Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 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: 

gina.brackett@fda.hhs.gov. 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: rickm@xavier.edu 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

Attendee type Early rate 

(through 2/3/16) 

Advance rate 

(2/4/16–3/3/16) 

Standard rate 

(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 

1The 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 


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