Federal Register: December 3, 2004 (Volume 69, Number 232)
DOCID: FR Doc E4-3453
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
Docket ID: [Docket No. 04-125-1]
NOTICE: NOTICES
DOCUMENT ACTION: Extension of approval of an information collection; comment request.
SUBJECT CATEGORY:
Notice of Request for Extension of Approval of an Information Collection
DATES: We will consider all comments that we receive on or before February 1, 2005.
DOCUMENT 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.
SUMMARY:
Agency information collection activities; proposals, submissions, and approvals,
SUPPLEMENTAL INFORMATION
Title: Select Agent Registration.
OMB Number: 05790213.
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. 107188). 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]]
201204) and the Department of Agriculture (USDA) (subtitle B, sections
211213). 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. E43453 Filed 12204; 8:45 am]
BILLING CODE 341034P
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) 7347211.
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 BrownReid, Select Agent Program Manager, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737; (301) 7343399.
For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 7347477.