Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds, 47147-47149 [2023-15487]
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Federal Register / Vol. 88, No. 139 / Friday, July 21, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2796]
Bristol Myers Products Inc.;
Withdrawal of Approval of a New Drug
Application for BUFFERIN (Aspirin)
Tablets
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of a new drug
application (NDA) for BUFFERIN
(aspirin) tablets. The basis for the
withdrawal is that the holder of the
NDA has repeatedly failed to file
required annual reports for this NDA.
DATES: Approval is withdrawn as of July
21, 2023.
FOR FURTHER INFORMATION CONTACT:
Jennifer Forde, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228,
Silver Spring, MD 20993–0002, 301–
348–3035, Jennifer.Forde@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
holder of an approved application to
market a new drug for human use is
required to submit annual reports to
FDA concerning its approved
application in accordance with § 314.81
(21 CFR 314.81). In the Federal Register
of November 23, 2022 (87 FR 71652),
FDA published a notice offering an
opportunity for a hearing (NOOH) on a
proposal to withdraw approval of NDA
006499 for BUFFERIN (aspirin) tablets,
and all amendments and supplements
thereto, on the grounds that the holder
of NDA 006499 has repeatedly failed to
file required annual reports for this
NDA.
NDA 006499 for BUFFERIN (aspirin)
tablets became effective on June 30,
1948. The holder of NDA 006499 is
currently identified in FDA’s records as
Bristol Myers Products Inc. The Agency
has received conflicting information
regarding the identity of the current
NDA holder. However, to change the
holder of record, information specified
in § 314.72 (21 CFR 314.72) must be
provided to the Agency. Since the time
that the holder of record was identified
as Bristol Myers Products Inc., the
Agency has not received change of
application ownership information that
would satisfy the requirements of
§ 314.72. The Agency therefore
identified Bristol Myers Products Inc. as
the NDA holder of record in the NOOH
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
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Jkt 259001
published in the Federal Register of
November 23, 2022, but if another entity
held NDA 006499, the Agency also
provided notice to that entity through
the same NOOH.
Bristol Myers Products Inc. did not
respond to the NOOH and nor did any
other party. Failure of the NDA holder
to file a written notice of participation
and request for hearing pursuant to
§ 314.200 (21 CFR 314.200) constitutes
an election by the holder of the NDA not
to make use of the opportunity for a
hearing concerning the proposal to
withdraw approval of its NDA and a
waiver of any contentions concerning
the legal status of the drug product.
FDA finds that the holder of NDA
006499 has repeatedly failed to submit
reports required by § 314.81. In
addition, under § 314.200, FDA finds
that the holder of the NDA 006499 has
waived the opportunity for a hearing
concerning the withdrawal of approval
of this NDA as well as any contentions
concerning the legal status of the drug
product covered by this NDA.
Therefore, under these findings,
approval of NDA 006499 and all
amendments and supplements thereto is
hereby withdrawn as of July 21, 2023.
Based on information available to the
Agency, it appears that the product
covered by NDA 006499 has not been
marketed for many years and another
buffered aspirin drug product, using the
same trade name ‘‘BUFFERIN’’ but with
a different formulation, is currently
being marketed as an over the counter
(OTC) monograph drug. The marketing
of this current ‘‘BUFFERIN’’ product is
subject to the requirements for legal
marketing of OTC monograph drugs
under section 505G of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 355h). Withdrawal of the
approval of NDA 006499 does not
impact nonprescription aspirin products
that are legally marketed without an
approved application as OTC
monograph drugs in accordance with
section 505G of the FD&C Act, including
conforming to applicable conditions of
use specified in OTC Monograph M013:
Internal Analgesic, Antipyretic, and
Antirheumatic Drug Products for Overthe-Counter Human Use (See OTC
Monographs@FDA web page available at
https://www.accessdata.fda.gov/scripts/
cder/omuf/?event=reqOrders).
Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–15454 Filed 7–20–23; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
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47147
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0601]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice Regulations for
Medicated Feeds
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 August 21,
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 0910–0152. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
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:
Current Good Manufacturing Practice
Regulations for Medicated Feeds—21
CFR Part 225
OMB Control Number 0910–0152—
Extension
Under section 501 of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 351), FDA has the
statutory authority to issue current good
manufacturing practice (CGMP)
regulations for drugs, including
medicated feeds. Medicated feeds are
E:\FR\FM\21JYN1.SGM
21JYN1
47148
Federal Register / Vol. 88, No. 139 / Friday, July 21, 2023 / Notices
administered to animals for the
prevention, cure, mitigation, or
treatment of disease, or growth
promotion and feed efficiency. Statutory
requirements for CGMPs have been
codified under part 225 (21 CFR part
225). Medicated feeds that are not
manufactured in accordance with these
regulations are considered adulterated
under section 501(a)(2)(B) of the FD&C
Act. Under part 225, a manufacturer is
required to establish, maintain, and
retain records for a medicated feed,
including records to document
procedures required during the
manufacturing process to assure that
proper quality control is maintained.
Such records would, for example,
contain information concerning receipt
and inventory of drug components,
batch production, laboratory assay
control because of the need for a
withdrawal period before slaughter or
because of carcinogenic concerns.
Conversely, a license is not required,
and the recordkeeping requirements are
less demanding, for those medicated
feeds for which FDA has determined
that the drugs used in their manufacture
need less control. Respondents to this
collection of information are
commercial feed mills and mixers/
feeders.
In the Federal Register of February 6,
2023 (88 FR 7741), FDA published a 60day notice requesting public comment
on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited.
FDA estimates the burden of this
collection of information as follows:
results (i.e., batch and stability testing),
labels, and product distribution.
This information is needed so that
FDA can monitor drug usage and
possible misformulation of medicated
feeds to investigate violative drug
residues in products from treated
animals and to investigate product
defects when a drug is recalled. In
addition, FDA will use the CGMP
criteria in part 225 to determine
whether the systems and procedures
used by manufacturers of medicated
feeds are adequate to ensure that their
feeds meet the requirements of the
FD&C Act as to safety, and also that they
meet their claimed identity, strength,
quality, and purity, as required by
section 501(a)(2)(B) of the FD&C Act.
A license is required when the
manufacturer of a medicated feed
involves the use of a drug or drugs that
FDA has determined requires more
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Registered licensed commercial feed mills] 1
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Total
annual
responses
Average burden
per response
Total
hours
225.42(b)(5) through (8) requires records of receipt, storage, and inventory
control of medicated feeds.
225.58(c) and (d) requires records of the results of periodic assays for medicated feeds that are in accord with label specifications and also those
medicated feeds not within documented permissible assay limits.
225.80(b)(2) requires that verified medicated feed label(s) be kept for 1 year
225.102(b)(1) through (5), requires records of master record files and production records for medicated feeds.
225.110(b)(1) and (2) requires maintenance of distribution records for medicated feeds.
225.115(b)(1) and (2) requires maintenance of complaint files by the medicated feed manufacturer.
791
260
205,660
1 ..................................
205,660
791
45
35,595
0.5 (30 minutes) .........
17,798
791
791
1,600
7,800
1,265,600
6,169,800
0.12 (7 minutes) .........
0.08 (5 minutes) .........
151,872
493,584
791
7,800
6,169,800
0.02 (1 minute) ...........
123,396
791
5
3,955
0.12 (7 minutes) .........
475
Total ............................................................................................................
..........................
..........................
....................
.....................................
992,785
Average burden per
recordkeeping
Total
hours
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Registered licensed mixer/feeders] 1
Total
annual
records
225.42(b)(5) through (8) requires records of receipt, storage, and inventory
control of medicated feeds.
225.58(c) and (d) requires records of the results of periodic assays for medicated feeds that are in accord with label specifications and also those
medicated feeds not within documented permissible assay limits.
225.80(b)(2) requires that verified medicated feed label(s) be kept for 1 year
225.102(b)(1) through (5) requires records of master record files and production records for medicated feeds.
100
260
26,000
0.15 (9 minutes) .........
3,900
100
36
3,600
0.5 (30 minutes) .........
1,800
100
100
48
260
4,800
26,000
0.12 (7 minutes) .........
0.4 (24 minutes) .........
576
10,400
Total ............................................................................................................
..........................
..........................
....................
.....................................
16,676
1 There
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section; activity
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Nonregistered non-licensed commercial feed mills] 1
225.142 requires procedures for identification, storage, and inventory control
(receipt and use) of Type A medicated articles and Type B medicated
feeds.
VerDate Sep<11>2014
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Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section; activity
Frm 00050
Fmt 4703
4,357
Sfmt 4703
Total
annual
records
4
E:\FR\FM\21JYN1.SGM
17,428
21JYN1
Average burden per
recordkeeping
1 ..................................
Total
hours
17,428
47149
Federal Register / Vol. 88, No. 139 / Friday, July 21, 2023 / Notices
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN—Continued
[Nonregistered non-licensed commercial feed mills] 1
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section; activity
Total
annual
records
Average burden per
recordkeeping
Total
hours
225.158 requires records of investigation and corrective action when the results of laboratory assays of drug components indicate that the medicated
feed is not in accord with the permissible assay limits.
225.180 requires identification, storage, and inventory control of labeling in a
manner that prevents label mix-ups and assures that correct labels are
used for medicated feeds.
225.202 requires records of formulation, production, and distribution of medicated feeds.
4,357
1
4,357
4 ..................................
17,428
4,357
96
418,272
0.12 (7 minutes) .........
50,193
4,357
260
1,132,820
0.65 (39 minutes) .......
736,333
Total ............................................................................................................
..........................
..........................
....................
.....................................
821,382
Average burden per
recordkeeper
Total
hours
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Nonregistered non-licensed mixer/feeders] 1
225.142 requires procedures for identification, storage, and inventory control
(receipt and use) of Type A medicated articles and Type B medicated
feeds.
225.158 requires records of investigation and corrective action when the results of laboratory assays of drug components indicate that the medicated
feed is not in accord with the permissible assay limits.
225.180 requires identification, storage, and inventory control of labeling in a
manner that prevents label mix-ups and assures that correct labels are
used for medicated feeds.
225.202 requires records of formulation, production, and distribution of medicated feeds.
Total ............................................................................................................
1 There
Total
annual
records
3,400
4
13,600
1 ..................................
13,600
3,400
1
3,400
4 ..................................
13,600
3,400
32
108,800
0.12 (7 minutes) .........
13,056
3,400
260
884,000
0.33 (20 minutes) .......
291,720
..........................
..........................
....................
.....................................
331,976
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall decrease of 10,435 hours and an
increase of 831,545 records since the
last OMB approval. We attribute this
adjustment due to an increase in the
number of non-registered, non-licensed
commercial medicated feed mills and
decrease in non-licensed medicated feed
mill recordkeeping the last few years.
Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–15487 Filed 7–20–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0343]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice for Blood and
Blood Components and Reducing the
Risk of Transfusion-Transmitted
Infections
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) 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 August 21,
2023.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section; activity
VerDate Sep<11>2014
19:06 Jul 20, 2023
Jkt 259001
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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 0910–0116. 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, 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:
E:\FR\FM\21JYN1.SGM
21JYN1
]]>Agencies
[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Pages 47147-47149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15487]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0601]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice Regulations for Medicated Feeds
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 August 21, 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 0910-0152. 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.
Current Good Manufacturing Practice Regulations for Medicated Feeds--21
CFR Part 225
OMB Control Number 0910-0152--Extension
Under section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 351), FDA has the statutory authority to issue current
good manufacturing practice (CGMP) regulations for drugs, including
medicated feeds. Medicated feeds are
[[Page 47148]]
administered to animals for the prevention, cure, mitigation, or
treatment of disease, or growth promotion and feed efficiency.
Statutory requirements for CGMPs have been codified under part 225 (21
CFR part 225). Medicated feeds that are not manufactured in accordance
with these regulations are considered adulterated under section
501(a)(2)(B) of the FD&C Act. Under part 225, a manufacturer is
required to establish, maintain, and retain records for a medicated
feed, including records to document procedures required during the
manufacturing process to assure that proper quality control is
maintained. Such records would, for example, contain information
concerning receipt and inventory of drug components, batch production,
laboratory assay results (i.e., batch and stability testing), labels,
and product distribution.
This information is needed so that FDA can monitor drug usage and
possible misformulation of medicated feeds to investigate violative
drug residues in products from treated animals and to investigate
product defects when a drug is recalled. In addition, FDA will use the
CGMP criteria in part 225 to determine whether the systems and
procedures used by manufacturers of medicated feeds are adequate to
ensure that their feeds meet the requirements of the FD&C Act as to
safety, and also that they meet their claimed identity, strength,
quality, and purity, as required by section 501(a)(2)(B) of the FD&C
Act.
A license is required when the manufacturer of a medicated feed
involves the use of a drug or drugs that FDA has determined requires
more control because of the need for a withdrawal period before
slaughter or because of carcinogenic concerns. Conversely, a license is
not required, and the recordkeeping requirements are less demanding,
for those medicated feeds for which FDA has determined that the drugs
used in their manufacture need less control. Respondents to this
collection of information are commercial feed mills and mixers/feeders.
In the Federal Register of February 6, 2023 (88 FR 7741), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden
[Registered licensed commercial feed mills] \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section; activity Number of responses per annual Average burden per Total
respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (8) 791 260 205,660 1....................... 205,660
requires records of receipt,
storage, and inventory
control of medicated feeds.
225.58(c) and (d) requires 791 45 35,595 0.5 (30 minutes)........ 17,798
records of the results of
periodic assays for
medicated feeds that are in
accord with label
specifications and also
those medicated feeds not
within documented
permissible assay limits.
225.80(b)(2) requires that 791 1,600 1,265,600 0.12 (7 minutes)........ 151,872
verified medicated feed
label(s) be kept for 1 year.
225.102(b)(1) through (5), 791 7,800 6,169,800 0.08 (5 minutes)........ 493,584
requires records of master
record files and production
records for medicated feeds.
225.110(b)(1) and (2) 791 7,800 6,169,800 0.02 (1 minute)......... 123,396
requires maintenance of
distribution records for
medicated feeds.
225.115(b)(1) and (2) 791 5 3,955 0.12 (7 minutes)........ 475
requires maintenance of
complaint files by the
medicated feed manufacturer.
----------------------------------------------------------------------------------
Total.................... ............... ............... ........... ........................ 992,785
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden
[Registered licensed mixer/feeders] \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section; activity Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (8) 100 260 26,000 0.15 (9 minutes)........ 3,900
requires records of receipt,
storage, and inventory
control of medicated feeds.
225.58(c) and (d) requires 100 36 3,600 0.5 (30 minutes)........ 1,800
records of the results of
periodic assays for
medicated feeds that are in
accord with label
specifications and also
those medicated feeds not
within documented
permissible assay limits.
225.80(b)(2) requires that 100 48 4,800 0.12 (7 minutes)........ 576
verified medicated feed
label(s) be kept for 1 year.
225.102(b)(1) through (5) 100 260 26,000 0.4 (24 minutes)........ 10,400
requires records of master
record files and production
records for medicated feeds.
----------------------------------------------------------------------------------
Total.................... ............... ............... ........... ........................ 16,676
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Recordkeeping Burden
[Nonregistered non-licensed commercial feed mills] \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section; activity Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
----------------------------------------------------------------------------------------------------------------
225.142 requires procedures 4,357 4 17,428 1....................... 17,428
for identification, storage,
and inventory control
(receipt and use) of Type A
medicated articles and Type
B medicated feeds.
[[Page 47149]]
225.158 requires records of 4,357 1 4,357 4....................... 17,428
investigation and corrective
action when the results of
laboratory assays of drug
components indicate that the
medicated feed is not in
accord with the permissible
assay limits.
225.180 requires 4,357 96 418,272 0.12 (7 minutes)........ 50,193
identification, storage, and
inventory control of
labeling in a manner that
prevents label mix-ups and
assures that correct labels
are used for medicated feeds.
225.202 requires records of 4,357 260 1,132,820 0.65 (39 minutes)....... 736,333
formulation, production, and
distribution of medicated
feeds.
----------------------------------------------------------------------------------
Total.................... ............... ............... ........... ........................ 821,382
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Estimated Annual Recordkeeping Burden
[Nonregistered non-licensed mixer/feeders] \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section; activity Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeper hours
----------------------------------------------------------------------------------------------------------------
225.142 requires procedures 3,400 4 13,600 1....................... 13,600
for identification, storage,
and inventory control
(receipt and use) of Type A
medicated articles and Type
B medicated feeds.
225.158 requires records of 3,400 1 3,400 4....................... 13,600
investigation and corrective
action when the results of
laboratory assays of drug
components indicate that the
medicated feed is not in
accord with the permissible
assay limits.
225.180 requires 3,400 32 108,800 0.12 (7 minutes)........ 13,056
identification, storage, and
inventory control of
labeling in a manner that
prevents label mix-ups and
assures that correct labels
are used for medicated feeds.
225.202 requires records of 3,400 260 884,000 0.33 (20 minutes)....... 291,720
formulation, production, and
distribution of medicated
feeds.
----------------------------------------------------------------------------------
Total.................... ............... ............... ........... ........................ 331,976
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated burden for the information collection reflects an
overall decrease of 10,435 hours and an increase of 831,545 records
since the last OMB approval. We attribute this adjustment due to an
increase in the number of non-registered, non-licensed commercial
medicated feed mills and decrease in non-licensed medicated feed mill
recordkeeping the last few years.
Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15487 Filed 7-20-23; 8:45 am]
BILLING CODE 4164-01-P
