Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds, 32848-32851 [2017-14995]
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32848
Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1
E6(R2) Good clinical practice; International Council for
Harmonisation; guidance for industry
Number of
recordkeepers
Section 5.0—Quality Management (including sections
5.0.1 to 5.0.7)—Developing a Quality Management System ....................................................................................
1 There
Number of
records per
recordkeeper
1,457
Total annual
records
1
Average
burden per
recordkeeping
1,457
60
Total hours
87,420
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
E6(R2) Good clinical practice; International Council for
Harmonisation; guidance for industry
Number of
respondents
Section 5.0.7—Risk Reporting—Describing the Quality
Management Approach Implemented in a Clinical Trial
and Summarizing Important Deviations From the
Predefined Quality Tolerance Limits and Remedial Actions Taken in the Clinical Study Report .........................
1 There
Number of
responses per
respondent
1,457
Average
burden per
response
Total annual
responses
4.6
6,702
Total hours
3
20,107
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1
E6(R2) Good clinical practice; International Council for
Harmonisation; guidance for industry
Number of
recordkeepers
Section 5.0—Quality Management (including 5.0.1 to
5.0.7)—Developing a Quality Management System ........
1 There
Number of
records per
recordkeeper
218
Total annual
records
1
Average
burden per
recordkeeping
218
60
Total hours
13,080
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1
E6(R2) Good clinical practice; International Council for
Harmonisation; guidance for industry
Number of
responses
Section 5.0.7—Risk Reporting—Describing the Quality
Management Approach Implemented in a Clinical Trial
and Summarizing Important Deviations From the
Predefined Quality Tolerance Limits and Remedial Actions Taken in the Clinical Study Report .........................
1 There
[FR Doc. 2017–14999 Filed 7–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0601]
sradovich on DSK3GMQ082PROD with NOTICES
218
Total annual
responses
3.69
804
Average
burden per
response
Total hours
3
2,413
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice Regulations for
Medicated Feeds
AGENCY:
Number of
responses per
respondent
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:47 Jul 17, 2017
Jkt 241001
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 August 17,
2017.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0152. Also
SUMMARY:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
include the FDA docket number found
in brackets in the heading of this
document.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726, PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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\18JYN1.SGM
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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
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 (the
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
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 or not the systems and
procedures used by manufacturers of
medicated feeds are adequate to assure
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 mixerfeeders.
32849
In the Federal Register of October 17,
2016 (81 FR 71508), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one letter in
response to the notice, which contained
multiple comments. One comment was
generally supportive of the
recordkeeping provisions of part 225.
Another comment suggested that we
should collect data from manufacturers
of medicated feed, and described several
benefits of having this information. Our
regulations in part 225 require
recordkeeping to document procedures
required during the manufacturing
process to assure that proper quality
control is maintained. The regulations
do not require manufacturers to submit
this information to us on a routine basis
but, rather, to make the information
available to us upon inspection. To the
extent that the comments recommend
changes to our cGMP regulations for
medicated feed, which can only be
accomplished by rulemaking, the
comments were outside the scope of the
four collection of information topics on
which the notice requested comments
and will not be discussed in this
document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Registered Licensed Commercial Feed Mills] 1
225.42(b)(5) through (b)(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), requires records of Master Record
Files and production records for medicated feeds.
225.110(b)(1) and (b)(2), requires maintenance of
distribution records for medicated feeds.
225.115(b)(1) and (b)(2), requires maintenance of
complaint files by the medicated feed manufacturer.
sradovich on DSK3GMQ082PROD with NOTICES
Total ..................................................................
1 There
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR Section
Total annual
records
Average burden per
recordkeeping
877
260
228,020
1 ................................
228,020
877
45
39,465
.50 (30 minutes) ........
19,732.5
877
1,600
1,403,200
.12 (7 minutes) ..........
168,384
877
7,800
6,840,600
.08 (5 minutes) ..........
547,248
877
7,800
6,840,600
.02 (1 minute) ............
136,812
877
5
4,385
.12 (7 minutes) ..........
526.2
........................
........................
........................
....................................
1,100,722.7
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
17:47 Jul 17, 2017
Jkt 241001
PO 00000
Total hours
Frm 00065
Fmt 4703
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E:\FR\FM\18JYN1.SGM
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32850
Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Registered Licensed Mixer-Feeders] 1
225.42(b)(5) through (b)(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 (b)(5), requires records of
Master Record Files and production records for
medicated feeds.
Total ..................................................................
1
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR Section
Total annual
records
Average burden per
recordkeeping
Total hours
100
260
26,000
.15 (9 minutes) ..........
3,900
100
36
3,600
.50 (30 minutes) ........
1,800
100
48
4,800
.12 (7 minutes) ..........
576
100
260
26,000
.40 (24 minutes) ........
10,400
........................
........................
........................
....................................
16,676
There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Nonregistered Unlicensed Commercial Feed Mills] 1
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR Section
Total annual
records
Average burden per
recordkeeping
Total hours
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.
4,186
4
16,744
1 ................................
16,744
4,186
1
4,186
4 ................................
16,744
4,186
96
401,856
.12 (7 minutes) ..........
48,223
4,186
260
1,088,360
.65 (39 minutes) ........
707,434
Total ..................................................................
........................
........................
........................
....................................
789,145
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Nonregistered Unlicensed Mixer-Feeders] 1
Number of
recordkeepers
sradovich on DSK3GMQ082PROD with NOTICES
21 CFR Section
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.
VerDate Sep<11>2014
17:47 Jul 17, 2017
Jkt 241001
PO 00000
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours
3,400
13,600
1 ................................
13,600
3,400
1
3,400
4 ................................
13,600
3,400
32
108,800
.12 (7 minutes) ..........
13,056
3,400
Frm 00066
4
260
884,000
.33 (20 minutes) ........
291,720
Fmt 4703
Sfmt 4703
E:\FR\FM\18JYN1.SGM
18JYN1
32851
Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN—Continued
[Nonregistered Unlicensed Mixer-Feeders] 1
Number of
recordkeepers
21 CFR Section
Total ..................................................................
1
Total annual
records
Average burden per
recordkeeping
........................
........................
........................
....................................
Total hours
331,976
There are no capital costs or operating and maintenance costs associated with this collection of information.
We based our estimate of the time
required for record preparation and
maintenance on our communications
with industry. We derived additional
information needed to calculate the total
burden hours (i.e., number of
recordkeepers, number of medicated
feeds being manufactured, etc.) from our
records and experience. The burden has
not changed since the last OMB
approval.
Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–14995 Filed 7–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2017–0692]
Equivalency Determination for ‘‘Marine
Charts,’’ ‘‘Charts,’’ or ‘‘Maps,’’
‘‘Publications,’’ and Navigation
Functions—Notice of Availability of
Navigation and Vessel Inspection
Circular 01–16 Change 1
Coast Guard, DHS.
Notice of availability.
AGENCY:
ACTION:
The Coast Guard (USCG) is
announcing, the availability of
Navigation and Vessel Inspection
Circular (NVIC) 01–16 change 1. The
NVIC provides that display of certain
electronic charts and publications will
meet—as an equivalency—the ‘‘marine
charts,’’ ‘‘charts,’’ ‘‘maps,’’ or
‘‘publications’’ carriage requirements
and provides for an equivalency for
position fixing and plotting. USCG
intends, by this policy, to provide a path
for U.S. flagged vessels to replace paper
charts and most hard copy publications
if so desired.
FOR FURTHER INFORMATION CONTACT:
Please address questions or feedback
concerning this policy to LCDR
Matthew Walter, telephone 202–372–
1565 or email cgnav@uscg.mil.
SUPPLEMENTARY INFORMATION: In
response to recommendations from
SUMMARY:
sradovich on DSK3GMQ082PROD with NOTICES
Number of
records per
recordkeeper
VerDate Sep<11>2014
17:47 Jul 17, 2017
Jkt 241001
Coast Guard Federal Safety Advisory
Committees, industry stakeholders and
agency partners, the Coast Guard
updated its original policy on electronic
charts and publications. Navigation and
Vessel Inspection Circular (NVIC) 01–16
change 1 is revised to focus on the
equivalency determination for charts,
publications and, newly added,
navigation functions. It only accepts
certain electronic charts as described. It
requires vessels that operate offshore to
display charts on certain systems. It
describes the minimum performance
requirements for equipment receiving
position information and restates our
policy on electronic navigation
publications.
Title 33 of the Code of Federal
Regulations requires ‘‘currently
corrected marine charts’’ of a large
enough scale and with enough detail to
make safe navigation possible. In 2002,
the Coast Guard authorized U.S. flagged
SOLAS-compliant vessels to use an
Electronic Chart Display and
Information System (ECDIS) in lieu of
paper charts.1 That policy did not apply
to the U.S. flagged vessels engaged
solely on domestic voyages. Therefore,
the Coast Guard is publishing an
equivalency to address electronic chart
carriage on those vessels.
Title 33 of the CFR 164 also requires
that some vessels fix their position 2 and
other vessels fix and plot their
position.3 The USCG recognizes the
benefit of real-time positioning data,
and that it can provide greater
situational awareness than what could
be achieved using paper charts.
Therefore, USCG is announcing an
equivalency to fixing and plotting. Title
33 of the CFR, along with the
International Convention of Safety of
Life at Sea (SOLAS) Chapter V
Regulation 27, also requires currently
corrected editions of, or applicable
currently corrected extracts from,
nautical publications necessary for the
1 67 Federal Register 53382 as amended by 69
Federal Register 42192, Carriage of Navigation
Equipment for Ships on International Voyages.
2 33 CFR 164.11 & 164.78—Self-propelled vessels
1600 or more gross tons and towing vessels 12
meters or more in length.
3 33 CFR 164.11—Self-propelled vessels 1600 or
more gross tons.
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
intended voyage. In 2010, USCG
announced policy accepting some
electronic publications in lieu of paper
publications.4 NVIC 01–16 change 1
does not substantively change this
USCG publication policy, but rather
consolidates information.
Additionally, NVIC 01–16 change 1
also provides guidance to marine
inspectors regarding how to identify
approved and/or appropriate electronic
charts, display systems, position
information and electronic publications.
Finally, this Circular recommends
practices that vessel owners and
operators should consider when
navigating with the assistance of
electronics.
This Circular is not a substitute for
applicable legal requirements, nor is it
itself a rule. It does not provide
equivalence for the purposes of SOLAS
certificates. Mariners are responsible to
safely navigate and follow applicable
regulatory requirements.
Dated: July 10, 2017.
RADM Paul F. Thomas,
Assistant Commandant for Prevention Policy,
U.S. Coast Guard.
[FR Doc. 2017–15056 Filed 7–17–17; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–4320–
DR; Docket ID FEMA–2017–0001]
Tennessee; Major Disaster and Related
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
This is a notice of the
Presidential declaration of a major
disaster for the State of Tennessee
(FEMA–4320–DR), dated June 23, 2017,
and related determinations.
DATES: Effective Date: June 23, 2017.
SUMMARY:
4 CG–543 Policy Letter 10–05 canceled and
replaced by Navigation and Vessel Inspection
Circular 01–16.
E:\FR\FM\18JYN1.SGM
18JYN1
]]>Agencies
[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32848-32851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14995]
-----------------------------------------------------------------------
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: Fax written comments on the collection of information by August
17, 2017.
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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0152.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
PRAStaff@fda.hhs.gov.
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.
[[Page 32849]]
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 (the
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 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 or not the systems and
procedures used by manufacturers of medicated feeds are adequate to
assure 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 mixer-feeders.
In the Federal Register of October 17, 2016 (81 FR 71508), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one letter in response to the
notice, which contained multiple comments. One comment was generally
supportive of the recordkeeping provisions of part 225. Another comment
suggested that we should collect data from manufacturers of medicated
feed, and described several benefits of having this information. Our
regulations in part 225 require recordkeeping to document procedures
required during the manufacturing process to assure that proper quality
control is maintained. The regulations do not require manufacturers to
submit this information to us on a routine basis but, rather, to make
the information available to us upon inspection. To the extent that the
comments recommend changes to our cGMP regulations for medicated feed,
which can only be accomplished by rulemaking, the comments were outside
the scope of the four collection of information topics on which the
notice requested comments and will not be discussed in this document.
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
21 CFR Section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8), requires 877 260 228,020 1......................................... 228,020
records of receipt, storage, and inventory
control of medicated feeds.
225.58(c) and (d), requires records of the 877 45 39,465 .50 (30 minutes).......................... 19,732.5
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 877 1,600 1,403,200 .12 (7 minutes)........................... 168,384
medicated feed label(s) be kept for 1 year.
225.102(b)(1), requires records of Master 877 7,800 6,840,600 .08 (5 minutes)........................... 547,248
Record Files and production records for
medicated feeds.
225.110(b)(1) and (b)(2), requires 877 7,800 6,840,600 .02 (1 minute)............................ 136,812
maintenance of distribution records for
medicated feeds.
225.115(b)(1) and (b)(2), requires 877 5 4,385 .12 (7 minutes)........................... 526.2
maintenance of complaint files by the
medicated feed manufacturer.
---------------
Total................................... .............. .............. .............. .......................................... 1,100,722.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 32850]]
Table 2--Estimated Annual Recordkeeping Burden
[Registered Licensed Mixer-Feeders] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8), requires 100 260 26,000 .15 (9 minutes)........................... 3,900
records of receipt, storage, and inventory
control of medicated feeds.
225.58(c) and (d), requires records of the 100 36 3,600 .50 (30 minutes).......................... 1,800
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 100 48 4,800 .12 (7 minutes)........................... 576
medicated feed label(s) be kept for 1 year.
225.102(b)(1) through (b)(5), requires 100 260 26,000 .40 (24 minutes).......................... 10,400
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 Unlicensed Commercial Feed Mills] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142, requires procedures for 4,186 4 16,744 1......................................... 16,744
identification, storage, and inventory
control (receipt and use) of Type A
medicated articles and Type B medicated
feeds.
225.158, requires records of investigation 4,186 1 4,186 4......................................... 16,744
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, 4,186 96 401,856 .12 (7 minutes)........................... 48,223
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, 4,186 260 1,088,360 .65 (39 minutes).......................... 707,434
production, and distribution of medicated
feeds.
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Total................................... .............. .............. .............. .......................................... 789,145
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 4--Estimated Annual Recordkeeping Burden
[Nonregistered Unlicensed Mixer-Feeders] \1\
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Number of
21 CFR Section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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225.142, requires procedures for 3,400 4 13,600 1......................................... 13,600
identification, storage, and inventory
control (receipt and use) of Type A
medicated articles and Type B medicated
feeds.
225.158, requires records of investigation 3,400 1 3,400 4......................................... 13,600
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, 3,400 32 108,800 .12 (7 minutes)........................... 13,056
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, 3,400 260 884,000 .33 (20 minutes).......................... 291,720
production, and distribution of medicated
feeds.
---------------
[[Page 32851]]
Total................................... .............. .............. .............. .......................................... 331,976
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We based our estimate of the time required for record preparation
and maintenance on our communications with industry. We derived
additional information needed to calculate the total burden hours
(i.e., number of recordkeepers, number of medicated feeds being
manufactured, etc.) from our records and experience. The burden has not
changed since the last OMB approval.
Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14995 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P
