[Federal Register Volume 84, Number 235 (Friday, December 6, 2019)]
[Notices]
[Pages 66899-66901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-0263; Docket No. CDC-2019-0110]


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 the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on Requirements for 
the Importation of Nonhuman Primates into the United States. This 
information collection contains the reporting and documentation 
requirements for registered importers of nonhuman primates, as outlined 
in 42 Code of Federal Regulations part 71.53 Requirements for importers 
of nonhuman primates.

DATES: CDC must receive written comments on or before February 4, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0110 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments 
to Regulations.gov.

    Please note: Submit all comments 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 Jeffrey M. Zirger, 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 the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

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 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

[[Page 66900]]

determine if adequate measures are 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 (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.
    All registered importers of non-human primates are required by 42 
CFR part 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 and costs reflects 
assembling and reporting only. CDC requests approval for an estimated 
185 annual burden hours. There is no cost to respondents other than 
their time.

                                                            Estimated Annualized Burden Hours
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                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
              Type of  respondent                        Form name/CFR reference            respondents    responses per   response  (in       hours
                                                                                                            respondent        hours)
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Nonhuman Primate Importer......................  CDC 75.10A Application for Registration               1               1           10/60               1
                                                  as an Importer of Nonhuman Primates
                                                  (New Importer).
Nonhuman Primate Importer......................  CDC 75.10A Application for Registration              12               1           10/60               2
                                                  as an Importer of Nonhuman Primates
                                                  (Re-Registration).
Nonhuman Primate Importer......................  71.53(g)(1)(iii) and (h) Documentation                1               1              10              10
                                                  and Standard Operating Procedures (no
                                                  form) (New Importer).
Nonhuman Primate Importer......................  71.53(g)(1)(iii) and (h) Documentation               12               1           30/60               6
                                                  and Standard Operating Procedures (no
                                                  form) (Registered Importer).
Nonhuman Primate Importer......................  Recordkeeping and reporting                          25               6           15/60              38
                                                  requirements for importing NHPs:
                                                  Notification of shipment arrival
                                                  71.53(n) (no form).
Nonhuman Primate Importer......................  Statements regarding the health of the               25               6           15/60              38
                                                  nonhuman primates during travel and
                                                  CDC quarantine (42 CFR 71.53(m) (no
                                                  form).
Nonhuman Primate Importer......................  Statements, including necropsy reports,              25               3           15/60              19
                                                  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)(no form)...              25               6           15/60              38
Nonhuman Primate Importer......................  71.53 (v) Form: Filovirus Diagnostic                 10              10           20/60              33
                                                  Specimen Submission Form for Non-human
                                                  Primate Materials.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............             185
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-26371 Filed 12-5-19; 8:45 am]
 BILLING CODE 4163-18-P