Document ID: FDA-2014-N-0001-0033
Agency: fda
Document Type: Notice
Title: The Food and Drug Administration and Global Engagement: Progress on the Pathway to Global Product Safety
Posted Date: 2014-03-31T04:00Z

[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Pages 18033-18034]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07059]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

The Food and Drug Administration and Global Engagement: Progress 
on the Pathway to Global Product Safety

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) Denver District Office, 
in cosponsorship with the Association of Food and Drug Officials 
(AFDO), will be hosting the 118th AFDO Annual Educational Conference. 
During the conference, a 2-day public workshop will be held entitled 
``FDA and Global Engagement: Progress on the Pathway to Global Product 
Safety,'' This 2-day public workshop is intended to provide information 
about FDA drug and device regulation to the regulated industry.

DATES:  Dates and Times: The conference will be held from June 21 
through June 25. The public workshop, ``FDA and Global Engagement: 
Progress on the Pathway to Global Product Safety,'' will be held on 
June 23 and 24, 2014, from 10:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the Grand Hyatt 
Denver, 1750 Welton St., Denver, CO 80202, 1-303-295-1234 or toll free 
800-233-1234; http://granddenver.hyatt.com. Attendees are responsible 
for their own accommodations. To make reservations at the Grand Hyatt 
Denver at the reduced conference rate, please go to https://resweb.passkey.com/go/afdo2014 or call 1-303-295-1234 and mention 
``AFDO Conference'' before May 21, 2014.
    AFDO Contact Information: Randy Young, Association of Food and Drug 
Officials, 2550 Kingston Rd., Suite 311, York, PA 17402, 1-717-757-
2888, FAX: 717-650-3650, ryoung@afdo.org.
    Registration: You are encouraged to register by May 23, 2014. The 
AFDO registration fees cover the cost of facilities, materials, and 
breaks. Seats are limited; therefore, please submit your registration 
as soon as possible. Public workshop space will be filled in order of 
receipt of registration. Those accepted into the public workshop will 
receive confirmation. Registration will close after the public workshop 
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:

[[Page 18034]]

                         Cost of Registration *
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ADFO Member.............................................         $475.00
Non-ADFO Member.........................................          575.00
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* A $100 registration fee will be added if payment is postmarked after
  June 1, 2014.

    If you need special accommodations due to a disability, please 
contact Randy Young (see AFDO Contact information) 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/conference. (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 1-717-757-2888, 
FAX: 717-650-3650, or email: afdo@afdo.org.

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, but are not limited to the 
following:
     Medical Device Single Audit Program;
     Contract Manufacturing Arrangements for Drugs: Quality 
Agreements;
     Compliance Question and Answer Panel;
     Draft Guidance: Distinguishing Medical Device Recalls from 
Product Enhancements and Associated Reporting Requirements;
     Compounding Pharmacies;
     Overview of Global Device/Drug Requirements vs. U.S. 
System;
     Case for Quality Initiative Update;
     Unique Device Identifier Implementation Update;
     Metric, Data, and Analysis; Biometrics;
     Pharmaceutical Inspection Cooperation Scheme; and
     Biosimilar Regulations.
    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 public 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: March 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07059 Filed 3-28-14; 8:45 am]
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