Amended Notice of Establishment, 15987 [2011-6742]
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15987
Federal Register / Vol. 76, No. 55 / Tuesday, March 22, 2011 / Notices
Cincinnati, OH 45207, 513–745–3073 or
513–745–3396.
Contact Persons:
For information regarding this notice:
Gina Brackett, Food and Drug
Administration, 6751 Steger Dr.,
Cincinnati, OH 45237, 513–679–2700,
ext 167, FAX: 513–679–2772, e-mail:
gina.brackett@fda.hhs.gov.
For information regarding the
conference and registration: Marla
Phillips, Xavier University, 3800
Victory Pkwy., Cincinnati, OH 45207,
513–745–3073, e-mail:
phillipsm4@xavier.edu.
Registration: There is a registration
fee. The conference registration fees
cover the cost of the presentations,
training materials, receptions,
breakfasts, lunches, and dinners for the
3 days of the conference. Early
registration ends April 3, 2011.
Standard registration ends May 2, 2011.
There will be onsite registration. The
cost of registration is as follows:
TABLE 1—REGISTRATION FEES
Fee by April
3, 2011
Attendee
Fee by May
3, 2011
$995
800
600
140
$1,200
1,000
750
140
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Industry ............................................................................................................................................................................
Small Business (<100 employees) ..................................................................................................................................
Academic .........................................................................................................................................................................
FDA/Government Employee ............................................................................................................................................
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 and fax numbers, e-mail, and
payment information for the fee to
Xavier University, Attention: Sue
Bensman, 3800 Victory Pkwy.,
Cincinnati, OH 45207. An e-mail 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 12,
2011. 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 Contact Persons) at least 7 days in
advance of the conference.
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:
• Changes Within the Center for
Devices and Radiological Health (CDRH)
That Will Impact Our Industry.
• 510(k) Changes: Panel Discussion.
• Combination Products Panel.
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• Update on Quality System
Regulations. Warning Letter and
Enforcement Action Trends.
• MDUFMA Legislation.
• Corrective and Preventive Actions.
• Clinical Data Requirement
Changes—Premarket Clearance.
• Reimbursement Panel.
• MDR Reporting/Vigilance.
• Ethical Issues Leading to NonCompliance In Clinical Trials.
• Risk Management and Design
Controls.
• 510(k) SE Decision Making Process.
• Warning Letter Trends for SponsorMonitors and CRO’s.
• Supplier Controls.
• Advertising, and Promotion and
Labeling Pre- and Post-Market.
• Ensuring Site Compliance in
Clinical Trials.
• FDA’s Bioresearch Monitoring
Program–Overview and Current
Activities.
• Inspection Readiness.
• Training.
• International Regulatory Update.
• FDCA, Anti Kickback and False
Claims Act, Implications of InvestigatorInitiated Trials.
• Recalls, Requirements and
Challenges.
• CE Mark.
• Adverse Event Reporting During
Clinical Investigation in the EU.
• Clinical Evaluation for EU Market
Access.
• Using Electronic Medical Records.
• Cooperative Research Activities
Between Academia and Industry.
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
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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.
Dated: March 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–6619 Filed 3–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Amended Notice of Establishment
Notice is hereby given as a correction
in the announcement of the
establishment of the NCI–Frederick
Advisory Committee, which was
published in the Federal Register on
March 15, 2011, 75 FR 14035.
This FRN is amended to replace the
word ‘‘Council’’ used in the second
paragraph to the word ‘‘Committee’’.
Dated: March 16, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–6742 Filed 3–21–11; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 76, Number 55 (Tuesday, March 22, 2011)]
[Notices]
[Page 15987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6742]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Amended Notice of Establishment
Notice is hereby given as a correction in the announcement of the
establishment of the NCI-Frederick Advisory Committee, which was
published in the Federal Register on March 15, 2011, 75 FR 14035.
This FRN is amended to replace the word ``Council'' used in the
second paragraph to the word ``Committee''.
Dated: March 16, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-6742 Filed 3-21-11; 8:45 am]
BILLING CODE 4140-01-P
