Document ID: FDA-2012-N-0001-0017
Agency: fda
Document Type: Notice
Title: Food and Drug Administration/Xavier University Global Medical Device; Public Conference
Posted Date: 2012-02-22T05:00Z

[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Notices]
[Pages 10537-10538]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4036]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-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, and has two separate tracks of 
interest. 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 2, 2012, 
from 8:30 a.m. to 5 p.m.; May 3, 2012, from 8:30 a.m. to 5 p.m.; and 
May 4, 2012, 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: Gina Brackett, Food and Drug Administration, 6751 
Steger Dr., Cincinnati, OH 45237, 513-679-2700, ext. 2167, 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, lunches, and dinners for the 3 days 
of the conference. Early registration ends March 6, 2012. Standard 
registration ends March 27, 2012. There will be onsite registration. 
The cost of registration is as follows:

                      Table 1--Registration Fees 1
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             Attendee               Fee by March 6th   Fee by March 27th
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Industry.........................  $995..............  $1,295
Small Business (<100 employees)..  800...............  900
Consultant.......................  500...............  600
Academic.........................  200...............  250
FDA/Government Employee..........  Free..............  Free
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\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: 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 headquarters hotel is the Downtown Cincinnati Hilton 
Netherlands Plaza, 35 West 5th St., Cincinnati, OH, 45202, 513-421-
9100. Special conference block rates are available through April 11, 
2012. 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 Medical Device Innovation Initiative Keynote Address;
     510(k)--Office of Device Evaluation Perspective;
     The Purchasing Control Subsystem--Requirements and 
Implementation;
     Draft 510(k) Guidance--Deciding When to Submit a 510(k) 
for a Change or Modification;
     Challenges of Design Controls;
     FDA 483s and Regulatory Action--Response Workshop;

[[Page 10538]]

     Recalls--Globally;
     GHTF Document on CAPA--Workshop;
     510(k)--An Industry Perspective;
     Interdependency of Postmarket Surveillance, Risk, and 
CAPA;
     Promotional Practices--Global;
     Office of Compliance Initiatives;
     U.S. Senate HELP Committee Keynote Dinner;
     Risk Management Across the Quality Systems--FDA 
Expectations and Implementation;
     Global Regulatory Strategy; and
     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 (Pub. L. 105-115) (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 15, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4036 Filed 2-21-12; 8:45 am]
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