[Federal Register Volume 81, Number 106 (Thursday, June 2, 2016)]
[Notices]
[Page 35362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12942]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Collaborating To Strengthen Food, Drug, and Medical Device Safety 
Systems; Notice of Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of conference.

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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: 717-650-3650, [email protected].

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:

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                Date                             Meeting time
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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.
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    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:

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                                                               Cost of
                         Category                           registration
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Member....................................................          $475
Non-Member................................................           575
Additional Fee for Registration Postmarked After June 1,             100
 2016.....................................................
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    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 [email protected], 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.
[FR Doc. 2016-12942 Filed 6-1-16; 8:45 am]
 BILLING CODE 4164-01-P