[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]


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

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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondent                    Form name           respondents    responses per     response
                                                                                    respondent        (hours)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


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