This PDF is the current document as it appeared on Public Inspection on 03/07/2017 at 08:45 am.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a revision request for the information collection titled “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.
Written comments must be received on or before May 8, 2017.
You may submit comments, identified by Docket No. CDC-2017-0021 by any of the following methods:
- Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.
- Mail: Leroy A. Richardson, 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. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.
Please note: All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.Start Further Info
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 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@example.com.End Further Info End Preamble Start Supplemental 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 OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.
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 and to investigate the number and species of imported nonhuman primates. Also, it enables CDC to 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 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 2 years, reducing much of the respondent burden. CDC feels these regulatory changes and reporting Start Printed Page 12963requirements 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.
|Type of respondent||Form name||Number of respondents||Number of responses per respondent||Average burden per response (in hours)||Total burden hours|
|Nonhuman Primate Importer||CDC 75.10A Application for Registration as an Importer of Nonhuman Primates (New Importer)||1||1||10/60||1|
|Nonhuman Primate Importer||CDC 75.10A Application for Registration as an Importer of Nonhuman Primates (Re-Registration)||12||1||10/60||2|
|Nonhuman Primate Importer||71.53(g)(1)(iii) and (h) Documentation and Standard Operating Procedures (no form) (New Importer)||1||1||10||10|
|Nonhuman Primate Importer||71.53(g)(1)(iii) and (h) Documentation and Standard Operating Procedures (no form) (Registered Importer)||12||1||30/60||6|
|Nonhuman Primate Importer||Recordkeeping and reporting requirements for importing NHPs: Notification of shipment arrival 71.53(n) (no form)||24||6||15/60||36|
|Nonhuman Primate Importer||Quarantine release 71.53(l) (No form)||24||6||15/60||36|
|Nonhuman Primate Importer||71.53(v) Form: Filovirus Diagnostic Specimen Submission Form for Non-human Primate Materials||10||10||20/60||33|
|Importer/Filer||CDC Partner Government Agency Message Set for Importing Live Nonhuman Primates||150||1||15/60||38|
|Importer/Filer||CDC Partner Government Agency Message Set for Importing Nonhuman Primate Products||2,280||1||15/60||570|
|Importer/Filer||Documentation of Non-infectiousness 71.53(t)||2,280||1||5/60||190|
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. 2017-04507 Filed 3-7-17; 8:45 am]
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