[Federal Register Volume 85, Number 103 (Thursday, May 28, 2020)]
[Notices]
[Pages 32040-32041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11455]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1398]


Mitigation Strategies to Protect Food Against Intentional 
Adulteration; Draft Guidance for Industry; Extension of the Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
extending the comment period for the notice of availability that 
appeared in the Federal Register of February 14, 2020, entitled 
``Mitigation Strategies to Protect Food Against Intentional 
Adulteration; Draft Guidance for Industry.'' This supplemental draft 
guidance document, when finalized, will help food facilities that 
manufacture, process, pack, or hold food, and that are required to 
register under the Federal Food, Drug, and Cosmetic Act comply with the 
requirements of our regulation entitled ``Mitigation Strategies to 
Protect Food Against Intentional Adulteration.'' FDA is taking this 
action in response to a request for an extension to allow interested 
persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice of 
availability published February 14, 2020 (85 FR 8599). Submit either 
electronic or written comments on the supplemental draft guidance by 
August 14, 2020.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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: Supplemental 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.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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
requests. See the SUPPLEMENTARY

[[Page 32041]]

INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Ryan Newkirk, Center for Food Safety 
and Applied Nutrition (HFS-005), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-3712, 
ryan.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 14, 2020 
(85 FR 8599), we published a notice announcing the availability of a 
supplemental draft guidance for industry entitled ``Mitigation 
Strategies to Protect Food Against Intentional Adulteration: Draft 
Guidance for Industry.'' This multichapter supplemental draft guidance 
for industry is intended to help food facilities required to comply, 
develop, and implement some of the components of a food defense plan, 
and meet other requirements under 21 CFR part 121.
    The Agency has received a request for an extension of the comment 
period for 120 days. The request conveyed concern that the current 
comment period does not allow sufficient time to develop a 
comprehensive response.
    FDA has considered the request and is extending the comment period 
for the notice of availability for 60 days, until August 14, 2020. The 
Agency believes that a 60-day extension allows adequate time for 
interested persons to submit comments.

    Dated: May 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11455 Filed 5-27-20; 8:45 am]
BILLING CODE 4164-01-P


