[Federal Register Volume 74, Number 151 (Friday, August 7, 2009)]
[Notices]
[Pages 39610-39611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18988]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2009-0043]


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.

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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:
    <bullet> 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.
    <bullet> 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,

[[Page 39611]]

please call (202) 690-2817 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; (301) 734-8245. For 
copies of more detailed information on the information collection, 
contact Mrs. Celeste Sickles, APHIS' Information Collection 
Coordinator, at (301) 851-2908.

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.
[FR Doc. E9-18988 Filed 8-6-09; 8:45 am]
BILLING CODE 3410-34-P