2016-12942. Collaborating To Strengthen Food, Drug, and Medical Device Safety Systems; Notice of Conference

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of conference.

SUMMARY:

The Food and Drug Administration (FDA) Philadelphia District Office, in co-sponsorship with the Association of Food and Drug Officials (AFDO), and the North Central Association of Food and Drug Officials, is announcing a conference entitled “Collaborating to Strengthen Food, Drug, and Medical Device Safety Systems.” This conference is intended to provide information about FDA drug and device regulation to the regulated industry.

DATES:

The conference will be held on June 25 to June 29, 2016. See SUPPLEMENTARY INFORMATION for meeting times.

ADDRESSES:

The Omni William Penn Hotel, 530 William Penn Pl., Pittsburgh, PA 15219. Attendees are responsible for their own accommodations.

FOR FURTHER INFORMATION CONTACT:

Randy Young, Association of Food and Drug Officials, 2550 Kingston Rd., Suite 311, York, PA 17402, 717-757-2888, FAX: [phone], [e-mail].

SUPPLEMENTARY INFORMATION:

FDA has made education of the food, feed, drug, and device manufacturing community a high priority to help ensure the quality of FDA-regulated products. The conference 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 for stakeholders and the public. The conference 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.

The conference helps fulfill the U.S. Department of Health and Human Services' and FDA's important mission to protect the public health. The conference 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, but are not limited to the following:

• FDA Program Alignment
• Recalls from the Perspective of the District
• Inspection of Licensed Producers under the Marijuana for Medical Purposes Regulations (Health Canada)
• Foreign inspections
• Regulatory Intelligence
• FDA Inspections: Challenges and Opportunities (Working Luncheon)
• Drug Shortages
• Drug Supply Chain Act: Wholesale Drug Distributor and 3rd Party Logistics Provider
• Medical Device Single Audit Program
• Compliance Questions Panel

The Conference Web site is: http://afdo.org/​conference. The meeting times are as follows:

Date	Meeting time
June 25	8 a.m. to 5 p.m.
June 26	8 a.m. to 6 p.m.
June 27	8 a.m. to 5:30 p.m.
June 28	8 a.m. to 5 p.m.
June 29	8 a.m. to 11:30 a.m.

Registration: The AFDO registration fees cover the cost of facilities, materials, and breaks. Seats are limited and registration will close after the course is filled; therefore, please submit your registration as soon as possible. Conference space will be filled in order of receipt of registration; those accepted will receive confirmation. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the conference, beginning at 7:30 a.m. The cost of registration follows:

Category	Cost of registration
Member	$475
Non-Member	575
Additional Fee for Registration Postmarked After June 1, 2016	100

To register, please complete and submit an AFDO conference registration form, available at http://pitt.afdo.org/​registration.html,, along with a check, money order payable to “AFDO”; the registrar will also accept Visa and MasterCard credit cards. Please mail your completed registration form and payment to: AFDO, 2550 Kingston Rd., Suite 311, York, PA 17402. To register online, please visit http://pitt.afdo.org/​registration.html (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.) For more information on the conference, or for questions about registration, please contact Randy Young (see FOR FURTHER INFORMATION CONTACT), email inquiries will also be accepted at [e-mail], or visit http://www.afdo.org.

If you need special accommodations due to a disability, please contact Randy Young (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the conference.

Dated: May 26, 2016.

Leslie Kux,

Associate Commissioner for Policy.