[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.
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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).
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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]
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