[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Pages 44795-44796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-0199; Docket No. CDC-2017-0058]


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 to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the Import Permit 
Applications information collection project.

DATES: Written comments must be received on or before November 27, 
2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0058 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comments should be submitted 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 Leroy A. Richardson, of the Information 
Collection Review Office, Centers for Disease Control and Prevention, 
1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden is the total time, effort, or financial 
resources expended by persons to generate, maintain, retain, disclose, 
or provide information to or for a Federal agency. This includes the 
time needed to review instructions; to develop, acquire, install and 
utilize technology and systems for the purpose of collecting, 
validating and verifying information, processing and maintaining 
information, and disclosing and providing information; to train 
personnel to respond to a collection of information, search data 
sources, and complete and review the collection of information; and to 
transmit or otherwise disclose the information.

Proposed Project

    Importation of Etiologic Agents (42 CFR 71.54) (OMB Control No. 
0920-0199, exp. 12/31/2019)--Revision--Office of Public Health 
Preparedness and Response (OPHPR), 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

[[Page 44796]]

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) Based on processing applications, remove questions that 
duplicative or not required to process the import permit request such 
as CDC plans to revise this application to request information on where 
the imported material will be stored at the recipient facility and who 
would be responsible for this location and revise the format for the 
form to ease of user to complete the form.
    (2) Request information the biosafety officer's contact information 
for the permittee to provide biosafety information in case the 
permittee is unavailable.
    These additional data requests will not affect the burden hours.
    In addition, CDC proposes to revise the Application for Permit to 
Import Biological Agents, Infectious Substances and Vectors of Human 
Disease into the United States form to verify that the recipient for 
subsequent transfers has implemented biosafety measures commensurate 
with the hazard posed by the infectious biological agent, infectious 
substance, and/or vector to be imported, and the level of risk given 
its intended use. CDC believes that it will take the applicant 
additional 10 minutes to complete this section for subsequent 
transfers. Estimates of burden for the additional questions survey are 
based on information obtained from the CDC import permit database on 
the number of permits issued for 2016 for subsequent transfers, which 
is 380 permits.
    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 plans to revise 
this application to add a question about what personal protective 
measures will be used. This additional data request will not affect the 
burden hours.
    Estimates of burden for the survey are based on information 
obtained from the CDC import permit database on the number of permits 
issued on annual basis since 2010. The total estimated burden for the 
one-time data collection is 1592.
    There are no costs to respondents except their time.

                                                            Estimated Annualized Burden Hours
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                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
               Type of respondent                               Form name                   respondents    responses per   response  (in       hours
                                                                                                            respondent        hours)
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Applicants Requesting to Import Biological       Application for Permit to Import                   2380               1           30/60            1190
 Agents, Infectious Substances and Vectors.       Biological Agents, Infectious
                                                  Substances and Vectors of Human
                                                  Disease into the United States.
Applicants Requesting to Import Biological       Application for Permit to Import                   2380               1           10/60             397
 Agents, Infectious Substances and Vectors.       Biological Agents, Infectious
                                                  Substances and Vectors of Human
                                                  Disease into the United States
                                                  Guidance.
Applicants Requesting to Import Live Bats......  Application for a Permit to Import Live              10               1           20/60               3
                                                  Bats.
Applicants Requesting to Import Live Bats......  Application for a Permit to Import Live              10               1           10/60               2
                                                  Bats.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............            1592
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2017-20509 Filed 9-25-17; 8:45 am]
 BILLING CODE 4163-18-P