[Federal Register Volume 85, Number 204 (Wednesday, October 21, 2020)]
[Notices]
[Pages 66987-66988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-0199; Docket No. CDC-2020-0107]


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 proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled 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, and 
Application for Permit to Import Infectious Human Remains into the 
United States (OMB Control No. 0920-0199). The purpose of this data 
collection is to support Section 361 of the Public Health Service (PHS) 
Act and 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.

DATES: CDC must receive written comments on or before December 21, 
2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0199 by any of the following methods:
     Federal eRulemaking Portal: 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-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (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 instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; 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; and
    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.
    5. Assess information collection costs.

Proposed Project

    Import regulations for infectious biological agents, infectious 
substances, and vectors (42 CFR 71.54) (OMB Control No. 0920-0199, Exp. 
4/30/

[[Page 66988]]

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 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.
    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.
    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 1,098. There is a decrease in burden 
from 1,355 hours to 1,098 hours to reflect the implementation of the 
Electronic Import Permit Program portal (eIPP) which has decreased the 
time required to enter information.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of        Number        burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
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Applicants Requesting to        Application for            2,000               1           30/60           1,000
 Import Biological Agents,       Permit to
 Infectious Substances and       Import
 Vectors.                        Biological
                                 Agents,
                                 Infectious
                                 Substances and
                                 Vectors of
                                 Human Disease
                                 into the United
                                 States.
Applicants Requesting to        Application for              380               1           10/60              63
 Import Biological Agents,       Permit to
 Infectious Substances and       Import
 Vectors.                        Biological
                                 Agents,
                                 Infectious
                                 Substances and
                                 Vectors of
                                 Human Disease
                                 into the United
                                 States-
                                 Subsequent
                                 Transfer.
Applicants Requesting to        Application for                3               1           20/60               1
 Import Live Bats.               a Permit to
                                 Import Live
                                 Bats.
Applicants Requesting to        Application for              100               1           20/60              33
 Import Infectious Human         Permit to
 Remains into the United         Import
 States.                         Infectious
                                 Human Remains
                                 into the United
                                 States.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,098
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-23248 Filed 10-20-20; 8:45 am]
BILLING CODE 4163-18-P