[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46825-46827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18845]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-14-14AQA]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC), as part of 
its continuing effort to reduce public burden, invites the general 
public and other Federal agencies to take this opportunity to comment 
on proposed and/or continuing information collections, as required by 
the Paperwork Reduction Act of 1995. To request more information on the 
below proposed project or to obtain a copy of the information 
collection plan and instruments, call 404-639-7570 or send comments to 
Leroy Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send 
an email to [email protected].
    Comments submitted in response to this notice will be summarized 
and/or included in the request for Office of Management and Budget 
(OMB) approval. Comments are invited on: (a) Whether the proposed 
collection of information is necessary for the proper performance of 
the functions of the agency, including whether the information shall 
have practical utility; (b) the accuracy of the agency's estimate of 
the burden of the proposed collection of information; (c) ways to 
enhance the quality, utility, and clarity of the information to be 
collected; (d) ways to minimize the burden of the collection of 
information on respondents, including through the use of automated 
collection techniques or other forms of information technology; and (e) 
estimates of capital or start-up costs and costs of operation, 
maintenance, and purchase of services to provide information. Burden 
means the total time, effort, or financial resources expended by 
persons to generate, maintain, retain, disclose or provide information 
to or for a Federal agency. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. Written comments should be received within 60 
days of this notice.

Proposed Project

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

[[Page 46826]]

Background and Brief Description

    The Enhanced STD Surveillance Network (eSSuN) project is an active 
STD sentinel surveillance network comprised of 10 surveillance sites 
including 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.
    The enhanced STD Surveillance Network is a sentinel surveillance 
initiative designed to collect longitudinal data of a magnitude 
sufficient to detect trends and changes over time in the clinical and 
demographic characteristics of persons presenting for care in STD and 
family planning/reproductive health clinical facilities and those being 
diagnosed and reported with gonorrhea in funded jurisdictions. Data 
collection activities will be ongoing and continuous and will take five 
years to complete to establish annual trends, allowing for accretion of 
a sufficient number of investigated cases or patient visits to detect 
statistically meaningful differences between population sub groups.
    While routine STD surveillance activities are ongoing in all states 
and jurisdictions through the National Notifiable Disease Surveillance 
System, these data do not include the patient populations and specific 
clinical data elements and behavioral data proposed for collection in 
eSSuN. No other sources of information currently collected by, or 
available to, CDC answer the specific questions eSSuN is designed to 
answer.
    A similar data collection infrastructure, the STD Surveillance 
Network (OMB No. 0920-0842), expires on September 30th, 2015. However, 
funding for this cooperative agreement ended in September 29th, 2013 
and the protocols have been retired. The enhanced STD network is not a 
continuation of SSuN, instead, it is a new initiative to collect 
different kinds of data in different jurisdictions and to respond to 
different national objectives.
    The objectives of the eSSuN Project are (1) provide a dataset of 
supplemental information on case reports of STDs of interest; (2) 
provide geographic information on case reports of STDs of interest for 
investigating social determinants of STDs; (3) monitor screening 
coverage for chlamydial infection among young women in sentinel 
clinical settings; (4) monitor STD screening, incidence, prevalence, 
epidemiologic and health care access trends in populations of interest 
such as men-who-have-sex-with men (MSM), young people and persons 
diagnosed with gonorrhea; (5) monitor STD treatment and prevention 
services practices; (6) monitor selected adverse health outcomes of 
STDs; (7) evaluate and enhance local and state STD surveillance 
capacity; (8) enhance local STD-specific health information technology 
and epidemiologic capacity, and, (9) establish a core of exemplary 
state, tribal, territorial, county and/or city health department STD 
surveillance programs employing innovative approaches to STD 
surveillance.
    This project collects data using two surveillance strategies; (1) 
enhanced surveillance in participating STD and Family planning/
reproductive health clinics and (2) enhanced gonorrhea surveillance on 
a random sample of persons diagnosed with gonorrhea in participating 
jurisdictions of these 10 local and state health departments.
    For the clinic-based surveillance, participating sites have 
developed common protocols stipulating which data elements would be 
collected, including demographic, clinical, risk and sexual behaviors. 
The specified data elements are abstracted from existing electronic 
medical records for (1) all patient visits to participating STD clinics 
and (2) for all female patient visits aged 15-44 years of age to 
participating family planning/reproductive health clinics. Data are de-
identified and recoded by health departments and then are transmitted 
to CDC through secure file transport mechanisms on an every two month 
basis. Each eSSuN site will spend 16 hours to transmit the data to CDC 
every two months. At CDC, data will be aggregated with data from all 
participating sites in a common language and formatted for analysis.
    For the population-based surveillance, a random sample of 
individuals reported with gonorrhea residing within participating 
jurisdictions are interviewed using locally designed interview 
templates.
    Enhanced data collection includes detailed information on 
demographic characteristics, behavioral risk factors and clinical 
history of persons with gonorrhea. Each of the 10 sites will interview 
a minimum of 250 persons or 2.5% of total morbidity if annual GC cases 
exceed 10,000 cases and each interview is expected to take about 10 
minutes per person. Data for the population-based component will be 
collected through telephone-administered or in-person interviews 
conducted by trained interviewers in the 10 eSSuN sites.
    The survey results will be entered into the existing information 
systems at each health department and sent to CDC through secure file 
transport mechanisms on an every two month basis.
    This information is being collected to (1) enhance and improve STD 
surveillance data, (2) inform a more comprehensive understanding of 
tends and determinants of STDs of interest, (3) monitor public health 
program impact and (4) provide a more robust evidence base for 
directing public health action in the US.
    Participation is voluntary. There is no cost to the respondents 
other than their time.

                                          Estimate of Annualized Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents    responses per     response          hours
                                                                    respondent        (hours)
----------------------------------------------------------------------------------------------------------------
Data manager at clinic          Record                        33               6               3             594
 (Electronic transmittal of      Abstraction.
 clinical variables in clinic
 databases).
Data manager at each of the 10  Record                        10              12              16            1920
 local/state health department.  Abstraction.
Gonorrhea cases sampled.......  Telephone/in-              3,225               1           10/60             538
                                 person
                                 interview.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           3,050
----------------------------------------------------------------------------------------------------------------



[[Page 46827]]

LeRoy 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. 2014-18845 Filed 8-8-14; 8:45 am]
BILLING CODE 4163-18-P