[Federal Register Volume 89, Number 136 (Tuesday, July 16, 2024)]
[Notices]
[Pages 57897-57899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15535]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-24-0199]


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

[[Page 57898]]

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.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                    Number of     Average burden
         Type of respondents                   Form name            Number of     responses per    per response
                                                                   respondents      respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Applicants Requesting to Import        Application for Permit             3,300                1           20/60
 Biological Agents, Infectious          to Import Biological
 Substances and Vectors.                Agents, Infectious
                                        Substances and Vectors
                                        of Human Disease into
                                        the United States.
Applicants Requesting to Import        Application for Permit               650                1           10/60
 Biological Agents, Infectious          to Import Biological
 Substances and Vectors.                Agents, Infectious
                                        Substances and Vectors
                                        of Human Disease into
                                        the United States
                                        Subsequent Transfer.
Applicants Requesting to Import Live   Application for a Permit               3                1           20/60
 Bats.                                  to Import Live Bats.
Applicants Requesting to Import        Application for Permit                 3                1           20/60
 Infectious Human Remains into the      to Import Infectious
 United States.                         Human Remains into the
                                        United States.
Importer Attestation that the          Importer Certification             5,000                1           10/60
 Imported Biological Agent or           Statement.
 Substance is Noninfectious.
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[[Page 57899]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2024-15535 Filed 7-15-24; 8:45 am]
BILLING CODE 4163-18-P