Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, 18211-18213 [2010-8051]
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Federal Register / Vol. 75, No. 68 / Friday, April 9, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0182]
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.
srobinson on DSKHWCL6B1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
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
the information collection provisions of
FDA’s regulations requiring reporting
and recordkeeping for processors and
importers of fish and fishery products.
DATES: Submit written or electronic
comments on the collection of
information by June 8, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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
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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
FDA regulations in part 123 (21 CFR
part 123) 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 (a)(4) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
342(a)(1) and (a)(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
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Sfmt 4703
18211
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 of this
document 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.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 75, No. 68 / Friday, April 9, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section2
No. of
Recordkeepers
123.6(a),(b), and (c)
Total Annual
Records
Annual Frequency
per Recordkeeping3
Hours Per
Record4
Total Hours
50
1
50
16.00
800
123.6(c)(5)
15,000
4
60,000
0.30
18,000
123.8(a)(1) and (c)
15,000
1
15,000
4.00
60,000
4,100
80
328,000
0.20
65,600
15,000
280
4,200,000
0.30
1,260,000
123.7(d)
6,000
4
24,000
0.10
2,400
123.8(d)
15,000
47
705,000
0.10
70,500
123.11(c)
15,000
280
4,200,000
0.10
420,000
123.12(c)
4,100
80
328,000
0.10
32,800
41
1
41
4.00
164
123.12(a)(2)(ii)
123.6(c)(7)
123.12(a)(2)
Total
1,930,264
1 There
srobinson on DSKHWCL6B1PROD with NOTICES
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 work day unless one-time response.
FDA bases this hour burden estimate
on its 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 (21 CFR 1240.60) is
a customary and usual practice among
seafood processors.
Based on its records, FDA estimates
that there are 15,000 processors and
4,100 importers.
FDA estimates that 50 processors will
undertake the initial preparation of a
hazard analysis and HAACP plan
(§ 123.6(a),(b), and (c)). FDA estimates
the burden for the initial preparation of
a hazard analysis and HAACP plan to be
16 hours per processor for a total burden
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of 800 hours. FDA estimates that all
processors (15,000 processors) will
undertake and keep records of 4
corrective action plans (§ 123.6(c)(5)) for
a total of 60,000 records. FDA estimates
the burden for the preparation of each
record to be 0.30 hours for a total
burden of 18,000 hours.
FDA estimates that all processors
(15,000 processors) will annually
reassess their hazard analysis and
HACCP plan (§ 123.8(a)(1) and (c)). FDA
estimates the burden for the
reassessment of the hazard analysis and
HAACP plan to be 4 hours per processor
for a total burden of 60,000 hours.
FDA estimates that all importers
(4,100 importers) will take affirmative
steps to verify compliance of imports
and prepare 80 records of their
verification activities (§ 123.12(a)(2)(ii))
for a total of 328,000 records. FDA
estimates the burden for the preparation
of each record to be 0.20 hours for a
total burden of 65,600 hours.
FDA estimates that all processors
(15,000 processors) will document the
monitoring of critical control points
(§ 123.6(c)(7)) at 280 records per
processor for a total of 4,200,000
records. FDA estimates the burden for
the preparation of each record to be 0.30
hours for a total burden of 1,260,000
hours.
FDA estimates that 40 percent of all
processors (6,000 processors) will
maintain records of any corrective
actions taken due to a deviation from a
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
critical limit (§ 123.7(d)) at 4 records per
processor for a total of 24,000 records.
FDA estimates the burden for the
preparation of each record to be 0.10
hours for a total burden of 2,400 hours.
FDA estimates that all processors
(15,000 processors) will maintain
records of the calibration of processmonitoring instruments and the
performing of any periodic end-product
and in-process testing (§ 123.8(d)) at 47
records per processor for a total of
705,000 records. FDA estimates the
burden for the preparation of each
record to be 0.10 hours for a total
burden of 70,500 hours.
FDA estimates that all processors
(15,000 processors) will maintain
sanitation control records (§ 123.11(c))
at 280 records per processor for a total
of 4,200,000 records. FDA estimates the
burden for the preparation of each
record to be 0.10 hours for a total
burden of 420,000 hours.
FDA estimates that all importers
(4,100 importers) will 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(c)). FDA estimates that 80
records will be prepared per importer
for a total of 328,000 records. FDA
estimates the burden for the preparation
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Federal Register / Vol. 75, No. 68 / Friday, April 9, 2010 / Notices
of each record to be 0.10 hours for a
total burden of 32,800 hours.
FDA estimates that 1 percent of all
importers (41 importers) will require
new written verification procedures to
verify compliance of imports
(§ 123.12(a)(2)). FDA estimates the
burden for preparing the new
procedures to be 4 hours per importer
for a total burden of 164 hours.
Dated: April 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–8051 Filed 4–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0164]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; MOZOBIL
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSKHWCL6B1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
MOZOBIL and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
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Jkt 220001
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product MOZOBIL
(plerixafor). MOZOBIL is indicated in
combination with granulocyte-colony
stimulating factor to mobilize
hematopoietic stem cells to the
peripheral blood for collection and
subsequent autologous transplantation
in patients with non-Hodgkin’s
lymphoma and multiple myeloma.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
MOZOBIL (U.S. Patent No. 5,583,131)
from Genzyme Corp., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated September 29, 2009, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of MOZOBIL
represented the first permitted
commercial marketing or use of the
product. Thereafter, the Patent and
Trademark Office requested that FDA
determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
MOZOBIL is 3,849 days. Of this time,
3,666 days occurred during the testing
phase of the regulatory review period,
while 183 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
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18213
355(i)) became effective: June 4, 1998.
The applicant claims June 3, 1998, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was June 4, 1998,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: June 16, 2008. FDA
has verified the applicant’s claim that
the new drug application (NDA) 22–311
was submitted on June 16, 2008.
3. The date the application was
approved: December 15, 2008. FDA has
verified the applicant’s claim that NDA
22–311 was approved on December 15,
2008.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,826 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by June 8, 2010.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
October 6, 2010. To meet its burden, the
petition must contain sufficient facts to
merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document.
Comments and petitions may be seen
in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: March 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–8172 Filed 4–8–10; 8:45 am]
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 75, Number 68 (Friday, April 9, 2010)]
[Notices]
[Pages 18211-18213]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8051]
[[Page 18211]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0182]
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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the 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 the information collection
provisions of FDA's regulations requiring reporting and recordkeeping
for processors and importers of fish and fishery products.
DATES: Submit written or electronic comments on the collection of
information by June 8, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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
FDA regulations in part 123 (21 CFR part 123) 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 (a)(4) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (a)(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 of this document
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.
FDA estimates the burden of this collection of information as
follows:
[[Page 18212]]
Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours Per
21 CFR Section\2\ Recordkeepers per Recordkeeping\3\ Records Record\4\ Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.6(a),(b), and (c) 50 1 50 16.00 800
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.6(c)(5) 15,000 4 60,000 0.30 18,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.8(a)(1) and (c) 15,000 1 15,000 4.00 60,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.12(a)(2)(ii) 4,100 80 328,000 0.20 65,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.6(c)(7) 15,000 280 4,200,000 0.30 1,260,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.7(d) 6,000 4 24,000 0.10 2,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.8(d) 15,000 47 705,000 0.10 70,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.11(c) 15,000 280 4,200,000 0.10 420,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.12(c) 4,100 80 328,000 0.10 32,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.12(a)(2) 41 1 41 4.00 164
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
FDA bases this hour burden estimate on its 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 (21 CFR 1240.60) is a customary and usual practice among
seafood processors.
Based on its records, FDA estimates that there are 15,000
processors and 4,100 importers.
FDA estimates that 50 processors will undertake the initial
preparation of a hazard analysis and HAACP plan (Sec. 123.6(a),(b),
and (c)). FDA estimates the burden for the initial preparation of a
hazard analysis and HAACP plan to be 16 hours per processor for a total
burden of 800 hours. FDA estimates that all processors (15,000
processors) will undertake and keep records of 4 corrective action
plans (Sec. 123.6(c)(5)) for a total of 60,000 records. FDA estimates
the burden for the preparation of each record to be 0.30 hours for a
total burden of 18,000 hours.
FDA estimates that all processors (15,000 processors) will annually
reassess their hazard analysis and HACCP plan (Sec. 123.8(a)(1) and
(c)). FDA estimates the burden for the reassessment of the hazard
analysis and HAACP plan to be 4 hours per processor for a total burden
of 60,000 hours.
FDA estimates that all importers (4,100 importers) will take
affirmative steps to verify compliance of imports and prepare 80
records of their verification activities (Sec. 123.12(a)(2)(ii)) for a
total of 328,000 records. FDA estimates the burden for the preparation
of each record to be 0.20 hours for a total burden of 65,600 hours.
FDA estimates that all processors (15,000 processors) will document
the monitoring of critical control points (Sec. 123.6(c)(7)) at 280
records per processor for a total of 4,200,000 records. FDA estimates
the burden for the preparation of each record to be 0.30 hours for a
total burden of 1,260,000 hours.
FDA estimates that 40 percent of all processors (6,000 processors)
will maintain records of any corrective actions taken due to a
deviation from a critical limit (Sec. 123.7(d)) at 4 records per
processor for a total of 24,000 records. FDA estimates the burden for
the preparation of each record to be 0.10 hours for a total burden of
2,400 hours.
FDA estimates that all processors (15,000 processors) will maintain
records of the calibration of process-monitoring instruments and the
performing of any periodic end-product and in-process testing (Sec.
123.8(d)) at 47 records per processor for a total of 705,000 records.
FDA estimates the burden for the preparation of each record to be 0.10
hours for a total burden of 70,500 hours.
FDA estimates that all processors (15,000 processors) will maintain
sanitation control records (Sec. 123.11(c)) at 280 records per
processor for a total of 4,200,000 records. FDA estimates the burden
for the preparation of each record to be 0.10 hours for a total burden
of 420,000 hours.
FDA estimates that all importers (4,100 importers) will 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 (Sec.
123.12(c)). FDA estimates that 80 records will be prepared per importer
for a total of 328,000 records. FDA estimates the burden for the
preparation
[[Page 18213]]
of each record to be 0.10 hours for a total burden of 32,800 hours.
FDA estimates that 1 percent of all importers (41 importers) will
require new written verification procedures to verify compliance of
imports (Sec. 123.12(a)(2)). FDA estimates the burden for preparing
the new procedures to be 4 hours per importer for a total burden of 164
hours.
Dated: April 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8051 Filed 4-8-10; 8:45 am]
BILLING CODE 4160-01-S
