Food and Drug Administration/Xavier University Global Medical Device Conference, 15986-15987 [2011-6619]
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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.
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:
SUMMARY:
Electronic Submissions
Submit electronic objections in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
srobinson on DSKHWCL6B1PROD with NOTICES
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
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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
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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.
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.,
SUMMARY:
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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
srobinson on DSKHWCL6B1PROD with NOTICES
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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17:11 Mar 21, 2011
Jkt 223001
• 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
PO 00000
Frm 00054
Fmt 4703
Sfmt 9990
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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]]>Agencies
[Federal Register Volume 76, Number 55 (Tuesday, March 22, 2011)]
[Notices]
[Pages 15986-15987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6619]
-----------------------------------------------------------------------
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.,
[[Page 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
------------------------------------------------------------------------
Fee by
Attendee April 3, Fee by May
2011 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 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.
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 Non-Compliance In Clinical
Trials.
Risk Management and Design Controls.
510(k) SE Decision Making Process.
Warning Letter Trends for Sponsor-Monitors 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
Investigator-Initiated 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
