[Federal Register Volume 86, Number 47 (Friday, March 12, 2021)]
[Notices]
[Pages 14120-14121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05118]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-21-0199]


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 October 21, 2020 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. 04/30/2021)--Revision--Center for Preparedness and Response 
(CPR), 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

[[Page 14121]]

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. CDC plans to 
revise this application to:
    (1) Remove question 10 ``Will the permittee be the courier of the 
imported biological agent?'' from Section A since it is the same 
question found in Section C, Question 1.
    (2) Add example to Section F, Question 2 for clarity to read, 
``Protective Clothing (e.g., laboratory coat).''
    These revisions will not affect the burden hours.
    CDC received one comment regarding this notice. The commenter 
requested that the contact information for the biosafety officer field 
be mandatory. The commenter also requested that communications 
regarding the permit application be sent to the biosafety officer and 
permittee. CDC made no changes based on these comments as these 
recommendations did not request changes to the form but requested 
changes on how the program processes the application.
    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.
    Due to the implementation of eIPP and the applicants ability to 
complete the applications on-line without the need of the guidance 
document, the ``Guidance Document for Completing Application for Permit 
to Import Biological Agents, Infectious Substances and Vectors of Human 
Disease into the United States'' is no longer needed. As such, the 
total burden hours of 333 for applicants to review this document was 
reduced and this entry was removed from the burden table.
    The Application Requesting to Import Live Bats 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 of bats. 
Based on information from eIPP, IPP receives three ``Application 
Requesting to Import Live Bats'' requests per year. It takes applicants 
20 minutes to complete the application. The number of applicants was 
reduced from ten to three to accurately reflect the requests received. 
As such this change, the total burden hours from three to one.
    Due to the implementation of eIPP and the applicants' ability to 
complete the applications on-line without the need of the guidance 
document, the ``Guidance Document for Completing Application Requesting 
to Import Live Bats'' is no longer needed. As such, the total of two 
burden hours for applicants to review this document was reduced and 
this entry was removed from the burden table.
    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. Due to the implementation 
of eIPP in 2020 which increased response efficiency and the applicants' 
ability to complete the applications on-line without the need of the 
guidance documents, the burden hours were reduced. Total response 
burden decreased from 1355 hours to 764 hours.

                                        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              2000               1           20/60
 Biological Agents, Infectious           to Import Biological
 Substances and Vectors.                 Agents, Infectious
                                         Substances and Vectors
                                         of Human Disease into
                                         the United States (42
                                         CFR 71.54).
Applicants Requesting to Import         Application for Permit               380               1           10/60
 Biological Agents, Infectious           to Import Biological
 Substances and Vectors.                 Agents, Infectious
                                         Substances and Vectors
                                         of Human Disease into
                                         the United States (42
                                         CFR 71.54)--Subsequent
                                         Transfers.
Applicants Requesting to Import Live    Application for a Permit               3               1           20/60
 Bats.                                   to Import Live Bats (42
                                         CFR 71.54).
Applicants Requesting to Import         Application for Permit               100               1           20/60
 Infectious Human Remains into the       to Import Infectious
 United States.                          Human Remains into the
                                         United States (42 CFR
                                         71.54).
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-05118 Filed 3-11-21; 8:45 am]
BILLING CODE 4163-18-P