Notice2024-15535
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 16, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 89 Issue 136 (Tuesday, July 16, 2024)</title>
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[Federal Register Volume 89, Number 136 (Tuesday, July 16, 2024)]
[Notices]
[Pages 57897-57899]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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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
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