[Federal Register Volume 79, Number 244 (Friday, December 19, 2014)]
[Notices]
[Pages 75813-75815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29715]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-14AQA]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (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 [email protected]. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 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 75814]]
Background and Brief Description
The Enhanced STD surveillance network 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 purpose of eSSuN is to be a robust platform for the
identification of STD trends, monitor STD epidemiology and evaluate the
effectiveness of public health interventions through active
surveillance collection, reporting, analysis, visualization (e.g.,
mapping) and interpretation of disease information.
The objectives of the eSSuN project are (1) provide a dataset of
supplemental information on gonorrhea 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
service 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 approaches to STD surveillance.
This project will utilize two distinct surveillance strategies to
collect information. The first strategy employs facility-based sentinel
surveillance, which will abstract standardized data from existing
electronic medical records for all patient visits to participating STD
clinics and female patients aged 15-44 years of age visiting
participating family planning/reproductive health clinics and other
facilities (school-based clinics and federally qualified healthcare
centers) during the project period. The second strategy is population-
based STD surveillance among a random sample of reported gonorrhea
cases. Sampled cases will be contacted for standardized interview and
the sample fraction will be 250 completed enhanced investigations or up
to 2.5% of total morbidity if annual cases exceed 10,000 cases.
Enhanced investigations will also include verification of treatment and
an internal health department record review (performed on either all
cases or on the sampled cases).
For the facility-based component of eSSuN, 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
existing electronic medical records for; (1) all patient visits to
participating STD clinics, (2) female patients aged 15--24 at
participating family planning/reproductive health clinics and, (3)
visits of female patients aged 15-44 at school-based clinics and those
attending federally qualified health centers (FQHCs) specifically for
family planning services.
Some of the participating facilities are satellites clinics of
large network providers where clinical data systems are centralized.
Hence, there are a total of 22 unique clinic data managers that will be
abstracting the facility data. Each of the 22 clinic data managers will
spend 3 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. Data transmission will occur on a monthly
basis. Each eSSuN site will spend 16 hours to recode and transmit the
data to CDC every month. At CDC, data will be aggregated across all
participating sites in a common data structures and formatted for
analysis.
For the population-based surveillance component, a random sample of
individuals residing within participating jurisdictions and reported
with gonorrhea will be interviewed using locally designed interview
templates following standardized data protocols. 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 up to 2.5% of total morbidity if annual GC cases
exceed 10,000 cases) and each interview is expected to take 10 minutes
per person. Interview 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. These 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 a
monthly basis.
Patient participation in the interview is voluntary and refusal to
participate has no impact on other STD services the local health
provides to persons diagnosed with gonorrhea. There is no cost to the
respondents beyond their time and no compensation for participation.
Both components of eSSuN 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 eSSuN
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 or city 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 2,854 hours of effort.
[[Page 75815]]
Estimated Annualized Burden Hours
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Average
Number of Number of burden per
Type of respondent Form name respondents responses per response
respondent (hours)
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Clinic Data manager at clinic......... Data Manager electronic 22 6 3
Transmission.
Record Abstraction (No
Form).
Health Department Data Manager........ Case Reports (No Form).. 10 12 16
Gonorrhea Patients sampled and Patient Interview....... 3,225 1 10/60
interviewed.
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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. 2014-29715 Filed 12-18-14; 8:45 am]
BILLING CODE 4163-18-P