[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
[[Page 49374]]
requested for this information collection total 185, which is a
decrease of 737 hours.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per
Type of respondent Form name/CFR reference respondents responses per response (in
respondent hours)
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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.
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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. 2020-17709 Filed 8-12-20; 8:45 am]
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