[Federal Register Volume 85, Number 95 (Friday, May 15, 2020)]
[Notices]
[Pages 29454-29456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10411]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-20ND; Docket No. CDC-2020-0044]


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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[[Page 29455]]

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 Investigation of SARS-CoV-2 
Seroprevalence and Factors Associated with Seropositivity in a 
Community Setting. CDC will, at the request of state and local health 
departments, collect epidemiological data and blood samples from 
households to determine the extent of COVID-19 infection in communities 
as determined by overall SARS-CoV-2 seroprevalence.

DATES: CDC must receive written comments on or before July 14, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0044 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 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

    Investigation of SARS-CoV-2 Seroprevalence and Factors Associated 
with Seropositivity in a Community Setting--New--National Center for 
Immunization and Respiratory Diseases (NCIRD), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC), National 
Center for Immunization and Respiratory Diseases (NCRID), Division of 
Viral Diseases (DVD) requests approval for a new information 
collection, ``Investigation of SARS-CoV-2 Seroprevalence and Factors 
Associated with Seropositivity in a Community Setting.'' Coronavirus 
disease 2019 (COVID-19), caused by the severe acute respiratory 
syndrome coronavirus 2 (SARS-CoV-2), was first reported in Wuhan, Hubei 
Province, China in late December 2019. On February 26, 2020, CDC 
announced that an infection with the novel coronavirus had been 
confirmed ``in a person who reportedly did not have relevant travel 
history or exposure to another known patient with COVID-19,'' making 
this the first suspected United States (U.S.) case of community 
transmission.
    We propose to conduct an investigation to (1) determine the extent 
of infection in communities as determined by overall SARS-CoV-2 
seroprevalence; and (2) determine factors associated with SARS-CoV-2 
seropositivity among persons residing in areas with evidence of 
community transmission. The data collected under this information 
collection request (ICR) will be used immediately by CDC's emergency 
COVID-19 response at the national level, and by state and local health 
departments, to understand the cumulative incidence in a given 
population within their jurisdiction. A cross-sectional household 
survey design will be used to measure SARS-CoV-2 seroprevalence at one 
or more time points in >=1 U.S. areas with evidence of community 
transmission of SARS-CoV-2. Areas with existing population-based 
surveillance platforms with well-defined catchment areas will be 
preferentially selected. The investigation population will consist of 
all persons residing in selected households from selected defined 
geographic areas, according to the sampling framework. CDC and health 
departments alike will use this seroprevalence data to prioritize the 
allocation of resources and response efforts.
    CDC will collect epidemiological information in the form of a 
standardized questionnaire which will capture information on household 
characteristics, age, sex, race, ethnicity, exposures, underlying 
medical conditions and symptoms consistent with COVID-19 infection that 
occurred prior to the survey. One respondent in each household (an 
adult who knows all residents of the household) will provide responses 
for the household questionnaire. The household questionnaire will 
capture information on household characteristics and document all 
household members, whether they are present at the time of the visit or 
not. Blood samples will be collected by trained phlebotomists from all 
individuals in the household and tested for antibodies to SARS-CoV-2 
using an enzyme-linked immunosorbent assay with confirmatory 
microneutralization testing as needed. Investigations will be conducted 
at a total of four sites throughout the clearance period. There are no 
costs to respondents other than their time to participate. The total 
estimated annualized burden hours requested for this collection is 
2,420.

[[Page 29456]]



                                        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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Household Participants........  Individual                 4,000               1           20/60           1,333
                                 Questionnaire.
                                Household                  1,680               1           15/60             420
                                 Questionnaire.
                                Blood collection           4,000               1           10/60             667
                                 (no form).
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           2,420
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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. 2020-10411 Filed 5-14-20; 8:45 am]
BILLING CODE 4163-18-P