2023-04968. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled ”Traveler-based Genomic Surveillance” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on May 6, 2022, to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) 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;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) 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 submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone]. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

Traveler-based Genomic Surveillance—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's (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Global Migration and Quarantine (DGMQ), Travelers' Health Branch (THB) requests three-year approval for information collection from international air travelers that participate in the Traveler-based Genomic Surveillance project. Genetic variants of SARS-CoV-2 have been emerging and circulating around the world throughout the COVID-19 pandemic. Of particular concern are variants for which there is evidence of an increase in transmissibility, more severe disease (for example, increased hospitalizations or deaths), significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures.

CDC recommends that all arriving international travelers get tested before departing and 3-5 days after travel. However, this testing is not mandatory for all travelers. Furthermore, there are currently few systems that conduct disease surveillance in the population of arriving international travelers. Moreover, as testing and sequencing for SARS-CoV-2 continue to decline worldwide, detecting emerging variants of concern (VOCs) in a timely manner is becoming more and more difficult.

To address this gap, in September 2021, the THB, 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. Since November 2022, the program has expanded to Los Angeles, Seattle, and Washington Dulles. Information collection for this project is currently approved under a Public Health Emergency PRA Waiver.

The information collection for which approval is sought is in accordance with CDC/DGMQ's mission to reduce morbidity and mortality among travelers and to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the U.S. This mission is supported by the Section 361 of the Public Health Service Act regulations found in 42 Code of Federal Regulations part 70 and 71. Also supported under general authorities provided by Sections 301 and 311 in the Public Health Service Act regulations.

CDC requests OMB approval for an estimated 46,250 annual burden hours. There is no cost to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Arriving international traveler	Questionnaire	555,000	1	6/60

Jeffrey M. Zirger,

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