[Federal Register Volume 74, Number 49 (Monday, March 16, 2009)]
[Notices]
[Pages 11119-11120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5648]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


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) Chicago District, in 
cosponsorship with the Association of Food and Drug Officials (AFDO), 
is announcing a public workshop entitled ``Drugs and Devices--Promoting 
and Protecting the Public Health Through Risk Management and Product 
Cycle Improvement.'' 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 Monday, June 8, 
2009, from 10:20 a.m. to 5 p.m. and Tuesday, June 9, 2009, from 8 a.m. 
to 5 p.m.
    Location: The public workshop will be held at the Doubletree Hotel 
Chicago--Oakbrook, 1909 Spring Rd., Oak Brook, IL 60523, 800-222-TREE, 
800-222-8733, or 630-472-6000, FAX: 630-573-1909.
    Attendees are responsible for their own accommodations. To make 
reservations at the Doubletree Hotel Chicago--OakBrook, at the reduced 
conference rate, contact the Doubletree Hotel Chicago--OakBrook before 
May 5, 2009, citing meeting code ``AFDO Conference''.
    Contact: William Weissinger, Food and Drug Administration, 550 W. 
Jackson Blvd., 15th Fl., Chicago, IL 60661, 312-596-4210, FAX: 312-596-
4242, e-mail: <a href="/cdn-cgi/l/email-protection#95c2fcf9f9fcf4f8bbe2f0fce6e6fcfbf2f0e7d5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="d582bcb9b9bcb4b8fba2b0bca6a6bcbbb2b0a795b3b1b4fbbdbda6fbb2baa3">[email protected]</span></a>.
    Registration: You are encouraged to register by May 12, 2009. The 
AFDO registration fees cover the cost of facilities, materials, and 
breaks. Seats are limited; 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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                        Affiliation                               Fee
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Government (AFDO/North Central AFDO Member)                      $395.00
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Government (Non-Member)                                          $495.00
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Non-Government (AFDO/NCAFDO Member)                              $450.00
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Non-Government (Non-Member)                                      $550.00
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To be added to registration fee for workshop registration         $75.00
 postmarked after May 12,2009
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    If you need special accommodations due to a disability, please 
contact William Weissinger at least 7 days in advance of the workshop.
    Registration instructions: To register, please submit your name, 
affiliation, mailing address, phone, fax number, and e-mail, along with 
a check or money order payable to ``AFDO.'' Please mail your payment 
to: AFDO, 2550 Kingston Rd., suite 311, York, PA 17402. To register via 
the Internet, go to 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 by major credit cards (VISA/
MasterCard only). For more information on the meeting, or for questions 
on registration, contact AFDO, 717-757-2888, FAX: 717-755-8089, or e-
mail: <a href="/cdn-cgi/l/email-protection#4726212328072621232869283520"><span class="__cf_email__" data-cfemail="85e4e3e1eac5e4e3e1eaabeaf7e2">[email protected]</span></a>.

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:

[[Page 11120]]

    <bullet> Risk management approach to consumer protection and 
industry regulation
    <bullet> How quality management systems (including corrective and 
preventive action) contribute to product cycle improvement
    <bullet> Supplier management and component controls for drugs and 
devices
    <bullet> Adverse drug event reporting requirements
    <bullet> Medical device reporting requirements
    <bullet> Recalls, corrections and removals
    <bullet> Complaint handling from the FDA investigator's 
perspective.
    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 (Public Law 
104-121), as outreach activities by Government agencies to small 
businesses.

    Dated: March 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-5648 Filed 3-13-09; 8:45 am]
BILLING CODE 4160-01-S


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