0920-0263 Revision ITDS Supptg Stmt B

Requirements for the Importation of Nonhuman Primates into the United States

(OMB Control No. 0920-0263)

Request for Revision of Currently Approved Data Collection

June 5, 2014

Contact:

Amy McMillen

Office of Policy and Planning

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, N.E., MS C12

Atlanta, Georgia 30333

Phone: (404) 639-1045

Email: [email protected]

Requirements for the Importation of Nonhuman Primates into the United States

(OMB Control No. 0920-0263)

B. Collection of Information Employing Statistical Methods

Statistical methods do not apply to this data collection. No statistical methods are used in this data collection. A registered importer must request a permit to import nonhuman primates into the U.S. To receive the permit, the importer must submit a written plan to the Director of CDC which specifies steps that will be taken to prevent exposure of persons and animals during the entire importation and quarantine process for the arriving non-human primates. This includes disease prevention procedures throughout the chain of custody of these nonhuman primates from embarkation in the country of origin to release from quarantine. Information such as species, origin, and intended use for primates, transit information, isolation and quarantine procedures, and procedures for tuberculosis and filovirus testing of quarantined nonhuman primates. CDC evaluates compliance with the standards and determines whether adequate measures being taken to prevent the exposure of persons and animals during importation, transportation, and quarantine.

CDC monitors at least two shipments of non-human primates to be assured that the provisions of a permit are being followed by a new permit holder. Once CDC is assured that adequate disease control practices are being used by new permit holders, the permit can be extended to cover the receipt of additional shipments under the same plan for a period of two years and may be renewed upon request.

Concerning this revision, there will be no sampling of importers seeking to bring live nonhuman primates or nonhuman primate products.

1. Respondent Universe and Sampling Methods

There are no sampling methods employed for this data collection as the importation of these animals is covered by a regulatory requirement. The respondent universe is all animal importers who want to import nonhuman primates and nonhuman primate products into the United States.

2. Procedures for the Collection of Information

With regard to this revision, information pertaining to the importation of nonhuman primate and nonhuman primate products will be accomplished when individuals arrive at ports of entry and may be done so through the ITDS/ACE systems using CDC Partner Government Agency Message Sets for those importers voluntarily using ITDS/ACE. Importers are required to provide documentation clearly indicating that nonhuman primate products have been rendered non-infectious, and this documentation may be submitting using the Document Imagine System provided by Customs and Border Protection.

A registered importer must request a permit to import nonhuman primates into the U.S. To receive the permit, the importer must submit a written plan to the Director of CDC which specifies steps that will be taken to prevent exposure of persons and animals during the entire importation and quarantine process for the arriving nonhuman primates. This includes disease prevention procedures throughout the chain of custody of these primates from embarkation in the country of origin to release from quarantine. Information such as species, origin, and intended use for primates, transit information, isolation and quarantine procedures, and procedures for tuberculosis and filovirus testing of quarantined animals. CDC evaluates compliance with the standards and determines whether adequate measures being taken to prevent the exposure of persons and animals during importation.

CDC monitors at least two shipments of nonhuman primates to be assured that the provisions of a permit are followed by a new permit holder. Once CDC confirms that adequate disease control practices are used by new permit holders, the permit can be extended to cover the receipt of additional shipments under the same plan for a period of two years and may be renewed upon request.

3. Methods to Maximize Response Rates and Deal with No response

Concerning this revision, electronic submission of information concerning CDC-regulated products via ITDS/ACE is voluntary at this current time; therefore CDC has maintained the requisite burden hours to collect import related information via hard copies.

The information collected for the import permit is required in the event that any registered importer wants to import nonhuman primates into the U.S. If the importer does not comply with each part of the permit, required notification to CDC, documentation requirements, or submit to required testing procedures, importation is not permitted and the importer may lose their permit. It is in the importers interest to respond to the requirements for the permit if indeed it intends to import the specified animals.

Importers are also required to provide documentation clearly indicating that nonhuman primate products have been rendered non-infectious, and this documentation may be submitting using the Document Imagine System provided by Customs and Border Protection. Without this documentation, the import may not enter the United States.

4. Tests of Procedures or Methods to be Undertaken

The information pertaining to nonhuman primate shipments, documentation requirements, notifications to CDC, and tuberculosis and filovirus testing collected from the importers is defined by regulations and requirements set by CDC. No tests of procedures or questions were performed. This program has a long history and has functioned well.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

There are no statistical aspects of the information collected and no statistical consultants were contacted. Collection and review of the information is the responsibility of CDC’s Division of Global Migration and Quarantine.