[Federal Register Volume 69, Number 232 (Friday, December 3, 2004)]
[Notices]
[Pages 70216-70217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-3453]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-125-1]


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 associated with regulations for the possession, use, and 
transfer of biological agents and toxins that have the potential to 
pose a severe threat to human and animal health, to animal health, to 
plant health, or to animal products and plant products.

DATES: We will consider all comments that we receive on or before 
February 1, 2005.

ADDRESSES: You may submit comments by any of the following methods:
     EDOCKET: Go to http://www.epa.gov/feddocket to submit or 
view public comments, access the index listing of the contents of the 
official public docket, and to access those documents in the public 
docket that are available electronically. Once you have entered 
EDOCKET, click on the ``View Open APHIS Dockets'' link to locate this 
document.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. 04-125-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comment refers to Docket No. 04-125-1.
     E-mail: Address your comment to 
[email protected]. Your comment must be contained in the body 
of your message; do not send attached files. Please include your name 
and address in your message and ``Docket No. 04-125-1'' on the subject 
line.
     Agency Web Site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html for a form you can use to submit an e-mail comment through 
the APHIS Web site.
    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 (202) 690-2817 before coming.
    Other Information: You may view APHIS documents published in the 
Federal Register and related information, including the names of groups 
and individuals who have commented on APHIS dockets, on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: For information regarding the select 
agent registration process associated with the possession, use, or 
transfer of biological agents and toxins in 7 CFR part 331, contact Ms. 
Gwendolyn Burnett, Regulatory Permit Specialist, Biological and 
Technical Services, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 
20737; (301) 734-7211.
    For information regarding the select agent registration process 
associated with the possession, use, or transfer of biological agents 
and toxins in 9 CFR part 121, contact Dr. Monica Brown-Reid, Select 
Agent Program Manager, National Center for Import and Export, VS, 
APHIS, 4700 River Road Unit 39, Riverdale, MD 20737; (301) 734-3399.
    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: Select Agent Registration.
    OMB Number: 0579-0213.
    Type of Request: Extension of approval of an information 
collection.
    Abstract: On June 12, 2002, the President signed into law the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002 (Pub. L. 107-188). Title II of that Act provides for the 
regulation of certain biological agents and toxins by the Department of 
Health and Human Services (HHS) (subtitle A, sections

[[Page 70217]]

201-204) and the Department of Agriculture (USDA) (subtitle B, sections 
211-213). Under section 212 of the Act, the Secretary of Agriculture 
must establish regulations governing the possession, use, and transfer 
of listed biological agents and toxins in order to protect animal and 
plant health, and animal and plant products. The Animal and Plant 
Health Inspection Service is the USDA agency with primary 
responsibility for establishing and enforcing regulations in 7 CFR part 
331 and 9 CFR part 121 associated with the possession, use, and 
transfer of those biological agents and toxins under USDA's 
jurisdiction.
    APHIS regulations require an individual or entity (unless 
specifically exempted under the regulations) to register with APHIS or, 
for overlap agents or toxins (affecting both humans and animals), APHIS 
or the Centers for Disease Control and Prevention, HHS, in order to 
possess, use, or transfer biological agents or toxins.
    To register, an individual or entity must submit a registration 
application package; develop and implement a Biocontainment and 
Security Plan or Biosafety and Security Plan, as applicable; and 
request access approval for individuals who have been identified as 
having a legitimate need to handle or use listed agents or toxins and 
who have the appropriate training and skills to handle or use such 
agents or toxins.
    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 our information collection. 
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 
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 1.5442 hours per response.
    Respondents: Researchers, universities, research and development 
organizations, diagnostic laboratories and other interested parties who 
possess, use, or transfer agents or toxins deemed a severe threat to 
animal or plant health, or to animal or plant products.
    Estimated annual number of respondents: 490.
    Estimated annual number of responses per respondent: 2.6327.
    Estimated annual number of responses: 1,290.
    Estimated total annual burden on respondents: 1,992 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 29th day of November 2004.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E4-3453 Filed 12-2-04; 8:45 am]
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