[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Pages 34633-34634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12241]


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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

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 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.


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 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].

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

[[Page 34634]]

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-of-care testing sites for the public health response to 
SARS-CoV-2 and COVID-19.
    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 Sec.  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 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.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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State epidemiologist or         CDC-provided CSV              54             180               1           9,720
 informatics staff.              file or HL7
                                 messages.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           9,720
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-12241 Filed 6-4-20; 8:45 am]
 BILLING CODE 4163-18-P