[Federal Register Volume 89, Number 24 (Monday, February 5, 2024)]
[Notices]
[Pages 7712-7714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     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 www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.regulations.gov) 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: 
[email protected].

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)
----------------------------------------------------------------------------------------------------------------
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.
                                                           -----------------------------------------------------
    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