Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, 65820-65821 [2019-25857]
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Federal Register / Vol. 84, No. 230 / Friday, November 29, 2019 / Notices
been convicted of a felony count under
Federal law for conduct relating to the
importation into the United States of an
article of food and that he is subject to
a 5-year period of debarment.
As a result of the foregoing finding,
Mr. Casey is debarred for a period of 5
years from importing articles of food or
offering such articles for import into the
United States, effective (see DATES).
Pursuant to section 301(cc) of the FD&C
Act (21 U.S.C. 331(cc)), the importing or
offering for import into the United
States of an article of food by, with the
assistance of, or at the direction of Mr.
Casey is a prohibited act.
Any application by Mr. Casey for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2019–
N–1537 and sent to the Dockets
Management Staff (see ADDRESSES). All
such submissions are to be filed in four
copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20.
Publicly available submissions will be
placed in the docket, and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: November 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25848 Filed 11–27–19; 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 and Sanitary 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: Fax written comments on the
collection of information by December
30, 2019.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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16:49 Nov 27, 2019
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To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0354. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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 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.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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
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 September
4, 2019 (84 FR 46544), we 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:
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Federal Register / Vol. 84, No. 230 / Friday, November 29, 2019 / Notices
65821
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section 2
Number of
recordkeepers
Number of
records per
recordkeeper 3
50
15,000
1
4
50
60,000
15,000
1
15,000
4,100
80
328,000
15,000
280
4,200,000
6,000
4
15,000
123.6(a)–(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 processmonitoring instruments and the performing of any periodic end-product and in-process 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.
Total ...........................................................................
Average burden
per recordkeeping 4
Total annual
records
Total hours
16 .....................
0.30 (18 minutes).
4 .......................
800
18,000
65,600
1,260,000
24,000
0.20 (12 minutes).
0.30 (18 minutes).
0.10 (6 minutes)
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
........................
........................
........................
...........................
1,930,264
60,000
2,400
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.
khammond on DSKJM1Z7X2PROD with NOTICES
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
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.
Dated: November 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25857 Filed 11–27–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0163]
Hospira, Inc., et al.; Withdrawal of
Approval of Six Abbreviated New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of six abbreviated
new drug applications (ANDAs) from
SUMMARY:
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
December 30, 2019.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
Application No.
Drug
Applicant
ANDA 040806 .............................
Mepivacaine Hydrochloride (HCl) Injection USP, 3%,
30 milligrams (mg)/milliliter (mL).
Hospira, Inc., 275 North Field Dr., Bldg. H, Lake Forest, IL 60045.
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]]>Agencies
[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Notices]
[Pages 65820-65821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25857]
-----------------------------------------------------------------------
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 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 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: Fax written comments on the collection of information by
December 30, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0354.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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 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 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 September 4, 2019 (84 FR 46544), we
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:
[[Page 65821]]
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of records per Total annual
21 CFR section \2\ recordkeepers recordkeeper records Average burden per recordkeeping \4\ Total hours
\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.6(a)-(c); Prepare hazard analysis and HACCP 50 1 50 16..................................... 800
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 imports 4,100 80 328,000 0.20 (12 minutes)...................... 65,600
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 records. 15,000 280 4,200,000 0.10 (6 minutes)....................... 420,000
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 verification 41 1 41 4...................................... 164
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 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: November 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25857 Filed 11-27-19; 8:45 am]
BILLING CODE 4164-01-P
