Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Public Meeting on Proposed Rule, 64425-64427 [2013-25125]

Download as PDF Federal Register / Vol. 78, No. 209 / Tuesday, October 29, 2013 / Proposed Rules collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before November 4, 2013. You can find more information, including routine uses permitted by the Privacy Act, in the Commission’s privacy policy, at https://www.ftc.gov/ftc/privacy.htm. 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: aleta.sindelar@fda.hhs.gov. SUPPLEMENTARY INFORMATION: By direction of the Commission. Donald S. Clark, Secretary. 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 [FR Doc. 2013–25452 Filed 10–28–13; 8:45 am] BILLING CODE 6750–01–P 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. 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 mstockstill on DSK4VPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 16:26 Oct 28, 2013 Jkt 232001 PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 64425 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). E:\FR\FM\29OCP1.SGM 29OCP1 64426 Federal Register / Vol. 78, No. 209 / Tuesday, October 29, 2013 / Proposed Rules 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 https:// 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 https:// 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 Wiley Auditorium, Harvey W. Wiley Federal Bldg., 5100 Paint Branch Pkwy., College Park, MD 20740. We encourage you to use electronic registration if possible 1. Onsite registration from 8 a.m. to 8:30 a.m. November 21, 2013, from 8:30 a.m. to 2:30 p.m. This meeting will be available for public viewing via Adobe Connect at https://collaboration.fda.gov/r4g7zwj0vea/ at the time of the meeting. College Park, MD, Advance registration. By November 19, 2013. Individuals who wish to participate in person are asked to preregister at https:// www.fda.gov/Food/GuidanceRegulation/ FSMA/ucm247568.htm. College Park, MD, Request to make an oral presentation. By November 14, 2013. https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247568.htm 2. .................................... College Park, MD, Request special accommodations due to a disability. College Park, MD, Submit electronic or written comments. Chicago, IL, Public meeting. By November 14, 2013. Aleta Sindelar, fda.hhs.gov. See FOR FURTHER INFORMATION CONTACT. By February 26, 2014 Docket No. FDA 2011–N–0922. November 25, 2013, from 8:30 a.m. to 2:30 p.m. ......................................................................... Chicago, IL, Advance registration. By November 21, 2013. Individuals who wish to participate in person are asked to preregister at https:// www.fda.gov/Food/GuidanceRegulation/ FSMA/ucm247568.htm. Chicago, IL, Request to make an oral presentation. mstockstill on DSK4VPTVN1PROD with PROPOSALS College Park, MD, Public meeting. By November 18, 2013. https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247568.htm 2. VerDate Mar<15>2010 16:26 Oct 28, 2013 Jkt 232001 PO 00000 Frm 00019 email: Fmt 4702 aleta.sindelar@ Sfmt 4702 Ralph Metcalfe Federal Building, 77 West Jackson Blvd., Chicago, IL 60604. We encourage you to use electronic registration if possible 1. .................................... E:\FR\FM\29OCP1.SGM 29OCP1 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 as 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. Onsite registration from 8 a.m. to 8:30 a.m. 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 as 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. 64427 Federal Register / Vol. 78, No. 209 / Tuesday, October 29, 2013 / Proposed Rules TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETINGS AND ON SUBMITTING COMMENTS TO THE RULEMAKING DOCKETS—Continued Date Electronic address email: Address Chicago, IL, Request special accommodations due to a disability. Chicago, IL, Submit electronic or written comments. Sacramento, CA, Public meeting. By November 18, 2013. Aleta Sindelar, fda.hhs.gov. By February 26, 2014 Docket No. FDA 2011–N–0922. December 6, 2013, from 8:30 a.m. to 2:30 p.m. Stanford Room, 650 Capitol Mall, Sacramento, CA 95814. Onsite registration from 8 a.m. to 8:30 a.m. Sacramento, CA, Advance registration. By December 4, 2013 This meeting will be available for public viewing via Adobe Connect https://collaboration.fda.gov/dec_6_fda_fsma_public_ meeting/. Individuals who wish to participate in person are asked to preregister at https:// www.fda.gov/Food/GuidanceRegulation/ FSMA/ucm247568.htm. We encourage you to use electronic registration if possible 1. Sacramento, CA, Request to make an oral presentation. By November 29, 2013. https://www.fda.gov/Food/ GuidanceRegulation/FSMA/ ucm247568.htm 2. .................................... 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 as 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. Sacramento, CA, Request special accommodations due to a disability. Sacramento, CA, Submit electronic or written comments. By November 29, 2013. Aleta Sindelar, fda.hhs.gov. See FOR FURTHER INFORMATION CONTACT. By February 26, 2014 Docket No. FDA 2011–N–0922. email: aleta.sindelar@ Other information aleta.sindelar@ See FOR FURTHER INFORMATION CONTACT. 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: aleta.sindelar@fda.hhs.gov. 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: aleta.sindelar@fda.hhs.gov. mstockstill on DSK4VPTVN1PROD with PROPOSALS 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 https://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 https:// www.regulations.gov, Docket No. FDA– 2011–N–0922, and at FDA’s FSMA Web site at: https://www.fda.gov/Food/ GuidanceRegulation/FSMA/ default.htm. It may also be viewed at the Division of Dockets Management (HFA– VerDate Mar<15>2010 16:26 Oct 28, 2013 Jkt 232001 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 https://www.fda.gov/Food/ GuidanceRegulation/FSMA/ default.htm. PO 00000 Frm 00020 Fmt 4702 Sfmt 9990 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 E:\FR\FM\29OCP1.SGM 29OCP1

Agencies

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

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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:
aleta.sindelar@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 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 https://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 https://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 https:// 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, https://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 https://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. aleta.sindelar@fda.hh 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 https:// 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, https://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 https://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. aleta.sindelar@fda.hh 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 https:// 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, https://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 https://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. aleta.sindelar@fda.hh 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: aleta.sindelar@fda.hhs.gov. 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:
aleta.sindelar@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
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 the
rulemaking. Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov, Docket
No. FDA-2011-N-0922, and at FDA's FSMA Web site at: https://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 https://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

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