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Notice of Request for Approval of an Information Collection; Approval of Laboratories for Conducting Aquatic Animal Tests for Export Health Certificates

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New information collection; comment request.


In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request approval of a new information collection for the approval of laboratories for conducting aquatic animal tests for export health certificates.


We will consider all comments that we receive on or before March 3, 2014.


You may submit comments by either of the following methods:

Supporting documents and any comments we receive on this docket may be viewed at!docketDetail;D=APHIS-2013-0023 or in our reading room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.


For information on the approval of laboratories for conducting aquatic animal tests for export health certificates, contact Dr. Christa Speekmann, Import-Export Specialist-Aquaculture, NAHPP-NCIE, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD, 20737; (301) 851-3365. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.


Title: Approval of Laboratories for Conducting Aquatic Animal Tests for Export Health Certificates.

OMB Control Number: 0579-XXXX.

Type of Request: Approval of a new information collection.

Abstract: The Animal Health Protection Act (AHPA) is the primary Federal law governing the protection of animal health. The AHPA gives the Secretary of Agriculture broad authority to detect, control, or eradicate pests or diseases of livestock or poultry. The Secretary may also prohibit or restrict import or export of any animal or related material if necessary to prevent the spread of any livestock or poultry pest or disease.

The export of agricultural commodities, including animals and animal products, is a major business in the United States and contributes to a favorable balance of trade. To facilitate the export of U.S. animals and animal products, the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture maintains information regarding the import health requirements of other countries for animals and animal products, including aquaculture animals, exported from the United States.

Some countries that import aquaculture animals from the United States require these animals to be tested for certain diseases and the test results recorded on the export certificates. In addition, the test results must originate from a laboratory approved by the competent authority of the exporting country, which is APHIS in this case. State, university, and private laboratories can voluntarily seek APHIS approval of individual diagnostic methods. Though APHIS does not have regulations for the approval or certification of laboratories that conduct tests for the export of aquaculture animals, APHIS provides this approval as a service to U.S. exporters who export aquaculture animals to countries that require this certification.

As part of the approval process, APHIS evaluates diagnostic methods for aquatic animal pathogens listed by the World Organization for Animal Health (OIE) according to international standards in the OIE diagnostic manual and other supporting scientific literature. APHIS maintains a list of approved laboratories [1] and inspects each approved laboratory every 2 years.

The approval of laboratories to conduct tests for the export of aquaculture animals requires the use of certain information collection activities, including notification of intent to request approval, application for APHIS approval, protocol statement, submission and recordkeeping of sample copies of diagnostic reports, quality assurance/control plans and their recordkeeping, notification of proposed changes to assay protocols, recordkeeping of supporting assay documentation, and request for removal of approved status.

We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

(1) Evaluate whether the 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 our estimate of the burden of the 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, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

Estimate of burden: The public reporting burden for this collection of information is estimated to average 37.04 hours per response.

Respondents: State, university, and private laboratories.

Estimated annual number of respondents: 12.

Estimated annual number of responses per respondent: 41.25.

Estimated annual number of responses: 495.

Estimated total annual burden on respondents: 18,336 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Done in Washington, DC, this 20th day of December 2013.

Kevin Shea,

Administrator, Animal and Plant Health Inspection Service.


[FR Doc. 2013-31245 Filed 12-30-13; 8:45 am]