Food Defense; Public Workshop, 59404-59405 [2012-23778]

Download as PDF 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FDA has reviewed its records and, under 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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
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