[Federal Register Volume 82, Number 64 (Wednesday, April 5, 2017)]
[Notices]
[Page 16599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06699]
[[Page 16599]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0001]
Food and Drug Administration/Xavier University Medical Device
Conference (MedCon)
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 University 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 3, 2017, from 8:30
a.m. to 5 p.m.; May 4, 2017, from 8:30 a.m. to 5 p.m.; and May 5, 2017,
from 8:30 a.m. to 12:30 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: Marla
Phillips, Xavier Health, Xavier University, 3800 Victory Pkwy.,
Cincinnati, OH 45207-5471, 513-745-3073, 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:
Center Director Corner: Strategic Priorities for 2017 and
Beyond.
European Union (EU) Regulations--Exploring the Unknown.
Impact of the New EU Regulations on Your Global Regulatory
Strategy.
Digital Health--Key Focus Areas for FDA and Industry.
Office of Compliance Strategic Priorities.
Update from the Office of Device Evaluation.
FDA Insight on the 510(k) Modifications Guidance.
510(k) Modifications: To submit or not to submit?
Your Contract Manufacturer Received a Warning Letter. What
Now?
Defending Claims for Your Device.
The Impact of Cultural Misalignment . . . . and the Path
Forward.
The Importance of Quality and Regulatory throughout the
Merger and Acquisition Lifecycle--Landmines or Opportunities.
What to Expect with FDA's Program Alignment?
Investigator Insights and Breaking News.
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. There will be onsite registration. The cost of registration
is as follows:
Table 1--Registration Fees\1\
------------------------------------------------------------------------
Standard
Attendee type rate
------------------------------------------------------------------------
Industry..................................................... 1,695
Small Business (<100 employees).............................. 1,200
Start-up Manufacturer........................................ $300
Academic..................................................... $300
FDA/Government Employee...................................... 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, Attention: Marla Phillips, 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 West 5th St., Cincinnati, OH, 45202, 513-421-
9100. Special Conference Block rates are available through April 11,
2017. 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 FOR FURTHER
INFORMATION CONTACT) at least 7 days in advance of the conference.
Dated: March 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06699 Filed 4-4-17; 8:45 am]
BILLING CODE 4164-01-P