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