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 “Import Permit Applications (42 CFR 71.54)” 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 February 5, 2024 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 (404) 639-7570. 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 (202) 395-5806. Provide written comments within 30 days of notice publication.

Proposed Project

Import Permit Applications (42 CFR 71.54) (OMB Control No. 0920-0199, Exp. 8/31/2024)—Revision—Office of Readiness and Response (ORR), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Section 361 of the Public Health Service Act (42 U.S.C. 264), as amended, authorizes the Secretary of Health and Human Services to make and enforce such regulations as are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. Part 71 of title 42, Code of Federal Regulations (Foreign Quarantine) sets forth provisions to prevent the introduction, transmission, and spread of communicable disease from foreign countries into the United States. Subpart F—Importations—contains provisions for the importation of infectious biological agents, infectious substances, and vectors (42 CFR 71.54); requiring persons that import these materials to obtain a permit issued by the CDC.

The Application for Permit to Import Biological Agents, Infectious Substances and Vectors of Human Disease into the United States form is used by laboratory facilities, such as those operated by government agencies, universities, and research institutions to request a permit for the importation of biological agents, infectious substances, or vectors of human disease. This form currently requests applicant and sender contact information; description of material for importation; facility isolation and containment information; and personnel qualifications. Based on questions we have received from prior applicants, CDC is proposing to reduce open text questions and replace them with more streamlined check boxes. The goal is that this will clarify what is being asked of applicants and will increase efficiency and speed of processing by reducing back and forth communication necessary to clarify to applicants.

On February 5, 2024, CDC published in the Federal Register a 60-day notice (89 FR 7712) seeking public comments on “Application for Permit to Import Biological Agents and Vectors of Human Disease into the United States,” “Application for Permit to Import or Transport Live Bats,” “Application for Permit to Import Infectious Human Remains into the United States,” and “Importer Certification Statement” to initiate the revision of the information collection. As a result of this notice, CDC received one comment that was not related to the notice or CDC's Import Permit Program's regulatory authority, therefore, no changes to the data collection instruments were made.

The Application for Permit to Import or Transport Live Bats form is used by laboratory facilities such as those operated by government agencies, universities, research institutions, and for educational, exhibition, or scientific purposes to request a permit for the importation, and any subsequent distribution after importation, of live bats. This form currently requests the applicant and sender contact information; a description and intended use of bats to be imported; and facility isolation and containment information. CDC does not plan to revise this application.

The Application for Permit to Import Infectious Human Remains into the United States is used by facilities that will bury/cremate the imported cadaver and educational facilities to request a permit for the importation and subsequent transfers throughout the U.S. of human remains or body parts that contains biological agents, infectious substances, or vectors of human disease. This form will request applicant and sender contact information; facility processing human remains; cause of death; biosafety and containment information; and final destination(s) of imported infectious human remains. CDC does not plan to revise this application.

The Importer Certification Statement is a new form and will be used as an attestation by an importer stating that they are importing only noninfectious biological agent(s) or biological substance(s). The noninfectious, imported agent or substance must be accompanied by an importer certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent or has been rendered noninfectious. This form requests a detailed description of the material, statements affirming that the material is not known or suspected to contain an infectious biological agent, and one of the following: (1) How the person knows that the material does not contain an infectious biological agent; (2) Why there is no reason to suspect that the material contains an infectious biological agent; or (3) A detailed description of how the material was rendered noninfectious.

Annualized burden hours were calculated based on updated data obtained from the CDC import permit database on the number of permits issued on annual basis since 2021. There is an increase in burden from 764 hours to 2,044 hours which reflects the new, proposed form (Importer Certification Statement) and the increase in the number of respondents, to this project. There was no change due to program changes or adjustments.