[Federal Register Volume 76, Number 55 (Tuesday, March 22, 2011)]
[Notices]
[Pages 15986-15987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6619]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


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 
co-sponsorship 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. The public conference has three 
separate tracks of interest for quality, regulatory affairs, and 
clinical research professionals, and is intended for companies of all 
sizes and employees at all levels.
    Dates and Times: The public conference will be held on May 4, 2011, 
from 8:30 a.m. to 5 p.m.; May 5, 2011, from 8:30 a.m. to 5 p.m.; and 
May 6, 2011, 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.,

[[Page 15987]]

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, 
ext 167, FAX: 513-679-2772, e-mail: [email protected].
    For information regarding the conference and registration: Marla 
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 
513-745-3073, e-mail: [email protected].
    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 April 3, 2011. Standard 
registration ends May 2, 2011. There will be onsite registration. The 
cost of registration is as follows:

                       Table 1--Registration Fees
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                                                   Fee by
                   Attendee                       April 3,    Fee by May
                                                    2011       3, 2011
------------------------------------------------------------------------
Industry......................................         $995       $1,200
Small Business (<100 employees)...............          800        1,000
Academic......................................          600          750
FDA/Government Employee.......................          140          140
------------------------------------------------------------------------

    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, e-mail, and payment information for 
the fee to Xavier University, Attention: Sue Bensman, 3800 Victory 
Pkwy., Cincinnati, OH 45207. An e-mail 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 5th St., Cincinnati, OH, 45202, 513-421-
9100. Special conference block rates are available through April 12, 
2011. 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:
     Changes Within the Center for Devices and Radiological 
Health (CDRH) That Will Impact Our Industry.
     510(k) Changes: Panel Discussion.
     Combination Products Panel.
     Update on Quality System Regulations. Warning Letter and 
Enforcement Action Trends.
     MDUFMA Legislation.
     Corrective and Preventive Actions.
     Clinical Data Requirement Changes--Premarket Clearance.
     Reimbursement Panel.
     MDR Reporting/Vigilance.
     Ethical Issues Leading to Non-Compliance In Clinical 
Trials.
     Risk Management and Design Controls.
     510(k) SE Decision Making Process.
     Warning Letter Trends for Sponsor-Monitors and CRO's.
     Supplier Controls.
     Advertising, and Promotion and Labeling Pre- and Post-
Market.
     Ensuring Site Compliance in Clinical Trials.
     FDA's Bioresearch Monitoring Program-Overview and Current 
Activities.
     Inspection Readiness.
     Training.
     International Regulatory Update.
     FDCA, Anti Kickback and False Claims Act, Implications of 
Investigator-Initiated Trials.
     Recalls, Requirements and Challenges.
     CE Mark.
     Adverse Event Reporting During Clinical Investigation in 
the EU.
     Clinical Evaluation for EU Market Access.
     Using Electronic Medical Records.
     Cooperative Research Activities Between Academia and 
Industry.
    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 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6619 Filed 3-21-11; 8:45 am]
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