[Federal Register Volume 79, Number 21 (Friday, January 31, 2014)]
[Proposed Rules]
[Pages 5353-5355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01985]


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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 Meetings on Proposed Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meetings.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing two 
public meetings 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 proposed these 
requirements as part of our implementation of the FDA Food Safety 
Modernization Act (FSMA). The purpose of the public meetings 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 for dates and times of the public 
meetings, 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.

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.
    FDA is announcing additional public meetings so that the food 
industry, consumers, foreign governments, and other stakeholders can 
better evaluate and comment on the proposals. These meetings, following 
the College Park, MD, public event on February 20, are the final two 
public meetings FDA plans to hold during the proposed rule comment 
period. All three public meetings are intended to facilitate and 
support the proposed rule's evaluation and commenting process.

II. How To Participate in the Public Meetings

    FDA is holding the public meetings 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 meetings 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.
    Those requesting an opportunity to make an oral presentation during 
the time allotted for public comment at the meetings 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 
meetings. 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 each meeting and will do our best to accommodate 
all persons who wish to make a presentation or express their opinions 
at a 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 meetings, 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.
    Table 1 of this document provides information on participation in 
the public meetings:

[[Page 5354]]



   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
----------------------------------------------------------------------------------------------------------------
Chicago, IL, Public meeting....  February 27, 2014.  http://www.fda.gov/ Hilton Chicago,     Onsite registration
                                                      Food/               720 South           from 8 a.m. to
                                                      GuidanceRegulatio   Michigan Ave.,      8:30 a.m.
                                                      n/FSMA/             Chicago, IL 60605.
                                                      ucm247568.htm.
Chicago, IL, Advance             Until February 18,  http://www.fda.gov/ We encourage you    There is no
 registration.                    2014.               Food/               to use electronic   registration fee
                                                      GuidanceRegulatio   registration if     for the public
                                                      n/FSMA/             possible.\1\        meetings. Early
                                                      ucm247568.htm.                          registration is
                                                                                              recommended
                                                                                              because seating is
                                                                                              limited.
Chicago, IL, Request to make a   February 10, 2014.  http://www.fda.gov/ ..................  Requests made on
 Public Comment.                                      Food/                                   the day of the
                                                      GuidanceRegulatio                       meeting to make an
                                                      n/FSMA/                                 oral presentation
                                                      ucm247568.htm.\2\                       will be granted as
                                                                                              time permits.
                                                                                              Information on
                                                                                              requests to make
                                                                                              an oral
                                                                                              presentation may
                                                                                              be posted without
                                                                                              change to http://www.regulations.gov v, including any
                                                                                              personal
                                                                                              information
                                                                                              provided.
Chicago, IL, Request special     February 10, 2014.  Juanita Yates,      See FOR FURTHER
 accommodations due to a                              email:              INFORMATION
 disability.                                          Juanita.yates@fda   CONTACT.
                                                      .hhs.gov.
Chicago, IL, Closing date for    March 31, 2014....  Docket No. FDA-
 electronic or written comments.                      2013-N-1425.
Anaheim, CA, Public meeting....  March 13, 2014....  http://www.fda.gov/ Sheraton Park       Onsite registration
                                                      Food/               Hotel, 1855 South   from 8 a.m. to
                                                      GuidanceRegulatio   Harbor Blvd.,       8:30 a.m.
                                                      n/FSMA/             Anaheim, CA 92802.
                                                      ucm247568.htm.
Anaheim, CA, Advance             Until March 4,      http://www.fda.gov/ We encourage you    There is no
 registration.                    2014.               Food/               to use electronic   registration fee
                                                      GuidanceRegulatio   registration if     for the public
                                                      n/FSMA/             possible.\1\        meetings. Early
                                                      ucm247568.htm.                          registration is
                                                                                              recommended
                                                                                              because seating is
                                                                                              limited.
Anaheim, CA, Request to make a   February 18, 2014.  http://www.fda.gov/ ..................  Requests made on
 Public Comment.                                      Food/                                   the day of the
                                                      GuidanceRegulatio                       meeting to make an
                                                      n/FSMA/                                 oral presentation
                                                      ucm247568.htm.\2\.                      will be granted as
                                                                                              time permits.
                                                                                              Information on
                                                                                              requests to make
                                                                                              an oral
                                                                                              presentation may
                                                                                              be posted without
                                                                                              change to http://www.regulations.gov v, including any
                                                                                              personal
                                                                                              information
                                                                                              provided.
Anaheim, CA, Request special     February 18, 2014.  Juanita Yates,      See FOR FURTHER
 accommodations due to a                              email:              INFORMATION
 disability.                                          Juanita.yates@fda   CONTACT.
                                                      .hhs.gov.
Anaheim, CA, Closing date for    March 31, 2014....  Docket No. FDA-
 electronic or written comments.                      2013-N-1425.
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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: Nick Cane, Nakamoto Group, Inc., 11820
  Parklawn Dr., Suite 240, Rockville, MD 20852, 240-357-1176, FAX: 301-468-6536, email:
  [email protected]. Onsite registration will also be available.
\2\ You may also request to make an oral presentation at the public meetings 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].

III. Comments, Transcripts, and Recorded Video

    Information and data submitted voluntarily to FDA during the public 
meetings will become part of the administrative record for the 
rulemaking and will be accessible to the public at http://www.regulations.gov. The transcript of the proceedings from the public 
meetings will become part of the administrative record for the 
rulemaking. 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 video recording and live 
Web casting both of the public meetings. 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.


[[Page 5355]]


    Dated: January 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01985 Filed 1-30-14; 8:45 am]
BILLING CODE 4160-01-P