Food and Drug Administration/Xavier University Medical Device Conference (MedCon), 16599 [2017-06699]
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Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices
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.
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:
gina.brackett@fda.hhs.gov.
For information regarding the
conference and registration: Marla
Phillips, Xavier Health, Xavier
University, 3800 Victory Pkwy.,
Cincinnati, OH 45207–5471, 513–745–
3073, email: phillipsm4@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:
• 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.
jstallworth on DSK7TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
15:11 Apr 04, 2017
Jkt 241001
• 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 FEES1
16599
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 https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–3560]
Determination That CEDAX (Ceftibuten
Dihydrate) for Oral Suspension, 90
Milligrams/5 Milliliters and 180
Milligrams/5 Milliliters, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that CEDAX (ceftibuten
Industry .........................................
1,695 dihydrate) for oral suspension, 90
Small Business (<100 employees)
1,200 milligrams (mg)/5 milliliters (mL) and
Start-up Manufacturer ...................
$300 180 mg/5 mL, were not withdrawn from
Academic ......................................
$300 sale for reasons of safety or
FDA/Government Employee .........
Free effectiveness. This determination will
1 The following forms of payment will be acallow FDA to approve abbreviated new
cepted: American Express, Visa, MasterCard, drug applications (ANDAs) for
and company checks.
ceftibuten dihydrate for oral suspension,
90 mg/5 mL and 180 mg/5 mL, if all
To register online for the public
other legal and regulatory requirements
conference, please visit the
are met.
‘‘Registration’’ link on the conference
Web site at https://
FOR FURTHER INFORMATION CONTACT:
www.XavierMedCon.com. FDA has
Anuj Shah, Center for Drug Evaluation
verified the Web site address, but is not
and Research, Food and Drug
responsible for subsequent changes to
Administration, 10903 New Hampshire
the Web site after this document
Ave., Bldg. 51, Rm. 6228, Silver Spring,
publishes in the Federal Register.
MD 20993–0002, 301–796–2246.
PO 00000
Standard
rate
Attendee type
Frm 00030
Fmt 4703
Sfmt 4703
SUMMARY:
E:\FR\FM\05APN1.SGM
05APN1
]]>Agencies
[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: gina.brackett@fda.hhs.gov.
For information regarding the conference and registration: Marla
Phillips, Xavier Health, Xavier University, 3800 Victory Pkwy.,
Cincinnati, OH 45207-5471, 513-745-3073, email: phillipsm4@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:
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 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, 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 https://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
