Food and Drug Administration/Xavier Medical Device Conference, 4915 [2016-01681]
Agencies
[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:
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 https://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 https://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
https://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
