Food Defense Workshop; Public Workshop, 5442-5443 [E7-1865]
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Federal Register / Vol. 72, No. 24 / Tuesday, February 6, 2007 / Notices
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[FR Doc. E7–1866 Filed 2–5–07; 8:45 am]
BILLING CODE 6820–34–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food Defense Workshop; 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 cosponsorship with the University of
Arkansas (UA) Institute of Food Science
and Engineering (IFSE), is announcing a
public workshop entitled ‘‘Food Defense
Workshop.’’ This public workshop is
intended to provide information about
food defense, the regulations authorized
by the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act), and other related subjects to FDAregulated food facilities (farms,
manufacturers, processors, distributors,
retailers, and restaurants).
Date and Time: This public workshop
will be held on May 23 through 24,
2007, from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Continuing Education
Center, 2 East Center St., Fayetteville,
AR (located downtown).
Contact: 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, or e-mail:
david.arvelo@fda.hhs.gov.
For information on accommodation
options, contact Steven C. Seideman,
2650 North Young Ave., Institute of
Food Science and Engineering,
University of Arkansas, Fayetteville, AR
72704, 479–575–4221, FAX: 479–575–
2165, or email: seideman@uark.edu.
Registration: You are encouraged to
register by May 9, 2007. The University
of Arkansas has a $150 registration fee
to cover the cost of facilities, materials,
speakers, and breaks. Seats are limited;
please submit your registration as soon
as possible. Course space will be filled
in order of receipt of registration. Those
accepted into the course will receive
confirmation. Registration will close
after the course 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 8 a.m. The cost of
registration at the site is $200 payable
to: ‘‘The University of Arkansas.’’ If you
need special accommodations due to a
disability, please contact Steven C.
Seideman (see Contact section of this
document) at least 7 days in advance.
Registration Form Instructions: To
register, please complete the following
form and submit along with a check or
money order for $150 payable to the
‘‘The University of Arkansas.’’ Mail to:
Institute of Food Science and
Engineering, University of Arkansas,
2650 North Young Ave., Fayetteville,
AR 72704.
FOOD DEFENSE WORKSHOP REGISTRATION FORM
Name:
Affiliation:
Mailing Address:
City:
State:
Zip Code:
Phone:
FAX:
(
(
)
)
E-mail:
sroberts on PROD1PC70 with NOTICES
Special Accommodations Required:
Transcripts: Transcripts of the public
workshop will not be available due to
the format of this workshop. Workshop
handouts may be requested at cost
through the Freedom of Information
Office (HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page.
SUPPLEMENTARY INFORMATION: This
public workshop is being held in
response to the large volume of food
VerDate Aug<31>2005
16:03 Feb 05, 2007
Jkt 211001
defense concerns from FDA-regulated
food facilities (farms, manufacturers,
processors, distributors, retailers, and
restaurants) 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
PO 00000
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Fmt 4703
Sfmt 4703
consistent with the purposes of the
Small Business Representative Program,
which are in part to respond to industry
inquiries, develop educational
materials, sponsor workshops and
conferences to provide firms,
particularly small businesses, with
firsthand working knowledge of FDA’s
guidance, requirements, and compliance
policies. This workshop is also
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Public Law 104–121), as outreach
E:\FR\FM\06FEN1.SGM
06FEN1
Federal Register / Vol. 72, No. 24 / Tuesday, February 6, 2007 / Notices
activities by Government agencies to
small businesses.
The goal of this public workshop is to
present information that will enable
FDA-regulated food facilities (farms,
manufacturers, processors, distributors,
retailers, and restaurants) to better
comply with the regulations authorized
by the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act), and with food defense guidance,
especially in light of growing concerns
about food defense. 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: (1) Food defense awareness, (2)
ALERT: The basics, (3) FDA actions on
bioterrorism legislation (food supply),
(4) food recalls, (5) crisis management,
(6) food defense technologies and
methodologies, and other related topics.
FDA expects that participation in this
public workshop will provide regulated
industry with greater understanding of
the regulatory and policy perspectives
on food defense and increase voluntary
compliance and food defense
awareness.
Dated: January 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1865 Filed 2–5–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0031]
Global Harmonization Task Force,
Study Groups 1, 2, and 4; New
Proposed and Final Documents;
Availability
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of proposed and final
documents that have been prepared by
Study Groups 1, 2, and 4 of the Global
Harmonization Task Force (GHTF).
These documents represent a
harmonized proposal and
recommendation from the GHTF Study
Groups that may be used by
governments developing and updating
their regulatory requirements for
medical devices. These documents are
intended to provide information only
VerDate Aug<31>2005
16:03 Feb 05, 2007
Jkt 211001
and do not describe current regulatory
requirements; elements of these
documents may not be consistent with
current U.S. regulatory requirements.
FDA is requesting comments on these
documents.
DATES: Submit written or electronic
comments on any of the proposed
documents byMay 7, 2007. After May 7,
2007, written comments or electronic
comments may be submitted at any time
to the contact persons listed in this
document.
ADDRESSES: Submit written requests for
single copies of the documents to the
Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–443–8818. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit written comments concerning
this guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
For Study Group 1: Ginette Y.
Michaud, Chairperson, GHTF,
Study Group 1, Office of Device
Evaluation, Center for Devices and
Radiological Health (HFZ–480),
Food and Drug Administration,
9200 Corporate Blvd., Rockville,
MD 20850, 240–276–3700.
For Study Group 2: Mary Brady,
GHTF, Study Group 2, Office of
Surveillance and Biometrics, Center
for Devices and Radiological Health
(HFZ–530), Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850, 240–276–
3458.
For Study Group 4: Jacqueline Welch,
GHTF, Study Group 4, Office of
Compliance, Center for Devices and
Radiological Health (HFZ–320),
Food and Drug Administration,
2094 Gaither Rd., Rockville, MD
20850, 240–276–0115.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has participated in a number of
activities to promote the international
harmonization of regulatory
requirements. In September 1992, a
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Fmt 4703
Sfmt 4703
5443
meeting was held in Nice, France by
senior regulatory officials to evaluate
international harmonization. This
meeting led to the development of the
organization now known as the GHTF to
facilitate harmonization. Subsequent
meetings have been held on a yearly
basis in various locations throughout
the world.
The GHTF is a voluntary group of
representatives from national medical
device regulatory authorities and the
regulated industry. Since its inception,
the GHTF has been comprised of
representatives from five founding
members grouped into three
geographical areas: Europe, Asia-Pacific,
and North America, each of which
actively regulates medical devices using
its own unique regulatory framework.
The objective of the GHTF is to
encourage convergence at the global
level of regulatory systems of medical
devices to facilitate trade while
preserving the right of participating
members to address the protection of
public health by regulatory means
considered most suitable. One of the
ways this objective is achieved is by
identifying and developing areas of
international cooperation to facilitate
progressive reduction of technical and
regulatory differences in systems
established to regulate medical devices.
In an effort to accomplish these
objectives, the GHTF formed five study
groups to draft documents and carry on
other activities designed to facilitate
global harmonization. This notice is a
result of documents that have been
developed by three of the Study Groups
(1, 2, and 4).
Study Group 1 was initially tasked
with the responsibility of identifying
differences between various regulatory
systems. In 1995, the group was asked
to propose areas of potential
harmonization for premarket device
regulations and possible guidance that
could help lead to harmonization. As a
result of its efforts, this group has
developed proposed document
SG1(PD)N044:2006. SG1(PD)N044:2006
(proposed document), entitled ‘‘Role of
Standards,’’ provides guidance on the
use of standards by a manufacturer
when designing a medical device and,
subsequently, when demonstrating the
device conforms to relevant essential
safety and performance criteria. FDA
seeks comment on the document and
particularly ‘‘Section 5.2 Revision or
Replacement of Recognised Standards.’’
This section addresses the use of a
recognized standard during the
transitional period when it is being
replaced by a revised version.
Study Group 4 was initially tasked
with the responsibility of developing
E:\FR\FM\06FEN1.SGM
06FEN1
]]>Agencies
[Federal Register Volume 72, Number 24 (Tuesday, February 6, 2007)]
[Notices]
[Pages 5442-5443]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1865]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Food Defense Workshop; 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
the University of Arkansas (UA) Institute of Food Science and
Engineering (IFSE), is announcing a public workshop entitled ``Food
Defense Workshop.'' This public workshop is intended to provide
information about food defense, the regulations authorized by the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (the Bioterrorism Act), and other related subjects to FDA-
regulated food facilities (farms, manufacturers, processors,
distributors, retailers, and restaurants).
Date and Time: This public workshop will be held on May 23 through
24, 2007, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Continuing
Education Center, 2 East Center St., Fayetteville, AR (located
downtown).
Contact: 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, or e-mail:
david.arvelo@fda.hhs.gov.
For information on accommodation options, contact Steven C.
Seideman, 2650 North Young Ave., Institute of Food Science and
Engineering, University of Arkansas, Fayetteville, AR 72704, 479-575-
4221, FAX: 479-575-2165, or email: seideman@uark.edu.
Registration: You are encouraged to register by May 9, 2007. The
University of Arkansas has a $150 registration fee to cover the cost of
facilities, materials, speakers, and breaks. Seats are limited; please
submit your registration as soon as possible. Course space will be
filled in order of receipt of registration. Those accepted into the
course will receive confirmation. Registration will close after the
course 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 8 a.m. The cost of registration at the site is $200
payable to: ``The University of Arkansas.'' If you need special
accommodations due to a disability, please contact Steven C. Seideman
(see Contact section of this document) at least 7 days in advance.
Registration Form Instructions: To register, please complete the
following form and submit along with a check or money order for $150
payable to the ``The University of Arkansas.'' Mail to: Institute of
Food Science and Engineering, University of Arkansas, 2650 North Young
Ave., Fayetteville, AR 72704.
Food Defense Workshop Registration Form
Name: ......................... ...... .........................
------------------------------------------------------------------------
Affiliatio ......................... ...... .........................
n:
------------------------------------------------------------------------
Mailing ......................... ...... .........................
Address:
------------------------------------------------------------------------
City: ......................... State: .........................
------------------------------------------------------------------------
Zip Code: ......................... ...... .........................
------------------------------------------------------------------------
Phone: ( ) ......................... ...... .........................
------------------------------------------------------------------------
FAX: ( ) ......................... ...... .........................
------------------------------------------------------------------------
E-mail: ......................... ...... .........................
------------------------------------------------------------------------
Special Accommodations Required: .........................
------------------------------------------------------------------------
Transcripts: Transcripts of the public workshop will not be
available due to the format of this workshop. Workshop handouts may be
requested at cost through the Freedom of Information Office (HFI-35),
Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville,
MD 20857, approximately 15 working days after the public workshop at a
cost of 10 cents per page.
SUPPLEMENTARY INFORMATION: This public workshop is being held in
response to the large volume of food defense concerns from FDA-
regulated food facilities (farms, manufacturers, processors,
distributors, retailers, and restaurants) 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 Small Business Representative Program, which are in part to respond
to industry inquiries, develop educational materials, sponsor workshops
and conferences to provide firms, particularly small businesses, with
firsthand working knowledge of FDA's guidance, requirements, and
compliance policies. This workshop is also consistent with the Small
Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-
121), as outreach
[[Page 5443]]
activities by Government agencies to small businesses.
The goal of this public workshop is to present information that
will enable FDA-regulated food facilities (farms, manufacturers,
processors, distributors, retailers, and restaurants) to better comply
with the regulations authorized by the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism
Act), and with food defense guidance, especially in light of growing
concerns about food defense. 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: (1) Food defense awareness, (2)
ALERT: The basics, (3) FDA actions on bioterrorism legislation (food
supply), (4) food recalls, (5) crisis management, (6) food defense
technologies and methodologies, and other related topics. FDA expects
that participation in this public workshop will provide regulated
industry with greater understanding of the regulatory and policy
perspectives on food defense and increase voluntary compliance and food
defense awareness.
Dated: January 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-1865 Filed 2-5-07; 8:45 am]
BILLING CODE 4160-01-S
