[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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
               Type of respondents                   Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
                                                   Recruitment
----------------------------------------------------------------------------------------------------------------
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)..................
----------------------------------------------------------------------------------------------------------------
                                       Access to BioSense 2.0 Application
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
                               Data Collection: Administrator Sharing Permissions
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


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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