Notice2026-11762
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 11, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 91 Issue 112 (Thursday, June 11, 2026)</title>
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[Federal Register Volume 91, Number 112 (Thursday, June 11, 2026)]
[Notices]
[Pages 35484-35485]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11762]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0498]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Procedures for the
Safe Processing and Importing of Fish and Fishery Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by July 13, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function The OMB control number for
this information collection is 0910-0354. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Christopher Colburn, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8758,
<a href="/cdn-cgi/l/email-protection#6b3b392a381f0a0d0d2b0d0f0a45030318450c041d"><span class="__cf_email__" data-cfemail="134341524067727575537577723d7b7b603d747c65">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Procedures for the Safe Processing and Importing of Fish and Fishery--
21 CFR Part 123
OMB Control Number 0910-0354--Reinstatement
This information collection supports regulations in part 123 (21
CFR part 123), which mandate the application of hazard analysis and
critical control point (HACCP) principles to the processing of seafood.
HACCP is a preventive system of hazard control designed to help ensure
the safety of foods. The regulations were issued under FDA's statutory
authority to regulate food safety, including section 402(a)(1) and (4)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and
(4)). Certain provisions in part 123 require that processors and
importers of seafood collect and record information.
The HACCP records compiled and maintained by a seafood processor
primarily consist of the periodic observations recorded at selected
monitoring points during processing and packaging operations, as called
for in a processor's HACCP plan (e.g., the
[[Page 35485]]
values for processing times, temperatures, acidity, etc., as observed
at critical control points). The primary purpose of HACCP records is to
permit a processor to verify that products have been produced within
carefully established processing parameters (critical limits) that
ensure that hazards have been avoided.
HACCP records are normally reviewed by appropriately trained
employees at the end of a production lot or at the end of a day or week
of production to verify that control limits have been maintained, or
that appropriate corrective actions were taken if the critical limits
were not maintained. Such verification activities are essential to
ensure that the HACCP system is working as planned. A review of these
records during the conduct of periodic plant inspections also permits
FDA to determine whether the products have been consistently processed
in conformance with appropriate HACCP food safety controls.
Section 123.12 requires that importers of seafood products take
affirmative steps and maintain records that verify that the fish and
fishery products they offer for import into the United States were
processed in accordance with the HACCP and sanitation provisions set
forth in part 123. These records are to be made available for review by
FDA as provided in Sec. 123.12(c).
The time and costs of these recordkeeping activities will vary
considerably among processors and importers of fish and fishery
products, depending on the type and number of products involved, and on
the nature of the equipment or instruments required to monitor critical
control points. The burden estimate in table 1 includes only those
collections of information under the seafood HACCP regulations that are
not already required under other statutes and regulations. The estimate
also does not include collections of information that are a usual and
customary part of businesses' normal activities. For example, the
tagging and labeling of molluscan shellfish (21 CFR 1240.60) is a
customary and usual practice among seafood processors. Consequently,
the estimates in table 1 account only for information collection and
recording requirements attributable to part 123.
Description of Respondents: Respondents to this collection of
information include processors and importers of seafood.
In the Federal Register of February 19, 2026 (91 FR 8010), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
Number of records per Total annual
21 CFR section; \2\ activity recordkeepers recordkeeper records Average burden per recordkeeping \4\ Total hours
\3\
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123.6(a), (b), and (c); Prepare hazard 50 1 50 16....................................... 800
analysis and HACCP plan.
123.6(c)(5); Undertake and prepare records of 15,000 4 60,000 0.30 (18 minutes)........................ 18,000
corrective actions.
123.8(a)(1) and (c); Reassess hazard analysis 15,000 1 15,000 4........................................ 60,000
and HACCP plan.
123.12(a)(2)(ii); Verify compliance of 4,100 80 328,000 0.20 (12 minutes)........................ 65,600
imports and prepare records of verification
activities.
123.6(c)(7); Document monitoring of critical 15,000 280 4,200,000 0.30 (18 minutes)........................ 1,260,000
control points.
123.7(d); Undertake and prepare records of 6,000 4 24,000 0.10 (6 minutes)......................... 2,400
corrective actions due to a deviation from a
critical limit.
123.8(d); Maintain records of the calibration 15,000 47 705,000 0.10 (6 minutes)......................... 70,500
of process-monitoring instruments and the
performing of any periodic end-product and
in-process testing.
123.11(c); Maintain sanitation control 15,000 280 4,200,000 0.10 (6 minutes)......................... 420,000
records.
123.12(c); Maintain records that verify that 4,100 80 328,000 0.10 (6 minutes)......................... 32,800
the fish and fishery products they offer for
import into the United States were processed
in accordance with the HACCP and sanitation
provisions set forth in part 123.
123.12(a)(2); Prepare new written 41 1 41 4........................................ 164
verification procedures to verify compliance
of imports.
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Total.................................... .............. .............. .............. ......................................... 1,930,264
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ These estimates include the information collection requirements in the following sections:
Sec. 123.16--Smoked--Fish--process controls (see Sec. 123.6(b));
Sec. 123.28(a)--SourceControls--molluscan shellfish (see Sec. 123.6(b));
Sec. 123.28(c)--and (d)--Records--molluscan shellfish (see Sec. 123.6(c)(7).
\3\ Based on an estimated 280 working days per year.
\4\ Estimated average time per 8-hour workday unless one-time response.
Based on a review of the information collection since its last OMB
approval, we have made no adjustments to our burden estimate.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-11762 Filed 6-10-26; 8:45 am]
BILLING CODE 4164-01-P
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