[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]
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Recruitment
----------------------------------------------------------------------------------------------------------------
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)............
----------------------------------------------------------------------------------------------------------------
Access to BioSense 2.0 Application
----------------------------------------------------------------------------------------------------------------
State, Local, and Territorial Public Health Jurisdictions....... 200 1 5/60
Federal Government.............................................. 30 1 5/60
Private Sector.................................................. 50 1 5/60
----------------------------------------------------------------------------------------------------------------
Data Collection: Administrator Sharing Permissions
----------------------------------------------------------------------------------------------------------------
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)............
----------------------------------------------------------------------------------------------------------------
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