[Federal Register Volume 78, Number 240 (Friday, December 13, 2013)]
[Notices]
[Pages 75921-75922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29742]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-14-0199]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
(404) 639-7570 or send an email to [email protected]. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC 
20503 or by fax to (202) 395-5806. Written comments should be received 
within 30 days of this notice.

Proposed Project

    Importation of Etiologic Agents (42 CFR 71.54) (OMB Control No. 
0920-0199, exp. 1/31/2014)--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.
    CDC requests Office of Management and Budget approval to collect 
information for three years using the Application for Permit to Import 
Biological Agents, Infectious Substances and Vectors of Human Disease 
into the United States and Application for a Permit to Import or 
Transport Live Bats.

[[Page 75922]]

We are also requesting a title change to read--Import Permit 
Applications (42 CFR 71.54).
    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 request 
information on where the imported material will be stored at the 
recipient facility and who would be responsible for this location; 
verification that the permittee 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; and a secondary contact information for 
the permittee to provide in case the permittee is unavailable. These 
additional data requests 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 plans to revise 
this application to request secondary contact information for the 
permittee to provide in case the permittee is unavailable. These 
additional data requests will not affect the burden hours.
    Estimates of burden for the survey are based on information 
obtained from the CDC import permit database based on the number of 
permits issued on annual basis since 2010. The total estimated annual 
burden for the data collection is 545 hours. We estimate a decrease in 
the number of respondents from 2,000 in 2011 to 1,625 due to recent 
trends and changes in the regulation. The daily operations have 
observed a decrease in the number of request for an import permit since 
2011. In addition, the changes in 42 CFR 71.54, which became effective 
April 5, 2013, specify situations where an application for a permit is 
no longer required. For example, the importation of a select agent that 
is regulated under 42 CFR Part 73 no longer requires a permit be 
issued.
    There are no costs to respondents except their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent         hrs.)
----------------------------------------------------------------------------------------------------------------
Applicants Requesting to Import         Application for Permit             1,625               1           20/60
 Biological Agents, Infectious           to Import Infectious
 Substances and Vectors.                 Biological Agents into
                                         the United States.
Applicants Requesting to Import Live    Application for a Permit              10               1           20/60
 Bats.                                   to Import Live Bats.
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LeRoy 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. 2013-29742 Filed 12-12-13; 8:45 am]
BILLING CODE 4163-18-P