Food Defense Workshop; Public Workshop, 60505-60506 [2011-25114]
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Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / Notices
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
§ 330.14 have been approved under
OMB control number 0910–0688. The
collections of information in 21 CFR
part 25 and the guidance for industry
entitled ‘‘Environmental Assessment of
Human Drug and Biologics
Applications,’’ which are referenced in
the guidance announced in this
document, are approved under OMB
control number 0910–0322.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: September 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–25118 Filed 9–28–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0690]
Center for Drug Evaluation and
Research, Approach to Addressing
Drug Shortage; Public Workshop;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is opening a
comment period for the notice of public
workshop published in the Federal
Register of July 28, 2011 (76 FR 45268).
In that notice, FDA announced a public
workshop regarding the approach of the
Center for Drug Evaluation and Research
to addressing drug shortages. FDA is
opening a comment period in light of
public interest in this topic and in order
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to gain additional insight about the
causes and impact of drug shortages,
and possible strategies for preventing or
mitigating drug shortages.
DATES: Either electronic or written
comments will be accepted after the
workshop until December 23, 2011.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Christine Moser or Lori Benner, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6202,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA held a public workshop
regarding CDER’s current approach to
addressing drug shortages. Given the
increasing number of drug shortages and
the attendant safety concerns for the
public’s health, it is important to
discuss the causes of these shortages, as
well as strategies to address them. This
public workshop focused on collecting
information and gaining perspective
from professional societies, patient
advocates, industry, consumer groups,
health care professionals, researchers,
and other interested persons. The topics
discussed: How CDER becomes aware of
drug shortages, Reasons behind drug
shortages, Determination of medically
necessary products, CGMP (current
good manufacturing practice) and other
compliance issues, Actions taken when
a drug shortage occurs, and Outcomes of
mitigated drug shortages. Additional
discussions included the public health
impact of drug shortages and what
measures can be taken to prevent the
occurrence of a drug shortage. The
Agency encouraged professional
societies, patient advocates, industry,
consumer groups, health care
professionals, researchers, and other
interested persons to attend this public
workshop.
II. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov, approximately 45
days after the public workshop. It may
be viewed at the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
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60505
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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.
Dated: September 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–25116 Filed 9–28–11; 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 Defense Workshop; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Office of Regulatory Affairs,
Southwest Regional Office (SWRO), in
cosponsorship with Oklahoma State
University, 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 2, 2011, from
8 a.m. to 5 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: David Arvelo, Office of
Regulatory Affairs, Food and Drug
Administration, Southwest Regional
Office, 4040 North Central Expressway,
suite 900, Dallas, TX 75204, 214–253–
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60506
Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / Notices
4952, FAX: 214–253–4970, e-mail:
david.arvelo@fda.hhs.gov.
For information on accommodation
options, contact conference coordinator
Karen Smith or Andrea Graves at the
Robert M. Kerr Food & Agricultural
Products Center, Oklahoma State
University, 148 FAPC, Stillwater, OK
74078–6055, 405–744–6071, FAX: 405–
744–6313, or e-mail:
karenl.smith@okstate.edu or
andrea.graves@okstate.edu. More
information is also available online at
https://www.fapc.biz/fooddefense.html.
(FDA has verified the Web site address,
but FDA is not responsible for any
subsequent changes to the Web site after
this document publishes in the Federal
Register.)
Registration: You are encouraged to
register by October 21, 2011. The
workshop 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. 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 8 a.m. The cost of
registration at the site is $200 payable to
FAPC. There is no registration fee for
FDA employees.
If you need special accommodations
due to a disability, please contact Karen
Smith (see Contact) at least 7 days in
advance.
Registration Form Instructions: To
register, please complete the online
registration form at https://www.fapc.biz/
fooddefense.html.
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 through the
contact persons (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 SWRO 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 Southwest Regional
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15:29 Sep 28, 2011
Jkt 223001
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
regulations and compliance policies.
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 regulations authorized by the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002
(the Bioterrorism Act) and to better
understand FDA’s food defense
guidance documents, especially in light
of growing concerns about food
protection. Information that FDA
presents 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
(both by FDA and non-FDA speakers)
include: (1) Food defense awareness and
definitions, (2) FDA food defense tools
such as ALERT and Employees FIRST,
(3) regulations issued under the
Bioterrorism Act, (4) food defense
guidance documents, (5) investigating
food-related incidents effectively, (6)
physical plant security, (7) crisis
management, and other related topics.
For more information, please visit
https://www.fapc.biz/fooddefense.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 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–25114 Filed 9–28–11; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
and Request for Nominations for a
Nonvoting Industry Representative on
the Vaccines and Biological Products
Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of a
nonvoting industry representative to
serve on the Vaccines and Related
Biological Products Advisory
Committee for the Center for Biologics
Evaluation and Research (CBER) notify
FDA in writing. FDA is also requesting
nominations for a nonvoting industry
representative to serve the Vaccines and
Related Biological Products Advisory
Committee. A nominee may either be
self-nominated or nominated by an
organization to serve as a nonvoting
industry representative. Nomination
will be accepted for current vacancies
effective with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
the FDA by October 31, 2011, for the
vacancy listed in this document.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by October 31, 2011.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Donald Jehn (see FOR FURTHER
INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Donald Jehn, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852–
1448, 301–827–0314, FAX: 301–827–
0294, e-mail: donald.jehn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative on the CBER
Advisory Committee.
SUMMARY:
I. Vaccines and Related Biological
Products Advisory Committee
The Vaccines and Related Biological
Products Advisory Committee (the
Committee) advises the Commissioner
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]]>Agencies
[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60505-60506]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25114]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Food Defense Workshop; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA), Office of Regulatory
Affairs, Southwest Regional Office (SWRO), in cosponsorship with
Oklahoma State University, 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 2,
2011, from 8 a.m. to 5 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: David Arvelo, Office of Regulatory Affairs, Food and Drug
Administration, Southwest Regional Office, 4040 North Central
Expressway, suite 900, Dallas, TX 75204, 214-253-
[[Page 60506]]
4952, FAX: 214-253-4970, e-mail: david.arvelo@fda.hhs.gov.
For information on accommodation options, contact conference
coordinator Karen Smith or Andrea Graves at the Robert M. Kerr Food &
Agricultural Products Center, Oklahoma State University, 148 FAPC,
Stillwater, OK 74078-6055, 405-744-6071, FAX: 405-744-6313, or e-mail:
karenl.smith@okstate.edu or andrea.graves@okstate.edu. More information
is also available online at https://www.fapc.biz/fooddefense.html. (FDA
has verified the Web site address, but FDA is not responsible for any
subsequent changes to the Web site after this document publishes in the
Federal Register.)
Registration: You are encouraged to register by October 21, 2011.
The workshop 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. 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 8 a.m. The cost of registration at the site is
$200 payable to FAPC. There is no registration fee for FDA employees.
If you need special accommodations due to a disability, please
contact Karen Smith (see Contact) at least 7 days in advance.
Registration Form Instructions: To register, please complete the
online registration form at https://www.fapc.biz/fooddefense.html.
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 through the contact
persons (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 SWRO 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 Southwest Regional 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 regulations and compliance policies. 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 regulations
authorized by the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (the Bioterrorism Act) and to better
understand FDA's food defense guidance documents, especially in light
of growing concerns about food protection. Information that FDA
presents 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 (both by FDA and non-FDA
speakers) include: (1) Food defense awareness and definitions, (2) FDA
food defense tools such as ALERT and Employees FIRST, (3) regulations
issued under the Bioterrorism Act, (4) food defense guidance documents,
(5) investigating food-related incidents effectively, (6) physical
plant security, (7) crisis management, and other related topics. For
more information, please visit https://www.fapc.biz/fooddefense.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 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25114 Filed 9-28-11; 8:45 am]
BILLING CODE 4160-01-P
