[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Pages 15957-15958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05727]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Food and Drug Administration/Xavier University Global Medical
Device Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
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SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in
cosponsorship with Xavier University, is announcing a public conference
entitled ``FDA/Xavier University Global Medical Device Conference.''
This 3-day public conference includes presentations from key FDA
officials and industry experts with small group breakout sessions. The
conference is intended for companies of all sizes and employees at all
levels.
Date and Time: The public conference will be held on May 1, 2013,
from 8:30 a.m. to 5 p.m.; May 2, 2013, from 8:30 a.m. to 5 p.m.; and
May 3, 2013, from 8:30 a.m. to 1 p.m.
Location: The public conference will be held on the campus of
Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-
3073 or 513-745-3396.
Contact Persons: For information regarding this notice: Gina
Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH
45237, 513-679-2700, Fax: 513-679-2771, Gina.Brackett@fda.hhs.gov.
For information regarding the conference and registration: Marla
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207,
513-745-3073, phillipsm4@xavier.edu.
Registration: There is a registration fee. The conference
registration fees cover the cost of the presentations, training
materials, receptions, breakfasts, and lunches for the 3 days of the
conference. Early registration ends March 13, 2013. Standard
registration ends April 9, 2013. There will be onsite registration. The
cost of registration is as follows:
[[Page 15958]]
Table 1--Registration Fees \1\
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Advanced rate
(March 13, 2013 Standard rate
Attendee type to April 8, (April 9, 2013
2013) to May 3, 2013)
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Industry............................ $1,295 $1,495
Small Business (<100 employees)..... 900 1,000
Consultant.......................... 600 700
Startup Manufacturer................ 250 300
Academic............................ 250 300
FDA/Government Employee............. (2) Free
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\1\ The following forms of payment will be accepted: American Express,
Visa, Mastercard, and company checks.
\2\ Free.
To register online for the public conference, please visit the
``Register Now'' link on the conference Web site at http://www.XavierMedCon.com. 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.
To register by mail, please send your name, title, firm name,
address, telephone and fax numbers, email, and payment information for
the fee to Xavier University, Attention: Sue Bensman, 3800 Victory
Pkwy., Cincinnati, OH 45207. An email will be sent confirming your
registration.
Attendees are responsible for their own accommodations. The
conference headquarter hotel is the Downtown Cincinnati Hilton
Netherlands Plaza, 35 West Fifth St., Cincinnati, OH, 45202, 513-421-
9100. Special Conference Block rates are available through April 9,
2013. To make reservations online, please visit the ``Venue &
Logistics'' link at http://www.XavierMedCon.com.
If you need special accommodations due to a disability, please
contact Marla Phillips (see Contact Persons) at least 7 days in advance
of the conference.
SUPPLEMENTARY INFORMATION: The public conference helps fulfill the
Department of Health and Human Services and FDA's important mission to
protect the public health. The conference will provide those engaged in
FDA-regulated medical devices (for humans) with information on the
following topics:
CDRH Future Vision and Strategy Keynote Address
U.S. Congressman Erik Paulsen Keynote Dinner
EU Regulations: New Regulations, Company Strategy, and
Open Discussion Forum
FDA Safety and Innovation Act
Unique Device Identification
Update from the Office of Device Evaluation
Total Product Life Cycle: Interactive Workshop
Pre-Submission Program and Meetings with the FDA
510(k): New FDA Guidance and Industry Regulations
PMAs: New Guidance and Compliance Initiatives
Software and Mobile Apps
Combination Products
Entering the EU Market and CE Mark Hot Topics
Global Product Strategy
Success in Central and South America
FDA Inspectional Approach--Panel with Current FDA
Investigators
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 conference 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 conference also is consistent with the
Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L.
104-121) by providing outreach activities by Government Agencies to
small businesses.
Dated: March 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05727 Filed 3-12-13; 8:45 am]
BILLING CODE 4160-01-P