Document ID: FDA-2011-N-0002-0007
Agency: fda
Document Type: Notice
Title: Industry Exchange Workshop on Drug and Device Requirements; Public Workshop
Posted Date: 2011-02-04T05:00Z

[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Notices]
[Pages 6477-6478]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2458]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

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: 
214-253-4970, e-mail: David.Arvelo@fda.hhs.gov.
    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               100.00
 registration postmarked after May 24, 2011.............
------------------------------------------------------------------------

    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

[[Page 6478]]

717-757-2888, FAX: 717-650-3650, or e-mail: 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 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.
[FR Doc. 2011-2458 Filed 2-3-11; 8:45 am]
BILLING CODE 4160-01-P