E9-20294. Notice of Availability of Biotechnology Quality Management System Pilot Project Draft Audit Standard

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice; reopening of comment period.

SUMMARY:

We are reopening the comment period on the draft audit standard developed by the Animal and Plant Health Inspection Service for its Biotechnology Quality Management System pilot project. This action will allow interested persons additional time to prepare and submit comments. The Biotechnology Quality Management System is a voluntary compliance assistance program designed to help stakeholders develop sound management practices, thus enhancing compliance with the regulatory requirements for environmental releases and movements of regulated articles in accordance with 7 CFR part 340.

DATES:

We will consider all comments that we receive on or before October 23, 2009.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2008-0098 to submit or view comments and to view supporting and related materials available electronically.
• Postal Mail/Commercial Delivery: Please send two copies of your comment to Docket No. APHIS-2008-0098, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2008-0098.

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: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT:

Dr. Edward Jhee, Biotechnology Quality Management System Program Manager, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 91, Riverdale, MD 20737-1236; [phone], [e-mail]. To obtain copies of the draft audit standard, contact Ms. Cindy Eck at [phone], e-mail: [e-mail]. The draft audit standard is also available on the Internet at http://www.aphis.usda.gov/​biotechnology/​news_​bqms.shtml.

SUPPLEMENTARY INFORMATION:

On June 4, 2009, APHIS published a notice in the Federal Register (74 FR 26831-26832, Docket No. APHIS-2008-0098) announcing the availability of the Biotechnology Quality Management System (BQMS) draft audit standard. Comments on the BQMS draft audit standard were to have been received on or before August 3, 2009. We are reopening the comment period on Docket No. APHIS-2008-0098 for an additional 60 days. This action will allow interested persons additional time to prepare and submit comments. We will also consider all comments received between August 4, 2009, and the date of this notice.

Upon conclusion of the BQMS pilot project, APHIS will consider all comments received during the comment period to revise the draft audit standard to improve the efficacy of this project. This feedback, as well as comments from the pilot participants on the pilot BQMS project, will be used to inform the development of a BQMS audit standard and any future BQMS initiative. The BQMS draft audit standard is available for public review, and copies of this document are available as indicated under the FOR FURTHER INFORMATION CONTACT section of this notice.

Done in Washington, DC, this 18th day of August 2009.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.