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Docket ID: [Docket No. APHIS-2008-0047]

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; Select Agent Registration

DATES: We will consider all comments that we receive on or before August 29, 2008.

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: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 provides for the regulation of certain biological agents and toxins by the Department of Agriculture (USDA) and the Department of Health and Human Services (HHS). Under section 212 of the Act, USDA regulates biological agents and toxins that have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal and plant products. The Animal and Plant Health Inspection Service (APHIS) has the primary responsibility for implementing the provisions of the Act within USDA. Select agents and toxins that have been determined to pose a severe threat to both human and animal health or animal products are subject to regulation by both APHIS and the Centers for Disease Control and Prevention (CDC), HHS, which has the primary responsibility for implementing the provisions of the Act within HHS.

APHIS regulations are contained in 7 CFR 331 (plant) and 9 CFR 121 (animal and overlap). They require an individual or entity (unless specifically exempted under the regulations) to register with APHIS or, for overlap agents or toxins, APHIS or CDC, 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 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 1.7033 hours per response.

Respondents: Researchers, universities, research and development organizations, diagnostic laboratories, and other interested parties who possess, use, or transfer select agents or toxins.

Estimated annual number of respondents: 655.

Estimated annual number of responses per respondent: 1.1526717.

Estimated annual number of responses: 755.

Estimated total annual burden on respondents: 1,286 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 24th day of June 2008. Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E814792 Filed 62708; 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 331, contact Dr. Charles L. Divan, Senior Agricultural Microbiologist, Agriculture Select Agent Program, Permits, Registrations, Imports and Manuals, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737; (301) 7345663.

For information regarding the select agent registration process associated with the possession, use, or transfer of biological agents and toxins in 9 CFR 121, contact Mr. Robert Rice, Security Manager, Agriculture Select Agent Program, Technical Trade Services Team, NCIE, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737; (301) 734 5557.

For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 8512908.