[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Proposed Rules]
[Pages 9987-9989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05149]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 121
[Docket No. FDA-2018-D-1398]
Mitigation Strategies To Protect Food Against Intentional
Adulteration: Draft Guidance for Industry; Public Meeting; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public meeting entitled ``Mitigation Strategies to Protect
Food Against Intentional Adulteration: Draft Guidance for Industry.''
The purpose of the public meeting is to discuss the draft guidance for
compliance and implementation of the ``Mitigation Strategies to Protect
Food Against Intentional Adulteration'' rule, which was issued under
the FDA Food Safety Modernization Act.
DATES: The public meeting will be held on April 17, 2019 (from 8:30
a.m. to 2 p.m.). Submit either electronic or written comments on this
public meeting by July 5, 2019, in order for comments to be considered
before work begins on the final guidance. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
ADDRESSES: The public meeting will be held at the Food and Drug
Administration, Center for Food Safety and Applied Nutrition, Harvey
Wiley Building Auditorium (First Floor), 5001 Campus Dr., College Park,
MD 20740. Public meeting participants (non-FDA employees) will undergo
routine security check procedures.
You may submit comments as follows. Please submit comments by July
5, 2019, for your comments to be considered before we begin work on the
final guidance.
[[Page 9988]]
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 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-2018-D-1398 for ``Mitigation Strategies to Protect Food Against
Intentional Adulteration: Draft Guidance for Industry.'' Received
comments 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.
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT:
For questions about registering for the meeting or to register by
phone: Melissa Schroeder, SIDEM, 1775 Eye St. NW, Ste. 1150,
Washington, DC 20006, 240-393-4496, [email protected].
For general questions about the meeting, to request an opportunity
to make oral comments or to request 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
The Mitigation Strategies to Protect Food Against Intentional
Adulteration rule (IA rule, 21 CFR part 121, published in the Federal
Register of May 27, 2016, 81 FR 34165) requires domestic and foreign
food facilities that are required to register under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) to address hazards that may be
introduced with the intention to cause wide scale public health harm.
These food facilities are required to conduct a vulnerability
assessment to identify significant vulnerabilities and actionable
process steps and implement mitigation strategies to significantly
minimize or prevent significant vulnerabilities identified at
actionable process steps in a food operation. The rule is part of the
Agency's ongoing efforts to implement the FDA Food Safety Modernization
Act (FSMA; Pub. L. 111-353).
In the Federal Register of June 20, 2018 (83 FR 28651), we
announced the first installment of the draft guidance on complying with
the IA rule, ``Mitigation Strategies to Protect Food Against
Intentional Adulteration: Draft Guidance for Industry.'' More recently,
in the Federal Register of March 6, 2019 (84 FR 8103), we announced the
availability of the second installment of the draft guidance. Both
installments provide information on and recommendations for compliance
with important requirements of the IA rule. The comment period on both
installments of the draft guidance is open until July 5, 2019, for
comments to be considered before work in begun on a final guidance.\1\
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\1\ Under FDA's Good Guidance Practices regulation, anyone may
comment on an FDA guidance document at any time (see 21 CFR
10.115(g)(5)).
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FDA is announcing a public meeting entitled, ``Mitigation
Strategies to Protect Food Against Intentional Adulteration: Draft
Guidance for Industry.'' The meeting will be held during the comment
period on the draft guidance.
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 draft guidance (Docket No. FDA-2018-D-
1398).
II. Purpose and Format of the Public Meeting
The purpose of the public meeting is to provide information and
facilitate comments so that stakeholders can better evaluate and
provide input on the draft guidance. We invite interested parties to
provide information and offer comments related to the IA rule draft
guidance. During the public meeting, we will present information on the
draft guidance, with emphasis on chapters related to rule requirements
for vulnerability assessments; mitigation
[[Page 9989]]
strategies; food defense monitoring; and education, training, or
experience. There will be an opportunity for questions, as well as an
opportunity for open public comment.
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website by April 10, 2019: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
Registration is free and based on space availability. Persons
interested in attending this public meeting must register by April 10,
2019, 11:59 p.m. Eastern Time. Early registration is recommended
because seating is limited; therefore, FDA may limit the number of
participants from each organization. Registrants will receive
confirmation when they have been accepted. If time and space permit,
onsite registration on the day of the public meeting will be provided
beginning at 8 a.m. We will let registrants know if registration closes
before the day of the public meeting.
For questions about registering for the meeting or to register by
phone, please contact Melissa Schroeder (see FOR FURTHER INFORMATION
CONTACT).
If you need special accommodations due to a disability, please
contact Juanita Yates, (see FOR FURTHER INFORMATION CONTACT) no later
than March 28, 2019.
Requests for Oral Presentations: During online or telephone
registration you may indicate if you wish to present during a public
comment session or participate in a specific session, and which
topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and request time for a joint presentation, or submit
requests for designated representatives to participate in the focused
sessions. Following the close of registration, we will determine the
amount of time allotted to each presenter and the approximate time each
oral presentation is to begin, and will select and notify participants
by April 3, 2019. All requests to make oral presentations must be
received by March 28, 2019. No commercial or promotional material will
be permitted to be presented or distributed at the public meeting.
Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the transcript will also be available
on the internet at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Dated: March 14, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05149 Filed 3-18-19; 8:45 am]
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