Food and Drug Administration Food Safety Modernization Act; Public Meeting, 63346-63348 [2014-25261]
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<![CDATA[
63346
Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Proposed Rules
the Commission’s standards in more
specific, codified, and readily accessible
form, the amendment safeguards against
accountants professing lack of
knowledge of the applicable standards—
or exploiting perceived ambiguities in
them—to the detriment of market
participants and the public.
Threats to the safety of customer
funds generate public distrust in
financial market integrity. To the extent
this rule amendment better informs
accountants and fosters their
understanding of the Commission’s
standards and the consequences of
improper actions—actions that
potentially could threaten the safety of
customer funds—the proposed
amendment promotes the integrity of
financial markets.
(3) Price Discovery
The Commission does not foresee that
the proposed amendment will directly
impact price discovery.
(4) Sound Risk Management Practices
As noted, improper accounting
practices may lead to unnecessary risks
being undertaken, as certain risk
measures or managerial decisions are
based on accounting data. To the extent
the proposed amendment improves
accountants’ understanding of the
Commission’s standards, thereby
deterring improper conduct that
potentially could result in unnecessary
risks being undertaken, the proposed
amendment promotes sound risk
management practices.
(5) Other Public Interest Considerations
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By harmonizing the CFTC Rule
14.8(c) standard for accountants with
that of SEC Rule 102(e), the proposed
amendment helps to ensure consistency
and reduces potential for confusion.
The Commission requests comment
on all aspects of this consideration of
costs and benefits, including whether
any alternative is perceived as more
beneficial, less costly, or otherwise
better suited to serve the public interests
articulated in CEA section 15(a) than the
amendment herein proposed.
List of Subjects in 17 CFR Part 14
Administrative practice and
procedure, Professional conduct and
competency standards, Ethical conduct,
Penalties.
For the reasons discussed in the
preamble, the Commodity Futures
Trading Commission proposes to amend
17 CFR part 14 as set forth below:
16:37 Oct 22, 2014
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
1. The authority citation for part 14
continues to read as follows:
21 CFR Parts 1, 16, 112, 117, and 507
Authority: Pub. L. 93–463, sec. 101(a)(11),
88 Stat. 1391, 7 U.S.C. 4a(j), unless otherwise
noted.
[Docket Nos. FDA–2011–N–0920, FDA–
2011–N–0921, FDA–2011–N–0922, and FDA–
2011–N–0143]
■
(2) Efficiency, Competitiveness, and
Financial Integrity of Futures Markets
VerDate Sep<11>2014
PART 14—RULES RELATING TO
SUSPENSION OR DISBARMENT FROM
APPEARANCE AND PRACTICE
2. Amend § 14.8 by revising paragraph
(c) to read as follows:
RIN 0910–AG36, RIN 0910–AG35, RIN 0910–
AG10, and RIN 0910–AG64
§ 14.8 Lack of requisite qualifications,
character and integrity.
Food and Drug Administration Food
Safety Modernization Act; Public
Meeting
■
*
*
*
*
*
(c) To have engaged in unethical or
improper professional conduct either in
the course of any adjudicatory,
investigative, or rulemaking or other
proceeding before the Commission or
otherwise. With respect to the
professional conduct of persons
licensed to practice as accountants,
‘‘unethical or improper professional
conduct’’ means:
(1) Intentional or knowing conduct,
including reckless conduct, that results
in a violation of applicable professional
principles or standards; or
(2) Either of the following two types
of negligent conduct:
(i) A single instance of highly
unreasonable conduct that results in a
violation of applicable professional
principles or standards in circumstances
in which an accountant knows, or
should know, that heightened scrutiny
is warranted.
(ii) Repeated instances of
unreasonable conduct, each resulting in
a violation of applicable professional
principles or standards, which indicate
a lack of competence to practice before
the Commission.
Issued in Washington, DC, on October 17,
2014, by the Commission.
Christopher J. Kirkpatrick,
Secretary of the Commission.
Note: The following appendix will not
appear in the Code of Federal Regulations.
Appendix to Proceedings Before the
Commodity Futures Trading
Commission; Rules Relating to
Suspension or Disbarment From
Appearance and Practice—Commission
Voting Summary
On this matter, Chairman Massad and
Commissioners Wetjen, Bowen, and
Giancarlo voted in the affirmative. No
Commissioner voted in the negative.
[FR Doc. 2014–25194 Filed 10–22–14; 8:45 am]
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of public meeting.
The Food and Drug
Administration (FDA) is announcing a
public meeting to discuss proposed
revisions to four rules originally
proposed in 2013 to implement the FDA
Food Safety Modernization Act (FSMA).
In response to the comments received
on these foundational FSMA proposed
rules, FDA issued supplemental notices
of proposed rulemaking that propose
significant changes to four of the
proposed rules including: Current Good
Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive
Controls for Human Food (Preventive
Controls for Human Food); Standards
for the Growing, Harvesting, Packing,
and Holding of Produce for Human
Consumption (Produce Safety); Current
Good Manufacturing Practice and
Hazard Analysis and Risk-Based
Preventive Controls for Food for
Animals (Preventive Controls for
Animal Food); and Foreign Supplier
Verification Programs for Importers of
Food for Humans and Animals (Foreign
Supplier Verification Programs). The
purpose of the public meeting is to
solicit oral stakeholder and public
comments on the new content of the
supplemental 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
supplemental proposed rules.
DATES: See section II, ‘‘How to
Participate in the Public Meeting,’’ in
the SUPPLEMENTARY INFORMATION section
of this document for the 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
SUMMARY:
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Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Proposed Rules
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the SUPPLEMENTARY INFORMATION section
of this document.
FOR FURTHER INFORMATION CONTACT:
For questions about registering for the
meeting; to register by telephone; or to
submit a notice of participation by mail,
FAX, or email: Courtney Treece,
Planning Professionals Ltd., 1210 W.
McDermott St., 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:
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 U.S. food supply. FSMA
amends the Federal Food, Drug, and
Cosmetic 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
food and animal food, setting standards
for produce safety, and requiring
importers to verify that their foreign
suppliers produce food that is as safe as
food produced in the United States.
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. Since January 2013, FDA
has proposed seven foundational rules
to implement FSMA: Produce Safety,
Preventive Controls for Human Food,
Preventive Controls for Animal Food,
Foreign Supplier Verification Programs,
Accreditation of Third-Party Auditors/
Certification Bodies to Conduct Food
Safety Audits and to Issue
Certifications, Focused Mitigation
Strategies to Protect Food Against
Intentional Adulteration, and Sanitary
Transportation of Human and Animal
Food. FDA conducted extensive
outreach to industry, growers, academia,
VerDate Sep<11>2014
16:37 Oct 22, 2014
Jkt 235001
consumer groups, tribal governments,
and the Agency’s counterparts at the
Federal, State and local levels, and
received thousands of comments on the
proposals.
In response to the comments received
on some of the foundational FSMA
proposed rules, which FDA continues to
review, FDA issued supplemental
notices of proposed rulemaking that
propose significant changes to four of
the proposed rules: Preventive Controls
for Human Food, Produce Safety,
Preventive Controls for Animal Food,
and Foreign Supplier Verification
Programs. FDA’s proposed changes are
intended to provide more flexible,
practical, and targeted approaches to
ensuring a safe food supply system.
In the Federal Register of September
29, 2014 (79 FR 58523, 58433, 58475,
and 58573), FDA announced the
reopening of these four dockets so that
the public can review the supplemental
proposed rules and submit comments to
the Agency. The Agency is accepting
comments on the revised provisions of
all four proposed rules until December
15, 2014. No additional comments will
be accepted on the original proposed
rules.
FDA is announcing a public meeting
entitled ‘‘Food and Drug Administration
Food Safety Modernization Act’’ so that
the food industry, consumers, foreign
governments, and other stakeholders
can evaluate and comment on the
supplemental proposals. The meeting is
intended to facilitate and support the
supplemental proposed rules’
evaluation and commenting process.
For information on the supplemental
proposed rules and related fact sheets,
see FDA’s FSMA Web page located at
https://www.fda.gov/Food/FoodSafety/
FSMA/default.htm.
II. How To Participate in the Public
Meeting
FDA is holding the public meeting on
the supplemental proposed rules to
inform the public about the rulemaking
process, including how to submit
comments, data, and other information
to the rulemaking dockets; to respond to
questions about the supplemental
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 meetings, and
registration will be on a first-come, first-
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63347
served basis. Early registration is
recommended because seating is
limited. Onsite registration will be
accepted, as space permits, after all
preregistered attendees are seated. Live
Webcasting of the event is also being
offered through the registration process.
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 the
number of supplemental proposals
being addressed at the public meeting,
time for making public comment is
necessarily limited. 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 relevant rulemaking.
All relevant data and documentation
should be submitted with the comments
to the appropriate docket (Docket Nos.
FDA–2011–N–0920, FDA–2011–N–
0921, FDA–2011–N–0922, and FDA–
2011–N–0143).
Table 1 of this document provides
information on participation in the
public meeting:
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Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Proposed Rules
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS TO THE RULEMAKING
DOCKETS
Date
Electronic address
Public meeting .....................
November 13, 2014
Advance registration ............
By November 7, 2014
Request to make an oral
presentation.
By October 27, 2014
Request special accommodations due to a disability.
Submit electronic or written
comments.
Address
Other information
https://www.fda.gov/Food/
NewsEvents/Workshops
MeetingsConferences/default.htm.
Individuals who wish to participate in person are
asked to preregister at
https://www.fda.gov/Food/
NewsEvents/Workshops
MeetingsConferences/default.htm.
https://www.fda.gov/Food/
NewsEvents/Workshops
MeetingsConferences/default.htm 2.
Wiley Building, 5100 Paint
Branch Pkwy., College
Park, MD 20740.
Onsite registration from 8
a.m.–8:30 a.m.
We encourage you to use
electronic registration if
possible.1
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 only if 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.
By October 27, 2014
Juanita Yates, email: Juanita.yates@fda.hhs.gov.
See FOR FURTHER INFORMATION CONTACT.
By December 15,
2014
Docket Nos. FDA–2011–N–
0920, FDA–2011–N–
0921, FDA–2011–N–
0922, and FDA–2011–N–
0143; https://
www.regulations.gov.
Division of Dockets Management (HFA–305),
Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
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, Planning Professionals Ltd., 1210 W. McDermott St., Suite 111, Allen, TX 75013, 704–258–
4983, FAX: 469–854–6992, email: ctreece@planningprofessionals.com. 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, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1731,
email: Juanita.yates@fda.hhs.gov.
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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/GuidanceRegulation/FSMA/
ucm247568.htm. 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
VerDate Sep<11>2014
16:37 Oct 22, 2014
Jkt 235001
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. Additionally,
FDA will be live Webcasting the event.
When available, the Webcast video
recording of the public meeting will be
accessible at FDA’s FSMA Web site at
https://www.fda.gov/Food/
GuidanceRegulation/FSMA/
ucm247568.htm.
Dated: October 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–25261 Filed 10–22–14; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1271
[Docket No. FDA–2014–D–1584]
Same Surgical Procedure Exception
Questions and Answers Regarding the
Scope of the Exception; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
Request for comment on draft
guidance.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Same Surgical
Procedure Exception Questions and
Answers Regarding the Scope of the
Exception’’ dated October 2014. The
draft guidance document is intended for
tissue establishments and healthcare
SUMMARY:
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]]>Agencies
[Federal Register Volume 79, Number 205 (Thursday, October 23, 2014)]
[Proposed Rules]
[Pages 63346-63348]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25261]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 16, 112, 117, and 507
[Docket Nos. FDA-2011-N-0920, FDA-2011-N-0921, FDA-2011-N-0922, and
FDA-2011-N-0143]
RIN 0910-AG36, RIN 0910-AG35, RIN 0910-AG10, and RIN 0910-AG64
Food and Drug Administration Food Safety Modernization Act;
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 proposed revisions to four rules originally proposed
in 2013 to implement the FDA Food Safety Modernization Act (FSMA). In
response to the comments received on these foundational FSMA proposed
rules, FDA issued supplemental notices of proposed rulemaking that
propose significant changes to four of the proposed rules including:
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based
Preventive Controls for Human Food (Preventive Controls for Human
Food); Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption (Produce Safety); Current Good
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive
Controls for Food for Animals (Preventive Controls for Animal Food);
and Foreign Supplier Verification Programs for Importers of Food for
Humans and Animals (Foreign Supplier Verification Programs). The
purpose of the public meeting is to solicit oral stakeholder and public
comments on the new content of the supplemental 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 supplemental proposed rules.
DATES: See section II, ``How to Participate in the Public Meeting,'' in
the SUPPLEMENTARY INFORMATION section of this document for the 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
[[Page 63347]]
the SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT:
For questions about registering for the meeting; to register by
telephone; or to submit a notice of participation by mail, FAX, or
email: Courtney Treece, Planning Professionals Ltd., 1210 W. McDermott
St., 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: 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 U.S. food supply. FSMA amends the
Federal Food, Drug, and Cosmetic 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 food and animal food, setting standards for produce safety,
and requiring importers to verify that their foreign suppliers produce
food that is as safe as food produced in the United States.
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. Since January 2013, FDA has proposed seven foundational rules to
implement FSMA: Produce Safety, Preventive Controls for Human Food,
Preventive Controls for Animal Food, Foreign Supplier Verification
Programs, Accreditation of Third-Party Auditors/Certification Bodies to
Conduct Food Safety Audits and to Issue Certifications, Focused
Mitigation Strategies to Protect Food Against Intentional Adulteration,
and Sanitary Transportation of Human and Animal Food. FDA conducted
extensive outreach to industry, growers, academia, consumer groups,
tribal governments, and the Agency's counterparts at the Federal, State
and local levels, and received thousands of comments on the proposals.
In response to the comments received on some of the foundational
FSMA proposed rules, which FDA continues to review, FDA issued
supplemental notices of proposed rulemaking that propose significant
changes to four of the proposed rules: Preventive Controls for Human
Food, Produce Safety, Preventive Controls for Animal Food, and Foreign
Supplier Verification Programs. FDA's proposed changes are intended to
provide more flexible, practical, and targeted approaches to ensuring a
safe food supply system.
In the Federal Register of September 29, 2014 (79 FR 58523, 58433,
58475, and 58573), FDA announced the reopening of these four dockets so
that the public can review the supplemental proposed rules and submit
comments to the Agency. The Agency is accepting comments on the revised
provisions of all four proposed rules until December 15, 2014. No
additional comments will be accepted on the original proposed rules.
FDA is announcing a public meeting entitled ``Food and Drug
Administration Food Safety Modernization Act'' so that the food
industry, consumers, foreign governments, and other stakeholders can
evaluate and comment on the supplemental proposals. The meeting is
intended to facilitate and support the supplemental proposed rules'
evaluation and commenting process.
For information on the supplemental proposed rules and related fact
sheets, see FDA's FSMA Web page located at https://www.fda.gov/Food/FoodSafety/FSMA/default.htm.
II. How To Participate in the Public Meeting
FDA is holding the public meeting on the supplemental proposed
rules to inform the public about the rulemaking process, including how
to submit comments, data, and other information to the rulemaking
dockets; to respond to questions about the supplemental 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 meetings, 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. Live
Webcasting of the event is also being offered through the registration
process.
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 the number of supplemental proposals being addressed at the
public meeting, time for making public comment is necessarily limited.
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 relevant rulemaking. All relevant data and
documentation should be submitted with the comments to the appropriate
docket (Docket Nos. FDA-2011-N-0920, FDA-2011-N-0921, FDA-2011-N-0922,
and FDA-2011-N-0143).
Table 1 of this document provides information on participation in
the public meeting:
[[Page 63348]]
Table 1--Information on Participation in the Meeting and on Submitting Comments to the Rulemaking Dockets
----------------------------------------------------------------------------------------------------------------
Electronic Other
Date address Address information
----------------------------------------------------------------------------------------------------------------
Public meeting............... November 13, 2014 https:// Wiley Building, Onsite
www.fda.gov/ 5100 Paint registration
Food/NewsEvents/ Branch Pkwy., from 8 a.m.-
WorkshopsMeetin College Park, 8:30 a.m.
gsConferences/ MD 20740.
default.htm.
Advance registration......... By November 7, 2014 Individuals who We encourage you There is no
wish to to use registration
participate in electronic fee for the
person are registration if public
asked to possible.\1\ meetings. Early
preregister at registration is
https:// recommended
www.fda.gov/ because seating
Food/NewsEvents/ is limited.
WorkshopsMeetin
gsConferences/
default.htm.
Request to make an oral By October 27, 2014 https:// ................ Requests made on
presentation. www.fda.gov/ the day of the
Food/NewsEvents/ meeting to make
WorkshopsMeetin an oral
gsConferences/ presentation
default.htm \2\. will be granted
only if 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.
Request special By October 27, 2014 Juanita Yates, See FOR FURTHER ................
accommodations due to a email: INFORMATION
disability. Juanita.yates@f CONTACT.
da.hhs.gov.
Submit electronic or written By December 15, 2014 Docket Nos. FDA- Division of ................
comments. 2011-N-0920, Dockets
FDA-2011-N-0921 Management (HFA-
, FDA-2011-N- 305), Food and
0922, and FDA- Drug
2011-N-0143; Administration,
https:// 5630 Fishers
www.regulations Lane, rm. 1061,
.gov. Rockville, MD
20852.
----------------------------------------------------------------------------------------------------------------
\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, Planning Professionals
Ltd., 1210 W. McDermott St., Suite 111, Allen, TX 75013, 704-258-4983, FAX: 469-854-6992, email:
ctreece@planningprofessionals.com. 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, Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1731, email:
Juanita.yates@fda.hhs.gov.
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/GuidanceRegulation/FSMA/ucm247568.htm. 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), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857. Additionally, FDA
will be live Webcasting the event. When available, the Webcast video
recording of the public meeting will be accessible at FDA's FSMA Web
site at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247568.htm.
Dated: October 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25261 Filed 10-22-14; 8:45 am]
BILLING CODE 4164-01-P
