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CDC TA during the previous funding
cycle.
The previous Clinic-level Data
Collection instrument assessed: (1)
Health system and clinic characteristics,
(2) EBI and supporting activities
implementation within clinics; (3)
monitoring and quality improvement
activities, and (4)CRC screening rates.
The revised instrument was reorganized
(e.g., sections merged, variables moved
to new sections) for increased efficiency
and to improve overall data quality. In
addition, wording and responses for
many variables and their response
options have undergone minor revisions
to better capture awardees’ partnerships
with both health systems and clinics,
and appropriate capture of baseline and
annual variables. The revised

Redesigned data elements will enable
CDC to better gauge progress in meeting
CRCCP program goals and monitor
implementation activities, evaluate
outcomes, and identify awardee TA
needs. In addition, data collected will
inform program improvement and help
identify successful activities that need
to be maintained, replicated, or
expanded.
OMB approval is requested for three
years. The number of awardees will
increase from 30 awardees in DP15–
1502 to 35 awardees in DP20–2002, and
the number of clinic partners is
expected to increase from 12 to 24 per
awardee. Therefore, the total estimated
annualized burden hours have increased
from 204 to 663 hours.

instrument gathers information to assess
health system and clinic characteristics;
program reach; CRC screening practices
and outcomes; clinics’ quality
improvement and monitoring activities;
EBI implementation, and additional
factors that affect EBI implementation
over time.
The new Quarterly Program Update
will collect standardized awardee-level
information on aspects of program
management, including (1) quarterly
program expenditures, (2) current staff
vacancies, (3) program successes and
challenges, and (4) current TA needs.
This information collection will provide
CDC staff rapid reporting of
programmatic information to inform
their efforts to provide awardees with
tailored TA.

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

Total burden
(in hr)

Form name

CRCCP Awardees .........

CRCCP Annual Awardee Survey ........................
CRCCP Clinic-level Information Collection Instrument.
CRCCP Quarterly Program Update ....................

35
35

1
24

15/60
43/60

9
602

35

4

22/60

52

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

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

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

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

663

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–12244 Filed 6–4–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–20OS; Docket No. CDC–2020–
0062]

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.

SUMMARY:

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Number of
responses per
respondent

Number of
respondents

Type of respondent

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18:21 Jun 04, 2020

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This notice invites comment on a
proposed information collection project
titled COVID–19 Pandemic Response,
Laboratory Data Reporting. The
collection will be used to gather
comprehensive laboratory testing data to
ensure a rapid and thorough federal
response to the COVID–19 pandemic.
DATES: CDC must receive written
comments on or before August 4, 2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0062 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.

To
request more information on the
proposed project or to obtain a copy of

FOR FURTHER INFORMATION CONTACT:

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the information collection plan and
instruments, contact Jeffrey M. Zirger,
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].
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

SUPPLEMENTARY INFORMATION:

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Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices

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
COVID–19 Pandemic Response,
Laboratory Data Reporting—New—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) requests an emergency
six-month approval for a New
Information Collection titled COVID–19
Pandemic Response, Laboratory Data
Reporting. Efforts are underway to
ensure that laboratory data—including
diagnostic viral testing data and
serologic testing data—are
comprehensive and readily available
from laboratories and other facilities
providing testing, including point-ofcare testing sites for the public health
response to SARS–CoV–2 and COVID–
19.

to receive these data in the most
efficient manner, the Secretary is
requiring that all data be reported
through existing public health data
reporting methods as described below.
As a guiding principle, data will be
sent first to the state or local public
health agencies (in accordance with
state law or policies) to ensure rapid
initiation of case investigations by the
state and/or local public health agency.
At the same time, laboratory order
results will be shared with ordering
providers or patients if there is not an
ordering provider.
All laboratories, defined as
laboratories, non-laboratory testing
locations, and other facilities or
locations offering point of care testing or
in-home testing related to SARS–CoV–2
shall report data for all testing
completed, for each individual tested,
within 24 hours of result known or
determined, on a daily basis to the
appropriate state or local public health
agency based on the individual’s
residence.
Reporting to the state and/or local
public health agencies meets the
requirement for reporting stated above
as this information—under current
processes and policies—will then be
subsequently provided electronically to
the Centers for Disease Control and
Prevention (CDC) using an existing
pathway and storage location for the
data.
For the purposes of this ICR, federal
burden is only being placed on fifty
states, the District of Columbia, Puerto
Rico, US Virgin Islands, and Guam.
Authorizing legislation comes from
Section 301 of the Public Health Service
Act (42 U.S.C. 241). Total estimated
burden is 9,720 hours.

Ensuring a rapid and thorough public
health response to the COVID–19
pandemic necessitates comprehensive
laboratory testing data. These data
contribute to understanding disease
incidence and trends: Initiating
epidemiologic case investigations,
assisting with contact tracing, assessing
availability and use of testing resources,
and identifying of supply chain issues
for reagents and other material.
Laboratory testing data, in conjunction
with case reports and other data, also
provide vital guidance for mitigation
and control activities.
Public Law 116–136 § 18115(a), the
Coronavirus Aid, Relief, and Economic
Security (CARES) Act, requires ‘‘every
laboratory that performs or analyzes a
test that is intended to detect SARS–
CoV–2 or to diagnose a possible case of
COVID–19’’ to report the results from
each such test to the Secretary of the
Department of Health and Human
Services (HHS).
Through the CARES Act, and other
coronavirus supplemental funding
packages including the Paycheck
Protection Program and Health Care
Enhancement Act, jurisdictions have
received funding to accelerate and
improve data collection and reporting of
SARS–CoV–2. Improvements with the
laboratory data collection and reporting,
laboratory information management
systems (LIMS) enhancements and
expansions, increased completeness of
case data reporting, and improvements
with timeliness of reporting are among
the prioritized activities for
implementation with this funding.
This ICR outlines the requirements for
data submission to the U.S. Department
of Health and Human Services (HHS) as
authorized under this law. In an effort

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Number of
respondents

Form name

State epidemiologist or informatics staff ......
Total .......................................................

CDC-provided CSV file or
HL7 messages.
...............................................

Number of
responses per
respondent
180

1

9,720

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

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

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

9,720

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Total burden
(in hours)

54

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.

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burden per
response
(in hours)

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