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, 6760-6761 [2023-02051]
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Federal Register / Vol. 88, No. 21 / Wednesday, February 1, 2023 / Notices
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
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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copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Shabnam Naseer, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Avenue, Bldg. 22, Rm. 6239,
Silver Spring, MD 20993, 301–796–
8539.
SUPPLEMENTARY INFORMATION:
I. Background
lotter on DSK11XQN23PROD with NOTICES1
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Early Lyme Disease as Manifested by
Erythema Migrans: Developing Drugs for
Treatment.’’
The purpose of this draft guidance is
to assist sponsors in the clinical
development of drugs for the treatment
of early Lyme disease as manifested by
EM. Specifically, this guidance
addresses FDA’s current thinking
regarding clinical trial design
considerations such as trial populations,
efficacy endpoints and clinical
microbiology considerations.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Early Lyme Disease as Manifested
by Erythema Migrans: Developing Drugs
for Treatment.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
VerDate Sep<11>2014
21:04 Jan 31, 2023
Jkt 259001
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information contained in 21 CFR part
312 relating to investigational new drug
applications have been approved under
OMB control number 0910–0014. The
collections of information in 21 CFR
part 314 relating to new drug
applications have been approved under
OMB control number 0910–0001. The
collections of information contained in
21 CFR part 601 relating to biologics
license applications have been approved
under OMB control number 0910–0338.
The collections of information in 21
CFR part 201 relating to prescription
product labeling requirements have
been approved under OMB control
number 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: January 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–02103 Filed 1–31–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0879]
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.
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 March 3,
2023.
SUMMARY:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Procedures for the Safe Processing and
Importing of Fish and Fishery
Products—21 CFR Part 123
OMB Control Number 0910–0354—
Extension
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
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
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Federal Register / Vol. 88, No. 21 / Wednesday, February 1, 2023 / Notices
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 (21 CFR 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 also
to be made available for review by FDA
as provided in § 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
(§ 1240.60 (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 August 2,
2022 (87 FR 47214), 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
Number of
recordkeepers
Number of
records per
recordkeeper 3
123.6(a), (b), and (c); Prepare hazard analysis and HACCP plan .........
123.6(c)(5); Undertake and prepare records of corrective actions .........
123.8(a)(1) and (c); Reassess hazard analysis and HACCP plan ..........
123.12(a)(2)(ii); Verify compliance of imports and prepare records of
verification activities.
123.6(c)(7); Document monitoring of critical control points .....................
123.7(d); Undertake and prepare records of corrective actions due to a
deviation from a critical limit.
123.8(d); Maintain records of the calibration of process-monitoring instruments and the performing of any periodic end-product and inprocess testing.
123.11(c); Maintain sanitation control records .........................................
123.12(c); 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.
123.12(a)(2); Prepare new written verification procedures to verify compliance of imports.
50
15,000
15,000
4,100
1
4
1
80
50
60,000
15,000
328,000
16 ................................
0.30 (18 minutes) .......
4 ..................................
0.20 (12 minutes) .......
800
18,000
60,000
65,600
15,000
6,000
280
4
4,200,000
24,000
0.30 (18 minutes) .......
0.10 (6 minutes) .........
1,260,000
2,400
15,000
47
705,000
0.10 (6 minutes) .........
70,500
15,000
4,100
280
80
4,200,000
328,000
0.10 (6 minutes) .........
0.10 (6 minutes) .........
420,000
32,800
41
1
41
4 ..................................
164
Total ..................................................................................................
........................
........................
........................
.....................................
1,930,264
21 CFR section; 2 activity
Total annual
records
Average burden per
recordkeeping 4
Total hours
1 There
lotter on DSK11XQN23PROD with NOTICES1
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:
§ 123.16—Smoked Fish—process controls (see § 123.6(b));
§ 123.28(a)—Source Controls—molluscan shellfish (see § 123.6(b));
§ 123.28(c) and (d)—Records—molluscan shellfish (see § 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 our last OMB approval,
we have made no adjustments to our
burden estimate. We base this hour
burden estimate on our experience with
the application of HACCP principles in
food processing. Further, the burdens
have been estimated using typical small
seafood processing firms as a model
because these firms represent a
significant proportion of the industry.
The hour burden of HACCP
recordkeeping activities will vary
considerably among processors and
importers of fish and fishery products,
depending on the size of the facility and
complexity of the HACCP control
scheme (i.e., the number of products
VerDate Sep<11>2014
21:04 Jan 31, 2023
Jkt 259001
and the number of hazards controlled);
the daily frequency that control points
are monitored and values recorded; and
also on the extent that data recording
time and cost are minimized by the use
of automated data logging technology.
The burden estimate does not include
burden hours for activities that are a
usual and customary part of businesses’
normal activities. For example, the
tagging and labeling of molluscan
shellfish (§ 1240.60) is a customary and
usual practice among seafood
processors.
PO 00000
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Fmt 4703
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Dated: January 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–02051 Filed 1–31–23; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Notices]
[Pages 6760-6761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02051]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0879]
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.
-----------------------------------------------------------------------
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 March 3, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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
Products--21 CFR Part 123
OMB Control Number 0910-0354--Extension
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 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
[[Page 6761]]
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 (21 CFR 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 also 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 (Sec. 1240.60 (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 August 2, 2022 (87 FR 47214), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of records per Total annual
21 CFR section; \2\ activity recordkeepers recordkeeper records Average burden per recordkeeping \4\ Total hours
\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 1,930,264
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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)--Source Controls--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 our last OMB
approval, we have made no adjustments to our burden estimate. We base
this hour burden estimate on our experience with the application of
HACCP principles in food processing. Further, the burdens have been
estimated using typical small seafood processing firms as a model
because these firms represent a significant proportion of the industry.
The hour burden of HACCP recordkeeping activities will vary
considerably among processors and importers of fish and fishery
products, depending on the size of the facility and complexity of the
HACCP control scheme (i.e., the number of products and the number of
hazards controlled); the daily frequency that control points are
monitored and values recorded; and also on the extent that data
recording time and cost are minimized by the use of automated data
logging technology. The burden estimate does not include burden hours
for activities that are a usual and customary part of businesses'
normal activities. For example, the tagging and labeling of molluscan
shellfish (Sec. 1240.60) is a customary and usual practice among
seafood processors.
Dated: January 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02051 Filed 1-31-23; 8:45 am]
BILLING CODE 4164-01-P
