[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Adulteration: Draft Guidance for Industry; Public Meeting; Request for 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Food Against Intentional Adulteration: Draft Guidance for Industry.'' 
The purpose of the public meeting is to discuss the draft guidance for 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]
BILLING CODE 4164-01-P