a 7,380 1 10/60
diagnosed with gonorrhea). random sample of
gonorrhea cases.
Data Managers: 11 local/state health Data cleaning/ 11 12 44
department. validation, HIV
registry matching and
data transmission for
Strategy A and Strategy
B.
General Public--Adults (persons Clinic Survey........... 3,850 1 5/60
visiting STD clinics and
participating in the clinic survey).
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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. 2020-07975 Filed 4-15-20; 8:45 am]
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