Food Protection; Public Workshop, 6641-6642 [E9-2814]
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Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
persons with a total of 90 days to submit
comments before FDA begins work on
the final version of the guidance. The
agency believes that this 30-day
extension allows adequate time for
interested persons to submit comments
without significantly delaying FDA
consideration of these important issues.
II. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on this document. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://
www.regulations.gov.
Dated: February 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–2800 Filed 2–9–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Food Labeling Workshop; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
erowe on PROD1PC63 with NOTICES
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA), Office of
Regulatory Affairs, Southwest Regional
Small Business Representative (SWR
SBR) Program, in collaboration with The
University of Arkansas, is announcing a
public workshop entitled ‘‘Food
Labeling Workshop.’’ This public
workshop is intended to provide
information about FDA food labeling
regulations and other related subjects to
the regulated industry, particularly
small businesses and startups.
Date and Time: This public workshop
will be held on April 21, 2009, from 8
a.m. to 5 p.m., and on April 22, 2009,
from 8 a.m. to 4 p.m.
VerDate Nov<24>2008
18:40 Feb 09, 2009
Jkt 217001
Location: The public workshop will
be held at the Continuing Education
Center, Two East Center St.,
Fayetteville, AR (located downtown).
Contact: David Arvelo, Small
Business Representative, 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 & Engineering, University
of Arkansas, Fayetteville, AR 72704,
479–575–4221, FAX: 479–575–2165, or
e–mail: seideman@uark.edu.
Registration: You are encouraged to
register by April 10, 2009. The
University of Arkansas has a $250
registration fee to cover the cost of
facilities, materials, 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
$350 payable to: ‘‘The University of
Arkansas.’’ If you need special
accommodations due to a disability,
please contact Steven C. Seideman (see
Contact) at least 14 days in advance.
Registration Instructions: To register,
please submit your name, affiliation,
mailing address, phone/fax number, and
e–mail, along with a check or money
order for $250 payable to the ‘‘The
University of Arkansas.’’ Mail to:
Institute of Food Science & Engineering,
University of Arkansas, 2650 North
Young Ave., Fayetteville, AR 72704.
Transcripts: Transcripts of the public
workshop will not be available due to
the format of this workshop. Course
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
labeling inquiries from small food
manufacturers and startups originating
from the area covered by the FDA Dallas
District Office. The SWR SBR presents
these workshops to help achieve
objectives set forth in section 406 of the
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
6641
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 SBR
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 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
activities by government agencies to
small businesses.
The goal of this public workshop is to
present information that will enable
manufacturers and regulated industry to
better comply with labeling
requirements, especially in light of
growing concerns about obesity and
food allergens. Information presented
will be based on agency position as
articulated through regulation,
compliance policy guides, and
information previously made available
to the public. Topics to be discussed at
the workshop include: (1) Mandatory
label elements, (2) nutrition labeling
requirements, (3) health and nutrition
claims, (4) the Food Allergen Labeling
and Consumer Protection Act of 2004,
and (5) special labeling issues such as
exemptions. FDA expects that
participation in this public workshop
will provide regulated industry with
greater understanding of the regulatory
and policy perspectives on food labeling
and increase voluntary compliance.
Dated: January 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–2811 Filed 2–9–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Food Protection; Public Workshop
AGENCY:
Food and Drug Administration,
HHS
ACTION:
Notice of public workshop
The Food and Drug Administration
(FDA), Office of Regulatory Affairs
(ORA), Southwest Regional Office
(SWRO), in co-sponsorship with the
University of Arkansas Institute of Food
E:\FR\FM\10FEN1.SGM
10FEN1
erowe on PROD1PC63 with NOTICES
6642
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
Science and Engineering (IFSE), is
announcing a public workshop entitled
‘‘Food Protection Workshop.’’ This
public workshop is intended to provide
information about food safety, food
defense, the regulations authorized by
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act), and other subjects related to the
Food Protection Plan 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 May 19 and 20, 2009,
from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Continuing Education
Center, Two East Center St.,
Fayetteville, AR (located downtown).
Contact Person: Regarding
information on accommodation options:
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.
Regarding this document and all
other information: 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.
Registration: You are encouraged to
register by May 8, 2009. The University
of Arkansas has a $250 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 it 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 $350 payable
to: The University of Arkansas. If you
need special accommodations due to a
disability, please contact Steven C.
Seideman (see Contact Person) at least
14 days in advance.
To register, please submit your name,
affiliation, mailing address, phone/fax
number, and e-mail, along with a check
or money order for $250 payable to: The
University of Arkansas. Mail to:
Institute of Food Science and
Engineering, University of Arkansas,
2650 North Young Ave., Fayetteville,
AR 72704.
Transcripts: Transcripts of the public
workshop will not be available due to
VerDate Nov<24>2008
14:17 Feb 09, 2009
Jkt 217001
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.
12A–16, 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
protection concerns from food facilities,
such as 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
activities by Government agencies to
small businesses.
The goal of this public workshop is to
present information that will enable
food facilities (such as farms,
manufacturers, processors, distributors,
retailers, and restaurants) to better
comply with the regulations authorized
by the Bioterrorism Act, and with food
protection guidance, especially in light
of growing concerns about food safety
and 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) Employees FIRST, (4)
FDA Actions on Bioterrorism
Legislation (Food Supply), (5)
CARVER+Shock Software Tool, (6) Food
Recalls, (7) Crisis Management, (8) Food
Protection 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 guidance
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
perspectives on food protection and
increase voluntary compliance and food
defense awareness.
Dated: January 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–2814 Filed 2–9–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2008–M–0522, FDA–
2008–M–0425, FDA–2008–M–0426, FDA–
2008–M–0478, FDA–2008–M–0402, FDA–
2008–M–0437, FDA–2008–M–0477, FDA–
2008–M–0467, FDA–2008–M–0501, FDA–
2008–M–0515]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
agency’s Division of Dockets
Management.
ADDRESSES: Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
number as listed in Table 1 of this
document when submitting a written
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the summaries of safety and
effectiveness.
FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, Center for Devices and
Radiological Health (HFZ–402), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–4010.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register. Instead,
E:\FR\FM\10FEN1.SGM
10FEN1
]]>Agencies
[Federal Register Volume 74, Number 26 (Tuesday, February 10, 2009)]
[Notices]
[Pages 6641-6642]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2814]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Food Protection; Public Workshop
AGENCY: Food and Drug Administration, HHS
ACTION: Notice of public workshop
-----------------------------------------------------------------------
The Food and Drug Administration (FDA), Office of Regulatory
Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with
the University of Arkansas Institute of Food
[[Page 6642]]
Science and Engineering (IFSE), is announcing a public workshop
entitled ``Food Protection Workshop.'' This public workshop is intended
to provide information about food safety, food defense, the regulations
authorized by the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (the Bioterrorism Act), and other subjects
related to the Food Protection Plan 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 May 19 and 20,
2009, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Continuing
Education Center, Two East Center St., Fayetteville, AR (located
downtown).
Contact Person: Regarding information on accommodation options:
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.
Regarding this document and all other information: 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.
Registration: You are encouraged to register by May 8, 2009. The
University of Arkansas has a $250 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 it
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
$350 payable to: The University of Arkansas. If you need special
accommodations due to a disability, please contact Steven C. Seideman
(see Contact Person) at least 14 days in advance.
To register, please submit your name, affiliation, mailing address,
phone/fax number, and e-mail, along with a check or money order for
$250 payable to: The University of Arkansas. Mail to: Institute of Food
Science and Engineering, University of Arkansas, 2650 North Young Ave.,
Fayetteville, AR 72704.
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. 12A-16, 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 protection concerns from food
facilities, such as 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 activities by Government agencies to small
businesses.
The goal of this public workshop is to present information that
will enable food facilities (such as farms, manufacturers, processors,
distributors, retailers, and restaurants) to better comply with the
regulations authorized by the Bioterrorism Act, and with food
protection guidance, especially in light of growing concerns about food
safety and 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) Employees FIRST, (4) FDA Actions on Bioterrorism Legislation (Food
Supply), (5) CARVER+Shock Software Tool, (6) Food Recalls, (7) Crisis
Management, (8) Food Protection 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 guidance perspectives on food protection and
increase voluntary compliance and food defense awareness.
Dated: January 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-2814 Filed 2-9-09; 8:45 am]
BILLING CODE 4160-01-S
