Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds, 71508-71510 [2016-25041]
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71508
Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
responses per
respondent
Number of
respondents
Total
annual
responses
Average
burden per
response
Total
hours
740(d)(1)(A); significant barrier to innovation.
740(d)(1)(B); fees exceed cost ................
740(d)(1)(C); free choice feeds ................
740(d)(1)(D); minor use or minor species
740(d)(1)(E); small business ....................
Request for reconsideration of a decision
Request for review (user fee appeal officer).
55
1 time for each application
55
2 ............................
110
8
5
69
1
1
0
3.75 ....................................
1 time for each application
1 time for each application
1 time for each application
1 time for each application
1 time for each application
30
5
69
1
1
0
0.5 (30 minutes) ....
2 ............................
2 ............................
2 ............................
2 ............................
0 ............................
15
10
138
2
2
0
Total ..................................................
........................
............................................
........................
...............................
277
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA’s database system, from
fiscal year (FY) 2014 to 2016 there were
an estimated 177 sponsors subject to
ADUFA. However, not all sponsors will
have any submissions in a given year
and some may have multiple
submissions. The total number of
waiver requests is based on the average
number of submission types received by
FDA in FY 2014 to 2016.
Dated: October 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25040 Filed 10–14–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0601]
Agency Information Collection
Activities; Proposed Collection;
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 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 recordkeeping requirements for
manufacturers of medicated animal
feeds.
jstallworth on DSK7TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
14:22 Oct 14, 2016
Jkt 241001
Submit either electronic or
written comments on the collection of
information by December 16, 2016.
ADDRESSES: You may submit comments
as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2010–N–0601 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Current
Good Manufacturing Practice
Regulations for Medicated Feeds.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
E:\FR\FM\17OCN1.SGM
17OCN1
Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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,
71509
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.
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
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Average
burden per
recordkeeper
Total annual
records
Total hours
jstallworth on DSK7TPTVN1PROD with NOTICES
225.42(b)(5) through (b)(8) ..........................................
225.28(c) and (d) ..........................................................
225.80(b)(2) ..................................................................
225.102(b)(1) ................................................................
225.110(b)(1) and (b)(2) ...............................................
225.115(b)(1) and (b)(2) ...............................................
877
877
877
877
877
877
260
45
1,600
7,800
7,800
5
228,020
39,465
1,403,200
6,840,600
6,840,600
4,385
1 ............................
0.50 (30 minutes) ..
0.12 (7 minutes) ....
0.08 (5 minutes) ....
0.02 (1 minute) .....
0.12 (7 minutes) ....
228,020
19,732.5
168,384
547,248
136,812
526.2
Total ......................................................................
........................
........................
........................
...............................
1,100,722.7
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Fmt 4703
Sfmt 4703
E:\FR\FM\17OCN1.SGM
17OCN1
71510
Federal Register / Vol. 81, No. 200 / Monday, October 17, 2016 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Registered licensed mixer-feeders] 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Average
burden per
recordkeeper
Total annual
records
225.42(b) through (b)(8) ...............................................
225.58(c) through (d) ...................................................
225.80(b) (2) .................................................................
225.102(b)(1) through (b)(5) ........................................
100
100
100
100
260
36
48
260
26,000
3,600
4,800
26,000
Total ......................................................................
........................
........................
........................
1 There
0.15
0.50
0.12
0.40
Total hours
(9 minutes) ....
(30 minutes) ..
(7 minutes) ....
(24 minutes) ..
3,900
1,800
576
10,400
...............................
16,676
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
recordkeepers
21 CFR Section
225.142
225.158
225.180
225.202
Number of
records per
recordkeeper
Average
burden per
recordkeeper
Total annual
records
Total hours
.........................................................................
.........................................................................
.........................................................................
.........................................................................
4,186
4,186
4,186
4,186
4
1
96
260
16,744
4,186
401,856
1,088,360
1 ............................
4 ............................
0.12 (7 minutes) ....
0.65 (39 minutes) ..
16,744
16,744
48,223
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
21 CFR Section
225.142
225.158
225.180
225.202
Number of
records per
recordkeeper
Average
burden per
recordkeeper
Total annual
records
Total hours
.........................................................................
.........................................................................
.........................................................................
.........................................................................
3,400
3,400
3,400
3,400
4
1
32
260
13,600
3,400
108,800
884,000
1 ............................
4 ............................
0.12 (7 minutes) ....
0.33 (20 minutes) ..
13,600
13,600
13,056
291,720
Total ......................................................................
........................
........................
........................
...............................
331,976
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of time required for
record preparation and maintenance is
based on Agency communications with
industry. Other information needed to
finally calculate the total burden hours
(i.e., number of recordkeepers, number
of medicated feeds being manufactured,
etc.) is derived from Agency records and
experience.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
[FR Doc. 2016–25041 Filed 10–14–16; 8:45 am]
SUMMARY:
jstallworth on DSK7TPTVN1PROD with NOTICES
BILLING CODE 4164–01–P
VerDate Sep<11>2014
14:22 Oct 14, 2016
Jkt 241001
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Substitutability of Generic Drugs:
Perceptions and Reality; Public
Workshop
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA), in collaboration
with the Johns Hopkins University
Center of Excellence in Regulatory
Science and Innovation, is announcing
a public workshop entitled
‘‘Substitutability of Generic Drugs:
Perceptions and Reality.’’ The objective
of this workshop is to discuss FDA and
industry practices related to postmarket
surveillance of generic drugs,
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
postmarket generic drug research
activities, public perceptions of generic
drug quality and effectiveness, and
verification of therapeutic equivalence
of generic drugs. This workshop will
also give stakeholders, including
scientists from government, academia,
and industry, patient advocacy groups,
clinicians, pharmacists, and the general
public an opportunity to provide their
insights on future research needs in
postmarket surveillance of generic
drugs.
DATES: The public workshop will be
held on November 18, 2016, from 8:30
a.m. to 4:30 p.m.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
E:\FR\FM\17OCN1.SGM
17OCN1
Agencies
[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71508-71510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25041]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0601]
Agency Information Collection Activities; Proposed Collection;
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 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 recordkeeping requirements
for manufacturers of medicated animal feeds.
DATES: Submit either electronic or written comments on the collection
of information by December 16, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2010-N-0601 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Current Good Manufacturing
Practice Regulations for Medicated Feeds.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
[[Page 71509]]
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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.
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 recordkeeper Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8)................... 877 260 228,020 1....................................... 228,020
225.28(c) and (d)............................. 877 45 39,465 0.50 (30 minutes)....................... 19,732.5
225.80(b)(2).................................. 877 1,600 1,403,200 0.12 (7 minutes)........................ 168,384
225.102(b)(1)................................. 877 7,800 6,840,600 0.08 (5 minutes)........................ 547,248
225.110(b)(1) and (b)(2)...................... 877 7,800 6,840,600 0.02 (1 minute)......................... 136,812
225.115(b)(1) and (b)(2)...................... 877 5 4,385 0.12 (7 minutes)........................ 526.2
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 1,100,722.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 71510]]
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 recordkeeper Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.42(b) through (b)(8)...................... 100 260 26,000 0.15 (9 minutes)........................ 3,900
225.58(c) through (d)......................... 100 36 3,600 0.50 (30 minutes)....................... 1,800
225.80(b) (2)................................. 100 48 4,800 0.12 (7 minutes)........................ 576
225.102(b)(1) through (b)(5).................. 100 260 26,000 0.40 (24 minutes)....................... 10,400
---------------------------------------------------------------------------------------------------------
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 recordkeeper Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142....................................... 4,186 4 16,744 1....................................... 16,744
225.158....................................... 4,186 1 4,186 4....................................... 16,744
225.180....................................... 4,186 96 401,856 0.12 (7 minutes)........................ 48,223
225.202....................................... 4,186 260 1,088,360 0.65 (39 minutes)....................... 707,434
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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 recordkeeper Total hours
recordkeepers recordkeeper records
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225.142....................................... 3,400 4 13,600 1....................................... 13,600
225.158....................................... 3,400 1 3,400 4....................................... 13,600
225.180....................................... 3,400 32 108,800 0.12 (7 minutes)........................ 13,056
225.202....................................... 3,400 260 884,000 0.33 (20 minutes)....................... 291,720
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Total..................................... .............. .............. .............. ........................................ 331,976
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of time required for record preparation and
maintenance is based on Agency communications with industry. Other
information needed to finally calculate the total burden hours (i.e.,
number of recordkeepers, number of medicated feeds being manufactured,
etc.) is derived from Agency records and experience.
Dated: October 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25041 Filed 10-14-16; 8:45 am]
BILLING CODE 4164-01-P