[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Notices]
[Pages 49373-49374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17709]



[[Page 49373]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-20-0263]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled Requirements for the Importation of Nonhuman 
Primates into the United States to the Office of Management and Budget 
(OMB) for review and approval. CDC previously published a ``Proposed 
Data Collection Submitted for Public Comment and Recommendations'' 
notice on December 6, 2019 to obtain comments from the public and 
affected agencies. CDC received six comments related to the previous 
notice. This notice serves to allow an additional 30 days for public 
and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct 
written comments and/or suggestions regarding the items contained in 
this notice to the Attention: CDC Desk Officer, Office of Management 
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 
395-5806. Provide written comments within 30 days of notice 
publication.

Proposed Project

    Requirements for the Importation of Nonhuman Primates into the 
United States (OMB Control No. 0920-0263, Exp. 08/31/2020)--Revision--
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Under 42 CFR 71.53, CDC collects information pertaining to 
importers and imported nonhuman primates (NHP). 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 into 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 (2/12/2013, Vol.78, No. 29, p. 9828). 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 part 71.53 with 
those found in the Special Permit to Import Cynomolgus, African Green, 
or Rhesus Monkeys into the United States (2/15/2013, Vol. 78, No. 32/p. 
11522). 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 two 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.
    This information collection is designed to support real-time 
regulatory and monitoring activities, and the prevention of disease 
transmission from NHP to humans. Therefore, there is no standard 
reporting deadline or frequency. Respondents are only required to 
provide the information under the regulation if they seek to import 
nonhuman primates in the United States.
    The CDC is requesting approval for a set of adjustments to the 
previously approved burden total for this information collection. The 
adjustments are as follows:
Adjustments
    Based on the number of registered importers processed by CDC, CDC 
is adjusting upward, two of the information collections within this 
submission:
     Nonhuman Primate Importer Recordkeeping and reporting 
requirements for importing NHPs: Notification of shipment arrival 
71.53(n).
     Nonhuman Primate Importer Quarantine release 71.53(l).
Changes
    CDC is proposing a reformatting and changes to CDC 75.10A 
Registration Form for NHP Importation to clarify for respondents the 
information that should be submitted. This results in no changes in 
respondent burden.
    CDC is adding the following information collections to delineate 
between specific information collections under the regulations at 42 
CFR 71.53(m):
     Statements regarding the health of the nonhuman primates 
during travel and CDC quarantine (42 CFR 71.53(m) (no form)
     Statements, including necropsy reports, about the nonhuman 
primates upon their release from CDC quarantine. (42 CFR 71.53(m)
    CDC is removing information collections, because CDC is not using 
the Partner Government Agency Message Set functionality within the 
Automated Commercial Environment:

 CDC Partner Government Agency Message Set for Importing Live 
Nonhuman Primates
 CDC Partner Government Agency Message Set for Importing 
Nonhuman Primate Products
 Documentation of Non-infectiousness 71.53(t)

    OMB approval is requested for three years. The total number of 
hours

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requested for this information collection total 185, which is a 
decrease of 737 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
         Type of respondent            Form name/CFR reference      respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Nonhuman Primate Importer..........  CDC 75.10A Application for                1               1           10/60
                                      Registration as an
                                      Importer of Nonhuman
                                      Primates (New Importer).
Nonhuman Primate Importer..........  CDC 75.10A Application for               12               1           10/60
                                      Registration as an
                                      Importer of Nonhuman
                                      Primates (Re-Registration).
Nonhuman Primate Importer..........  71.53(g1)(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 reporting              25               6           15/60
                                      requirements for importing
                                      NHPs: Notification of
                                      shipment arrival 71.53(k),
                                      (n) (no form).
Nonhuman Primate Importer..........  Statements regarding the                 25               6           15/60
                                      health of the nonhuman
                                      primates during travel and
                                      CDC quarantine (42 CFR
                                      71.53(m) (no form).
Nonhuman Primate Importer..........  Statements, including                    25               3           15/60
                                      necropsy reports, about
                                      the nonhuman primates upon
                                      their release from CDC
                                      quarantine. (42 CFR
                                      71.53(m) (no form).
Nonhuman Primate Importer..........  Quarantine release 71.53(l)              25               6           15/60
                                      (no form).
Nonhuman Primate Importer..........  71.53(v) Form: Filovirus                 10              10           20/60
                                      Diagnostic Specimen
                                      Submission Form for Non-
                                      human Primate Materials.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-17709 Filed 8-12-20; 8:45 am]
BILLING CODE 4163-18-P