E9-18988. Notice of Request for Extension of Approval of an Information Collection; Virus-Serum-Toxin Act and Regulations

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Extension of approval of an information collection; comment request.

SUMMARY:

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with the Virus-Serum-Toxin Act and regulations.

DATES:

We will consider all comments that we receive on or before October 6, 2009.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2009-0043 to submit or view comments and to view supporting and related materials available electronically.
• Postal Mail/Commercial Delivery: Please send two copies of your comment to Docket No. APHIS-2009-0043, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2009-0043.

Reading Room: You may read any comments that we receive on this docket in our reading room. The reading room 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 [phone] before coming.

Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT:

For information on the Virus-Serum-Toxin Act and regulations, contact Dr. Albert Morgan, Section Leader, Operational Support Staff, Center for Veterinary Biologics, VS, APHIS, 4700 River Road, Unit 148, Riverdale, MD 20737; [phone]. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at [phone].

SUPPLEMENTARY INFORMATION:

Title: Virus-Serum-Toxin Act and Regulations.

OMB Number: 0579-0318.

Type of Request: Extension of approval of an information collection.

Abstract: Under the Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture has authority to administer the regulations in 9 CFR, chapter I, subchapter E, to ensure that veterinary biological products are pure, safe, potent, and effective. Veterinary biological products are defined as all viruses, serums, toxins (excluding substances that are selectively toxic to microorganisms, e.g., antibiotics, or analogous products at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response. The term “biological products” includes, but is not limited to, vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, certain cytokines, antigenic or immunizing components of live organisms, and diagnostic components that are of natural or synthetic origin or that are derived from synthesizing or altering various substances or components of substances, such as microorganisms, genes or genetic sequences, carbohydrates, proteins, antigens, allergens, or antibodies.

In accordance with the regulations in 9 CFR 105.3 and 115.2, APHIS may notify a veterinary biologics licensee or permittee to stop the preparation, importation, and/or distribution and sale of a serial or a subserial of a veterinary biologic if, at any time, it appears that such product may be worthless, contaminated, dangerous, or harmful in the treatment of animals. This notification triggers two information collection activities: (1) After being contacted by APHIS, veterinary biologics licensees or permittees must immediately, but no later than 2 days, send stop distribution and sale notifications to any wholesalers, jobbers, dealers, foreign consignees, or other persons known to have such veterinary biologic in their possession, and (2) veterinary biologics licensees and permittees must account for the remaining quantity of each serial or subserial of any such veterinary biologic at each location in the distribution channel known to the licensee or permittee.

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

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning these information collection activities. 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 information collection, 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 information collection 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 1.7666 hours per response.

Respondents: U.S. establishments that produce and/or import veterinary biological products, and their wholesalers, dealers, jobbers, foreign consignees, or other persons known to have any such worthless, contaminated, dangerous, or harmful veterinary biological product in their possession.

Estimated annual number of respondents: 55.

Estimated annual number of responses per respondent: 1.09.

Estimated annual number of responses: 60.

Estimated total annual burden on respondents: 106 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 3rd day of August 2009.

William H. Clay,

Acting Administrator, Animal and Plant Health Inspection Service.