[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57432-57434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23369]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-20-1072; Docket No. CDC-2019-0091]
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 proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled ``The Enhanced STD surveillance
Network (SSuN)'', which is the only source for enhanced and sentinel
STD surveillance data in the United States that serves to strengthen
national and local surveillance capacity, collects information on
populations at risk for STDs attending healthcare facilities, and
provides more accurate estimates of the burden of disease, incidence of
disease, trends and impact of STDs at the population level.
DATES: CDC must receive written comments on or before December 24,
2019.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0091 by any of the following methods:
Federal eRulemaking Portal: 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-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (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-D74, Atlanta, Georgia 30329; phone: 404-639-7570; 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; and
4. 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
submissions of responses.
5. Assess information collection costs.
[[Page 57433]]
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 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 3,479 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) monitoring 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 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 US 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.
[[Page 57434]]
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 eleven 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 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. The total estimated annual
burden hours for which CDC seeks approval is 6,303. There are no
additional costs 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 Total burden
respondents respondent (in hours) (in hours)
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Data managers at sentinel STD Electronic 11 6 4 264
clinics. Clinical Record
Abstraction.
General Public--Adults Patient 7,380 1 10/60 1,230
(persons diagnosed with interviews for
gonorrhea). a random sample
of gonorrhea
cases.
Data Managers: 11 local/state Data cleaning/ 11 12 44 4,488
health department. validation, HIV
registry
matching and
data
transmission
for Strategy A
and Strategy B.
General Public--Adults Clinic Survey... 3850 1 5/60 321
(persons visiting STD clinics
and participating in the
clinic survey).
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Total..................... ................ 11,274 .............. .............. 6,303
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Jeffery Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-23369 Filed 10-24-19; 8:45 am]
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