Agency Forms Undergoing Paperwork Reduction Act Review, 21237-21239 [2020-07975]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[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]


-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------


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]
BILLING CODE 4163-18-P