[Federal Register Volume 84, Number 54 (Wednesday, March 20, 2019)]
[Notices]
[Pages 10315-10316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05188]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-0824; Docket No. CDC-2019-0024]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled the National Syndromic 
Surveillance Program (NSSP). The NSSP promotes and advances development 
of a syndromic surveillance system for the timely exchange of syndromic 
data.

DATES: CDC must receive written comments on or before May 20, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0024 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.

    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed 
above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Leroy A. Richardson, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    National Syndromic Surveillance Program--Revision--Center for 
Surveillance, Epidemiology and Laboratory Services (CSELS), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    Syndromic surveillance uses syndromic data and statistical tools to 
detect, monitor, and characterize unusual activity for further public 
health investigation or response. Syndromic data include electronic 
extracts of electronic health records (EHRs) from patient encounter 
data from emergency departments, urgent care, ambulatory care, and 
inpatient healthcare settings, as well as pharmacy and laboratory data. 
Though these data are being captured for different purposes, they are 
monitored in near real-time as potential indicators of an event, a 
disease, or an outbreak of public health significance. On the national 
level, these data are used to improve nationwide situational awareness 
and enhance responsiveness to hazardous events and disease outbreaks to 
protect America's health, safety, and security.
    The BioSense Program was created by congressional mandate as part 
of the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 and was launched by the CDC in 2003. The BioSense 
Program has since been expanded into the National Syndromic 
Surveillance Program (NSSP) which promotes and advances development of 
a syndromic surveillance system for the timely exchange of syndromic 
data.
    CDC requests a three-year approval for a Revision for NSSP (OMB 
Control No. 0920-0824, Expiration Date 5/31/2019). This Revision 
includes a new request for approval to receive onboarding data from 
state, local and territorial public health departments about healthcare 
facilities in their jurisdiction.
    NSSP features the BioSense Platform and a collaborative Community 
of Practice. The BioSense Platform is a secure integrated electronic 
health information system that CDC provides, primarily for use by 
state, local and territorial public health departments. It includes 
standardized analytic tools and processes that enable users to rapidly 
collect, evaluate, share, and store syndromic surveillance data. NSSP 
promotes a Community of Practice in which participants collaborate to 
advance the science and practice of syndromic surveillance. Health 
departments use the BioSense Platform to receive healthcare data from 
facilities in their jurisdiction, conduct syndromic surveillance, and 
share the data with other jurisdictions and CDC.
    The BioSense Platform provides the ability to analyze healthcare 
encounter data from EHRs, as well as laboratory data. All EHR and 
laboratory data reside outside of CDC in a cloud-enabled, web-based 
platform that has Authorization to Operate from CDC. The BioSense 
Platform sits in the secure, private Government Cloud which is simply 
used as a storage and processing mechanism, as opposed to on-site 
servers at CDC. This environment provides users with easily managed on-
demand access to a shared pool of configurable computing resources such 
as networks, servers, software, tools, storage, and services, with 
limited need for additional IT support. Each site (i.e., state or local 
public health department) controls its data within the cloud and is 
provided with free secure data storage

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space with tools for posting, receiving, controlling and analyzing 
their data; an easy-to-use data display dashboard; and a shared 
environment where users can collaborate and advance public health 
surveillance practice. Each site is responsible for creating its own 
data use agreements with the facilities that are sending the data, 
retains ownership of any data it contributes to its exclusive secure 
space, and can share data with CDC or users from other sites.
    NSSP has three different types of information collection:
    (1) Collection of onboarding data about healthcare facilities 
needed for state, local, and territorial public health departments to 
submit EHR data to the BioSense Platform;
    (2) Collection of registration data needed to allow users access to 
the BioSense Platform tools and services; and
    (3) Collection of data sharing permissions so that state and local 
health departments can share data with other state and local health 
departments and CDC.
    Healthcare data shared with CDC can include: EHR data received by 
state and local public health departments from facilities, including 
hospital emergency departments and inpatient settings, urgent care, and 
ambulatory care; laboratory tests ordered and their results from 
LabCorp, a national private sector laboratory company; and EHR data 
from the Department of Defense (DoD) and the Department of Health and 
Human Services (HHS) National Disaster Medical System (NDMS) Disaster 
Medical Assistance Teams (DMATs).
    Respondents include state, local, and territorial public health 
departments. There are no costs to respondents other than their time to 
participate. The only burden incurred by the health departments are for 
submitting onboarding data about facilities to CDC, submitting 
registration data about users to CDC, and setting up data sharing 
permissions with CDC. The estimated annual burden is 195 hours.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response (in     (in hours)
                                                                    respondent        hours)
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State, Local, and Territorial   Onboarding......              10             100           10/60             167
 Public Health Departments.
State, Local, and Territorial   Registration....              10              15           10/60              25
 Public Health Departments.
State, Local, and Territorial   Data Sharing                  10               1           15/60               3
 Public Health Departments.      Permissions.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             195
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Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-05188 Filed 3-19-19; 8:45 am]
 BILLING CODE 4163-18-P