[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Notices]
[Page 4915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01681]



[[Page 4915]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Food and Drug Administration/Xavier Medical Device Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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

SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in 
co-sponsorship with Xavier University, is announcing a public 
conference entitled ``FDA/Xavier Medical Device Conference (MedCon).'' 
This 3-day public conference includes presentations from key FDA 
officials and industry experts with small group break-out sessions. The 
conference is intended for companies of all sizes and employees at all 
levels.

DATES: The public conference will be held on May 4, 2016, from 8:30 
a.m. to 5 p.m.; May 5, 2016, from 8:30 a.m. to 5 p.m.; and May 6, 2016, 
from 8:30 a.m. to 12:05 p.m.

ADDRESSES: The public conference will be held on the campus of Xavier 
University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3016.

FOR FURTHER INFORMATION CONTACT: 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, Program Manager, Xavier Health, Xavier 
University, 3800 Victory Pkwy., Cincinnati, OH 45207-5471, 513-745-
3016, email: [email protected] or visit http://www.XavierMedCon.com.

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:

 Update from FDA's Office of Combination Products
 Center Director Corner: Strategic Priorities for 2016 and 
Beyond
 Office of Compliance Strategic Priorities
 Medical Device Innovation Consortium (MDIC)/Xavier University 
Medical Device Metrics Initiative
 Critical Thinking--Responding to FDA
 Working Through Challenges with Supplier Quality and Design--
What to Do and When
 FDA Inspections and Insights
 Canada's Changing Quality System Requirements
 European Medical Device Regulation Progress
 Update from the Office of Device Evaluation
 What to Expect with FDA's Program Alignment
 When to File a 510(k) for Modifications to Your Cleared Device
 Storing Clinical Data in the Cloud
 Regulatory Strategy for Innovation
 Internet and Social Media Concerns--FDA and Federal Trade 
Commission (FTC) Perspectives
 Navigating Japan's Regulatory Environment
 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 (Pub. L. 
104-121) by providing outreach activities by Government Agencies to 
small businesses.
    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 rates end February 3, 2016. Advance 
registration rates end on March 3, 2016. Standard registration rates 
begin March 4, 2016. There will be onsite registration. The cost of 
registration is as follows:

                                         Table 1--Registration Fees \1\
----------------------------------------------------------------------------------------------------------------
                                                                Early rate     Advance rate  (2/   Standard rate
                       Attendee type                         (through 2/3/16)     4/16-3/3/16)    (after 3/3/16)
----------------------------------------------------------------------------------------------------------------
Industry..................................................             $1,195             $1,495          $1,695
Small Business (<100 employees)...........................                900              1,000           1,200
Start-up Manufacturer.....................................                200                250             300
Academic..................................................                200                250             300
FDA/Government Employee...................................               Free               Free            Free
----------------------------------------------------------------------------------------------------------------
\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, Attn: 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 headquarter hotel is the Downtown Cincinnati Hilton 
Netherlands Plaza, 35 W. 5th St., Cincinnati, OH 45202, 513-421-9100. 
Special conference block rates are available through April 11, 2016. 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 FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance of the conference.

    Dated: January 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01681 Filed 1-27-16; 8:45 am]
 BILLING CODE 4164-01-P