82 FR 25290 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 82, Issue 104 (June 1, 2017)

[Federal Register Volume 82, Number 104 (Thursday, June 1, 2017)]
[Notices]
[Pages 25290-25291]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-11263]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-0263]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: 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

    Requirements for the Importation of Nonhuman Primates into the 
United States (OMB Control No. 0920-0263; Expiration Date 09/30/2017)--
Revision--National Center for Emerging and Zoonotic Infectious 
Diseases, Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Under the 42 CFR 71.53, CDC collects information pertaining to 
importers and imported nonhuman primates. This information collection 
enables CDC to evaluate compliance with pre-arrival of shipment 
notification requirements, to investigate the number and species of 
imported nonhuman primates, and to determine if adequate measures being 
taken for the prevention of exposure to persons and animals during 
importation.
    Since May 1990, CDC has monitored the arrival and/or uncrating of 
certain shipments of non-human primates imported in to the United 
States. In February 2013, CDC promulgated two regulations pertaining to 
the importation of nonhuman primates. The first rule, Establishment of 
User Fees for Filovirus Testing of Nonhuman Primate Liver Samples, 
outlines a process by which importers can send liver tissues to CDC 
from primates that die during importation from reasons other than 
trauma (78 FR 9828, February 12, 2013). CDC performs these tests due to 
the absence of a private sector option. The second rule, Requirements 
for Importers of Nonhuman Primates, consolidates into 42 CFR 71.53 the 
requirements previously found in 42 CFR 71.53 with those found in the 
Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys 
into the United States (78 FR 11522, February 15, 2013). It also 
rescinded the six-month special-permit requirements for cynomolgus, 
African green, and rhesus monkeys and extended the time period for 
registration/permit renewal from 180 days to 2 years, reducing much of 
the respondent burden. CDC feels these regulatory changes and reporting 
requirements balance the public health risks posed by the importation 
of nonhuman primates with the burden imposed on regulating their 
importation.
    Based on the number of registered importers and the number of 
filovirus samples processed by CDC, CDC is adjusting downward the 
number of burden hours for the following collections:
     Recordkeeping and reporting requirements for importing 
NHPs: Notification of shipment arrival 71.53(n) (no form): Reduction of 
two hours.
     Quarantine release 71.53(l) (No form): Reduction of two 
hours.
     71.53(v): Form: Filovirus Diagnostic Specimen Submission 
Form for Non-human Primate Materials: Reduction of 17 hours.
     71.53(g)(1)(iii) and (h) Documentation and Standard 
Operating Procedures (no form) (Registered Importer): Reduction of one 
hour.

Estimated Annualized Burden Hours

    All registered importers of non-human primates are required by 42 
CFR 71.53 to maintain certain disease control procedures and keep 
certain records. Standard business practices likely dictate that 
importers already keep records on the origin, transportation, and 
disposition of the nonhuman primates. Thus, CDC asks for information 
which should already be maintained by the importers and need only be 
assembled and reported. The estimate of burden hours totals 922,

[[Page 25291]]

which reflects assembling and reporting only.

----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent             Form name/CFR reference     Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Nonhuman Primate Importer.............  CDC 75.10A Application                 1               1           10/60
                                         for Registration as an
                                         Importer of Nonhuman
                                         Primates (New Importer).
Nonhuman Primate Importer.............  CDC 75.10A Application                12               1           10/60
                                         for Registration as an
                                         Importer of Nonhuman
                                         Primates (Re-
                                         Registration).
Nonhuman Primate Importer.............  71.53(g)(1)(iii) and (h)               1               1              10
                                         Documentation and
                                         Standard Operating
                                         Procedures (no form)
                                         (New Importer).
Nonhuman Primate Importer.............  71.53(g)(1)(iii) and (h)              12               1           30/60
                                         Documentation and
                                         Standard Operating
                                         Procedures (no form)
                                         (Registered Importer).
Nonhuman Primate Importer.............  Recordkeeping and                     24               6           15/60
                                         reporting requirements
                                         for importing NHPs:
                                         Notification of
                                         shipment arrival
                                         71.53(n) (no form).
Nonhuman Primate Importer.............  Quarantine release                    24               6           15/60
                                         71.53(l) (No form).
Nonhuman Primate Importer.............  71.53(v) Form: Filovirus              10              10           20/60
                                         Diagnostic Specimen
                                         Submission Form for Non-
                                         human Primate Materials.
Importer/Filer........................  CDC Partner Government               150               1           15/60
                                         Agency Message Set for
                                         Importing Live Nonhuman
                                         Primates.
Importer/Filer........................  CDC Partner Government              2280               1           15/60
                                         Agency Message Set for
                                         Importing Nonhuman
                                         Primate Products.
Importer/Filer........................  Documentation of Non-               2280               1            5/60
                                         infectiousness 71.53(t).
----------------------------------------------------------------------------------------------------------------


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. 2017-11263 Filed 5-31-17; 8:45 am]
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