[Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013)]
[Proposed Rules]
[Pages 64425-64427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-25125]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16, 225, 500, 507, and 579

[Docket No. FDA-2011-N-0922]


Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals; 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 
three public meetings to discuss the proposed rule to establish 
requirements for current good manufacturing practice and hazard 
analysis and risk-based preventive controls for animal food. This 
proposed rule is one of several proposed rules that will 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 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 proposed rule.

DATES: See section II, ``How to Participate in the Public Meetings,'' 
in the SUPPLEMENTARY INFORMATION section.

ADDRESSES: See section II, ``How to Participate in the Public 
Meetings,'' in the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: For general questions about the 
meeting, for assistance to register for the meeting, to request an 
opportunity to make an oral presentation, or to request special 
accommodations due to a disability, contact: Aleta Sindelar, Center for 
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., 
Rm. 133, Rockville, MD 20855, 240-276-9230, FAX: 240-276-9241, 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 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 food and animal food, set standards for produce 
safety, and require importers to have a program to verify that the food 
products they bring into the United States are produced in a manner 
consistent with applicable FDA food safety requirements.
    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. The proposed rule for preventive controls for food for animals 
can be found elsewhere in this issue of the Federal Register, and it 
establishes a docket so that the public can review the proposed rule 
and submit comments to FDA. This proposed rulemaking is one of several 
key proposals in furtherance of FSMA's food safety mandate.
    The proposed rule would establish regulations regarding the 
manufacturing, processing, packing, or holding of animal food in two 
ways. First, it would create new current good manufacturing practice 
(CGMP) regulations that specifically address the manufacturing, 
processing, packing, and holding of animal food. Second, it would 
include new preventive control provisions intended to implement section 
103 of FSMA for animal food. In general, with some exceptions the new 
preventive control provisions would apply to animal food facilities 
that are required to register with FDA under the FD&C Act. These 
preventive controls would include requirements for covered facilities 
to maintain a food safety plan, perform a hazard analysis, and 
institute preventive controls for the mitigation of those hazards. 
Facilities would also be required to monitor their controls, verify 
that they were effective, take appropriate corrective actions, and 
maintain records documenting these actions.
    For information on the proposed rule for preventive controls for 
food for animals and related fact sheets, see FDA's FSMA Web page 
located at www.fda.gov/FSMA.

II. How To Participate in the Public Meetings

    FDA is holding the public meetings on the proposed rule for 
preventive controls for food for animals to inform the public about the 
proposed rule and the rulemaking process, including how to submit 
comments, data, and other information to the rulemaking docket; to 
respond to questions about the proposed rule; 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 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 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).

[[Page 64426]]

    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 administration 
record (the docket) for the rulemaking. All relevant data and 
documentation should be submitted with the comments to Docket No. FDA-
2011-N-0922. Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. It is only necessary to send one set of comments. 
Identify comments with the docket number FDA-2011-N-0922. Received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday, and will be posted to the 
docket at http://www.regulations.gov.
    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       Other information
----------------------------------------------------------------------------------------------------------------
College Park, MD, Public         November 21,       This meeting will be    Wiley Auditorium,  Onsite
 meeting.                         2013, from 8:30    available for public    Harvey W. Wiley    registration
                                  a.m. to 2:30 p.m.  viewing via Adobe       Federal Bldg.,     from 8 a.m. to
                                                     Connect at https://     5100 Paint         8:30 a.m.
                                                     collaboration.fda.gov/  Branch Pkwy.,
                                                     r4g7zwj0vea/ at the     College Park, MD
                                                     time of the meeting.    20740.
College Park, MD, Advance        By November 19,    Individuals who wish    We encourage you   There is no
 registration.                    2013.              to participate in       to use             registration fee
                                                     person are asked to     electronic         for the public
                                                     preregister at http://  registration if    meetings. Early
                                                     www.fda.gov/Food/       possible \1\.      registration is
                                                     GuidanceRegulation/                        recommended
                                                     FSMA/ucm247568.htm.                        because seating
                                                                                                is limited.
College Park, MD, Request to     By November 14,    http://www.fda.gov/     .................  Requests made on
 make an oral presentation.       2013.              Food/                                      the day of the
                                                     GuidanceRegulation/                        meeting to make
                                                     FSMA/ucm247568.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 http://www.regulations.gov gov, including
                                                                                                any personal
                                                                                                information
                                                                                                provided.
College Park, MD, Request        By November 14,    Aleta Sindelar, email:  See FOR FURTHER
 special accommodations due to    2013.              [email protected]   INFORMATION
 a disability.                                       s.gov.                  CONTACT.
College Park, MD, Submit         By February 26,    Docket No. FDA 2011-N-
 electronic or written comments.  2014.              0922.
Chicago, IL, Public meeting....  November 25,       ......................  Ralph Metcalfe     Onsite
                                  2013, from 8:30                            Federal            registration
                                  a.m. to 2:30 p.m.                          Building, 77       from 8 a.m. to
                                                                             West Jackson       8:30 a.m.
                                                                             Blvd., Chicago,
                                                                             IL 60604.
Chicago, IL, Advance             By November 21,    Individuals who wish    We encourage you   There is no
 registration.                    2013.              to participate in       to use             registration fee
                                                     person are asked to     electronic         for the public
                                                     preregister at http://  registration if    meetings. Early
                                                     www.fda.gov/Food/       possible \1\.      registration is
                                                     GuidanceRegulation/                        recommended
                                                     FSMA/ucm247568.htm.                        because seating
                                                                                                is limited.
Chicago, IL, Request to make an  By November 18,    http://www.fda.gov/     .................  Requests made on
 oral presentation.               2013.              Food/                                      the day of the
                                                     GuidanceRegulation/                        meeting to make
                                                     FSMA/ucm247568.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 http://www.regulations.gov gov, including
                                                                                                any personal
                                                                                                information
                                                                                                provided.

[[Page 64427]]

 
Chicago, IL, Request special     By November 18,    Aleta Sindelar, email:  See FOR FURTHER
 accommodations due to a          2013.              [email protected]   INFORMATION
 disability.                                         s.gov.                  CONTACT.
Chicago, IL, Submit electronic   By February 26,    Docket No. FDA 2011-N-
 or written comments.             2014.              0922.
Sacramento, CA, Public meeting.  December 6, 2013,  This meeting will be    Stanford Room,     Onsite
                                  from 8:30 a.m.     available for public    650 Capitol        registration
                                  to 2:30 p.m.       viewing via Adobe       Mall,              from 8 a.m. to
                                                     Connect https://        Sacramento, CA     8:30 a.m.
                                                     collaboration.fda.gov/  95814.
                                                     dec--6--fda--fsma--pu
                                                     blic--meeting/.
Sacramento, CA, Advance          By December 4,     Individuals who wish    We encourage you   There is no
 registration.                    2013.              to participate in       to use             registration fee
                                                     person are asked to     electronic         for the public
                                                     preregister at http://  registration if    meetings. Early
                                                     www.fda.gov/Food/       possible \1\.      registration is
                                                     GuidanceRegulation/                        recommended
                                                     FSMA/ucm247568.htm.                        because seating
                                                                                                is limited.
Sacramento, CA, Request to make  By November 29,    http://www.fda.gov/     .................  Requests made on
 an oral presentation.            2013.              Food/                                      the day of the
                                                     GuidanceRegulation/                        meeting to make
                                                     FSMA/ucm247568.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 http://www.regulations.gov gov, including
                                                                                                any personal
                                                                                                information
                                                                                                provided.
Sacramento, CA, Request special  By November 29,    Aleta Sindelar, email:  See FOR FURTHER
 accommodations due to a          2013.              [email protected]   INFORMATION
 disability.                                         s.gov.                  CONTACT.
Sacramento, CA, Submit           By February 26,    Docket No. FDA 2011-N-
 electronic or written comments.  2014.              0922.
----------------------------------------------------------------------------------------------------------------
\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: Aleta Sindelar, Center for Veterinary
  Medicine, Food and Drug Administration, 7519 Standish Pl., Rm. 133, Rockville, MD 20855, 240-276-9230, FAX:
  240-276-9241, email: [email protected]. 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: Aleta Sindelar, Center for Veterinary Medicine, Food and Drug
  Administration, 7519 Standish Pl., Rm. 133, Rockville, MD 20855, 240-276-9230, FAX: 240-276-9241, email:
  [email protected].

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 
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 the 
rulemaking. Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov, Docket 
No. FDA-2011-N-0922, 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), Food and Drug 
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. 
Additionally, FDA will be recording the meeting via adobe connect on 
November 21, 2013. Once the recording has been made 508 compliant, it 
will be accessible at FDA's FSMA Web site at http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm.

    Dated: October 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25125 Filed 10-25-13; 8:45 am]
BILLING CODE 4160-01-P