Federal Register / Vol. 76, No. 55 / Tuesday, March 22, 2011 / Notices 15987 

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

Attendee Fee by April 

3, 2011 

Fee by May 

3, 2011 

Industry ............................................................................................................................................................................ $995 $1,200 

Small Business (<100 employees) .................................................................................................................................. 800 1,000 

Academic ......................................................................................................................................................................... 600 750 

FDA/Government Employee ............................................................................................................................................ 140 140 

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 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 

http://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. 

• 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 

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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