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Notice

Agency Forms Undergoing Paperwork Reduction Act Review

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Information about this document as published in the Federal Register.

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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 omb@cdc.gov. 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} 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 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

Type of respondentsNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)
Recruitment
State, Local, and Territorial Public Health Jurisdictions2011
Federal Government211
Private Sector (national clinical laboratory corporations, and a private sector health information exchange company)311
Access to BioSense 2.0 Application
State, Local, and Territorial Public Health Jurisdictions20015/60
Federal Government3015/60
Private Sector5015/60
Data Collection: Administrator Sharing Permissions
State, Local, and Territorial Public Health Jurisdictions2015/60
Federal Government200
Private Sector (national clinical laboratory corporations, and a private sector health information exchange company)300

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