[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Notices]
[Pages 11532-11535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05243]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-FY-1072; Docket No. CDC-2018-0020]


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

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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 comments on the 
proposed revision of the information collection titled ``The Enhanced 
STD surveillance Network (SSuN),'' which is the only source for 
enhanced and sentinel sexually transmitted disease (STD) surveillance 
data in the United States that: (1) Serves to strengthen national and 
local surveillance capacity; (2) collects information on populations at 
risk for STDs attending healthcare facilities; and (3) 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 May 14, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0020 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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 Leroy A. Richardson, 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.

Proposed Project

    The Enhanced STD surveillance Network (SSuN)--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 seeks to request a three-year revision approval of the 
information collection project entitled, The Enhanced STD surveillance 
Network (SSuN). Revisions to this submission include, removal of 
facility-based surveillance in family planning clinics, the addition of 
seven interview questions to the gonorrhea population component and 
eight new data elements to the facility component, and the addition of 
an enhanced surveillance activity to monitor adverse health outcomes of 
early syphilis cases with neurologic and/or ocular syphilis 
manifestations. The estimate of annualized burden hours will increase 
from 3,052 hours to 3,479 hours as a result of the revision.
    The purpose of this project is to: (1) Provide supplemental 
information on case reports of notifiable STDs that enhances the 
ability of public health authorities to interpret trends in reported 
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) monitor STD screening, 
incidence, prevalence, epidemiologic and health care access trends in 
at-risk populations seeking STD services in specific clinical settings.
    While routine STD surveillance activities are ongoing in all U.S. 
states and jurisdictions, through the National Notifiable Disease 
Surveillance System, these data are often missing critical patient 
demographics and are of limited scope with respect to risk behavior, 
provider and clinical information, treatment and partner 
characteristics needed to direct disease control activities. Enhanced 
SSuN is the only infrastructure providing information about diagnosed 
and reported STD cases with respect to patient and partner 
characteristics, clinical presentation, screening and uptake of HIV 
testing, treatment patterns or provider compliance with treatment 
recommendations for patients receiving STD-related care.
    The precursor to Enhanced SSuN was the STD Surveillance Network 
(SSuN), established in 2005 as a network of collaborating state and 
local public health agencies to provide 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.
    The current project comprises 10 US local/state health departments. 
These facilities include Baltimore City Health Department, California 
Department of Public Health, Florida Department of Health, 
Massachusetts Department of Public Health, Minnesota Department of 
Health, Multnomah County Health Department, New York City Department of 
Health & Mental Hygiene, Philadelphia Department of Public Health, San 
Francisco Department of Public Health, and Washington State Department 
of Health.
    Since the initial OMB approval in 2015, Enhanced SSuN has provided 
ongoing data addressing CDC/Division of Sexually Transmitted Disease 
and Prevention priorities (DSTDP), including contributing to CDC's 
annual STD surveillance report, CDC's quarterly progress indicators, 
and informed policy discussions on expedited partner therapy, pre-
exposure

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prophylaxis to prevent HIV infection (PrEP), documentation of critical 
clinical services provided by categorical STD clinics, and on the 
proportion of cases treated with appropriate antimicrobial regimens, 
which is an essential indicator of compliance with CDC treatment 
recommendations.
    The two major data collection components of the Enhanced SSuN 
project are grouped into two primary categories, reflecting sentinel 
and enhanced population-based surveillance activities. The first 
component includes sentinel surveillance in participating STD clinics, 
which monitors patient care, screening and diagnostic practices, 
treatment and STD-related services delivered. Participating local/state 
health departments have implemented common protocols to collect 
demographic, clinical, risk behaviors on patients presenting for care 
in selected facilities. Data for this activity is abstracted from 
existing electronic medical records at participating STD clinics, 
leveraging information routinely collected in the provision of clinical 
care. All records are fully de-identified by collaborating health 
departments and transmitted to CDC through secure file transport 
mechanisms six times annually (every 2 months). The estimated time for 
the clinic data managers to abstract data is 3 hours every 2 months.
    The second population-focused component is comprised of two 
activities, including enhanced surveillance on a random sample of 
persons diagnosed with gonorrhea, and enhanced surveillance on person 
diagnosed and reported with early syphilis with ocular/neurologic 
manifestations. For the first activity a random sample of all gonorrhea 
cases diagnosed and reported to health departments among persons 
residing within the participating jurisdictions are selected for 
enhanced interview. The second population of interest are persons 
diagnosed with primary, secondary, and early latent syphilis. Cases 
determined to have neurologic/ocular manifestations will be selected 
for enhanced interview/investigation. In both these activities, 
jurisdictions follow consensus protocols to collect uniform data on 
demographic characteristics, behavioral risk factors, and health care 
seeking behaviors.
    In 2016, there were 129,434 persons diagnosed and reported with 
gonorrhea across the 10 participating Enhanced SSuN jurisdictions. 
Approximately 10%, or 12,943 cases were randomly sampled for enhanced 
investigation. Many cases were lost to follow-up because of limited 
contact information. Hence, the response rate for gonorrhea patient 
interviews in the first three years of Enhanced SSuN data collection 
was 39.3%, with approximately 5,086 respondents interviewed.
    In 2016, there were 25,253 early syphilis cases reported across the 
10 participating SSuN jurisdictions. Studies estimate that 2% of all 
early syphilis cases will report neurologic and/or ocular 
manifestations, corresponding to 507 cases requiring additional 
investigation. CDC expects to interview 80% of 507 patients or 406 
respondents. The 5,492 patient interviews for both the gonorrhea and 
early syphilis are estimated to take 10 minutes to complete for an 
estimated annualized burden hours of 934.
    CDC will conduct an early syphilis case follow-up evaluation with 
diagnosing or reporting providers to ascertain additional information 
about physical exam findings, laboratory tests results, including 
cerebrospinal fluid (CSF) results, and prescribed (type and duration) 
treatment not present in the original case or laboratory report. CDC 
will collect clinical information from the diagnosing healthcare 
facilities for those diagnosed with early syphilis who reported 
neurologic/ocular symptoms (406 early syphilis cases). These 
evaluations can be either by direct contact with providers (phone) or 
through other methods such as secure fax-back, mail or other means as 
long as privacy of patient information can be strictly maintained.
    Collection of this information is estimated to take approximately 
10 minutes to complete, for 69 burden hours.
    For the syphilis cases with neurologic and/or ocular manifestations 
only, there will be a three-month follow up interview to document 
resolution of symptoms. Data collection for this three-month follow-up 
is expected to take about five minutes per person and will be conducted 
through either telephone-administered or in-person interviews. With an 
estimated 50% follow-up success rate, the total burden hours is 
estimated at 16 hours.
    Data managers at each of the 10 local/state health departments will 
be responsible for transmitting validated datasets to CDC every month, 
alternating between the facility and population-based activities in 
Enhanced SSuN. This reflects 2,280 burden hours for data management (10 
respondents x 12 data transmissions x 19 hours).
    The total estimated annual burden hours are 3,479 for Enhanced 
SSuN. Respondents from local/state health departments receive federal 
funds to participate in this project. Participation of patients and of 
facility staff are voluntary. There are no additional costs to 
respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                        Number of    Average burden     Total
      Type of respondents             Form name         Number of     responses per   per response    burden (in
                                                       respondents     respondent      (in hours)       hours)
----------------------------------------------------------------------------------------------------------------
Data manager at Sentinel STD     Record Abstraction              10               6               3          180
 clinics.
General Public--Adults (persons  Interview.........           5,492               1           10/60          934
 diagnosed with gonorrhea or
 early syphilis.
Diagnosing Provider............  Data for early                 406               1           10/60           69
                                  syphilis cases.
General Public--Adults (persons  Follow up                      203               1            5/60           16
 with early syphilis who have     Interview.
 neurologic/ocular
 manifestations.
Data Managers: 10 local/state    Data cleaning/                  10              12              19        2,280
 health department.               validation.
                                                    ------------------------------------------------------------
    Total......................  ..................  ..............  ..............  ..............        3,479
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Leroy A. Richardson,
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. 2018-05243 Filed 3-14-18; 8:45 am]
 BILLING CODE 4163-18-P