Document ID: FDA-2013-N-0001-0022
Agency: fda
Document Type: Notice
Title: Food and Drug Administration/Xavier University Global Medical Device Conference
Posted Date: 2013-03-13T04:00Z

[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Pages 15957-15958]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05727]

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

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.

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

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\
------------------------------------------------------------------------
                                        Advanced rate
                                       (March 13, 2013    Standard rate
            Attendee type                to April 8,     (April 9, 2013
                                            2013)        to May 3, 2013)
------------------------------------------------------------------------
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
------------------------------------------------------------------------
\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