80 FR 8327 - Food and Drug Administration/Xavier University Global Medical Device Conference; Public Conference

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 31 (February 17, 2015)

[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8327-8328]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03116]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Food and Drug Administration/Xavier University Global Medical 
Device Conference; Public Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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    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: Dates and Times: The public conference will be held on May 6, 
2015, from 8:30 a.m. to 5 p.m.; May 7, 2015, from 8:30 a.m. to 5 p.m.; 
and May 8, 2015, from 8:30 a.m. to 12:30 p.m.
    Location: The public conference will be held on the campus of 
Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-
3016.
    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: 
[email protected].
    For information regarding the conference and registration: Mason 
Rick, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207-5471, 
513-745-3016, email: [email protected], or visit http://www.XavierMedCon.com.
    Registration: There is a conference registration fee which covers 
the cost of the presentations, training materials, receptions, 
breakfasts, and lunches for the 3 days of the conference. Advanced 
registration begins February 6, 2015. Standard registration begins 
March 6, 2015. There will be onsite registration. The cost of 
registration is as follows:

[[Page 8328]]



                     Table 1--Registration Fees \1\
------------------------------------------------------------------------
                                    Advanced rate  (2/   Standard rate
           Attendee type             6/15 to 3/5/15)     (after 3/5/15)
------------------------------------------------------------------------
Industry..........................             $1,495             $1,695
Small Business (<100 Employees)...              1,000              1,200
Startup Manufacturer..............                250                300
Academic..........................                250                300
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, email, and payment information for the fee to 
Xavier University, Attention: Mason Rick, 3800 Victory Pkwy., 
Cincinnati, OH 45207-5471. An email will be sent confirming your 
registration.
    Attendees are responsible for their own accommodations. The 
conference headquarters hotel is the Downtown Hilton Cincinnati 
Netherland Plaza, 35 West Fifth St., Cincinnati, OH 45202, 513-421-
9100. Special conference block rates are available through April 16, 
2015. 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 Mason Rick (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 Director Corner: Strategic Priorities for 2015 and 
Beyond
 Office of Compliance Strategic Priorities
 Advancements in Medical Device Software Technology
 Understanding and Preparing for the Revision of ISO13485
 Update from FDA's Office of Combination Products
 Unique Device Identification--Implementation
 FDA Inspections and Insights
 Understanding the Current Activities of the International 
Medical Device Regulators Forum
 European Union Medical Device/In Vitro Diagnostics Regulation 
Review
 Update from the Office of Device Evaluation
 Regulatory Submissions and Strategies
 Complaints, Corrective and Preventive Actions, and Recalls
 Regulatory Challenges in Asia
 Action Plan Writing
 Lunch Networking by Topic

    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 (Public Law 
104-121) by providing outreach activities by Government agencies to 
small businesses.

    Dated: February 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03116 Filed 2-13-15; 8:45 am]
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