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.

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 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.