04-25141. Submission for OMB Review; Comment Request

November 5, 2004.

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 regarding (a) 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; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (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 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 should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), [e-mail] or fax [phone] and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. 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 Animal and Plant Health Inspection Service (APHIS) is responsible for ensuring that veterinary biological products are pure, safe, potent, and effective. This program is conducted under the Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.) and the regulations in 9 CFR Subchapter E, Parts 102 to 124. To fulfill its mission of preventing the importation, preparation, sale, or shipment of harmful veterinary biological products, the Veterinary Biologics Division of APHIS issues licenses to qualified establishments that produce biological products, and issues permits to importers seeking to import such products into the United States. 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.

Need and Use of the Information: 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. Also, APHIS uses the information to monitor the serials for purity, safety, potency and efficacy that are produced by licensed manufacturers prior to their release for marketing.

Description of Respondents: Business or other for profit; State, Local or Tribal Government.

Number of Respondents: 500.

Frequency of Responses: Recordkeeping; Reporting: On occasion.

Total Burden Hours: 51,617.

Animal Plant and Health Inspection Service

Title: Importation of Tomatoes from France, Morocco, Western Sahara, Chile, and Spain.

OMB Control Number: 0579-0131.

Summary of Collection: The Department of Agriculture is responsible for preventing plant diseases or insect pests from entering the United States, as well as the spread of pests not widely distributed and eradicating those imported when eradication is feasible. Regulations in 7 CFR 319.56 thru 319.56-8 prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests, including fruit flies. These regulations allow tomatoes from Spain, Chile, France, Morocco, and Western Sahara to be imported into the United States (subject to certain conditions).

Need and Use of the Information: The Animal and Plant Health Inspection Service (APHIS) will collect information using the phytosanitary certificate certifying that the tomatoes were grown in registered greenhouses in a specified area of the exporting country. If the information is not collected, APHIS' ability to protect the United States from exotic insect pests would be severely compromised.

Description of Respondents: Business or other for profit; Individuals or households; Farms.

Number of Respondents: 34.

Frequency of Responses: Recordkeeping; Reporting: On occasion.

Total Burden Hours: 1,704.

Animal Plant and Health Inspection Service

Title: BSE—Certificate of Origin.

OMB Control Number: 0579-0183.

Summary of Collection: Regulations in 9 CFR parts 93, 94, 95, and 96 govern the importation of certain animals, animal products, and animal byproducts into the United States in order to prevent the introduction of various animal diseases, including bovine spongiform encephalopathy (BSE). BSE is a progressive neurological disorder of cattle that result from infection by an unconventional transmissible agent.

Need and Use of the Information: The Animal and Plant Health Inspection Service (APHIS) will collect the applicant's name, address, the name and address of the individual who is exporting the material or product, the type and amount of material or product being shipped, the intended use of the material or product, and the origin and destination points of the material or product being shipped using form VS-16-3, Import Permit Application. The information contained in the VS form 16-3 enables APHIS to determine whether the shipment qualifies for import into the United States. Without the information it would be impossible for APHIS to effectively prevent BSE-contaminated animal products from entering the United States.

Description of Respondents: Business or other for profit.

Number of Respondents: 1,000.

Frequency of Responses: Reporting: On occasion.

Total Burden Hours: 1,494.

Sondra Blakey,

Departmental Information Collection Clearance Officer.