[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]
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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
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Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response hours
respondent (hours)
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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.
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Total..................... ................ .............. .............. .............. 3,050
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[[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]
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