Billing Code: 4163-18-P
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) 3955806. 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.
Estimated Annualized Burden Hours
Type of
Respondents
Applicants
Requesting to
Import
Biological
Agents,
Infectious
Substances and
Vectors.
Applicants
Requesting to
Import
Biological

Form Name

Number of
Respondents

Application for
Permit to Import
Biological Agents,
Infectious Substances
and Vectors of
Human Disease into
the United States.

3,300

Application for Permit
to Import Biological
Agents, Infectious
Substances and

Number of
Responses per
Respondent
1

Average
Burden per
Response (in
hours)
20/60

10/60

Agents,
Infectious
Substances and
Vectors.
Applicants
Requesting to
Import Live
Bats.
Applicants
Requesting to
Import Infectious
Human Remains
into the United
States.
Importer
Attestation that
the Imported
Biological Agent
or Substance is
Noninfectious.

Vectors of Human
Disease into the
United States
Subsequent Transfer.
Application for a
Permit to Import Live
Bats.

1

20/60

Application for Permit
to Import Infectious
Human Remains into
the United States.

1

20/60

Importer Certification
Statement

5,000

10/60

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: 7/15/2024 8:45 am; Publication Date: 7/16/2024]