2018-20559. Submission for OMB Review; Comment Request

September 18, 2018.

The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) 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) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to 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.

Comments regarding this information collection received by October 22, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [e-mail] or fax [phone] and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling [phone].

An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

Animal Plant and Health Inspection Service

Title: Virus-Serum-Toxin Act and Regulations in 9 CFR, Subchapter E, Parts 101-124.

OMB Control Number: 0579-0013.

Summary of Collection: The Virus-Serum-Toxin Act (37 Stat. 832-833, 21 U.S.C. 151-159) gives the United States Department of Agriculture, the Animal and Plant Health Inspection Service (APHIS) the authority to promulgate regulations designed to prevent the importation, preparation, sale, or shipment of harmful veterinary biological products. A veterinary biological product is defined as all viruses, serums, toxins, and analogous products of natural or synthetic origin (such as vaccines, antitoxins, or the immunizing components of microorganisms intended for the diagnosis, treatment, or prevention of diseases in domestic animals). In order to effectively implement the licensing, production, labeling, importation, and other requirements, APHIS employs a number of information gathering tools such as establishment license applications, product license applications, product permit applications, product and test report forms and field study summaries, event reports, stop distribution and sale notifications, and recordkeeping.

Need and Use of the Information: This information collection includes mergers with 0579-0209 and 0579-0460. APHIS uses the information collected as a primary basis for the approval or acceptance of issuing licenses or permits to ensure veterinary biological products that are used in the United States are pure, safe, potent, and effective. Failing to collect this information would severely cripple APHIS' ability to prevent harmful veterinary biologics from being distributed in the United States.

Description of the Respondents: Businesses or other for profit, Foreign and State Governments, Private Individuals.

Number of Respondents: 10,183.

Frequency of Responses: Recordkeeping; Third Party Disclosure; Reporting: On occasion.

Total Burden Hours: 122,998.

Animal and Plant Health Inspection Service

Title: Importation of Fruits and Vegetables.

OMB Control Number: 0579-0264.

Summary of Collection: Under the Plant Protection Act (7 U.S.C. 7701-7772), the Secretary of Agriculture is authorized to regulate the importation of plants, plant products, and other articles to prevent the introduction of injurious plant pests. Regulations contained in Title 7 of the Code of Federal Regulations, Part 319 (Subpart—Fruit and Vegetables), Sections 319.56 et seq. implement the intent of this Act by prohibiting or restricting the importation of certain fruits and Vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of fruit flies and other injurious plant pests that are new to the United States or not widely distributed within the United States. These regulations are enforced by the Plant Protection and Quarantine, a program with USDA's Animal and Plant Health Inspection Service (APHIS).

Need and Use of the Information: The use of certain information collection activities including Phytosanitary Certificates, Trapping Records, Cooperative Agreements (PPQ 519), Application of Sterile Insect Technique, Monitoring, Safeguarding, Emergency Action Notification (PPQ 523), and Notice of Arrival (PPQ 368) will be used to allow the entry of certain fruits and vegetables into the United States. Without the information all shipment would need to be inspected very thoroughly, thereby requiring considerably more time and would slow the clearance of international shipments.

Description of Respondents: Business or other for-profit; Federal Government.

Number of Respondents: 65.

Frequency of Responses: Recordkeeping; Reporting: On occasion.

Total Burden Hours: 381.

Ruth Brown,

Departmental Information Collection Clearance Officer.