[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Notices]
[Pages 27155-27156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09786]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-22-22ET; Docket No. CDC-2022-0060]


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 information 
collection, as required by the Paperwork Reduction Act of 1995. This 
notice invites comment on a proposed information collection project 
titled Traveler-based SARS-CoV-2 Genomic Surveillance. The information 
collection will monitor for the importation of SARS-CoV-2 variants 
among arriving international air travelers at select U.S. airports.

DATES: CDC must receive written comments on or before July 5, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0060 by either of the following methods:
     Federal eRulemaking Portal: www.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 H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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

[[Page 27156]]

Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; 
Telephone: 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;
    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; and
    5. Assess information collection costs.

Proposed Project

    Traveler-based SARS-CoV-2 Genomic Surveillance--New--National 
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    The traveler-based SARS-CoV-2 genomic surveillance project was 
developed as a surveillance platform for early detection of imported 
and emerging SARS-CoV-2 variants among international air travelers 
arriving into the United States. Despite layered mitigation measures, 
international travel facilitates spread of SARS-CoV-2, including novel 
variants of concern (VOCs). Although SARS-CoV-2 genomic sequencing has 
increased significantly during the pandemic, there is still a gap in 
early detection of emerging variants among arriving travelers.
    To address this gap, in September 2021, the Travelers' Health 
Branch, in collaboration with private partners, implemented a voluntary 
SARS-CoV-2 genomic surveillance program with the goal of early 
detection of novel VOCs. Surveillance for new and emerging variant 
strains among travelers can provide researchers and public health 
officials critical time to collect information about the 
transmissibility, virulence, and effectiveness of existing vaccines, 
diagnostics, and therapeutics. The project is conducted with external 
partners and groups within DGMQ and across CDC, including the Office of 
Advanced Molecular Detection. The program began at New York's John F. 
Kennedy International Airport in September 2021 and later expanded to 
include Newark Liberty International, San Francisco International, and 
Hartsfield-Jackson Atlanta International airports. Information 
collection for this project is currently approved under a Public Health 
Emergency PRA Waiver.
    Project data is collected as follows: A volunteer sample of 
travelers, 18 years and older, from selected flights from South Asia, 
South America, Europe, and southern Africa, complete an informed 
consent form and fill-out a questionnaire on enrollment at the airport. 
The questionnaire includes demographic, travel, and clinical 
information. The voluntary surveillance project also includes 
laboratory data collection as follows: Airport collection of nasal 
samples from arriving travelers and follow-up collection of individual 
at-home saliva samples 3-5 days later. Travelers participating in 
individual, at home sample collection also complete an electronic 
health information questionnaire prior to submission of their samples 
and have the opportunity to fill out an evaluation survey.
    CDC requests OMB approval for an estimated 169,433 annual burden 
hours. There is no cost to respondents other than their time to 
participate.

                                        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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Participant with sample         Participant               88,400               1               1          88,400
 collected in-airport.           information
                                 intake form
                                 (for pooled
                                 testing).
Participant with sample         Participant               44,200               1             1.5          66,300
 collected at home.              intake form
                                 (for individual
                                 at-home
                                 testing).
Participant with sample         Evaluation                44,200               1           20/60          14,733
 collection at-home.             Survey Form.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............         169,433
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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. 2022-09786 Filed 5-5-22; 8:45 am]
BILLING CODE 4163-18-P