[Federal Register Volume 62, Number 234 (Friday, December 5, 1997)]
[Notices]
[Pages 64349-64350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31903]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 97-088-1]


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: Comments on this notice must be received by February 3, 1998 to 
be assured of consideration.

ADDRESSES: Send comments regarding the accuracy of burden estimate, 
ways to minimize the burden (such as through the use of automated 
collection techniques or other forms of information technology), or any 
other aspect of this collection of information to: Docket No. 97-088-1, 
Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River 
Road Unit 118, Riverdale, MD 20737-1238. Please send an original and 
three copies, and state that your comments refer to Docket 97-088-1. 
Comments received may be inspected at USDA, room 1141, South Building, 
14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. 
and 4:30 p.m., Monday through Friday, except holidays. Persons wishing 
to inspect comments are requested to call ahead on (202) 690-2817 to 
facilitate entry into the comment reading room.

FOR FURTHER INFORMATION: For information regarding the Virus-Serum-
Toxin Act and regulations, contact Dr. David Espeseth, Director, Center 
for Veterinary Biologics, Licensing and Policy Development, VS, APHIS, 
4700 River Road Unit 148, Riverdale, MD 20737-1237, (301) 734-8245 or 
e-mail [email protected]. For copies of more detailed 
information on the information collection, contact Ms. Cheryl Jenkins, 
Agency Support Service Specialist, at (301) 734-5360.

SUPPLEMENTARY INFORMATION:

    Title: Virus-Serum-Toxin Act and Regulations.
    OMB Number: 0579-0013.
    Expiration Date of Approval: March 31, 1998.
    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 preventing the 
importation, preparation, sale, or shipment of worthless, contaminated, 
dangerous or harmful veterinary biological products. This program is 
conducted under the Virus-Serum-Toxin Act (21 U.S.C. 151, et seq.) and 
the regulations issued thereunder (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 this 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 employ 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.
    The information we obtain with the help of these documents enables 
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 
the continued use of this information collection activity.
    The purpose of this notice is to solicit comments from the public 
(as well as affected agencies) concerning our information collection. 
We need this outside input to help us:
    (1) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the Agency, 
including whether the information will have practical utility;

[[Page 64350]]

    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed collection of information, 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 collection of information 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 2.2063 hours per response.
    Respondents: U.S. importers of biological products, shippers, 
operators of establishments that produce or test biological products or 
that engage in product research and development.
    Estimated number of respondents: 114.
    Estimated number of responses per respondent: 298.73.
    Estimated annual number of responses: 34,056.
    Estimated total annual burden on respondents: 75,138 hours. (Due to 
rounding, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the average 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 28th day of November.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-31903 Filed 12-4-97; 8:45 am]
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