Food Defense; Public Workshop, 59404-59405 [2012-23778]
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59404
Federal Register / Vol. 77, No. 188 / Thursday, September 27, 2012 / Notices
the other drug products listed in the
table in this document are no longer
being marketed.
Application No.
Drug
Applicant
NDA 012524 ........................
Abbott Laboratories, 100 Abbott Park Rd., Abbott Park,
IL 60064–3500.
Valeant Pharmaceuticals International, Inc., 4787 Levy
St., Montreal, Quebec H4R 2P9, Canada.
NDA 017577 ........................
ENDURON (methyclothiazide) Tablets, 2.5 milligrams
(mg) and 5 mg.
LIMBITROL and LIMBITROL DS (amitriptyline hydrochloride; chlordiazepoxide) Tablets, equivalent to
(EQ) 12.5 mg (base), 5 mg, and EQ 25 mg (base),
10 mg.
DITROPAN (oxybutynin chloride) Tablets, 5 mg ............
NDA 017950 ........................
WESTCORT (hydrocortisone valerate) Cream, 0.2% ....
NDA 018763 ........................
TOPICORT (desoximetasone) Ointment, 0.25% ............
NDA 020036 ........................
AREDIA (pamidronate disodium) Injection, 30 mg/vial ..
NDA 020038 ........................
FLUDARA (fludarabine phosphate) Injection, 50 mg/vial
NDA 016949 ........................
FDA has reviewed its records and,
under 314.161, has determined that the
drug products listed in this document
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue
to list the drug products listed in this
document in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs listed in this document are
unaffected by the discontinued
marketing of the products subject to
those NDAs. Additional ANDAs that
refer to these products may also be
approved by the Agency if they comply
with relevant legal and regulatory
requirements. If FDA determines that
labeling for these drug products should
be revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: September 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–23779 Filed 9–26–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
erowe on DSK2VPTVN1PROD with
[Docket No. FDA–2012–N–0001]
Food Defense; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
VerDate Mar<15>2010
15:00 Sep 26, 2012
Jkt 226001
Janssen Pharmaceuticals, Inc., 1125 TrentonHarbourton Rd., P.O. Box 200, Titusville, NJ 08560.
Ranbaxy Laboratories, Ltd., 600 College Road East,
suite 2100, Princeton, NJ 08540.
Taro Pharmaceuticals, Inc., 3 Skyline Dr., Hawthorne,
NY 10532.
Novartis Pharmaceuticals Corporation, One Health
Plaza, East Hanover, NJ 07936–1080.
Genzyme Corporation, 1850 K St. NW., suite 650,
Washington, DC 20006.
The Food and Drug
Administration (FDA), Office of
Regulatory Affairs (ORA), Southwest
Regional Office (SWRO), in cosponsorship with Oklahoma State
University (OSU), Robert M. Kerr Food
& Agricultural Products Center (FAPC),
is announcing a public workshop
entitled ‘‘Food Defense Workshop.’’
This public workshop is intended to
provide information about food defense
as it relates to food facilities such as
farms, manufacturers, processors,
distributors, retailers, and restaurants.
Date and Time: This public workshop
will be held on November 7 and 8, 2012,
from 7:45 a.m. to 4:15 p.m.
Location: The public workshop will
be held at the Robert M. Kerr Food &
Agricultural Products Center, Oklahoma
State University, 148 FAPC, Stillwater,
OK 74078–6055.
Contact: For information regarding
the workshop: David Arvelo, Food and
Drug Administration, Southwest
Regional Office, 4040 North Central
Expressway, suite 900, Dallas, TX
75204, 214–253–4952, Fax: 214–253–
4970, email: david.arvelo@fda.hhs.gov.
For information on accommodations:
Karen Smith or Andrea Graves at the
Robert M. Kerr Food & Agricultural
Products Center, Oklahoma State
University, 148 FAPC, Stillwater, OK
74078–6055, 405–744–6277, Fax: 405–
744–6313, or email:
karenl.smith@okstate.edu or
andrea.graves@okstate.edu. More
information is also available online at
https://www.fapc.biz/
fooddefense2012.html.
Registration: You are encouraged to
register by October 31, 2012. The
workshop has a registration fee to cover
the cost of facilities, materials, speakers,
and breaks. The registration fee is $350
for companies with 10 or more
SUMMARY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
employees or $250 for companies with
less than 10 employees. Seats are
limited; please submit your registration
as soon as possible. To register, please
complete the online registration form at
https://www.fapc.biz/
fooddefense2012.html. The workshop
will be filled in order of receipt of
registration. Those accepted into the
workshop will receive confirmation.
Registration will close after the
workshop is filled. Registration at the
site is not guaranteed but may be
possible on a space available basis on
the day of the public workshop
beginning at 7:45 a.m. Make checks
payable to: ‘‘FAPC.’’ If you need special
accommodations due to a disability,
please contact Karen Smith (see
Contact) at least 7 days in advance.
There are no registration fees for FDA
employees.
Transcripts: Transcripts of the public
workshop will not be available due to
the format of this workshop. Course
handouts may be requested after the
date of the public workshop by
contacting Karen Smith or Andrea
Graves (see Contact) at cost plus
shipping.
This
public workshop is being held in
response to the large volume of food
defense inquiries from food
manufacturers originating from the area
covered by the FDA Dallas District
Office. The Southwest Regional Office
presents this workshop to help achieve
objectives set forth in section 406 of the
Food and Drug Administration
Modernization Act of 1997 (21 U.S.C.
393), which include working closely
with stakeholders and maximizing the
availability and clarity of information to
stakeholders and the public. This is
consistent with the purposes of the
SUPPLEMENTARY INFORMATION:
E:\FR\FM\27SEN1.SGM
27SEN1
Federal Register / Vol. 77, No. 188 / Thursday, September 27, 2012 / Notices
Small Business Representative Program,
which are, in part, to respond to
industry inquiries, develop educational
materials, and sponsor workshops and
conferences to provide firms,
particularly small businesses, with
firsthand working knowledge of FDA’s
guidance. This workshop is also
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Pub. L. 104–121), as outreach
activities by Government Agencies to
small businesses.
The goal of this public workshop is to
present information that will enable
regulated industry to better comply with
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act), and to better understand FDA’s
food defense guidance, especially in
light of growing concerns about food
protection. Information presented will
be based on Agency position as
articulated through regulation,
guidance, and information previously
made available to the public. Topics to
be discussed at the workshop include
the following:
• Food defense awareness and
definitions,
• FDA food defense tools such as
ALERT and Employees FIRST,
• Regulations mandated by the
Bioterrorism Act,
• Food Defense Guidance from the
Food Safety and Inspection Service,
• Investigating food-related incidents
effectively,
• Physical plant security,
• Crisis management, and
• A food related emergency exercise
bundle (FREE–B) tabletop exercise on
food defense.
For more information, please visit
https://www.fapc.biz/
fooddefense2012.html. FDA expects that
participation in this public workshop
will provide regulated industry with
greater understanding of the Agency’s
regulatory and policy perspectives on
food protection, increase compliance
with FDA regulations, and heighten
food defense awareness.
erowe on DSK2VPTVN1PROD with
Dated: September 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–23778 Filed 9–26–12; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
15:00 Sep 26, 2012
Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel; Hearing—
Clinical Trials & Translational Research.
Date: October 19, 2012.
Time: 11 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6120
Executive Blvd., Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Christine A. Livingston,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institutes of
Health/NIDCD, 6120 Executive Blvd.—MSC
7180, Bethesda, MD 20892, (301) 496–8683,
livingsc@mail.nih.gov.
Name of Committee: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel;
Vestibular—Clinical Trials.
Date: October 23, 2012.
Time: 11 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6120
Executive Blvd., Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Christine A. Livingston,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institutes of
Health/NIDCD, 6120 Executive Blvd.—MSC
7180, Bethesda, MD 20892, (301) 496–8683,
livingsc@mail.nih.gov.
Name of Committee: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel;
Chemosensory Fellowship Application
Review.
Date: October 24, 2012.
Time: 10:30 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6120
Executive Blvd., Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Andrea B. Kelly, Ph.D.,
Scientific Review Officer, Division of
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
59405
Extramural Activities, National Institutes of
Health/NIDCD, 6120 Executive Blvd.—MSC
7180, Rockville, MD 20892, (301) 496–8683,
kellya2@nidcd.nih.gov.
Name of Committee: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel;
Auditory—CNS Stimulation & Prostheses
Clinical Trials.
Date: October 25, 2012.
Time: 9 a.m. to 11 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6120
Executive Blvd., Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Christine A. Livingston,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institutes of
Health/NIDCD, 6120 Executive Blvd.—MSC
7180, Bethesda, MD 20892 (301) 496–8683,
livingsc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.173, Biological Research
Related to Deafness and Communicative
Disorders, National Institutes of Health, HHS)
Dated: September 21, 2012.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–23751 Filed 9–26–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute On Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; NIAAA AA–1 Member
Conflict Applications.
Date: October 9, 2012.
Time: 2:30 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: NIAAA, Rockville, MD, (Telephone
Conference Call).
Contact Person: Richard A Rippe, Ph.D.,
Scientific Review Officer, National Institute
E:\FR\FM\27SEN1.SGM
27SEN1
Agencies
[Federal Register Volume 77, Number 188 (Thursday, September 27, 2012)]
[Notices]
[Pages 59404-59405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23778]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Food Defense; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory
Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with
Oklahoma State University (OSU), Robert M. Kerr Food & Agricultural
Products Center (FAPC), is announcing a public workshop entitled ``Food
Defense Workshop.'' This public workshop is intended to provide
information about food defense as it relates to food facilities such as
farms, manufacturers, processors, distributors, retailers, and
restaurants.
Date and Time: This public workshop will be held on November 7 and
8, 2012, from 7:45 a.m. to 4:15 p.m.
Location: The public workshop will be held at the Robert M. Kerr
Food & Agricultural Products Center, Oklahoma State University, 148
FAPC, Stillwater, OK 74078-6055.
Contact: For information regarding the workshop: David Arvelo, Food
and Drug Administration, Southwest Regional Office, 4040 North Central
Expressway, suite 900, Dallas, TX 75204, 214-253-4952, Fax: 214-253-
4970, email: david.arvelo@fda.hhs.gov.
For information on accommodations: Karen Smith or Andrea Graves at
the Robert M. Kerr Food & Agricultural Products Center, Oklahoma State
University, 148 FAPC, Stillwater, OK 74078-6055, 405-744-6277, Fax:
405-744-6313, or email: karenl.smith@okstate.edu or
andrea.graves@okstate.edu. More information is also available online at
https://www.fapc.biz/fooddefense2012.html.
Registration: You are encouraged to register by October 31, 2012.
The workshop has a registration fee to cover the cost of facilities,
materials, speakers, and breaks. The registration fee is $350 for
companies with 10 or more employees or $250 for companies with less
than 10 employees. Seats are limited; please submit your registration
as soon as possible. To register, please complete the online
registration form at https://www.fapc.biz/fooddefense2012.html. The
workshop will be filled in order of receipt of registration. Those
accepted into the workshop will receive confirmation. Registration will
close after the workshop is filled. Registration at the site is not
guaranteed but may be possible on a space available basis on the day of
the public workshop beginning at 7:45 a.m. Make checks payable to:
``FAPC.'' If you need special accommodations due to a disability,
please contact Karen Smith (see Contact) at least 7 days in advance.
There are no registration fees for FDA employees.
Transcripts: Transcripts of the public workshop will not be
available due to the format of this workshop. Course handouts may be
requested after the date of the public workshop by contacting Karen
Smith or Andrea Graves (see Contact) at cost plus shipping.
SUPPLEMENTARY INFORMATION: This public workshop is being held in
response to the large volume of food defense inquiries from food
manufacturers originating from the area covered by the FDA Dallas
District Office. The Southwest Regional Office presents this workshop
to help achieve objectives set forth in section 406 of the Food and
Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which
include working closely with stakeholders and maximizing the
availability and clarity of information to stakeholders and the public.
This is consistent with the purposes of the
[[Page 59405]]
Small Business Representative Program, which are, in part, to respond
to industry inquiries, develop educational materials, and sponsor
workshops and conferences to provide firms, particularly small
businesses, with firsthand working knowledge of FDA's guidance. This
workshop is also consistent with the Small Business Regulatory
Enforcement Fairness Act of 1996 (Pub. L. 104-121), as outreach
activities by Government Agencies to small businesses.
The goal of this public workshop is to present information that
will enable regulated industry to better comply with the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (the
Bioterrorism Act), and to better understand FDA's food defense
guidance, especially in light of growing concerns about food
protection. Information presented will be based on Agency position as
articulated through regulation, guidance, and information previously
made available to the public. Topics to be discussed at the workshop
include the following:
Food defense awareness and definitions,
FDA food defense tools such as ALERT and Employees FIRST,
Regulations mandated by the Bioterrorism Act,
Food Defense Guidance from the Food Safety and Inspection
Service,
Investigating food-related incidents effectively,
Physical plant security,
Crisis management, and
A food related emergency exercise bundle (FREE-B) tabletop
exercise on food defense.
For more information, please visit https://www.fapc.biz/fooddefense2012.html. FDA expects that participation in this public
workshop will provide regulated industry with greater understanding of
the Agency's regulatory and policy perspectives on food protection,
increase compliance with FDA regulations, and heighten food defense
awareness.
Dated: September 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23778 Filed 9-26-12; 8:45 am]
BILLING CODE 4160-01-P