15986 Federal Register / Vol. 76, No. 55 / Tuesday, March 22, 2011 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1990–F–0390] (Formerly 

Docket No. 90F–0074) 

Alpha Omega Technology, Inc.; Denial 

Without Prejudice of Food Additive 

Petition 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying a food 

additive petition (FAP 0M4181) 

proposing that the food additive 

regulations be amended to provide for 

the safe use of a source of irradiation to 

treat shellfish and finfish. 

DATES: This order is effective June 20, 

2011; except as to any provisions that 

may be stayed by the filing of proper 

objections. Submit either electronic or 

written objections and requests for a 

hearing by April 21, 2011. 

ADDRESSES: You may submit either 

electronic or written objections and 

requests for a hearing, identified by 

FDA–1990–F–0390, by any of the 

following methods: 

Electronic Submissions 

Submit electronic objections in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written objections in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Richard E. Bonnette, Center for Food 

Safety and Applied Nutrition (HFS– 

255), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 301–436–1235. 

SUPPLEMENTARY INFORMATION: In a notice 

published in the Federal Register of 

March 15, 1990 (55 FR 9772), FDA 

announced that a food additive petition 

(FAP 0M4181) had been filed by Alpha 

Omega Technology, Inc., 1279 Route 46 

East, Parsippany, NJ 07054. The petition 

proposed to amend the food additive 

regulations in § 179.26 Ionizing 

radiation for the treatment of food (21 

CFR 179.26) to provide for the safe use 

of a source of irradiation to treat finfish 

and shellfish. 

For any food additive petition, the 

burden is on the petitioner to submit to 

FDA data and information that are 

adequate for the Agency to determine 

that the proposed use of the additive 

under the specified conditions of use is 

safe (21 U.S.C. 348(c)(3)(A); 21 CFR 

171.1). Alpha Omega Technology, Inc., 

was informed of significant deficiencies 

in its petition by letters from FDA dated 

May 28, 1992, September 15, 1993, 

February 10, 1999, July 20, 2004, March 

19, 2009, and May 22, 2009. The 

deficiencies related primarily to the 

possibility of Clostridium botulinum 

outgrowth in packaged products, 

especially where the normal growth 

pattern of typical spoilage organisms 

could be changed by irradiation, thus 

reducing perception of spoilage. 

FDA noted that the data provided in 

the petition indicated that there was 

very little margin of safety with regard 

to the concern for C. botulinum 

outgrowth and toxin elaboration, 

particularly in irradiated fish stored at 

temperatures between 46 and 50 degrees 

Fahrenheit. FDA therefore requested 

data demonstrating that products 

irradiated at the maximum dose 

requested and subjected to some 

temperature abuse would show 

evidence of spoilage before showing 

evidence of toxicity. 

Alpha Omega Technology, Inc., has 

been unresponsive to these requests, 

and other efforts to contact the 

petitioner regarding the petition have 

not been successful. The petitioner has 

not provided sufficient data and 

information for the Agency to conclude 

that the proposed use of the food 

additive is safe in accordance with 

section 409 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 348). Consequently, FDA is 

denying the petition without prejudice 

to a future filing (21 U.S.C. 348(c)(1)(B), 

21 CFR 171.100(a)). 

This order is effective as shown in the 

DATES section of this document; except 

as to any provisions that may be stayed 

by the filing of proper objections. Any 

person who will be adversely affected 

by this order may file with the Division 

of Dockets Management (see ADDRESSES) 

either electronic or written objections. 

Each objection shall be separately 

numbered, and each numbered 

objection shall specify with particularity 

the provisions of the regulation to 

which objection is made and the 

grounds for the objection. Each 

numbered objection on which a hearing 

is requested shall specifically so state. 

Failure to request a hearing for any 

particular objection shall constitute a 

waiver of the right to a hearing on that 

objection. Each numbered objection for 

which a hearing is requested shall 

include a detailed description and 

analysis of the specific factual 

information intended to be presented in 

support of the objection in the event 

that a hearing is held. Failure to include 

such a description and analysis for any 

particular objection shall constitute a 

waiver of the right to a hearing on the 

objection. It is only necessary to send 

one set of documents. It is no longer 

necessary to send three copies of all 

documents. Identify documents with the 

docket number found in brackets in the 

heading of this document. Any 

objections received in response to the 

order may be seen in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

FDA will publish notice of the 

objections that the Agency has received 

or lack thereof in the Federal Register. 

Dated: March 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6623 Filed 3–21–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Food and Drug Administration/Xavier 

University Global 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 

University Global Medical Device 

Conference.’’ This 3-day public 

conference includes presentations from 

key FDA officials and industry experts. 

The public conference has three 

separate tracks of interest for quality, 

regulatory affairs, and clinical research 

professionals, and is intended for 

companies of all sizes and employees at 

all levels. 

Dates and Times: The public 

conference will be held on May 4, 2011, 

from 8:30 a.m. to 5 p.m.; May 5, 2011, 

from 8:30 a.m. to 5 p.m.; and May 6, 

2011, from 8:30 a.m. to 1 p.m. 

Location: The public conference will 

be held on the campus of Xavier 

University, 3800 Victory Pkwy., 


srobinson on DSKHWCL6B1PROD with NOTICES
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 


srobinson on DSKHWCL6B1PROD with NOTICES