2011-2458. 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) Southwest Regional Office, in co-sponsorship with the Association of Food and Drug Officials (AFDO), the Mid-Continental Association of Food and Drug Officials (MCAFDO), and the FDA Medical Device Industry Coalition, is announcing a public workshop entitled “The Future of Medical Products Regulation: Ensuring Safety and Integrity in a Global Market”. 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 June 20 and 21, 2011, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Marriott Dallas/Plano at Legacy Town Center, Plano, Texas, 7120 Dallas Pkwy., Plano, Texas 75024, 972-473-6444, or toll-free 888-236-2427.

Attendees are responsible for their own accommodations. To make reservations at the Marriott Dallas/Plano at Legacy Town Center, at the reduced conference rate, contact the Marriott Dallas/Plano at Legacy Town Center before May 20, 2011, citing meeting code “AFDO Conference”.

Contact: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, Texas 75204, 214-253-4952, FAX: [phone], e-mail: [e-mail].

Registration: You are encouraged to register by May 24, 2011. The AFDO registration fees cover the cost of facilities, materials, and breaks. Seats are limited; therefore, 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

Government (AFDO/Mid-Continental AFDO Member)	$425.00
Government (Non-Member):	525.00
Non-Government (AFDO/MCAFDO Member)	425.00
Non-Government (Non-Member)	525.00
To be added to registration fee for public workshop registration postmarked after May 24, 2011	100.00

If you need special accommodations due to a disability, please contact David Arvelo (see Contact) at least 21 days in advance of the workshop.

Registration instructions: To register, please complete and submit an AFDO Conference Registration Form, along with a check or money order payable to “AFDO”. Please mail your completed registration form and payment to: AFDO, 2550 Kingston Rd., suite 311, York, PA 17402. To register online, please visit 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 through Visa and MasterCard credit cards. For more information on the public workshop, or for questions about registration, please contact AFDO at 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:

• Globalization, Imports, and Supplier Controls,
• Medical Product Theft and Criminal Investigations,
• Proposed Changes to the 510(K) Review Process,
• Health Fraud,
• Streamlining the FDA Enforcement Process,
• The Future of Medical Products Regulation,
• Medical Devices in Canada,
• The Freedom of Information Act,
• Medical Product Complaint Investigations,
• Writing Corrective and Preventive Actions Procedures and Documents to Reflect Compliance Initiatives, and
• Top Ten FDA-483 Objectionable Observations.

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 (Pub. L. 104-121), as outreach activities by government agencies to small businesses.

Dated: February 1, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.