[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73295-73296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28053]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0367]
Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-
Forming Fish and Fishery Products--Decomposition and Histamine;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft Compliance Policy Guide entitled ``Sec. 540.525
Scombrotoxin (Histamine)-forming Fish and Fishery Products--
Decomposition and Histamine.'' The draft guidance, when finalized, will
replace existing guidance for FDA staff on adulteration associated with
decomposition and histamine identified during surveillance sampling and
testing of fish and fishery products susceptible to histamine
formation.
DATES: Submit either electronic or written comments on the draft
guidance by February 25, 2022 to ensure that we consider your comment
on the draft guidance before we begin work on the final version of the
guidance.
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,
[[Page 73296]]
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-2021-D-0367 for ``Sec. 540.525 Scombrotoxin (Histamine)-forming
Fish and Fishery Products--Decomposition and Histamine (CPG 7108.24).''
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, 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.'' We will review
this copy, including the claimed confidential information, in our
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 draft guidance to
Division of Seafood Safety (HFS-325), 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 request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Steven Bloodgood, Division of Seafood
Safety (HFS-325), Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-5316, email: [email protected]; or Jessica Larkin,
Center for Food Safety and Applied Nutrition, Office of Regulations and
Policy (HFS-024), Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft Compliance Policy
Guide (CPG) entitled ``Sec. 540.525 Scombrotoxin (Histamine)-forming
Fish and Fishery Products--Decomposition and Histamine (CPG 7108.24).''
This draft CPG would update and replace existing guidance for FDA staff
on adulteration associated with decomposition and histamine identified
during surveillance sampling and testing of fish and fishery products
susceptible to scombrotoxin (histamine) formation. The draft CPG would
revise FDA regulatory action guidance for sensory analysis and/or
histamine levels in scombrotoxin-forming fish and fishery products.
We are issuing the draft guidance consistent with our good guidance
practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.
Dated: December 21, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28053 Filed 12-23-21; 8:45 am]
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