83 FR 11761 - Pathways to Global Unity; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 52 (March 16, 2018)

The Food and Drug Administration (FDA), in collaboration with the Association of Food and Drug Officials (AFDO), is announcing the following public workshop entitled ``Pathways to Global Unity.'' This 2\1/2\-day public workshop is intended to provide information about FDA drug and device regulation to the regulated industries.

[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Page 11761]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05389]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0757]


Pathways to Global Unity; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA), in collaboration with 
the Association of Food and Drug Officials (AFDO), is announcing the 
following public workshop entitled ``Pathways to Global Unity.'' This 
2\1/2\-day public workshop is intended to provide information about FDA 
drug and device regulation to the regulated industries.

DATES: The public workshop will be held on June 11-12, 2018, from 8 
a.m. to 5:30 p.m., and on June 13, 2018, from 8 a.m. to 12 p.m.

ADDRESSES: The public workshop will be held at the Doubletree by Hilton 
Hotel Burlington Vermont, 870 Williston Rd., Burlington, VT 05403, 802-
865-6626. For directions to the hotel and information on lodging, visit 
http://burlington.afdo.org/hotel.html. Attendees are responsible for 
their own accommodations.

FOR FURTHER INFORMATION CONTACT: Krystal Reed, Association of Food and 
Drug Officials, 155 West Market St., 3rd Floor, York, PA 17401, 717-
757-2888, Fax: 717-650-3650, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    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.

II. Topics for Discussion at the Public Workshop

    The public workshop helps fulfill the Department of Health and 
Human Services and FDA's 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. The public 
workshop's agenda is available at http://www.afdo.org/conference. 
Topics for discussion include the following:

 FDA Associate Commissioner for Regulatory Affairs Update
 Health Canada: Single Audit Program
 Enforcement Trends in Drug, Devices, and Compounding Pharmacy 
Inspections
 FDA Compliance Questions Panel
 International Compliance--Industry Perspective
 Puerto Rico Emergency Response Update
 Artificial Intelligence
 Supply Chain Control
 Dermal Abyss: Tattoos as Medical Condition Monitors
 Design Controls for Combination Products
 Benefit Risk--Using Benefit Risk in Making Post-Market 
Decisions

III. Participating in the Public Workshop

    Registration: You are encouraged to register by May 1, 2018. 
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 is as follows:

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                                                              Cost of
                        Category                           registration
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AFDO Members............................................            $550
AFDO Non-Members........................................             650
Additional Fee for Registration Postmarked After May 1,              100
 2018...................................................
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    To register online, please visit http://www.afdo.org/conference 
(FDA has verified the website address, but is not responsible for 
subsequent changes to the website after this document publishes in the 
Federal Register.) For alternative registration, please complete and 
submit an AFDO Conference Registration Form, available at http://burlington.afdo.org/registration.html, along with a check or money 
order payable to AFDO. Please mail your completed registration form and 
payment to: AFDO, 155 West Market St., 3rd Floor, York, PA 17401. The 
registrar will also accept payment through Visa, MasterCard, and 
American Express credit cards. For more information on the public 
workshop, or for questions about registration, please contact AFDO at 
717-757-2888, [email protected], or http://www.afdo.org/conference.
    If you need special accommodations due to a disability, please 
contact Krystal Reed (see FOR FURTHER INFORMATION CONTACT) at least 21 
days in advance of the workshop.

    Dated: March 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05389 Filed 3-15-18; 8:45 am]
 BILLING CODE 4164-01-P