[Federal Register Volume 66, Number 205 (Tuesday, October 23, 2001)]
[Notices]
[Pages 53584-53585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26594]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
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  Federal Register / Vol. 66, No. 205 / Tuesday, October 23, 2001 / 
Notices  

[[Page 53584]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 01-086-1]


Notice of Request for Extension of Approval of an Information 
Collection

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 in support of the Virus-Serum-Toxin Act and regulations.

DATES: We invite you to comment on this docket. We will consider all 
comments that we receive by December 24, 2001.

ADDRESSES: Please send four copies of your comment (an original and 
three copies) to: Docket No. 01-086-1, Regulatory Analysis and 
Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. 01-086-1.
    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 (202) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: For information on the Virus-Serum-
Toxin Act and regulations, contact Dr. Albert Morgan, Chief Staff 
Officer, Center for Veterinary Biologics, Operational Support Staff, 
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) 734-7477.

SUPPLEMENTARY INFORMATION:
    Title: Virus-Serum-Toxin Act and Regulations.
    OMB Number: 0579-0013.
    Type of Request: Extension of approval of an information 
collection.
    Abstract: The Animal and Plant Health Inspection Service (APHIS) of 
the U.S. Department of Agriculture is responsible for assuring 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, chapter I, subchapter E. 
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.
    To accomplish its mission, APHIS issues licenses to qualified 
establishments that produce biological products and issues permits to 
importers of such products. We also enforce requirements concerning 
production, packaging, labeling, and shipping of these products and set 
standards for the testing of these products.
    Fulfilling this responsibility requires us to use certain 
information collection activities such as establishment license 
applications, product license applications, product import permit 
applications, product and test report forms, and field study summaries. 
This information helps us to ensure that biological products used in 
the United States are pure, safe, potent, and effective.
    If we did not collect this information, we would be unable to carry 
out this mission.
    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 2.62813 hours per response.
    Respondents: U.S. importers and exporters of biological products, 
shippers, operators of establishments that produce or test biological 
products or that engage in product research and development.
    Estimated annual number of respondents: 200.
    Estimated annual number of responses per respondent: 97.36.

[[Page 53585]]

    Estimated annual number of responses: 19,472.
    Estimated total annual burden on respondents: 51,175 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 16th day of October 2001.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-26594 Filed 10-22-01; 8:45 am]
BILLING CODE 3410-34-U