Notice2024-02173
Proposed Data Collection Submitted for Public Comment and Recommendations
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
February 5, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Import Permit. The goal of the information collection is to support the Public Health Service (PHS) Act and 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.
Full Text
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<title>Federal Register, Volume 89 Issue 24 (Monday, February 5, 2024)</title>
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[Federal Register Volume 89, Number 24 (Monday, February 5, 2024)]
[Notices]
[Pages 7712-7714]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-02173]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-24-0199; Docket No. CDC-2024-0008]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies the opportunity to comment on a continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Import Permit. The goal of the information collection is to
support the Public Health Service (PHS) Act and 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.
DATES: CDC must receive written comments on or before April 5, 2024.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0008 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) or by U.S. mail to the address listed
above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and
[[Page 7713]]
instruments, contact Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; Email:
<a href="/cdn-cgi/l/email-protection#127d7f70527176713c757d64"><span class="__cf_email__" data-cfemail="5837353a183b3c3b763f372e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. 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
submissions of responses; and
5. Assess information collection costs.
Proposed Project
Import Permit Applicatons (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.
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 data obtained from
CDC import permit database on the number of permits issued on annual
basis since 2015, which is 2,000 respondents. The total estimated
burden for the data collection is 2,097. There is an increase in burden
from 1,097 hours to 2,097 hours which reflects the new, proposed form
(Importer Certification Statement), to this project.
[[Page 7714]]
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total
Type of respondents Form name respondents responses per response burden (in
respondent (in hours) hours)
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Applicants Requesting to Import Application for 2,000 1 30/60 1,000
Biological Agents, Infectious Permit to Import
Substances and Vectors. Biological Agents,
Infectious
Substances and
Vectors of Human
Disease into the
United States.
Applicants Requesting to Import Application for 380 1 10/60 63
Biological Agents, Infectious Permit to Import
Substances and Vectors. Biological Agents,
Infectious
Substances and
Vectors of Human
Disease into the
United States
Subsequent Transfer.
Applicants Requesting to Import Application for a 3 1 20/60 1
Live Bats. Permit to Import
Live Bats.
Applicants Requesting to Import Application for 100 1 20/60 33
Infectious Human Remains into the Permit to Import
United States. Infectious Human
Remains into the
United States.
Importers of Non-infectious Importer 2,000 1 30/60 1,000
Materials to the United States. Certification
Statement.
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Total.......................... ..................... ........... .............. ........... 2,097
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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. 2024-02173 Filed 2-2-24; 8:45 am]
BILLING CODE 4163-18-P
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