82_FR_44980 82 FR 44795 - Proposed Data Collection Submitted for Public Comment and Recommendations

82 FR 44795 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 185 (September 26, 2017)

Page Range44795-44796
FR Document2017-20509

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.

Federal Register, Volume 82 Issue 185 (Tuesday, September 26, 2017)
[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Pages 44795-44796]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
               Type of respondent                               Form name                   respondents    responses per   response  (in       hours
                                                                                                            respondent        hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------


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



                               Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices                                                          44795

                                                            ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                  Average
                                                                                                                                                  Number of
                                                                                                                                Number of                       burden per
                  Type of respondents                                              Form name                                                    responses per
                                                                                                                               respondents                       response
                                                                                                                                                  respondent     (in hours)

     Private Sector Organization Senior Leader ....         Interview Plan .................................................            45                  1              1
     Private Sector Organization Manager ............       Survey Plan ....................................................           100                  1          15/60



     Leroy A. Richardson,                                    received will be posted without change                             or start-up costs and costs of operation,
     Chief, Information Collection Review Office,            to Regulations.gov, including any                                  maintenance, and purchase of services
     Office of Scientific Integrity, Office of the           personal information provided. For                                 to provide information. Burden is the
     Associate Director for Science, Office of the           access to the docket to read background                            total time, effort, or financial resources
     Director, Centers for Disease Control and               documents or comments received, go to                              expended by persons to generate,
     Prevention.                                             Regulations.gov.                                                   maintain, retain, disclose, or provide
     [FR Doc. 2017–20508 Filed 9–25–17; 8:45 am]                Please note: All public comments                                information to or for a Federal agency.
     BILLING CODE 4163–18–P                                  should be submitted through the                                    This includes the time needed to review
                                                             Federal eRulemaking portal                                         instructions; to develop, acquire, install
                                                             (Regulations.gov) or by U.S. mail to the                           and utilize technology and systems for
     DEPARTMENT OF HEALTH AND                                address listed above.                                              the purpose of collecting, validating and
     HUMAN SERVICES                                          FOR FURTHER INFORMATION CONTACT: To                                verifying information, processing and
                                                             request more information on the                                    maintaining information, and disclosing
     Centers for Disease Control and
                                                             proposed project or to obtain a copy of                            and providing information; to train
     Prevention
                                                             the information collection plan and                                personnel to respond to a collection of
     [60Day–17–0199; Docket No. CDC–2017–                    instruments, contact Leroy A.                                      information, search data sources, and
     0058]                                                   Richardson, of the Information                                     complete and review the collection of
                                                             Collection Review Office, Centers for                              information; and to transmit or
     Proposed Data Collection Submitted                      Disease Control and Prevention, 1600                               otherwise disclose the information.
     for Public Comment and                                  Clifton Road NE., MS–D74, Atlanta,
     Recommendations                                         Georgia 30329; phone: 404–639–7570;                                Proposed Project
     AGENCY: Centers for Disease Control and                 Email: omb@cdc.gov.                                                  Importation of Etiologic Agents (42
     Prevention (CDC), Department of Health                  SUPPLEMENTARY INFORMATION: Under the                               CFR 71.54) (OMB Control No. 0920–
     and Human Services (HHS).                               Paperwork Reduction Act of 1995 (PRA)                              0199, exp. 12/31/2019)—Revision—
     ACTION: Notice with comment period.
                                                             (44 U.S.C. 3501–3520), Federal agencies                            Office of Public Health Preparedness
                                                             must obtain approval from the Office of                            and Response (OPHPR), Centers for
     SUMMARY:   The Centers for Disease                      Management and Budget (OMB) for each                               Disease Control and Prevention (CDC).
     Control and Prevention (CDC), as part of                collection of information they conduct
                                                                                                                                Background and Brief Description
     its continuing effort to reduce public                  or sponsor. In addition, the PRA also
     burden and maximize the utility of                      requires Federal agencies to provide a                                Section 361 of the Public Health
     government information, invites the                     60-day notice in the Federal Register                              Service Act (42 U.S.C. 264), as
     general public and other Federal                        concerning each proposed collection of                             amended, authorizes the Secretary of
     agencies to take this opportunity to                    information, including each new                                    Health and Human Services to make
     comment on proposed and/or                              proposed collection, each proposed                                 and enforce such regulations as are
     continuing information collections, as                  extension of existing collection of                                necessary to prevent the introduction,
     required by the Paperwork Reduction                     information, and each reinstatement of                             transmission, or spread of
     Act of 1995. This notice invites                        previously approved information                                    communicable diseases from foreign
     comment on the Import Permit                            collection before submitting the                                   countries into the States or possessions,
     Applications information collection                     collection to OMB for approval. To                                 or from one State or possession into any
     project.                                                comply with this requirement, we are                               other State or possession. Part 71 of
                                                             publishing this notice of a proposed                               Title 42, Code of Federal Regulations
     DATES: Written comments must be                                                                                            (Foreign Quarantine) sets forth
                                                             data collection as described below.
     received on or before November 27,                         Comments are invited on: (a) Whether                            provisions to prevent the introduction,
     2017.                                                   the proposed collection of information                             transmission, and spread of
     ADDRESSES:  You may submit comments,                    is necessary for the proper performance                            communicable disease from foreign
     identified by Docket No. CDC–2017–                      of the functions of the agency, including                          countries into the United States.
     0058 by any of the following methods:                   whether the information shall have                                 Subpart F—Importations—contains
       • Federal eRulemaking Portal:                         practical utility; (b) the accuracy of the                         provisions for the importation of
     Regulations.gov. Follow the instructions                agency’s estimate of the burden of the                             infectious biological agents, infectious
     for submitting comments.                                proposed collection of information; (c)                            substances, and vectors (42 CFR 71.54);
       • Mail: Leroy A. Richardson,                          ways to enhance the quality, utility, and                          requiring persons that import these
     Information Collection Review Office,                   clarity of the information to be                                   materials to obtain a permit issued by
     Centers for Disease Control and                         collected; (d) ways to minimize the                                the CDC.
     Prevention, 1600 Clifton Road NE., MS–                  burden of the collection of information                               The Application for Permit to Import
     D74, Atlanta, Georgia 30329.                            on respondents, including through the                              Biological Agents, Infectious Substances
       Instructions: All submissions received                use of automated collection techniques                             and Vectors of Human Disease into the
     must include the agency name and                        or other forms of information                                      United States form is used by laboratory
     Docket Number. All relevant comments                    technology; and (e) estimates of capital                           facilities, such as those operated by


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     44796                            Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices

     government agencies, universities, and                                    These additional data requests will                                        operated by government agencies,
     research institutions to request a permit                              not affect the burden hours.                                                  universities, research institutions, and
     for the importation of biological agents,                                 In addition, CDC proposes to revise                                        for educational, exhibition, or scientific
     infectious substances, or vectors of                                   the Application for Permit to Import                                          purposes to request a permit for the
     human disease. This form currently                                     Biological Agents, Infectious Substances                                      importation, and any subsequent
     requests applicant and sender contact                                  and Vectors of Human Disease into the                                         distribution after importation, of live
     information; description of material for                               United States form to verify that the                                         bats. This form currently requests the
     importation; facility isolation and                                    recipient for subsequent transfers has                                        applicant and sender contact
     containment information; and personnel                                 implemented biosafety measures                                                information; a description and intended
     qualifications. CDC plans to revise this                               commensurate with the hazard posed by                                         use of bats to be imported; and facility
     application to:                                                        the infectious biological agent,                                              isolation and containment information.
       (1) Based on processing applications,                                infectious substance, and/or vector to be                                     CDC plans to revise this application to
     remove questions that duplicative or not                               imported, and the level of risk given its                                     add a question about what personal
     required to process the import permit                                  intended use. CDC believes that it will                                       protective measures will be used. This
     request such as CDC plans to revise this                               take the applicant additional 10 minutes                                      additional data request will not affect
     application to request information on                                  to complete this section for subsequent                                       the burden hours.
     where the imported material will be                                    transfers. Estimates of burden for the
     stored at the recipient facility and who                               additional questions survey are based                                            Estimates of burden for the survey are
     would be responsible for this location                                 on information obtained from the CDC                                          based on information obtained from the
     and revise the format for the form to                                  import permit database on the number                                          CDC import permit database on the
     ease of user to complete the form.                                     of permits issued for 2016 for                                                number of permits issued on annual
       (2) Request information the biosafety                                subsequent transfers, which is 380                                            basis since 2010. The total estimated
     officer’s contact information for the                                  permits.                                                                      burden for the one-time data collection
     permittee to provide biosafety                                            The Application for Permit to Import                                       is 1592.
     information in case the permittee is                                   or Transport Live Bats form is used by                                           There are no costs to respondents
     unavailable.                                                           laboratory facilities such as those                                           except their time.

                                                                           ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                      Average
                                                                                                                                                        Number of
                                                                                                                             Number of                                              burden per              Total burden
                Type of respondent                                               Form name                                                            responses per
                                                                                                                            respondents                                              response                  hours
                                                                                                                                                        respondent                   (in hours)

     Applicants Requesting to Import Bio-                     Application for Permit to Import Bio-                                       2380                              1                   30/60               1190
       logical Agents, Infectious Sub-                          logical Agents, Infectious Sub-
       stances and Vectors.                                     stances and Vectors of Human
                                                                Disease into the United States.
     Applicants Requesting to Import Bio-                     Application for Permit to Import Bio-                                        2380                            1                    10/60                397
       logical Agents, Infectious Sub-                          logical Agents, Infectious Sub-
       stances and Vectors.                                     stances and Vectors of Human
                                                                Disease into the United States
                                                                Guidance.
     Applicants Requesting to Import Live                     Application for a Permit to Import                                               10                           1                   20/60                  3
       Bats.                                                    Live Bats.
     Applicants Requesting to Import Live                     Application for a Permit to Import                                               10                           1                   10/60                  2
       Bats.                                                    Live Bats.

          Total ...........................................   ..........................................................   ........................   ........................   ........................           1592



     Leroy A. Richardson,                                                   DEPARTMENT OF HEALTH AND                                                         Written comments and suggestions
     Chief, Information Collection Review Office,                           HUMAN SERVICES                                                                from the public and affected agencies
     Office of Scientific Integrity, Office of the                                                                                                        concerning the proposed collection of
     Associate Director for Science, Office of the                          Centers for Disease Control and                                               information are encouraged. Your
     Director, Centers for Disease Control and                              Prevention                                                                    comments should address any of the
     Prevention.                                                                                                                                          following: (a) Evaluate whether the
                                                                            [30Day–17–17HO]
     [FR Doc. 2017–20509 Filed 9–25–17; 8:45 am]                                                                                                          proposed collection of information is
     BILLING CODE 4163–18–P                                                 Agency Forms Undergoing Paperwork                                             necessary for the proper performance of
                                                                            Reduction Act Review                                                          the functions of the agency, including
                                                                                                                                                          whether the information will have
                                                                              The Centers for Disease Control and                                         practical utility; (b) Evaluate the
                                                                            Prevention (CDC) has submitted the                                            accuracy of the agencies estimate of the
                                                                            following information collection request                                      burden of the proposed collection of
                                                                            to the Office of Management and Budget                                        information, including the validity of
                                                                            (OMB) for review and approval in                                              the methodology and assumptions used;
                                                                            accordance with the Paperwork                                                 (c) Enhance the quality, utility, and
                                                                            Reduction Act of 1995. The notice for                                         clarity of the information to be
                                                                            the proposed information collection is                                        collected; (d) Minimize the burden of
                                                                            published to obtain comments from the                                         the collection of information on those
                                                                            public and affected agencies.                                                 who are to respond, including through


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Document Created: 2017-09-26 02:48:51
Document Modified: 2017-09-26 02:48:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before November 27, 2017.
ContactTo 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]
FR Citation82 FR 44795 

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