[Federal Register: December 3, 2004 (Volume 69, Number 232)]
[Notices]
[Page 70216-70217]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de04-18]
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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
regulations@aphis.usda.gov. 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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