[Federal Register: March 16, 2009 (Volume 74, Number 49)]
[Notices]
[Page 11119-11120]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr09-68]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: William.weissinger@fda.hhs.gov.
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
------------------------------------------------------------------------
Affiliation Fee
------------------------------------------------------------------------
Government (AFDO/North Central AFDO Member) $395.00
------------------------------------------------------------------------
Government (Non-Member) $495.00
------------------------------------------------------------------------
Non-Government (AFDO/NCAFDO Member) $450.00
------------------------------------------------------------------------
Non-Government (Non-Member) $550.00
------------------------------------------------------------------------
To be added to registration fee for workshop registration $75.00
postmarked after May 12,2009
------------------------------------------------------------------------
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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 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: 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:
[[Page 11120]]
Risk management approach to consumer protection and
industry regulation
How quality management systems (including corrective and
preventive action) contribute to product cycle improvement
Supplier management and component controls for drugs and
devices
Adverse drug event reporting requirements
Medical device reporting requirements
Recalls, corrections and removals
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