Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, 46544-46546 [2019-18987]
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Federal Register / Vol. 84, No. 171 / Wednesday, September 4, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
ANADA .....................................................
Phased Review with Administrative
ANADA .................................................
Biowaiver request for soluble powder
oral dosage form product, using same
formulation/manufacturing process approach ...................................................
Biowaiver request for soluble powder
oral dosage form product, using same
API/solubility approach .........................
Biowaiver request for Type A medicated
article, using same formulation/manufacturing process approach ..................
Biowaiver request for Type A medicated
article, using same API/solubility approach ...................................................
Total ..................................................
1 There
Average
burden per
response
Total annual
responses
Total
hours
356v
18
1
18
159
2,862
356v
3
5
15
31.8
477
N/A
1
1
1
5
5
N/A
5
1
5
10
50
N/A
2
1
2
5
10
N/A
10
1
10
20
200
........................
........................
........................
51
........................
3,604
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates on our records
of generic drug applications. We
estimate that we will receive 21 ANADA
submissions per year over the next 3
years and that 3 of those submissions
will request phased review. We estimate
that each applicant that uses the phased
review process will have approximately
five phased reviews per application. We
estimate that an applicant will take
approximately 159 hours to prepare
either an ANADA or the estimated five
ANADA phased review submissions
and the administrative ANADA. Our
estimates of the burden of biowaiver
requests for generic soluble powder oral
dosage form products and Type A
medicated articles differ based on the
type of product and the basis for the
request, as shown in table 1. We
estimate that an applicant will take
between 5 and 20 hours to prepare a
biowaiver request.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our previous estimate of
the number of respondents submitting
generic drug applications. However, as
discussed, the burden for this
information collection was increased by
265 hours and 18 responses since the
last OMB approval. This is due to
adding to this collection burden hours
and responses for biowaiver requests.
jbell on DSK3GLQ082PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
FDA form No.
Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–19078 Filed 9–3–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0879]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Procedures for the
Safe and Sanitary Processing and
Importing of Fish and Fishery Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection associated with safe and
sanitary processing and importing of
fish and fishery products.
DATES: Submit either electronic or
written comments on the collection of
information by November 4, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 4,
2019. The https://www.regulations.gov
electronic filing system will accept
SUMMARY:
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comments until 11:59 p.m. Eastern Time
at the end of November 4, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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:
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Federal Register / Vol. 84, No. 171 / Wednesday, September 4, 2019 / Notices
• 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–
2013–N–0879 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Procedures for the Safe and Sanitary
Processing and Importing of Fish and
Fishery Products.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), 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/201523389.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
VerDate Sep<11>2014
19:08 Sep 03, 2019
Jkt 247001
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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10 a.m.–12 p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Procedures for the Safe and Sanitary
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
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46545
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
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 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
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Federal Register / Vol. 84, No. 171 / Wednesday, September 4, 2019 / Notices
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.
information include processors and
importers of seafood.
We estimate the burden of this
collection of information as follows:
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
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
123.6(a), (b), and (c); Prepare hazard analysis and
HACCP plan. ..............................................................
123.6(c)(5); Undertake and prepare records of corrective actions. ................................................................
Total
annual
records
Number of
records per
recordkeeper 3
Number of
recordkeepers
21 CFR Section 2
Average
burden per
recordkeeping 4
Total
hours
50
1
50
16
800
15,000
4
60,000
0.30
(18 minutes)
18,000
15,000
1
15,000
4
60,000
4,100
80
328,000
0.20
(12 minutes)
65,600
123.6(c)(7); Document monitoring of critical control
points. .........................................................................
15,000
280
4,200,000
0.30
(18 minutes)
1,260,000
123.7(d); Undertake and prepare records of corrective
actions due to a deviation from a critical limit. ..........
6,000
4
24,000
0.10
(6 minutes)
2,400
123.8(d); Maintain records of the calibration of process-monitoring instruments and the performing of
any periodic end-product and in-process testing. ......
15,000
47
705,000
70,500
123.11(c); Maintain sanitation control records. .............
15,000
280
4,200,000
0.10
(6 minutes)
0.10
(6 minutes)
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. ............................................................................
4,100
80
328,000
0.10
(6 minutes)
32,800
123.12(a)(2); Prepare new written verification procedures to verify compliance of imports. .......................
41
1
41
4
164
Total ........................................................................
..............................
..............................
..................
..............................
1,930,264
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. .........................
420,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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 work day unless one-time response.
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2 These
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
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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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
HHS.
[FR Doc. 2019–18987 Filed 9–3–19; 8:45 am]
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[Docket No. FDA–2019–N–3793]
General Hospital and Personal Use
Panel of the Medical Devices Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
Notice, establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
SUMMARY:
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]]>Agencies
[Federal Register Volume 84, Number 171 (Wednesday, September 4, 2019)]
[Notices]
[Pages 46544-46546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18987]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0879]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Procedures for the Safe and Sanitary Processing and
Importing of Fish and Fishery Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with safe
and sanitary processing and importing of fish and fishery products.
DATES: Submit either electronic or written comments on the collection
of information by November 4, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 4, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
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:
[[Page 46545]]
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-2013-N-0879 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Procedures for the Safe and
Sanitary Processing and Importing of Fish and Fishery Products.''
Received comments, those filed in a timely manner (see ADDRESSES), 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Procedures for the Safe and Sanitary 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
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 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
[[Page 46546]]
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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
Number of records Total Average burden
21 CFR Section \2\ Number of per recordkeeper annual per recordkeeping Total
recordkeepers \3\ records \4\ hours
----------------------------------------------------------------------------------------------------------------
123.6(a), (b), and (c); Prepare 50 1 50 16 800
hazard analysis and HACCP
plan..........................
123.6(c)(5); Undertake and 15,000 4 60,000 0.30 18,000
prepare records of corrective (18 minutes)
actions.......................
123.8(a)(1) and (c); Reassess 15,000 1 15,000 4 60,000
hazard analysis and HACCP
plan..........................
123.12(a)(2)(ii); Verify 4,100 80 328,000 0.20 65,600
compliance of imports and (12 minutes)
prepare records of
verification activities.......
123.6(c)(7); Document 15,000 280 4,200,000 0.30 1,260,000
monitoring of critical control (18 minutes)
points........................
123.7(d); Undertake and prepare 6,000 4 24,000 0.10 2,400
records of corrective actions (6 minutes)
due to a deviation from a
critical limit................
123.8(d); Maintain records of 15,000 47 705,000 0.10 70,500
the calibration of process- (6 minutes)
monitoring instruments and the
performing of any periodic end-
product and in-process
testing.......................
123.11(c); Maintain sanitation 15,000 280 4,200,000 0.10 420,000
control records............... (6 minutes)
123.12(c); Maintain records 4,100 80 328,000 0.10 32,800
that verify that the fish and (6 minutes)
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 41 1 41 4 164
written verification
procedures to verify
compliance of imports.........
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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 work day 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: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18987 Filed 9-3-19; 8:45 am]
BILLING CODE 4164-01-P
