Document ID: FDA-2014-N-0001-0025
Agency: fda
Document Type: Notice
Title: Food and Drug Administration/Xavier University Global Medical Device
Conference
Posted Date: 2014-02-26T05:00Z

[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Notices]
[Pages 10815-10816]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04134]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-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 
(MedCon).'' 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.
    Dates and Times: The public conference will be held on May 7, 2014, 
from 8:30 a.m. to 5 p.m.; May 8, 2014, from 8:30 a.m. to 5 p.m.; and 
May 9, 2014, from 8:30 a.m. to 12:45 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 513-745-3020.
    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, email: 
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, email: 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 11, 2014. Advanced 
registration rates begin March 12, 2014. Standard registration rates 
begin April 9, 2014. There will be onsite registration. The cost of 
registration is as follows:

[[Page 10816]]

                                         Table 1--Registration Fees \1\
----------------------------------------------------------------------------------------------------------------
                                       Early rate  (through 3/   Advanced rate (3/12/14   Standard rate  (4/9/14
            Attendee Type                       11/14)                 to 4/8/14)               to 5/9/14)
----------------------------------------------------------------------------------------------------------------
Industry.............................                   $1,195                   $1,495                   $1,695
Small Business (<100 employees)......                     $900                   $1,000                   $1,200
Startup Manufacturer.................                     $200                     $250                     $300
Academic.............................                     $200                     $250                     $300
FDA/Government Employee..............               Fee Waived               Fee Waived             Fee Waived.
----------------------------------------------------------------------------------------------------------------
\1\ The following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks.

    To register online for the public conference, please visit the 
``Registration'' 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: Mason Rick, 3800 Victory 
Parkway, Cincinnati, OH 45207. An email will be sent confirming your 
registration.
    Attendees are responsible for their own accommodations. The 
conference headquarters hotel is the Cincinnati Hilton Netherlands 
Plaza, 35 West 5th Street, Cincinnati, OH, 45202, 513-421-9100. Special 
conference block rates are available through April 16, 2014. 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:
     Center for Devices and Radiological Health Future Vision 
and Strategy Keynote Address;
     European Union Regulations: New Regulations, Company 
Strategy, and Open Discussion Forum;
     How to Implement the Unique Device Identification 
Requirements;
     Update from the Office of Device Evaluation;
     FDA Regulation of Health Information Technology: Medical 
Apps, Cybersecurity, and ``the Cloud'';
     Managing Scientific and Regulatory Disagreement;
     Combination Products;
     FDA Inspectional Approach--Panel with current FDA 
investigators;
     Operationalizing Post-Market Surveillance;
     510(k) Process;
     Risk Management;
     Purchasing Controls;
     Office of Compliance Update; and
     Strategic Thinking on Access in China.
    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: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04134 Filed 2-25-14; 8:45 am]
BILLING CODE 4160-01-P