[Federal Register Volume 77, Number 109 (Wednesday, June 6, 2012)]
[Notices]
[Pages 33464-33465]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13689]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-12-0824]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-7570
and send comments to Kimberly S. Lane, 1600 Clifton Road, MS-D74,
Atlanta, GA 30333 or send an email to omb@cdc.gov.
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; and (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. Written comments should be received
within 60 days of this notice.
Proposed Project
BioSense 2.0 (OMB No. 0920-0824, exp. 10/31/2012)--Revision--Office
of Surveillance, Epidemiology, and Laboratory Services (OSELS), Public
Health Surveillance and Informatics Program Office (PHSIPO)
{Proposed{time} Centers for Disease Control and Prevention (CDC).
Background and Brief Description: The BioSense Program was created
by congressional mandate as part of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, and it was launched
by the Centers for Disease Control and Prevention (CDC) in 2003.
BioSense is a near real-time surveillance system that receives and
processes electronic healthcare encounter data, including, chief
complaints, final diagnosis codes, procedure codes, clinical
laboratory, pharmacy prescription, and patient demographic data from
participating public health jurisdictions' non-federal hospital
emergency departments and inpatient facilities in addition to all
United States Department of Defense (DoD) and Veterans Affairs (VA)
outpatient hospitals and clinics nationwide. The BioSense Program also
receives pharmacy data from a private sector health information
exchange firm and laboratory data from two national-level private
sector clinical laboratories.
The BioSense Program is in the process of transitioning from the
original BioSense application to the BioSense 2.0 application that has
new governance, a new organizational structure, and a new process for
data submission and management. The Association of State and
Territorial Health Officials (ASTHO) has been funded through a
cooperative agreement with CDC's Division of Notifiable Disease and
Healthcare Information (DNDHI) within the Public Health Surveillance
and Informatics Program Office (PHSIPO) of the Office of Surveillance,
Epidemiology, and Laboratory Services (OSELS) to facilitate the
governance of BioSense 2.0, and through a contract with a vendor, ASTHO
will offer access and use of BioSense 2.0 on a voluntary basis to
state, local, and territorial health jurisdictions.
Unlike the original BioSense application where participating
organizations' data were processed and stored at CDC in the CDC owned
and operated Information Technology Services Office's Mid-Tier Data
Center on secure servers, all data submitted by users in BioSense 2.0
will reside in a cloud-enabled, web-based platform that sits in the
secure, private Government Cloud and is in compliance with the Federal
Information Security Management Act. The platform will provide users
with an exclusive secure space as well as tools for posting, receiving,
controlling, analyzing, and sharing their public health surveillance
information with other public health jurisdictions, CDC, or other
public health partners. The public health jurisdiction will retain
ownership of any data it contributes to its exclusive secure space
within BioSense 2.0.
The BioSense 2.0 cloud also provides the CDC's BioSense Program its
own exclusive secure space to receive, store, and analyze data. CDC has
agreements with VA, DoD, two national-level private sector clinical
laboratories, and a private sector health information exchange firm to
provide healthcare encounter data to CDC's secure space for the purpose
of national public health situation awareness and syndromic
surveillance. These organizations automatically chose to share with CDC
when they were recruited to submit data to the BioSense 2.0 cloud
environment. Because they are not required to choose sharing
permissions, collecting already existing healthcare encounter data
submitted via electronic record transmission from them entails no
burden hours.
In addition to providing a secure, exclusive space for use by CDC
and secure, exclusive spaces for use by each participating state,
local, and territorial public health jurisdiction, BioSense 2.0
provides a second secure space in the cloud for public health
jurisdictions to share aggregate data with other participating
jurisdictions and CDC. Whenever possible, the BioSense
[[Page 33465]]
Program plans to share aggregate-level pharmacy and laboratory data
with public health jurisdictions. To participate in the shared space,
jurisdiction administrators must simply select from drop-down lists to
choose their sharing permissions on the BioSense 2.0 application, and
they will have the right at any time to revise the level of sharing
permissions regarding the data in their secure space.
As part of access to the shared space, public health jurisdictions
will be required to grant CDC access to, at minimum, aggregate level
data (city, county, or state) from their jurisdiction that has been
placed in the shared space. They must also agree that CDC may review
data contributed to the shared space for public health practice and
surveillance purposes.
In order to continue meeting the congressional mandate in the
BioSense 2.0 application, the BioSense Program maintains 3 different
types of information collection: (1) Contact information (name,
telephone number, email address, and street address) needed for
recruitment of up to 20 participating public health jurisdictions to
BioSense 2.0 per year; (2) one-time collection of information (name,
email address, title, organizational affiliation, security questions,
and password) to provide access to the BioSense 2.0 cloud and its tools
for all appropriate users in participating jurisdictions and
organizations, and (3) collection of already existing healthcare
encounter data submitted to the cloud via electronic record
transmission from participating public health jurisdictions' non-
federal hospitals, VA, DoD, two national-level private sector clinical
laboratories, and a private sector health information exchange firm.
Though a large number of electronic records are transmitted from each
entity each year, once the automated interfaces are set up for
transmission (choosing sharing permissions), there is no human burden
for record transmission.
This request is for a 3-year approval. There are no costs to survey
respondents other than their time to participate.
Estimates of Annualized Burden Hours
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Number of Average burden
Type of respondents Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Recruitment
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State, Local, and Territorial Public Health 20 1 1 20
Jurisdictions..................................
Federal Government.............................. 2 1 1 2
Private Sector (national clinical laboratory 3 1 1 3
corporations, and a private sector health
information exchange company)..................
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Access to BioSense 2.0 Application
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State, Local, and Territorial Public Health 200 1 5/60 17
Jurisdictions..................................
Federal Government.............................. 30 1 5/60 3
Private Sector.................................. 50 1 5/60 4
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Data Collection: Administrator Sharing Permissions
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State, Local, and Territorial Public Health 20 1 5/60 2
Jurisdictions..................................
Federal Government.............................. 2 0 0 0
Private Sector (national clinical laboratory 3 0 0 0
corporations, and a private sector health
information exchange company)..................
---------------------------------------------------------------
Total....................................... .............. .............. .............. 51
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Kimberly S. Lane,
Deputy Director, Office of Science Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2012-13689 Filed 6-5-12; 8:45 am]
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