Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds, 35358-35360 [2014-14472]
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35358
Federal Register / Vol. 79, No. 119 / Friday, June 20, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
516.119
516.121
516.123
516.125
516.129
516.141
516.143
516.145
516.161
516.163
516.165
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total Hours
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
2
30
3
2
30
20
20
20
1
1
10
1
2
1
3
2
1
1
1
1
1
2
2
60
3
6
60
20
20
20
1
1
20
1
4
8
20
20
16
120
20
4
2
8
2
240
24
120
1200
320
2400
400
4
2
160
Total ..............................................................................
........................
........................
........................
........................
4,872
1 There
is no capital or operating and maintenance cost associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
516.141 ................................................................................
516.165 ................................................................................
30
10
2
2
60
20
2 0.5
1
30
20
Total ..............................................................................
........................
........................
........................
........................
50
1 There
is no capital or operating and maintenance cost associated with this collection of information.
2 30 minutes.
Dated: June 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
Food and Drug Administration
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.
[Docket No. FDA–2004–N–0193]
FOR FURTHER INFORMATION CONTACT:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice Regulations for
Medicated Feeds
SUPPLEMENTARY INFORMATION:
[FR Doc. 2014–14473 Filed 6–19–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 21,
2014.
ADDRESSES: To ensure that comments on
the information collection are received,
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
22:31 Jun 19, 2014
Jkt 232001
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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.
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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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 that they
E:\FR\FM\20JNN1.SGM
20JNN1
Federal Register / Vol. 79, No. 119 / Friday, June 20, 2014 / Notices
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
35359
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four elements solicited in the notice
and therefore will not be discussed in
this document.
FDA estimates the burden for this
collection of information as follows:
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.
In the Federal Register of April 7,
2014 (79 FR 19091), FDA published a
60-day notice requesting public
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Registered licensed commercial feed mills] 1
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR Section
Total annual
records
Average burden per recordkeeper
Total hours
225.42(b)(5) through (b)(8) ...............
225.58(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) ...................
840
840
840
840
840
840
260
45
1,600
7,800
7,800
5
218,400
37,800
1,344,000
6,552,000
6,552,000
4,200
1 .......................................................
0.50 (30 minutes) .............................
0.12 (7 minutes) ...............................
0.08 (5 minutes) ...............................
.015 (1 minute) .................................
0.12 (7 minutes) ...............................
218,400
18,900
161,280
524,160
98,280
504
Total ...........................................
........................
........................
........................
...........................................................
1,021,524
1 There
are no capital or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Registered licensed mixer-feeders] 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
225.42(b)(5) through (b)(8) ...............
225.58(c) and (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
Average burden per recordkeeper
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
Total annual
records
Average burden per recordkeeper
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
mstockstill on DSK4VPTVN1PROD with NOTICES
[Nonregistered unlicensed mixer-feeders] 1
Number of
recordkeepers
21 CFR Section
225.142
225.158
225.180
225.202
.............................................
.............................................
.............................................
.............................................
VerDate Mar<15>2010
22:31 Jun 19, 2014
Jkt 232001
Number of
records per
recordkeeper
3,400
3,400
3,400
3,400
PO 00000
Frm 00050
4
1
32
260
Fmt 4703
Total annual
records
13,600
3,400
108,800
884,000
Sfmt 4703
Average burden per recordkeeper
1 .......................................................
4 .......................................................
0.12 (7 minutes) ...............................
0.33 (20 minutes) .............................
E:\FR\FM\20JNN1.SGM
20JNN1
Total hours
13,600
13,600
13,056
291,720
35360
Federal Register / Vol. 79, No. 119 / Friday, June 20, 2014 / Notices
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN—Continued
[Nonregistered unlicensed mixer-feeders] 1
Number of
recordkeepers
Total ...........................................
1 There
Number of
records per
recordkeeper
Total annual
records
Average burden per recordkeeper
........................
21 CFR Section
........................
........................
...........................................................
Dated: June 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–14472 Filed 6–19–14; 8:45 am]
BILLING CODE 4160–01–P
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 0910–0154. Also
include the FDA docket number found
in brackets in the heading of this
document.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0389]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice Regulations for
Type A Medicated Articles
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 21,
2014.
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,
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
331,976
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.
AGENCY:
Total hours
Current Good Manufacturing Practice
Regulations for Type A Medicated
Articles—21 CFR Part 226 (OMB
Control Number 0910–0154)—Extension
Under section 501 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), FDA has the statutory
authority to issue current good
manufacturing practice (cGMP)
regulations for drugs, including Type A
medicated articles. A Type A medicated
article is a feed product containing a
concentrated drug diluted with a feed
carrier substance. A Type A medicated
article is intended solely for use in the
manufacture of another Type A
medicated article or a Type B or Type
C medicated feed. Medicated feeds are
administered to animals for the
prevention, cure, mitigation, or
treatment of disease or for growth
promotion and feed efficiency.
Statutory requirements for cGMPs for
Type A medicated articles have been
codified in part 226 (21 CFR part 226).
Type A medicated articles which are not
manufactured in accordance with these
regulations are considered adulterated
under section 501(a)(2)(B) of the FD&C
Act (21 U.S.C. 351(a)(2)(B). Under part
226, a manufacturer is required to
establish, maintain, and retain records
for Type A medicated articles, including
records to document procedures
required under 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) and product
distribution.
This information is needed so that
FDA can monitor drug usage and
possible misformulation of Type A
medicated articles. The information
could also prove useful to FDA in
investigating product defects when a
drug is recalled. In addition, FDA will
use the cGMP criteria in part 226 to
determine whether or not the systems
used by manufacturers of Type A
medicated articles are adequate to
assure that their medicated articles meet
the requirements of the FD&C Act as to
safety and also meet the article’s
claimed identity, strength, quality, and
purity, as required by section
501(a)(2)(B) of the FD&C Act. The
respondents for Type A medicated
articles are pharmaceutical firms that
manufacture both human and veterinary
drugs, those firms that produce only
veterinary drugs, and commercial feed
mills.
In the Federal Register of April 7,
2014 (79 FR 19093), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
226.42 ...............................................
226.58 ...............................................
226.80 ...............................................
VerDate Mar<15>2010
22:31 Jun 19, 2014
Jkt 232001
Number of
records per
recordkeeper
65
65
65
PO 00000
Frm 00051
Total annual
records
260
260
260
Fmt 4703
16,900
16,900
16,900
Sfmt 4703
Average burden per recordkeeper
0.75 (45 minutes) .............................
1.75 ..................................................
0.75 (45 minutes) .............................
E:\FR\FM\20JNN1.SGM
20JNN1
Total hours
12,675
29,575
12,675
]]>Agencies
[Federal Register Volume 79, Number 119 (Friday, June 20, 2014)]
[Notices]
[Pages 35358-35360]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14472]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0193]
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 July
21, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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.
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 that they
[[Page 35359]]
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 April 7, 2014 (79 FR 19091), 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 elements solicited in the notice and
therefore will not be discussed in this document.
FDA estimates the burden for 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 Total hours
recordkeepers recordkeeper records per recordkeeper
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8)... 840 260 218,400 1............... 218,400
225.58(c) and (d)............. 840 45 37,800 0.50 (30 18,900
minutes).
225.80(b)(2).................. 840 1,600 1,344,000 0.12 (7 minutes) 161,280
225.102(b)(1)................. 840 7,800 6,552,000 0.08 (5 minutes) 524,160
225.110(b)(1) and (b)(2)...... 840 7,800 6,552,000 .015 (1 minute). 98,280
225.115(b)(1) and (b)(2)...... 840 5 4,200 0.12 (7 minutes) 504
------------------------------------------------ ---------------
Total..................... .............. .............. .............. ................ 1,021,524
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden
[Registered licensed mixer-feeders] \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of records per Total annual Average burden Total hours
recordkeepers recordkeeper records per recordkeeper
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8)... 100 260 26,000 0.15 (9 minutes) 3,900
225.58(c) and (d)............. 100 36 3,600 0.50 (30 1,800
minutes).
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 10,400
minutes).
------------------------------------------------ ---------------
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 Total hours
recordkeepers recordkeeper records per recordkeeper
----------------------------------------------------------------------------------------------------------------
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 (39 707,434
minutes).
------------------------------------------------ ---------------
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
21 CFR Section Number of records per Total annual Average burden Total hours
recordkeepers recordkeeper records per recordkeeper
----------------------------------------------------------------------------------------------------------------
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 (20 291,720
minutes).
------------------------------------------------ ---------------
[[Page 35360]]
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.
Dated: June 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14472 Filed 6-19-14; 8:45 am]
BILLING CODE 4160-01-P
