[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).
                                                 ---------------------------------------------------------------
    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]
 BILLING CODE 4163-18-P