[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39100-39102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16947]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-1072]


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 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 March, 15, 2018 to obtain 
comments from the public and affected agencies. CDC received 37 
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 or send an email to <a href="/cdn-cgi/l/email-protection#c0afada280a3a4a3eea7afb6"><span class="__cf_email__" data-cfemail="204f4d42604344430e474f56">[email protected]</span></a>. 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

    Enhanced STD surveillance Network (SSuN)--Reinstatement with 
Change--Division of STD Prevention (DSTDP), National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB prevention (NCHHSTP), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    The Enhanced STD surveillance network project was created to 
provide enhanced behavioral, demographic, and clinical information on 
gonorrhea cases reported to state and local health departments, to 
provide information on patients presenting for care in STD clinical 
settings, and to provide an infrastructure for identifying emerging 
sequelae of STDs.
    Enhanced SSuN continues to be a collaboration between different 
branches of the CDC Division of STD Prevention and selected state/local 
public health departments and their associated STD specialty care 
clinics in the US. Data from enhanced SSuN data is used to (1) provide 
a dataset of supplemental information on gonorrhea case reports; (2) 
provide geographic information on case reports of STDs of interest for 
investigating social determinants of STDs, (3) monitor STD screening, 
incidence, prevalence, epidemiologic and health care access trends in 
populations of interest, (4) monitor STD treatment and prevention 
service practices, and (5) monitor selected adverse health outcomes of 
STDs, including neuro/ocular syphilis,
    This project will continue to utilize two distinct surveillance 
strategies to collect information. The first strategy employs facility-
based sentinel surveillance, which will abstract routine standardized 
data from existing electronic medical records for all patient visits to 
participating STD clinics during the project period. For the facility-
based component of enhanced SSuN, participating sites have developed 
common protocols stipulating data elements to be collected, including 
patient demographics, clinical, risk and sexual behaviors. The 
specified data elements are abstracted by clinic staff from

[[Page 39101]]

existing electronic medical records for all patient visits to 
participating STD clinics. Some of the participating facilities are 
satellite clinics of large network providers where clinical data 
systems are centralized. Hence, there are 10 unique clinic data 
managers that will be abstracting the facility data. Each of the clinic 
data managers will spend three hours to extract and transmit data to 
local/state health departments. Individual patient records are de-
identified (all patient-specific identifiers are removed) by clinic 
staff before being transmitted to health departments, who recode the 
data into standardized formats before being transmitted to CDC through 
secure file transport mechanisms. Each enhanced SSuN site will spend 16 
hours to recode and transmit the data to CDC every other month. At CDC, 
data will be aggregated across all participating sites in a common data 
structure and formatted for analysis.
    Under this revision, the second strategy, population-based STD 
surveillance is being expanded to include not only a random sample of 
reported gonorrhea cases but also include patients diagnosed with early 
syphilis that report neurologic/ocular manifestations. For the 
gonorrhea population component, a probability sample of gonorrhea cases 
(up to 10% of total gonorrhea morbidity for participating 
jurisdictions) will be contacted by health department staff for a 
standardized interview either by phone or in-person. Enhanced gonorrhea 
investigations will also include verification of treatment and an 
internal health department record review (performed on either all cases 
or on the sampled cases). The focus of the new population activity 
focuses on obtaining additional clinical information on early syphilis 
cases who report neurologic/ocular symptoms. The subset of patients 
reporting these symptoms are asked to participate in an interview to 
obtain additional clinical information for a more complete assessment 
of neurologic/ocular involvement as well as obtain additional clinical 
information from the diagnosing or reporting provider. Lastly, early 
syphilis cases reporting neurologic and/or ocular symptoms are 
recontacted at approximately three months following prescribed 
treatment to ascertain whether initial symptoms have resolved.
    The population data will be directly entered into existing STD 
surveillance information systems at each health department. Data will 
be locally extracted, de-identified and recoded into standardized 
formats prior to being transmitted to CDC through secure file transport 
mechanisms on bimonthly basis. Patient participation in the interview 
is voluntary and refusal to participate has no impact on other STD 
services the health department provides to persons diagnosed with 
gonorrhea.
    This project will not collect name, social security number, or date 
of birth. A Patient ID, a unique patient identifier assigned by the 
clinic or health department depending on the component, is requested 
and will be provided to CDC for purposes of enhanced surveillance. 
Patient IDs are not linkable across enhanced SSuN components. Sensitive 
information such as sex of sex partners, HIV status, sex work exposure, 
and injection drug use are collected. All personally identifiable 
information (PII) is retained by the STD clinics and/or health 
departments and is not recorded with data sent to CDC. The electronic 
enhanced SSuN database is stored on the CDC mainframe computer and only 
approved Division of STD Prevention (DSTDP) staff have access rights to 
the data. As part of the revision, we will continue to systematically 
identify the risks and potential effects of collecting, maintaining, 
and disseminating PII and to examine and evaluate alternative processes 
for handling that information to mitigate potential privacy risks and 
risks to confidentiality.
    Both components of enhanced SSuN are designed to (1) Integrate 
traditional surveillance methods with innovative data management 
technologies to produce high-quality, timely surveillance and 
epidemiologic data, (2) provide valuable information to direct public 
health STD prevention and control efforts, (3) enhance understanding of 
the community burden of disease, (4) identify syndemic patterns and 
population at greatest risk, and, (5) monitor long-term health 
consequences of STDs. The enhanced SSuN surveillance platform allows 
CDC to establish and maintain common standards for data collection, 
transmission, and analysis, and to build and maintain STD surveillance 
expertise in 10 state/local health departments. Such common systems, 
established mechanisms of communication, and in-place expertise are all 
critical components for timely, flexible, and high quality 
surveillance. The total estimated annual burden is 3,479 hours. There 
are no costs 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 manager at Sentinel STD clinics..  Record Abstraction......              10               6               3
General Public--Adults (persons         Interview...............            5492               1           10/60
 diagnosed and reported with gonorrhea
 or early syphilis.
Diagnosing Provider...................  Data for early syphilis              406               1           10/60
                                         cases.
General Public--Adults (persons with    3 month follow-up                    203               1            5/60
 early syphilis who were reported with   telephone Interview.
 neurologic/ocular manifestations.
Data Managers: 10 local/state health    Data cleaning/validation/             10              12              19
 department.                             reformatting.
----------------------------------------------------------------------------------------------------------------



[[Page 39102]]

Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of 
Scientific Integrity, Office of the Associate Director for Science, 
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-16947 Filed 8-7-18; 8:45 am]
 BILLING CODE 4163-18-P


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