2010-8087. Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public educational forum.

SUMMARY:

The Food and Drug Administration (FDA) Baltimore District, in co-sponsorship with the Association of Food and Drug Officials (AFDO), is announcing a public educational forum entitled “Drugs & Medical Device Supplier Management Forum.” This 2-day public educational forum, a component of AFDO's Annual Educational Conference, is intended to provide information about FDA drug and device regulation to the regulated industry.

Date and Time: The public educational forum will be held on Monday, June 21, 2010, from 8 a.m. to 5 p.m. and Tuesday, June 22, 2010, from 8 a.m. to 5 p.m.

Location: The public educational forum will be held at the Sheraton Norfolk Waterside Hotel, 777 Waterside Dr., Norfolk, VA 23510, 800-325-3535, or 757-622-6664, FAX: [phone].

Attendees are responsible for their own accommodations. To make reservations at the reduced conference rate, contact the Sheraton Norfolk Waterside Hotel before May 21, 2010, citing meeting code “AFDO Conference”.

Contact: Evelyn Bonnin, Food and Drug Administration, 6000 Metro Dr., suite 101, Baltimore, MD 21215, 410-779-5424, FAX: [phone], e-mail: [e-mail].

Registration: You are encouraged to register by May 25, 2010. 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 educational forum beginning at 7:30 a.m. The cost of registration follows:

Cost of Registration

Affiliation	Fee
Government (AFDO/Central Atlantic State Association (CASA) Member)	$395.00
Government (Non-Member)	$495.00
Non-Government (AFDO/CASA Member)	$395.00
Non-Government (Non-Member)	$495.00
To be added to registration fee for event registration postmarked after May 26,2010	$75.00

If you need special accommodations due to a disability, please contact Evelyn Bonnin at least 7 days in advance of the educational forum.

Registration instructions: To register, please complete a Conference Registration Form with 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. The registration form is available at http://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 educational forum helps fulfill the Department of Health and Human Services' and FDA's important mission to protect the public health. The educational forum 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:

Regulating Medical Products in the Global Environment

FDA Revitalization Efforts—Top 10 Drug & Device 483 Observations

FDA's Expectations for Supplier Controls

FDA Import District Activities—Monitoring Foreign Drug and Device Suppliers

Do's and Don'ts for Implementing Effective Quality Agreements

Case Studies—Supplier Controls

Supplier Quality in a Global Economy—Consensus Standards

Inspectorate, Health Canada

Building an Effective Supplier Control Program

FDA's International Posts—Update on Activities and Future Plans

FDA Recalls—A Focus on Supplier-Related Incidents & Other Compliance Initiatives

Supplier Auditing—Tools of the Trade

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 educational forum 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 educational forum 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: April 5, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.