[Federal Register Volume 78, Number 247 (Tuesday, December 24, 2013)]
[Proposed Rules]
[Pages 78068-78069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30372]
[[Page 78067]]
Vol. 78
Tuesday,
No. 247
December 24, 2013
Part V
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Parts 16 and 121
Focused Mitigation Strategies To Protect Food Against Intentional
Adulteration; Public Meeting on Proposed Rule; Proposed Rule
Federal Register / Vol. 78 , No. 247 / Tuesday, December 24, 2013 /
Proposed Rules
[[Page 78068]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16 and 121
[Docket No. FDA-2013-N-1425]
Focused Mitigation Strategies To Protect Food Against Intentional
Adulteration; Public Meeting on Proposed Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public meeting.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing a
public meeting to discuss the proposed rule to require domestic and
foreign food facilities that are required to register under the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may
be intentionally introduced by acts of terrorism. FDA is proposing
these requirements as part of our implementation of the FDA Food Safety
Modernization Act (FSMA). The purpose of the public meeting is to
inform the public of the provisions of the proposed rule and the
rulemaking process (including how to submit comments, data, and other
information to the rulemaking docket) as well as solicit oral
stakeholder and public comments on the proposed rule and to respond to
questions about the rule.
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,
contact: Nick Cane, Nakamoto Group, Inc., 11820 Parklawn Dr., suite
240, Rockville, MD 20852, 240-357-1176, FAX: 301-468-6536, email:
[email protected].
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: [email protected].
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 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 domestic and foreign food facilities that are required to
register under the FD&C Act to address hazards that may be
intentionally introduced by acts of terrorism. These food facilities
would be required to identify and implement focused mitigation
strategies to significantly minimize or prevent significant
vulnerabilities identified at actionable process steps in a food
operation. We expect the rulemaking would help to protect food from
intentional adulteration caused by acts of terrorism.
Along with this public meeting, FDA is considering additional
public meetings on this subject or other public engagement
opportunities. Any further public meetings on this subject would be
announced at a later time in the Federal Register.
II. How To Participate in the Public Meeting
FDA is holding the public meeting on ``Focused Mitigation
Strategies to Protect Food Against Intentional Adulteration'' to: (1)
Inform the public about the rulemaking process, including how to submit
comments, data, and other information to the rulemaking docket; (2)
respond to questions about the proposed rules; and (3) 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 public
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 public meeting and will do our best to
accommodate all persons who wish to make a presentation or express
their opinions at the public 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).
Table 1 of this document provides information on participation in
the public meeting:
Table 1--Information on Participation in the Meeting and on Submitting Comments to the Rulemaking Dockets
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Date Electronic address Address Other information
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College Park, MD public meeting. February 20, 2014, https:// Wiley Auditorium,
8:30 a.m. to 3 collaboration.fda Harvey W. Wiley
p.m. .gov/r38z65kh91j/. Federal Bldg.,
5100 Paint Branch
Pkwy., College
Park, MD 20740.
[[Page 78069]]
Deadline for registration....... February 7, 2014.. http://www.fda.gov/ We encourage you There is no
Food/ to use electronic registration fee
GuidanceRegulatio registration if for the public
n/FSMA/ possible \1\. meeting. Early
ucm377956.htm. registration is
Docket No. FDA- recommended
2013-N-1425. because seating
is limited.
Request to make a public comment January 17, 2014.. http://www.fda.gov/ Requests made on
Food/NewsEvents/ the day of the
WorkshopsMeetings public meeting to
Conferences/ make an oral
default.htm \2\. presentation will
be granted as
time permits.
Information on
requests to make
an oral
presentation may
be posted without
change to http://www.regulations.gov ov, including any
personal
information
provided.
Request special accommodations January 17, 2014.. Juanita Yates, See FOR FURTHER
due to a disability. email: INFORMATION
Juanita.yates@fda CONTACT.
.hhs.gov.
Closing date for electronic or March 31, 2014.... Docket No. FDA-
written comments. 2013-N-1425.
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\1\ For questions about registering for the public meeting, to register by phone, or to submit a notice of
participation by mail, FAX or email, contact: Nick Cane, Nakamoto Group, Inc., 11820 Parklawn Dr., suite 240,
Rockville, MD 20852, 240-357-1176, FAX: 301-468-6536, email: [email protected].
\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:
[email protected].
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 be submitted with the comments to the relevant
docket, i.e., Docket No. FDA-2013-N-1425.
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 http://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 http://www.regulations.gov and at
FDA's FSMA Web site at: http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.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), 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. Additionally, FDA will be live webcasting and
recording the public meeting. Once the recorded video is available, it
will be accessible at FDA's FSMA Web site at http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm.
Dated: December 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30372 Filed 12-18-13; 8:45 am]
BILLING CODE 4160-01-P