2014-13824. 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 [phone] or send an email to [e-mail]. 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 [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Requirements for the Importation of Nonhuman Primates into the United States—Revision—(expiration date: 4/30/2016)—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Global Migration and Quarantine (DGMQ), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC is submitting this revision to obtain authority to collect electronic information from importers/filers on nonhuman primate and nonhuman primate products over which CDC has authority, notably those found in 42 CFR part 71. This request is consistent with requirements of the Security and Accountability for Every (SAFE) Port Act that states that all agencies that require documentation for clearing or licensing the importation and exportation of cargo participate in the International Trade Data System (ITDS), and is also consistent with CDC authorities under Section 361 of the Public Health Service Act (PHSA) (42 U.S.C. 264).

This electronic data is specified by CDC using Partner Government Agency (PGA) Message Sets and is collected by Customs and Border Protection (CBP) from importers/filers when they submit the information needed through International Trade Data System (ITDS) and the Automated Commercial Environment (ITDS/ACE) to clear an import. CDC has developed a PGA message set for each regulated import specified in 42 CFR part 71, and each PGA Message Set includes only those data requirements necessary in order to determine whether or not a CDC-regulated import poses a risk to public health and that the importer has met CDC's regulatory requirements for entry. CDC including the PGA Message Sets for review because there is no set form or format for the electronic submission of import related data to CBP and CDC. CDC is permitted access to the Automated Commercial Environment (ACE) data pursuant to 6 CFR 29.8(b) and 49 CFR 1520.11(b), which permit federal employees with a need to know to have access to this data.

CDC is maintaining its authority to collect hard copies of required documentation, as currently authorized by the Office of Management and Budget, because the use of ITDS/ACE will not be required for imports entering the United States until a later date. CDC will accept both hard copy and electronic filing of import-related documentation until the use of ACE is required for cargo entering the United States.

Through this revision, CDC is requesting a net increase in the estimated number of burden hours in the amount of 798 hours. Of these additional hours, 608 hours pertain to requests for CDC Message Set data via ITDS/ACE, and 190 hours pertain to required statements/documentation of products being rendered non-infectious.

Because the use of ITDS/ACE will not be required for imports entering the United States until a later date, CDC is maintaining its authority to collect hard copies of required documentation, as currently authorized by the Office of Management and Budget. CDC will accept both hard copy and electronic filing of import-related documentation until the use of ACE is required for cargo entering the United States.

Respondents to this data collection have not changed and remain new and registered importers of live nonhuman primates and importers of nonhuman primate products. The number of additional hours requested for this information collection total 798 hours. The total burden for this information collection request is 944 hours. There are no costs to respondents except for their time to complete the forms, and complete and submit data and documentation.

Estimated Annualized Burden Hours

Type of respondent	Form name/CFR reference	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Nonhuman Primate Importer	CDC 75.10A Application for Registration as an Importer of Nonhuman Primates (New Importer)	1	1	10/60
Nonhuman Primate Importer	CDC 75.10A Application for Registration as an Importer of Nonhuman Primates (Re-Registration)	12	1	10/60
Nonhuman Primate Importer	71.53(g)(1)(iii) and (h) Documentation and Standard Operating Procedures (no form) (New Importer)	1	1	10
Nonhuman Primate Importer	71.53(g)(1)(iii) and (h) Documentation and Standard Operating Procedures (no form) (Registered Importer)	12	1	30/60
Nonhuman Primate Importer	Recordkeeping and reporting requirements for importing NHPs: Notification of shipment arrival 71.53(n) (no form)	25	6	15/60
Nonhuman Primate Importer	Quarantine release 71.53(l) (No form)	25	6	15/60
Nonhuman Primate Importer	71.53(v) Form: Filovirus Diagnostic Specimen Submission Form for Non-human Primate Materials	10	15	20/60
Importer/Filer	CDC Partner Government Agency Message Set for Importing Live Nonhuman Primates	150	1	15/60
Importer/Filer	CDC Partner Government Agency Message Set for Importing Nonhuman Primate Products	2280	1	15/60
Importer/Filer	Documentation of Non-infectiousness 71.53(t)	2280	1	5/60

Leroy 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.