[Federal Register Volume 77, Number 166 (Monday, August 27, 2012)]
[Notices]
[Pages 51808-51809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-21024]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-12-0824]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. chapter 35). To request a copy of these requests, call 
(404) 639-7570 or send an email to [email protected]. Send written comments 
to 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

    BioSense 2.0 Recruitment of Data Sources (OMB No. 920-0824, 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 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 public health jurisdictions.
    All data collected by 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.
    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 exclusive 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.
    Whenever possible, the BioSense Program plans to share aggregate-
level pharmacy and laboratory data with public health jurisdictions in 
the shared space. 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.
    In order to continue meeting the congressional mandate in the 
BioSense 2.0 application BioSense Program maintains 3 different types 
of information collection: (1) contact information (name, telephone 
number, email address, and street address) needed for recruitment of 
participating public health jurisdictions to BioSense 2.0 each 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

[[Page 51809]]

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.
    Recruitment is estimated at 1 hour per respondent. This encompasses 
the unstructured conversation between the contractor and the 
respondent. Estimated annualized burden hours for public health 
jurisdictions, federal government, and private sector are 20, 2, and 3 
hours respectively. The public health jurisdiction number is an average 
divided over three years. We expect it to be highest for the first year 
then decrease in subsequent years with an estimated total of 60 
jurisdictions over 3 years.
    Applying for access to the BioSense 2.0 application is estimated at 
5/60th of an hour per respondent. This involves a onetime completion of 
an online questionnaire. Estimated annualized burden hours for public 
health jurisdictions, federal government, and private sector are 17, 3, 
and 4 hours respectively.
    Data collection (administering sharing permissions) is estimated at 
5/60th of an hour per respondent. This activity entails accessing a 
submenu of the BioSense 2.0 cloud-enabled, Web-based platform and 
choosing with whom to share data and at what level of aggregation from 
a series of drop-down lists. Estimated annualized burden hours for 
public health jurisdictions is 2 hours.
    VA, DoD, the two national clinical laboratory corporations, and the 
private sector health information exchange company (federal government 
and private sector) automatically chose to share with CDC when they 
were recruited to submit data to the BioSense 2.0 cloud environment. 
This entails 0 annualized burden hours per respondent, because the data 
is shared directly with the CDC BioSense Program.
    This request is for a 3-year approval. There are no costs to survey 
respondents other than their time to participate. The estimated total 
annualized burden hours for this data collection is 51 hours.

                                      Estimates of Annualized Burden Hours
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                                                                                     Number of    Average burden
                       Type of respondents                           Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
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                                                   Recruitment
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State, Local, and Territorial Public Health Jurisdictions.......              20               1               1
Federal Government..............................................               2               1               1
Private Sector (national clinical laboratory corporations, and a               3               1               1
 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 Jurisdictions.......             200               1            5/60
Federal Government..............................................              30               1            5/60
Private Sector..................................................              50               1            5/60
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                               Data Collection: Administrator Sharing Permissions
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State, Local, and Territorial Public Health Jurisdictions.......              20               1            5/60
Federal Government..............................................               2               0               0
Private Sector (national clinical laboratory corporations, and a               3               0               0
 private sector health information exchange company)............
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    Dated: August 21, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate 
Director for Science, Office of the Director, Centers for Disease 
Control and Prevention.
[FR Doc. 2012-21024 Filed 8-24-12; 8:45 am]
BILLING CODE 4163-18-P