Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Public Meeting, 6762-6764 [2013-02089]
Download as PDF
<![CDATA[
6762
Federal Register / Vol. 78, No. 21 / Thursday, January 31, 2013 / Proposed Rules
Control(s)
*
or .e, 9A110 (for items that are
‘‘specially designed’’ for non-military
unmanned air vehicles controlled by
9A012), 9B105, 9B106, 9B115, 9B116,
9D101, or 9D104.
Country chart
*
*
*
*
License Requirements Notes: * * *
*
*
*
*
*
*
List of Items Controlled
Unit: * * *
Related Controls: (1) See also 9E102. (2)
See also 1E002.f for ‘‘technology’’ for the
repair of controlled structures, laminates or
materials. (3) ‘‘Technology’’ that is required
for the ‘‘production’’ of equipment described
in ECCNs 9A004 (except for items that are
subject to the EAR) or 9A005 to 9A011 is
subject to the export licensing authority of
the U.S. Department of State, Directorate of
Defense Trade Controls (see 22 CFR part
121).
Related Definitions: * * *
Items: * * *
19. In Supplement No. 1 to part 774
(the Commerce Control List), Category
9—Aerospace and Propulsion, ECCN
9E101 is amended by revising the
heading of the ECCN and by revising the
‘‘Related Controls’’ paragraph in the List
of Items Controlled to read as follows:
■
9E101 ‘‘Technology’’ according to the
General Technology Note for the
‘‘development’’ or ‘‘production’’ of
commodities or ‘‘software’’ controlled
by ECCN 9A012, 9A101 (except for items
in 9A101.b that are subject to the ITAR,
see 22 CFR part 121), 9A106.d or .e,
9A110 (for items that are ‘‘specially
designed’’ for non-military unmanned
air vehicles controlled by 9A012),
9C110, 9D101, or 9D104.
*
*
*
*
*
List of Items Controlled
Unit: * * *
Related Controls: ‘‘Technology’’ that is
required for items specified in ECCNs
9A101.b (except for items that are subject
to the EAR), 9A104, 9A105, 9A106.a, .b,
and .c, 9A107 to 9A109, 9A110 (for items
that are ‘‘specially designed’’ for use in
missile systems and subsystems), 9A111,
9A115 to 9A119, 9D103, and 9D105 is
subject to the export licensing authority of
the U.S. Department of State, Directorate of
Defense Trade Controls (see 22 CFR part
121).
Related Definitions: * * *
Items: * * *
20. In Supplement No. 1 to part 774
(the Commerce Control List), Category
9—Aerospace and Propulsion, ECCN
9E102 is amended by revising the
heading of the ECCN and by revising the
‘‘Related Controls’’ paragraph in the List
of Items Controlled to read as follows:
sroberts on DSK5SPTVN1PROD with
■
9E102 ‘‘Technology’’ according to the
General Technology Note for the ‘‘use’’
of commodities or ‘‘software’’ controlled
by ECCN 9A004 (except for items in
9A004 that are subject to the ITAR, see
22 CFR part 121), 9A012, 9A101 (except
for items in 9A101.b that are subject to
the ITAR, see 22 CFR part 121), 9A106.d
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*
*
*
*
List of Items Controlled
Unit: * * *
Related Controls: (1) For the purpose of this
entry, ‘‘use’’ ‘‘technology’’ is limited to
items controlled for MT and their
subsystems. (2) ‘‘Technology’’ for items
specified in ECCNs 9A004 (except for
items that are subject to the EAR), 9A005
to 9A011, 9A101.b (except for items that
are subject to the EAR), 9A104, 9A105,
9A106.a, .b and .c, 9A107 to 9A109, 9A110
(for items that are ‘‘specially designed’’ for
use in missile systems and subsystems),
9A111, 9A115 to 9A119, 9D103, and 9D105
is subject to the export licensing authority
of the U.S. Department of State, Directorate
of Defense Trade Controls (see 22 CFR part
121).
Related Definitions: * * *
Items: * * *
21. In Supplement No. 1 to part 774
(the Commerce Control List), Category
9—Aerospace and Propulsion, add a
new ECCN 9E604 between ECCNs
9E102 and 9E990 to read as follows:
■
9E604 ‘‘Technology’’ ‘‘required’’ for the
‘‘development,’’ ‘‘production,’’
operation, installation, maintenance,
repair, overhaul, or refurbishing of
commodities controlled by ECCN 9A604
or 9B604, or ‘‘software’’ controlled by
ECCN 9D604.
License Requirements
Reason for Control: NS, RS, MT, AT
Related Definitions: N/A
Items:
a. ‘‘Technology’’ ‘‘required’’ for the
‘‘development,’’ ‘‘production,’’ operation,
installation, maintenance, repair, overhaul,
or refurbishing of commodities controlled by
ECCN 9A604 or 9B604, or ‘‘software’’
controlled by ECCN 9D604.
b. [RESERVED]
Dated: January 18, 2013.
Kevin J. Wolf,
Assistant Secretary for Export
Administration.
[FR Doc. 2013–01904 Filed 1–30–13; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 16, 106, 110, 112, 114,
117, 120, 123, 129, 179, and 211
[Docket Nos. FDA–2011–N–0920 and FDA–
2011–N–0921]
Food and Drug Administration Food
Safety Modernization Act: Proposed
Rules To Establish Standards for the
Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption and for Current Good
Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive
Controls for Human Food; Public
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Control(s)
Country chart
NS applies to entire entry .....
RS applies to entire entry .....
MT applies to ‘‘technology,’’
as described in paragraph
.a of this entry, for commodities and ‘‘software’’
controlled for MT reasons
in ECCN 9A604, 9B604 or
9D604.
AT applies to entire entry ......
NS Column 1
RS Column 1
MT Column 1
AT Column 1
License Exceptions
CIV: N/A
TSR: N/A
STA: Paragraph (c)(2) of License Exception
STA (§ 740.20(c)(2) of the EAR) may not be
used for any item in this ECCN 9E604.
List of Items Controlled
Unit: $ value
Related Controls: (1) Technical data directly
related to articles enumerated in USML
Category IV is controlled under USML
Category IV(i). (2) See also ECCNs 9E002,
9E101, and 9E102 for controls on
‘‘technology’’ for the ‘‘development,’’
‘‘production,’’ and ‘‘use’’ of missiles and
related items controlled on the CCL.
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
Notification of public meeting.
The Food and Drug
Administration (FDA) is announcing a
public meeting to discuss the proposed
rules to establish standards for the
growing, harvesting, packing, and
holding of produce for human
consumption (the produce safety
proposed rule) and for current good
manufacturing practice and hazard
analysis and risk-based preventive
controls for human food (the preventive
controls proposed rule), which are the
first of several proposed rules that
would establish the foundation of, and
central framework for, the modern food
safety system envisioned by Congress in
the FDA Food Safety Modernization Act
(FSMA). The purpose of the public
meeting is to solicit oral stakeholder and
public comments on the proposed rules
and to inform the public about the
rulemaking process (including how to
submit comments, data, and other
information to the rulemaking dockets),
and to respond to questions about the
proposed rules.
SUMMARY:
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Federal Register / Vol. 78, No. 21 / Thursday, January 31, 2013 / Proposed Rules
See section II ‘‘How to
Participate in the Public Meeting’’ in the
SUPPLEMENTARY INFORMATION section of
this document for date and time of the
public meeting, closing dates for
advance registration, and information
on deadlines for submitting either
electronic or written comments to FDA’s
Division of Dockets Management.
ADDRESSES: See section II ‘‘How to
Participate in the Public Meeting’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT: For
questions about registering for the
meeting, to register by phone, or to
submit a notice of participation by mail,
fax, or email: Courtney Treece, Planning
Professionals, Ltd., 1210 West
McDermott Dr., suite 111, Allen, TX
75013, 704–258–4983, FAX: 469–854–
6992, email:
ctreece@planningprofessionals.com.
For general questions about the
meeting, to request an opportunity to
make an oral presentation at the public
meeting, to submit the full text,
comprehensive outline, or summary of
an oral presentation, or for special
accommodations due to a disability,
contact: Juanita Yates, Center for Food
Safety and Applied Nutrition (HFS–
009), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 240–402–1731, email:
Juanita.yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
sroberts on DSK5SPTVN1PROD with
DATES:
I. Background
FSMA (Pub. L. 111–353), was signed
into law by President Obama on January
4, 2011, to better protect public health
by helping to ensure the safety and
security of the food supply. FSMA
amends the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to
establish the foundation of a
modernized, prevention-based food
safety system. Among other things,
FSMA requires FDA to issue regulations
requiring preventive controls for human
and animal food and set standards for
produce safety.
FSMA was the first major legislative
reform of FDA’s food safety authorities
in more than 70 years, even though FDA
has increased the focus of its food safety
efforts on prevention over the past
several years. For example, applying the
concept of Hazard Analysis and Critical
Control Point (HACCP) that was
pioneered by industry in the late 1960s,
FDA established HACCP-based
regulations for seafood (21 CFR part
123) in 1995 (60 FR 65096, December
18, 1995) and for juice (21 CFR part 120)
in 2001 (66 FR 6138, January 19, 2001).
Similarly, in 1996, the U.S. Department
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of Agriculture’s Food Safety and
Inspection Service instituted HACCPbased rules for meat and poultry (9 CFR
part 417) (61 FR 38806, July 25, 1996).
In the Federal Register of January 16,
2013 (78 FR 3503 and 78 FR 3646), FDA
announced the establishment of two
dockets so that the public can review
the produce safety proposed rule and
the preventive controls proposed rule
and submit comments to the Agency.
These proposed rulemakings are the
first of several key proposals in
furtherance of FSMA’s food safety
mandate. The produce safety proposed
rule would establish science-based
minimum standards for the safe
growing, harvesting, packing, and
holding of produce, meaning fruits and
vegetables, grown for human
consumption. The produce safety
proposed rule would set forth
procedures, processes, and practices
that FDA expects would reduce
foodborne illness associated with the
consumption of produce. The produce
safety proposed rule and related fact
sheets are available on FDA’s FSMA
Web page located at https://www.fda.gov/
Food/FoodSafety/FSMA/default.htm.
The preventive controls proposed rule
would apply to human food and require
domestic and foreign facilities that are
required to register under the FD&C Act
to have written plans that identify
hazards, specify the steps that will be
put in place to minimize or prevent
those hazards, monitor results, and act
to correct problems that arise. The
preventive controls proposed rule and
related fact sheets are available on
FDA’s FSMA Web page located at
https://www.fda.gov/Food/FoodSafety/
FSMA/default.htm.
FDA is announcing a series of public
meetings entitled ‘‘The Food Safety
Modernization Act Public Meeting on
Proposed Rules for Produce Safety and
for Preventive Controls for Human
Food’’ so that the food industry,
consumers, foreign governments, and
other stakeholders can evaluate and
comment on the proposals. The
Washington, DC public meeting is the
first of three that the Agency will hold
during the proposed rules’ comment
period. We intend to hold the additional
public meetings in Chicago, IL and
Portland, OR. Specific locations, dates,
and registration information for these
meetings will appear in a separate
Federal Register document to publish
shortly. All three public meetings will
have the same agenda and are intended
to facilitate and support the proposed
rules’ evaluation and commenting
process.
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6763
II. How To Participate in the Public
Meeting
FDA is holding the public meeting on
the produce safety proposed rule and
the preventive controls proposed rule to
inform the public about the rulemaking
process, including how to submit
comments, data, and other information
to the rulemaking docket; to respond to
questions about the proposed rules; and
to provide an opportunity for interested
persons to make oral presentations. Due
to limited space and time, FDA
encourages all persons who wish to
attend the meeting to register in
advance. There is no fee to register for
the public meeting, and registration will
be on a first-come, first-served basis.
Early registration is recommended
because seating is limited. Onsite
registration will be accepted, as space
permits, after all preregistered attendees
are seated.
Those requesting an opportunity to
make an oral presentation during the
time allotted for public comment at the
meeting are asked to submit a request
and to provide the specific topic or
issue to be addressed. Due to the
anticipated high level of interest in
presenting public comment and limited
time available, FDA is allocating 3
minutes to each speaker to make an oral
presentation. Speakers will be limited to
making oral remarks; there will not be
an opportunity to display materials such
as slide shows, videos, or other media
during the meeting. If time permits,
individuals or organizations that did not
register in advance may be granted the
opportunity to make an oral
presentation. FDA would like to
maximize the number of individuals
who make a presentation at the meeting
and will do our best to accommodate all
persons who wish to make a
presentation or express their opinions at
the meeting.
FDA encourages persons and groups
who have similar interests to
consolidate their information for
presentation by a single representative.
After reviewing the presentation
requests, FDA will notify each
participant before the meeting of the
approximate time their presentation is
scheduled to begin, and remind them of
the presentation format (i.e., 3-minute
oral presentation without visual media).
While oral presentations from specific
individuals and organizations will be
necessarily limited due to time
constraints during the public meeting,
stakeholders may submit electronic or
written comments discussing any issues
of concern to the administrative record
(the docket) for the rulemaking. All
relevant data and documentation should
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Federal Register / Vol. 78, No. 21 / Thursday, January 31, 2013 / Proposed Rules
be submitted with the comments to the
relevant docket (i.e., for the produce
safety proposed rule, Docket No. FDA–
2011–N–0921; and for the preventive
controls proposed rule, Docket No.
FDA–2011–N–0920).
Table 1 of this document provides
information on participation in the
public meetings:
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETINGS AND ON SUBMITTING COMMENTS TO THE RULEMAKING
DOCKETS
Date
Electronic address
Address
Public meeting ...........
February 28, 2013,
from 8:30 a.m. to 5
p.m. and March 1,
2013, from 8:30
a.m. to 12 p.m.
.........................................................................
Advance registration ..
By February 20, 2013
Individuals who wish to participate in person
are asked to preregister at https://
www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Jefferson Auditorium
U.S. Department of
Agriculture (USDA),
Wing 5 Entrance,
14th and Independence Ave. SW.,
Washington, DC
20024. Photo ID
Required.
We encourage you to
use electronic registration if possible1.
Request to make an
oral presentation.
By February 8, 2013 ..
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm 2.
Request special accommodations due
to a disability.
Submit electronic or
written comments.
By February 15, 2013
Juanita Yates,
hhs.gov.
By May 16, 2013 .......
Docket Nos. FDA–2011–N–0920 and FDA–
2011–N–0921.
Preventive Controls for Human Food Proposed Rule: https://www.regulations.gov/
#!docketDetail;D=FDA-2011-N-0920.
Produce Safety Proposed Rule: https://
www.regulations.gov/#!docketDetail;D=
FDA-2011-N-0921.
email:
Juanita.yates@fda.
Other information
Onsite registration
both days from 8
a.m. to 8:30 a.m.
There is no registration fee for the public meetings. Early
registration is recommended because
seating is limited.
Requests made on
the day of the meeting to make an oral
presentation will be
granted as time permits. Information on
requests to make
an oral presentation
may be posted without change to https://
www.regulations.
gov, including any
personal information
provided.
See FOR FURTHER
INFORMATION
CONTACT.
1 You may also register via email, mail, or fax. Please include your name, title, firm name, address, and phone and FAX numbers in your registration information and send to Courtney Treece (see FOR FURTHER INFORMATION CONTACT). Onsite registration will also be available.
2 You may also request to make an oral presentation at the public meeting via email. Please include your name, title, firm name, address, and
phone and fax numbers as well as the full text, comprehensive outline, or summary of your oral presentation, and send to Juanita Yates (see
FOR FURTHER INFORMATION CONTACT).
sroberts on DSK5SPTVN1PROD with
III. Comments, Transcripts, and
Recorded Video
Information and data submitted
voluntarily to FDA during the public
meeting will become part of the
administrative record for the relevant
rulemaking and will be accessible to the
public at https://www.regulations.gov.
The transcript of the proceedings from
the public meeting will become part of
the administrative record for each of the
rulemakings. Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov and at FDA’s
FSMA Web site at https://www.fda.gov/
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Jkt 229001
Food/FoodSafety/FSMA/. It may also be
viewed at the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or 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), 12420 Parklawn Dr., Element
Bldg., Rockville, MD 20857.
Additionally, FDA will be video
recording the public meeting. Once the
recorded video is available, it will be
accessible at FDA’s FSMA Web site at
PO 00000
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Fmt 4702
Sfmt 9990
https://www.fda.gov/Food/FoodSafety/
FSMA/.
Dated: January 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–02089 Filed 1–30–13; 8:45 am]
BILLING CODE 4160–01–P
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]]>Agencies
[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Proposed Rules]
[Pages 6762-6764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02089]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 16, 106, 110, 112, 114, 117, 120, 123, 129, 179,
and 211
[Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0921]
Food and Drug Administration Food Safety Modernization Act:
Proposed Rules To Establish Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption and for Current
Good Manufacturing Practice and Hazard Analysis and Risk-Based
Preventive Controls for Human Food; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to discuss the proposed rules to establish standards for the
growing, harvesting, packing, and holding of produce for human
consumption (the produce safety proposed rule) and for current good
manufacturing practice and hazard analysis and risk-based preventive
controls for human food (the preventive controls proposed rule), which
are the first of several proposed rules that would establish the
foundation of, and central framework for, the modern food safety system
envisioned by Congress in the FDA Food Safety Modernization Act (FSMA).
The purpose of the public meeting is to solicit oral stakeholder and
public comments on the proposed rules and to inform the public about
the rulemaking process (including how to submit comments, data, and
other information to the rulemaking dockets), and to respond to
questions about the proposed rules.
[[Page 6763]]
DATES: See section II ``How to Participate in the Public Meeting'' in
the SUPPLEMENTARY INFORMATION section of this document for date and
time of the public meeting, closing dates for advance registration, and
information on deadlines for submitting either electronic or written
comments to FDA's Division of Dockets Management.
ADDRESSES: See section II ``How to Participate in the Public Meeting''
in the SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: For questions about registering for
the meeting, to register by phone, or to submit a notice of
participation by mail, fax, or email: Courtney Treece, Planning
Professionals, Ltd., 1210 West McDermott Dr., suite 111, Allen, TX
75013, 704-258-4983, FAX: 469-854-6992, email:
ctreece@planningprofessionals.com.
For general questions about the meeting, to request an opportunity
to make an oral presentation at the public meeting, to submit the full
text, comprehensive outline, or summary of an oral presentation, or for
special accommodations due to a disability, contact: Juanita Yates,
Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1731, email: Juanita.yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FSMA (Pub. L. 111-353), was signed into law by President Obama on
January 4, 2011, to better protect public health by helping to ensure
the safety and security of the food supply. FSMA amends the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation
of a modernized, prevention-based food safety system. Among other
things, FSMA requires FDA to issue regulations requiring preventive
controls for human and animal food and set standards for produce
safety.
FSMA was the first major legislative reform of FDA's food safety
authorities in more than 70 years, even though FDA has increased the
focus of its food safety efforts on prevention over the past several
years. For example, applying the concept of Hazard Analysis and
Critical Control Point (HACCP) that was pioneered by industry in the
late 1960s, FDA established HACCP-based regulations for seafood (21 CFR
part 123) in 1995 (60 FR 65096, December 18, 1995) and for juice (21
CFR part 120) in 2001 (66 FR 6138, January 19, 2001). Similarly, in
1996, the U.S. Department of Agriculture's Food Safety and Inspection
Service instituted HACCP-based rules for meat and poultry (9 CFR part
417) (61 FR 38806, July 25, 1996).
In the Federal Register of January 16, 2013 (78 FR 3503 and 78 FR
3646), FDA announced the establishment of two dockets so that the
public can review the produce safety proposed rule and the preventive
controls proposed rule and submit comments to the Agency. These
proposed rulemakings are the first of several key proposals in
furtherance of FSMA's food safety mandate. The produce safety proposed
rule would establish science-based minimum standards for the safe
growing, harvesting, packing, and holding of produce, meaning fruits
and vegetables, grown for human consumption. The produce safety
proposed rule would set forth procedures, processes, and practices that
FDA expects would reduce foodborne illness associated with the
consumption of produce. The produce safety proposed rule and related
fact sheets are available on FDA's FSMA Web page located at https://www.fda.gov/Food/FoodSafety/FSMA/default.htm.
The preventive controls proposed rule would apply to human food and
require domestic and foreign facilities that are required to register
under the FD&C Act to have written plans that identify hazards, specify
the steps that will be put in place to minimize or prevent those
hazards, monitor results, and act to correct problems that arise. The
preventive controls proposed rule and related fact sheets are available
on FDA's FSMA Web page located at https://www.fda.gov/Food/FoodSafety/FSMA/default.htm.
FDA is announcing a series of public meetings entitled ``The Food
Safety Modernization Act Public Meeting on Proposed Rules for Produce
Safety and for Preventive Controls for Human Food'' so that the food
industry, consumers, foreign governments, and other stakeholders can
evaluate and comment on the proposals. The Washington, DC public
meeting is the first of three that the Agency will hold during the
proposed rules' comment period. We intend to hold the additional public
meetings in Chicago, IL and Portland, OR. Specific locations, dates,
and registration information for these meetings will appear in a
separate Federal Register document to publish shortly. All three public
meetings will have the same agenda and are intended to facilitate and
support the proposed rules' evaluation and commenting process.
II. How To Participate in the Public Meeting
FDA is holding the public meeting on the produce safety proposed
rule and the preventive controls proposed rule to inform the public
about the rulemaking process, including how to submit comments, data,
and other information to the rulemaking docket; to respond to questions
about the proposed rules; and to provide an opportunity for interested
persons to make oral presentations. Due to limited space and time, FDA
encourages all persons who wish to attend the meeting to register in
advance. There is no fee to register for the public meeting, and
registration will be on a first-come, first-served basis. Early
registration is recommended because seating is limited. Onsite
registration will be accepted, as space permits, after all
preregistered attendees are seated.
Those requesting an opportunity to make an oral presentation during
the time allotted for public comment at the meeting are asked to submit
a request and to provide the specific topic or issue to be addressed.
Due to the anticipated high level of interest in presenting public
comment and limited time available, FDA is allocating 3 minutes to each
speaker to make an oral presentation. Speakers will be limited to
making oral remarks; there will not be an opportunity to display
materials such as slide shows, videos, or other media during the
meeting. If time permits, individuals or organizations that did not
register in advance may be granted the opportunity to make an oral
presentation. FDA would like to maximize the number of individuals who
make a presentation at the meeting and will do our best to accommodate
all persons who wish to make a presentation or express their opinions
at the meeting.
FDA encourages persons and groups who have similar interests to
consolidate their information for presentation by a single
representative. After reviewing the presentation requests, FDA will
notify each participant before the meeting of the approximate time
their presentation is scheduled to begin, and remind them of the
presentation format (i.e., 3-minute oral presentation without visual
media).
While oral presentations from specific individuals and
organizations will be necessarily limited due to time constraints
during the public meeting, stakeholders may submit electronic or
written comments discussing any issues of concern to the administrative
record (the docket) for the rulemaking. All relevant data and
documentation should
[[Page 6764]]
be submitted with the comments to the relevant docket (i.e., for the
produce safety proposed rule, Docket No. FDA-2011-N-0921; and for the
preventive controls proposed rule, Docket No. FDA-2011-N-0920).
Table 1 of this document provides information on participation in
the public meetings:
Table 1--Information on Participation in the Meetings and on Submitting Comments to the Rulemaking Dockets
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Date Electronic address Address Other information
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Public meeting................. February 28, ...................... Jefferson Onsite
2013, from 8:30 Auditorium U.S. registration
a.m. to 5 p.m. Department of both days from 8
and March 1, Agriculture a.m. to 8:30
2013, from 8:30 (USDA), Wing 5 a.m.
a.m. to 12 p.m. Entrance, 14th
and Independence
Ave. SW.,
Washington, DC
20024. Photo ID
Required.
Advance registration........... By February 20, Individuals who wish We encourage you There is no
2013. to participate in to use registration fee
person are asked to electronic for the public
preregister at https:// registration if meetings. Early
www.fda.gov/Food/ possible\1\. registration is
NewsEvents/ recommended
WorkshopsMeetingsConf because seating
erences/default.htm. is limited.
Request to make an oral By February 8, https://www.fda.gov/ Requests made on
presentation. 2013. Food/NewsEvents/ the day of the
WorkshopsMeetingsConf meeting to make
erences/default.htm an oral
\2\. presentation
will be granted
as time permits.
Information on
requests to make
an oral
presentation may
be posted
without change
to https://www.regulations.gov gov, including
any personal
information
provided.
Request special accommodations By February 15, Juanita Yates, email: See FOR FURTHER
due to a disability. 2013. Juanita.yates@fda.hhs INFORMATION
.gov. CONTACT.
Submit electronic or written By May 16, 2013.. Docket Nos. FDA-2011-N-
comments. 0920 and FDA-2011-N-
0921.
Preventive Controls
for Human Food
Proposed Rule: https://www.regulations.gov/#!docketDetail;D=FDA-
2011-N-0920.
Produce Safety
Proposed Rule: https://www.regulations.gov/#!docketDetail;D=FDA-
2011-N-0921.
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\1\ You may also register via email, mail, or fax. Please include your name, title, firm name, address, and
phone and FAX numbers in your registration information and send to Courtney Treece (see FOR FURTHER
INFORMATION CONTACT). Onsite registration will also be available.
\2\ You may also request to make an oral presentation at the public meeting via email. Please include your name,
title, firm name, address, and phone and fax numbers as well as the full text, comprehensive outline, or
summary of your oral presentation, and send to Juanita Yates (see FOR FURTHER INFORMATION CONTACT).
III. Comments, Transcripts, and Recorded Video
Information and data submitted voluntarily to FDA during the public
meeting will become part of the administrative record for the relevant
rulemaking and will be accessible to the public at https://www.regulations.gov. The transcript of the proceedings from the public
meeting will become part of the administrative record for each of the
rulemakings. Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov and at
FDA's FSMA Web site at https://www.fda.gov/Food/FoodSafety/FSMA/. It may
also be viewed at the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. A transcript will also be available in either hardcopy or 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), 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Additionally, FDA will be video recording the public meeting. Once the
recorded video is available, it will be accessible at FDA's FSMA Web
site at https://www.fda.gov/Food/FoodSafety/FSMA/.
Dated: January 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02089 Filed 1-30-13; 8:45 am]
BILLING CODE 4160-01-P
