E9-5648. Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

SUMMARY:

The Food and Drug Administration (FDA) Chicago District, in cosponsorship with the Association of Food and Drug Officials (AFDO), is announcing a public workshop entitled “Drugs and Devices—Promoting and Protecting the Public Health Through Risk Management and Product Cycle Improvement.” This 2-day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry.

Date and Time: The public workshop will be held on Monday, June 8, 2009, from 10:20 a.m. to 5 p.m. and Tuesday, June 9, 2009, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Doubletree Hotel Chicago—Oakbrook, 1909 Spring Rd., Oak Brook, IL 60523, 800-222-TREE, 800-222-8733, or 630-472-6000, FAX: [phone].

Attendees are responsible for their own accommodations. To make reservations at the Doubletree Hotel Chicago—OakBrook, at the reduced conference rate, contact the Doubletree Hotel Chicago—OakBrook before May 5, 2009, citing meeting code “AFDO Conference”.

Contact: William Weissinger, Food and Drug Administration, 550 W. Jackson Blvd., 15th Fl., Chicago, IL 60661, 312-596-4210, FAX: [phone], e-mail: [e-mail].

Registration: You are encouraged to register by May 12, 2009. The AFDO registration fees cover the cost of facilities, materials, and breaks. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 7:30 a.m. The cost of registration follows:

Cost of Registration

Affiliation	Fee
Government (AFDO/North Central AFDO Member)	$395.00
Government (Non-Member)	$495.00
Non-Government (AFDO/NCAFDO Member)	$450.00
Non-Government (Non-Member)	$550.00
To be added to registration fee for workshop registration postmarked after May 12,2009	$75.00

If you need special accommodations due to a disability, please contact William Weissinger at least 7 days in advance of the workshop.

Registration instructions: To register, please submit your name, affiliation, mailing address, phone, fax number, and e-mail, along with a check or money order payable to “AFDO.” Please mail your payment to: AFDO, 2550 Kingston Rd., suite 311, York, PA 17402. To register via the Internet, go to www.afdo.org. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register).

The registrar will also accept payment by major credit cards (VISA/MasterCard only). For more information on the meeting, or for questions on registration, contact AFDO, 717-757-2888, FAX: [phone], or e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The public workshop helps fulfill the Department of Health and Human Services' and FDA's important mission to protect the public health. The workshop will provide FDA-regulated drug and device entities with information on a number of topics concerning FDA requirements related to the production and marketing of drugs and/or devices. Topics for discussion include the following:

• Risk management approach to consumer protection and industry regulation
• How quality management systems (including corrective and preventive action) contribute to product cycle improvement
• Supplier management and component controls for drugs and devices
• Adverse drug event reporting requirements
• Medical device reporting requirements
• Recalls, corrections and removals
• Complaint handling from the FDA investigator's perspective.

FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The workshop helps to achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393) which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), as outreach activities by Government agencies to small businesses.

Dated: March 4, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.