Requirements for Additional Traceability Records for Certain Foods; Proposed Rule; Public Meetings; Request for Comments, 62632-62634 [2020-21935]
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Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules
dates and times established, in advance, by
a Notice to Airmen. The effective date and
time will thereafter be continuously
published in the Chart Supplement.
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
*
*
*
ANM MT E5 Kalispell, MT [Amended]
Glacier Park International Airport, MT
(Lat. 48°18′38″ N, long. 114°15′22″ W)
That airspace extending upward from 700
feet above the surface within a 7.5-mile
radius of the airport, and within 2.3 miles
each side of the 138° bearing from the airport,
extending from the 7.5-mile radius to 13.4
miles southeast of the airport, and with 2
miles each side of the 215° bearing from the
airport, extending from the 7.5-mile radius to
19.5 miles southwest of the airport; and that
airspace extending upward from 1,200 feet
above the surface within a 25-mile radius of
the airport beginning at the 270° bearing from
the airport, clockwise to the 090° bearing
from the airport, thence along the 090°
bearing to 45 miles east of the airport, thence
within a 45-mile radius of the airport
clockwise to the 270° bearing from the
airport, thence along the 270° bearing to the
point of beginning, 25 miles west of Glacier
Park International Airport.
Issued in Seattle, Washington, on
September 18, 2020.
B.G. Chew,
Acting Group Manager, Operations Support
Group, Western Service Center.
Dated: August 21, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020–21037 Filed 10–2–20; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA–2014–N–0053]
BILLING CODE 4910–13–P
Requirements for Additional
Traceability Records for Certain
Foods; Proposed Rule; Public
Meetings; Request for Comments
DEPARTMENT OF ENERGY
AGENCY:
[FR Doc. 2020–21881 Filed 10–2–20; 8:45 am]
Food and Drug Administration,
HHS.
Federal Energy Regulatory
Commission
ACTION:
18 CFR Part 292
SUMMARY:
Notification of public meeting;
request for comments.
[Docket No. RM20–20–000]
Petition for Rulemaking of Bloom
Energy Corporation; Correction
Federal Energy Regulatory
Commission.
ACTION: Petition for rulemaking;
correcting amendment.
AGENCY:
This document contains a
correction to the Petition for rulemaking
(RM18–20–000) which published in the
Federal Register on Friday, September
18, 2020 (85 FR 58300). The docket
number was incorrect. This document
corrects the docket number in this
proceeding as captioned above.
DATES: Comments due 5:00 p.m. Eastern
time on September 8, 2020.
FOR FURTHER INFORMATION CONTACT:
Lawrence Greenfield, Office of the
General Counsel, Federal Energy
SUMMARY:
jbell on DSKJLSW7X2PROD with PROPOSALS
Regulatory Commission, 888 First Street
NE, Washington, DC 20426, (202) 502–
6415, Lawrence.Greenfield@ferc.gov.
SUPPLEMENTARY INFORMATION: On August
19, 2020, the Commission issued a
Petition for rulemaking informing that
Bloom Energy Corporation submitted a
petition for rulemaking requesting that
the Commission clarify that the thermal
energy output produced by a toppingcycle facility’s solid oxide fuel cell
system when used to reform methane
and produce hydrogen for fuel for
electricity generation by that facility is
useful thermal energy output that would
enable the facility powered by such fuel
cells to be certified as a qualifying
cogeneration facility, all as more fully
explained in the petition.
VerDate Sep<11>2014
23:47 Oct 02, 2020
Jkt 253001
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing three virtual public
meetings entitled ‘‘Requirements for
Additional Traceability Records for
Certain Foods; Proposed Rule.’’ The
purpose of the public meetings is to
discuss the proposed rule entitled
‘‘Requirements for Additional
Traceability Records for Certain Foods,’’
which was issued under the FDA Food
Safety Modernization Act (FSMA).
These public meetings are intended to
facilitate and support the public’s
evaluation and commenting process on
the proposed rule.
DATES: The public meetings will be held
on November 6, 2020, from 8:30 a.m.
Eastern Time to 3:30 p.m. Eastern Time;
November 18, 2020 from 9:30 a.m.
Eastern Time to 4:30 p.m. Eastern Time;
and December 2, 2020 from 11:30 a.m.
Eastern Time to 6:30 p.m. Eastern Time.
Submit either electronic or written
PO 00000
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Fmt 4702
Sfmt 4702
comments on the notice by January 21,
2021. See ‘‘How to Participate in the
Public Meetings’’ in the SUPPLEMENTARY
INFORMATION section of this document
for closing dates for advanced
registration and other information
regarding meeting participation.
ADDRESSES: Due to the impact of the
COVID–19 pandemic, these meetings
will be held virtually to help protect the
public and limit the spread of the virus.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before January 21, 2021. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of January 21, 2021. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
E:\FR\FM\05OCP1.SGM
05OCP1
jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–0053 for ‘‘Requirements for
Additional Traceability Records for
Certain Foods.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT: For
general questions about the public
meetings or for special accommodations
VerDate Sep<11>2014
23:47 Oct 02, 2020
Jkt 253001
due to a disability: Juanita Yates, Center
for Food Safety and Applied Nutrition
(HFS–009), Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1731,
Juanita.Yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FSMA (Pub. L. 111–353), enacted in
2011, modernized U.S. food safety law
to better ensure the safety and security
of the nation’s food supply. Section
204(d) of FSMA requires that FDA
establish recordkeeping requirements
for facilities that manufacture, process,
pack, or hold foods that the Agency
designates as high risk, to facilitate the
rapid and effective traceability of such
foods. These recordkeeping
requirements will be in addition to the
food traceability requirements under
section 414 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
350c) (added to the FD&C Act in title III,
subtitle A, section 306, of the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002
(Pub. L. 107–188)) and the
implementing regulations in subpart J of
part 1 of title 21 of the Code of Federal
Regulations (21 CFR 1.326 to 1.368) (the
subpart J regulations). Congress directed
FDA to adopt the subpart J regulations
recordkeeping requirements to allow the
Agency to identify the immediate
previous sources and immediate
subsequent recipients of foods
(commonly referred to as ‘‘one-up, oneback’’ recordkeeping) to address
credible threats of serious adverse
health consequences or death to humans
or animals. In section 204(d)(1) of
FSMA, Congress directed FDA to adopt
additional recordkeeping requirements
to prevent or mitigate foodborne illness
outbreaks and address credible threats
of serious adverse health consequences
or death to humans or animals resulting
from foods being adulterated under
section 402 of the FD&C Act (21 U.S.C.
342) or misbranded with respect to
allergen labeling under section 403(w)
of the FD&C Act (21 U.S.C. 343(w)).
In the Federal Register of September
23, 2020 (85 FR 59984), FDA published
the proposed rule entitled
‘‘Requirements for Additional
Traceability Records for Certain
Foods’’. The proposed additional
recordkeeping requirements, when
finalized, will fulfill Congress’s
directive in section 204(d)(1) of FSMA
and will help FDA follow the movement
of listed food products and ingredients
both backward and forward throughout
the supply chain.
Section 204(d)(4) of FSMA states that,
during the comment period for the
PO 00000
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Fmt 4702
Sfmt 4702
62633
proposed rule, FDA ‘‘shall conduct not
less than 3 public meetings in diverse
geographical areas of the United States
to provide persons in different regions
an opportunity to comment.’’ Due to the
impact of the COVID–19 pandemic,
these meetings will be held virtually to
help protect the public and limit the
spread of the virus.
FDA is therefore announcing a series
of virtual public meetings entitled
‘‘Requirements for Additional
Traceability Records for Certain Foods;
Proposed Rule’’ so that stakeholders can
better evaluate and comment on the
proposed rule. These meetings will be
held during the formal comment period
on the proposed rule. All three public
meetings will cover the same agenda
items and are intended to facilitate and
support the public’s evaluation and
commenting process.
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 proposed rule
(Docket No. FDA–2014–N–0053). (See
ADDRESSES).
II. Purpose and Format of the Public
Meetings
The purpose of the public meetings is
to provide information and facilitate
comment so that stakeholders can better
evaluate and provide input on the
proposed rule. We invite interested
parties to provide information and offer
comments related to the proposed rule.
During the public meetings we will
present information on the various
sections of the proposed rule: General
Provisions; Traceability Program
Records; Records of Growing, Receiving,
Transforming, Creating, and Shipping
Food; Special Requirements for Certain
Persons and Foods; Procedures for
Modified Requirements and
Exemptions; Waivers; Records
Maintenance and Availability; and
Updating the Food Traceability List.
Stakeholder panels will provide
discussion on the various issues. There
will be an opportunity for questions, as
well as an opportunity for open public
comment.
III. How To Participate in the Public
Meetings
There will be a total of three virtual
public meetings with different time
frames, which will provide persons in
different regions an opportunity to
comment on the proposed rule.
Table 1 provides information on
participation in the public meetings.
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Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules
TABLE 1—INFORMATION ON PARTICIPATING IN THE PUBLIC MEETINGS AND ON SUBMITTING COMMENTS TO THE PROPOSED
RULE ON REQUIREMENTS FOR ADDITIONAL TRACEABILITY RECORDS FOR CERTAIN FOODS DOCKET
Activity
Date
Electronic address
First public meeting .....
November 6, 2020;
8:30 a.m.–3:30 p.m.
EST.
by October 28, 2020 ..
Webcast information will be sent upon completion of registration.
Webcast will have closed captioning.
https://www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-and-dietary-supplements.
https://www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-and-dietary-supplements.
.........................................................................
There is no registration fee for the public
meetings. Early registration is recommended.
Advance registration ....
Request to make oral
presentation.
by October 9, 2020 ....
Notice confirming opportunity to make
oral presentation.
by October 16, 2020 ..
Submitting either electronic or written comments.
Second public meeting
Submit comments by
January 21, 2021.
https://www.regulations.gov ............................
November 18, 2020;
9:30 a.m.–4:30 p.m.
EST.
by November 6, 2020
Webcast information will be sent upon completion of registration.
Webcast will have closed captioning.
https://www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-and-dietary-supplements.
https://www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-and-dietary-supplements.
.........................................................................
There is no registration fee for the public
meetings. Early registration is recommended.
Advance registration ....
An Agency representative will confirm the opportunity to make an oral presentation and
will provide the approximate time on the
public meeting agenda to do so.
See ADDRESSES for additional information
on submitting comments.
Request to make oral
presentation.
by October 16, 2020 ..
Notice confirming opportunity to make
oral presentation.
by October 23, 2020 ..
Submitting either electronic or written comments.
Third public meeting ....
Submit comments by
January 21, 2021.
https://www.regulations.gov ............................
December 2, 2020;
11:30 a.m.–6:30
p.m. EST.
by November 18, 2020
Webcast information will be sent upon completion of registration.
Webcast will have closed captioning.
https://www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-and-dietary-supplements.
https://www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-and-dietary-supplements.
.........................................................................
There is no registration fee for the public
meetings. Early registration is recommended.
Advance registration ....
jbell on DSKJLSW7X2PROD with PROPOSALS
Other information
Request to make oral
presentation.
by October 26, 2020 ..
Notice confirming opportunity to make
oral presentation.
by November 9, 2020
Submitting either electronic or written comments.
Submit comments by
January 21, 2021.
https://www.regulations.gov ............................
IV. Transcripts
DEPARTMENT OF JUSTICE
Please be advised that as soon as a
transcript is available, it will be
accessible at: https://
www.regulations.gov. You may also
view the transcript at the Dockets
Management Staff (see ADDRESSES).
Drug Enforcement Administration
Dated: September 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–21935 Filed 10–2–20; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. DEA–377]
RIN 1117–AB37
Registering Emergency Medical
Services Agencies Under the
Protecting Patient Access to
Emergency Medications Act of 2017
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
VerDate Sep<11>2014
23:47 Oct 02, 2020
Jkt 253001
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An Agency representative will confirm the opportunity to make an oral presentation and
will provide the approximate time on the
public meeting agenda to do so.
See ADDRESSES for additional information
on submitting comments.
The ‘‘Protecting Patient
Access to Emergency Medications Act of
2017,’’ (hereafter the ‘‘Act’’) which
became law on November 17, 2017,
amended the Controlled Substances Act
to allow for a new registration category
for emergency medical services agencies
that handle controlled substances. It
also established standards for registering
emergency medical services agencies,
and set forth new requirements for
delivery, storage, and recordkeeping
related to their handling of controlled
substances. In addition, the Act allows
emergency medical services
professionals to administer controlled
substances outside the physical
SUMMARY:
21 CFR Parts 1300, 1301, 1304, 1306,
and 1307
AGENCY:
An Agency representative will confirm the opportunity to make an oral presentation and
will provide the approximate time on the
public meeting agenda to do so.
See ADDRESSES for additional information
on submitting comments.
E:\FR\FM\05OCP1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Proposed Rules]
[Pages 62632-62634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21935]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2014-N-0053]
Requirements for Additional Traceability Records for Certain
Foods; Proposed Rule; Public Meetings; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing three virtual public meetings entitled ``Requirements for
Additional Traceability Records for Certain Foods; Proposed Rule.'' The
purpose of the public meetings is to discuss the proposed rule entitled
``Requirements for Additional Traceability Records for Certain Foods,''
which was issued under the FDA Food Safety Modernization Act (FSMA).
These public meetings are intended to facilitate and support the
public's evaluation and commenting process on the proposed rule.
DATES: The public meetings will be held on November 6, 2020, from 8:30
a.m. Eastern Time to 3:30 p.m. Eastern Time; November 18, 2020 from
9:30 a.m. Eastern Time to 4:30 p.m. Eastern Time; and December 2, 2020
from 11:30 a.m. Eastern Time to 6:30 p.m. Eastern Time. Submit either
electronic or written comments on the notice by January 21, 2021. See
``How to Participate in the Public Meetings'' in the SUPPLEMENTARY
INFORMATION section of this document for closing dates for advanced
registration and other information regarding meeting participation.
ADDRESSES: Due to the impact of the COVID-19 pandemic, these meetings
will be held virtually to help protect the public and limit the spread
of the virus.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before January 21, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 21, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management
[[Page 62633]]
Staff, FDA will post your comment, as well as any attachments, except
for information submitted, marked and identified, as confidential, if
submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-0053 for ``Requirements for Additional Traceability Records
for Certain Foods.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: For general questions about the public
meetings or for special accommodations due to a disability: Juanita
Yates, Center for Food Safety and Applied Nutrition (HFS-009), Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
1731, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FSMA (Pub. L. 111-353), enacted in 2011, modernized U.S. food
safety law to better ensure the safety and security of the nation's
food supply. Section 204(d) of FSMA requires that FDA establish
recordkeeping requirements for facilities that manufacture, process,
pack, or hold foods that the Agency designates as high risk, to
facilitate the rapid and effective traceability of such foods. These
recordkeeping requirements will be in addition to the food traceability
requirements under section 414 of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 350c) (added to the FD&C Act in title III,
subtitle A, section 306, of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (Pub. L. 107-188)) and the
implementing regulations in subpart J of part 1 of title 21 of the Code
of Federal Regulations (21 CFR 1.326 to 1.368) (the subpart J
regulations). Congress directed FDA to adopt the subpart J regulations
recordkeeping requirements to allow the Agency to identify the
immediate previous sources and immediate subsequent recipients of foods
(commonly referred to as ``one-up, one-back'' recordkeeping) to address
credible threats of serious adverse health consequences or death to
humans or animals. In section 204(d)(1) of FSMA, Congress directed FDA
to adopt additional recordkeeping requirements to prevent or mitigate
foodborne illness outbreaks and address credible threats of serious
adverse health consequences or death to humans or animals resulting
from foods being adulterated under section 402 of the FD&C Act (21
U.S.C. 342) or misbranded with respect to allergen labeling under
section 403(w) of the FD&C Act (21 U.S.C. 343(w)).
In the Federal Register of September 23, 2020 (85 FR 59984), FDA
published the proposed rule entitled ``Requirements for Additional
Traceability Records for Certain Foods''. The proposed additional
recordkeeping requirements, when finalized, will fulfill Congress's
directive in section 204(d)(1) of FSMA and will help FDA follow the
movement of listed food products and ingredients both backward and
forward throughout the supply chain.
Section 204(d)(4) of FSMA states that, during the comment period
for the proposed rule, FDA ``shall conduct not less than 3 public
meetings in diverse geographical areas of the United States to provide
persons in different regions an opportunity to comment.'' Due to the
impact of the COVID-19 pandemic, these meetings will be held virtually
to help protect the public and limit the spread of the virus.
FDA is therefore announcing a series of virtual public meetings
entitled ``Requirements for Additional Traceability Records for Certain
Foods; Proposed Rule'' so that stakeholders can better evaluate and
comment on the proposed rule. These meetings will be held during the
formal comment period on the proposed rule. All three public meetings
will cover the same agenda items and are intended to facilitate and
support the public's evaluation and commenting process.
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 proposed rule (Docket No. FDA-2014-N-0053).
(See ADDRESSES).
II. Purpose and Format of the Public Meetings
The purpose of the public meetings is to provide information and
facilitate comment so that stakeholders can better evaluate and provide
input on the proposed rule. We invite interested parties to provide
information and offer comments related to the proposed rule. During the
public meetings we will present information on the various sections of
the proposed rule: General Provisions; Traceability Program Records;
Records of Growing, Receiving, Transforming, Creating, and Shipping
Food; Special Requirements for Certain Persons and Foods; Procedures
for Modified Requirements and Exemptions; Waivers; Records Maintenance
and Availability; and Updating the Food Traceability List. Stakeholder
panels will provide discussion on the various issues. There will be an
opportunity for questions, as well as an opportunity for open public
comment.
III. How To Participate in the Public Meetings
There will be a total of three virtual public meetings with
different time frames, which will provide persons in different regions
an opportunity to comment on the proposed rule.
Table 1 provides information on participation in the public
meetings.
[[Page 62634]]
Table 1--Information on Participating in the Public Meetings and on Submitting Comments to the Proposed Rule on
Requirements for Additional Traceability Records for Certain Foods Docket
----------------------------------------------------------------------------------------------------------------
Activity Date Electronic address Other information
----------------------------------------------------------------------------------------------------------------
First public meeting.............. November 6, 2020; Webcast information will Webcast will have closed
8:30 a.m.-3:30 p.m. be sent upon completion captioning.
EST. of registration.
Advance registration.............. by October 28, 2020.. https://www.fda.gov/food/ There is no registration
news-events-cfsan/ fee for the public
workshops-meetings- meetings. Early
webinars-food-and-dietary- registration is
supplements. recommended.
Request to make oral presentation. by October 9, 2020... https://www.fda.gov/food/ .........................
news-events-cfsan/
workshops-meetings-
webinars-food-and-dietary-
supplements.
Notice confirming opportunity to by October 16, 2020.. .......................... An Agency representative
make oral presentation. will confirm the
opportunity to make an
oral presentation and
will provide the
approximate time on the
public meeting agenda to
do so.
Submitting either electronic or Submit comments by https:// See ADDRESSES for
written comments. January 21, 2021. www.regulations.gov. additional information
on submitting comments.
Second public meeting............. November 18, 2020; Webcast information will Webcast will have closed
9:30 a.m.-4:30 p.m. be sent upon completion captioning.
EST. of registration.
Advance registration.............. by November 6, 2020.. https://www.fda.gov/food/ There is no registration
news-events-cfsan/ fee for the public
workshops-meetings- meetings. Early
webinars-food-and-dietary- registration is
supplements. recommended.
Request to make oral presentation. by October 16, 2020.. https://www.fda.gov/food/ .........................
news-events-cfsan/
workshops-meetings-
webinars-food-and-dietary-
supplements.
Notice confirming opportunity to by October 23, 2020.. .......................... An Agency representative
make oral presentation. will confirm the
opportunity to make an
oral presentation and
will provide the
approximate time on the
public meeting agenda to
do so.
Submitting either electronic or Submit comments by https:// See ADDRESSES for
written comments. January 21, 2021. www.regulations.gov. additional information
on submitting comments.
Third public meeting.............. December 2, 2020; Webcast information will Webcast will have closed
11:30 a.m.-6:30 p.m. be sent upon completion captioning.
EST. of registration.
Advance registration.............. by November 18, 2020. https://www.fda.gov/food/ There is no registration
news-events-cfsan/ fee for the public
workshops-meetings- meetings. Early
webinars-food-and-dietary- registration is
supplements. recommended.
Request to make oral presentation. by October 26, 2020.. https://www.fda.gov/food/ .........................
news-events-cfsan/
workshops-meetings-
webinars-food-and-dietary-
supplements.
Notice confirming opportunity to by November 9, 2020.. .......................... An Agency representative
make oral presentation. will confirm the
opportunity to make an
oral presentation and
will provide the
approximate time on the
public meeting agenda to
do so.
Submitting either electronic or Submit comments by https:// See ADDRESSES for
written comments. January 21, 2021. www.regulations.gov. additional information
on submitting comments.
----------------------------------------------------------------------------------------------------------------
IV. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at: https://www.regulations.gov. You may also view
the transcript at the Dockets Management Staff (see ADDRESSES).
Dated: September 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21935 Filed 10-2-20; 8:45 am]
BILLING CODE 4164-01-P
