[Federal Register Volume 78, Number 247 (Tuesday, December 24, 2013)]
[Proposed Rules]
[Pages 78067-78069]
From the Federal Register Online via the Government Printing 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: 
nick.cane@nakamotogroup.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 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
----------------------------------------------------------------------------------------------------------------
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: nick.cane@nakamotogroup.com.
\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.

    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