05-5065. Notice of Request for Emergency Approval of an Information Collection

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Emergency 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 emergency approval of an information collection in support of a final rule published in today's issue of the Federal Register regarding the possession, use, and transfer of select agents and toxins.

DATES:

We will consider all comments that we receive on or before March 25, 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. 02-088-5, 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. 02-088-5.

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 [phone] before coming.

Other Information: You may view APHIS documents published in the Federal Register and related information on the Internet at http://www.aphis.usda.gov/​ppd/​rad/​webrepor.html.

FOR FURTHER INFORMATION CONTACT:

For information concerning the regulations in 7 CFR part 331, contact Dr. Charles L. Divan, Senior Agricultural Microbiologist, Pest Permit Evaluations, Biological and Technical Services, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1236; [phone].

For information concerning the regulations in 9 CFR part 121, contact Dr. Lee Ann Thomas, Director, Animals, Organisms and Vectors, and Select Agents, VS, APHIS, 4700 River Road Unit 2, Riverdale, MD 20737-1231; [phone].

For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at [phone].

SUPPLEMENTARY INFORMATION:

In an interim rule published in the Federal Register on December 13, 2002 (67 FR 76908-76938, Docket No. 02-088-1) and effective on February 11, 2003, the Animal and Plant Health Inspection Service (APHIS) established regulations in 7 CFR part 331 and 9 CFR part 121 governing the possession, use, and transfer of biological agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal health, to plant health, or to animal or plant products. In a final rule published in today's issue of the Federal Register, APHIS is adopting, with changes, the December 2002 interim rule.

The final rule includes certain regulatory provisions that differ from those included in the December 2002 interim rule. Some of those provisions involve changes from the information collection requirements set out in the December 2002 interim rule, which were approved by the Office of Management and Budget (OMB) under OMB control number 0579-0213 (expires May 31, 2005). These changes include the following:

• As a condition of exemption, an entity must report any theft, loss, or release of a select agent or toxin during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin. This is a new requirement in the final rule.
• As a condition of exemption, an entity must immediately report the identification of specified select agents and toxins; identification of the other select agents and toxins must be reported within 7 calendar days after identification. This is a change from the requirement in the December 2002 interim rule that identifications of any select agent or toxin be immediately reported.
• The responsible official must report the identification and final disposition of any select agent or toxin contained in a specimen presented for diagnosis or verification. This is a change from the requirement in the December 2002 interim rule that the responsible official immediately report the identification of a select agent or toxin contained in a specimen presented for diagnosis.
• The responsible official must report the identification and final disposition of any select agent or toxin contained in a specimen presented for proficiency testing. This is a new requirement in the final rule.
• A select agent or toxin that is contained in a specimen for proficiency testing may be transferred without prior authorization from APHIS or the Centers for Disease Control and Prevention (CDC) provided that, at least 7 calendar days prior to the transfer, the sender reports to APHIS or CDC the select agent or toxin to be transferred and the name and address of the recipient. This is a change from the requirement in the December 2002 interim rule that the transfer of a select agent or toxin be authorized by APHIS or CDC prior to the transfer.
• An individual or entity must report the theft, loss, or release of a select agent or toxin. This is a change from the December 2002 interim rule that required such reporting for registered entities only.
• The responsible official is no longer required to notify APHIS 5 business days prior to the planned inactivation of a select agent or toxin if he/she wishes to discontinue possessing, using, or transferring a particular agent or toxin. In addition, the responsible official is no longer required to submit information about an individual's training and skills. These requirements have been deleted in the final rule.

In addition, there are a number of nonsubstantive changes, including changes in terminology and changes to form numbers.

In accordance with section 3507(j) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection and recordkeeping requirements included in the final rule have been submitted for emergency approval to the Office of Management and Budget (OMB). 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 2.8495857 hours per response.

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

Estimated annual number of respondents: 915.

Estimated annual number of responses per respondent: 5.1442622.

Estimated annual number of responses: 4,707.

Estimated total annual burden on respondents: 13,413. (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.)

APHIS will provide OMB with a copy of all comments received on this notice. All comments will also become a matter of public record.

When OMB notifies us of its decision, we will publish a document in the Federal Register providing notice of the assigned OMB control number or, if approval is denied, providing notice of what action we plan to take.

Done in Washington, DC, this 10th day of March 2005.

Elizabeth E. Gaston,

Acting Administrator, Animal and Plant Health Inspection Service.