60 Day FRN

Federal Register / Vol. 84, No. 54 / Wednesday, March 20, 2019 / Notices

Centers for Disease Control and
Prevention
[60Day–19–0824; Docket No. CDC–2019–
0024]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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.
SUMMARY:

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

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].

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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.

SUPPLEMENTARY INFORMATION:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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

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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, webbased 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 ondemand 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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Federal Register / Vol. 84, No. 54 / Wednesday, March 20, 2019 / Notices

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

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.

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

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Number of
responses per
respondent

Total burden
(in hours)

Form name

State, Local, and Territorial Public
Health Departments.
State, Local, and Territorial Public
Health Departments.
State, Local, and Territorial Public
Health Departments.

Onboarding .......................................

10

100

10/60

167

Registration ......................................

10

15

10/60

25

Data Sharing Permissions ...............

10

1

15/60

3

Total ...........................................

...........................................................

........................

........................

........................

195

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10553]

Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:

The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing

SUMMARY:

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Type of respondents

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collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
May 20, 2019.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to http://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following

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address: CMS, Office of Strategic
Operations and Regulatory Affairs
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll , Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
[email protected].
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).

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