Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping, 49395-49398 [2018-21208]
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Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
49395
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section
Controls to Prevent Adulteration Caused by Facilities—Recordkeeping of Testing for Bacteriological
Contaminants 106.20(f)(4) and 106.100(f)(1).
Controls to Prevent Adulteration by Equipment or
Utensils 106.30(d)(1) and 106.100(f)(2).
Controls to Prevent Adulteration by Equipment or
Utensils 106.30(e)(3)(iii) and 106.100(f)(3).
Controls to Prevent Adulteration by Equipment or
Utensils 106.30(f)(2) and 106.100(f)(4).
Controls to Prevent Adulteration Due to Automatic
(Mechanical or Electronic) Equipment 106.35(c)
and 106.100(f)(5).
Controls to Prevent Adulteration Due to Automatic
(Mechanical or Electronic) Equipment 106.35(c)
and 106.100(f)(5).
Controls to Prevent Adulteration Caused by Ingredients, Containers, and Closures 106.40(g) and
106.100(f)(6).
Controls to Prevent Adulteration During Manufacturing
106.50 and 106.100(e).
Controls to Prevent Adulteration From Microorganisms
106.55(d),
106.100(e)(5)(ii),
and
106.100(f)(7).
Controls to Prevent Adulteration During Packaging
and Labeling of Infant Formula 106.60(c).
General Quality Control—Testing 106.91(b)(1),
106.91(b)(2) and 106.91(b)(3).
General Quality Control 106.91(b)(1), 106.91(d), and
106.100(e)(5)(i).
General Quality Control 106.91(b)(2) 106.91(d), and
106.100(e)(5)(i).
General Quality Control 106.91(b)(3) 106.91(d), and
106.100(e)(5)(i).
Audit Plans and Procedures 106.94—Ongoing Review and Updating of Audits.
Audit Plans and Procedures 106.94—Regular Audits
Total
annual
records
Average
burden per
recordkeeper
Total
hours
3
52
156
0.08 (5 minutes) ....
12.48
3
52
156
0.21 (13 minutes) ..
32.76
3
52
156
0.21 (13 minutes) ..
32.76
3
52
156
0.19 (11 minutes) ..
29.64
3
52
156
520 ........................
81,120
3
2
6
640 ........................
3,840
3
52
156
0.17 (10 minutes) ..
26.52
3
52
156
0.23 (14 minutes) ..
35.88
3
52
156
0.25 (15 minutes) ..
39
1
12
12
0.25 (15 minutes) ..
3
2
1
2
2 ............................
4
2
52
104
0.15 (9 minutes) ....
15.6
2
52
104
0.15 (9 minutes) ....
15.6
2
52
104
0.15 (9 minutes) ....
15.6
3
1
3
8 ............................
24
3
52
156
4 ............................
624
Total Recurring Recordkeeping Burden ...............
........................
........................
........................
...............................
85,889.64
Total Recordkeeping Burden .........................
........................
........................
........................
...............................
105,209.64
1 There
amozie on DSK3GDR082PROD with NOTICES
Number of
records per
recordkeeper
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection, we made a correction since
the last OMB approval. While the onetime estimated recordkeeping burden
remains as 19,320 hours, we increased
the annual estimated recurring
recordkeeping burden to 85,889.64
hours due to a calculation error (a
79,561.58 hour increase) for a total
recordkeeping burden of 105,209.64
hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
[FR Doc. 2018–21207 Filed 9–28–18; 8:45 am]
SUMMARY:
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:50 Sep 28, 2018
Jkt 247001
Food and Drug Administration
[Docket No. FDA–2018–N–3353]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Antimicrobial
Animal Drug Distribution Reports and
Recordkeeping
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
PO 00000
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Fmt 4703
Sfmt 4703
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 information
collection provisions of our reporting
and recordkeeping requirements for
antimicrobial animal drug sales and
distribution.
Submit either electronic or
written comments on the collection of
information by November 30, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 30,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 30, 2018.
DATES:
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49396
Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
amozie on DSK3GDR082PROD with NOTICES
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2018–N–3353 for ‘‘Antimicrobial
Animal Drug Distribution Reports and
Recordkeeping.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
VerDate Sep<11>2014
17:50 Sep 28, 2018
Jkt 247001
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 Dockets Management
Staff. 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 information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
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
PO 00000
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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.
Antimicrobial Animal Drug Distribution
Reports and Recordkeeping—21 CFR
514.87
OMB Control Number 0910–0659—
Extension
Sponsors of approved or conditionally
approved applications for new animal
drugs containing an antimicrobial active
ingredient are required by section 512 of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360b) to
submit to FDA an annual report on the
amount of each such ingredient in the
drug that is sold or distributed for use
in food-producing animals. Sponsors are
also required to maintain distribution
records for their animal drug products,
including separate information for each
month of the calendar year, under
section 512(l)(3) of the FD&C Act. These
provisions were enacted to assist FDA
in our continuing analysis of the
interactions (including drug resistance),
efficacy, and safety of antimicrobials
approved for use in both humans and
food-producing animals for the purpose
of mitigating the public health risk
associated with antimicrobial resistance.
Section 514.87 of our regulations (21
CFR 514.87) codifies the reporting
requirements established in the FD&C
Act. Sponsors submit antimicrobial
animal drug sales and distribution
reports to the Agency on Form FDA
3744. Each report must specify: (1) The
amount of each antimicrobial active
ingredient by container size, strength,
and dosage form; (2) quantities
distributed domestically and quantities
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Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
exported; and (3) a listing of the target
animals, indications, and production
classes that are specified on the
approved label of the product. The
report must cover the period of the
preceding calendar year and include
separate information for each month of
the calendar year. Each report must also
provide a species-specific estimate of
the percentage of each product that was
sold or distributed domestically in the
reporting year for use in cattle, swine,
chickens, or turkeys for such species
that appear on the approved label.
Collection of information on the
amount of animal antimicrobials being
distributed, including species-specific
information, is necessary to support our
ongoing efforts to encourage the
judicious use of antimicrobials in foodproducing animals to help ensure the
continued availability of safe and
effective antimicrobials for animals and
humans. We intend to use these data to
supplement existing information,
including data collected under the
National Animal Health Monitoring
System and the National Antimicrobial
Resistance Monitoring System
programs. Data from multiple sources
are needed to provide a comprehensive
and science-based picture of
antimicrobial drug use and resistance in
animal agriculture.
Description of Respondents: Animal
drug manufacturers (sponsors).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
FDA Form
514.87(a) through (e)—Annual Reports
for Sponsors With Active Applications—Paper Submission .....................
514.87(a) through (e)—Annual Reports
for Sponsors With Active Applications—Electronic Submission ...............
514.87(a) through (e)—Annual Reports
for Sponsors With Inactive Applications—Paper Submission .....................
514.87(a) through (e)—Annual Reports
for Sponsors With Inactive Applications—Electronic Submission ...............
Total ..................................................
1 There
Number of
responses per
respondent
Number of
respondents
Total
annual
responses
Average
burden per
response
Total hours
3744
10
7.5
75
62
4,650
3744
10
7.5
75
52
3,900
3744
4
26.5
106
2
212
3744
3
35
105
2
210
........................
........................
........................
........................
8,972
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the average
burden per response on our recent
experience with the existing
antimicrobial animal drug distribution
reports program. We base our estimate
of the number of affected respondents
reported in tables 1 and 2 and the
average number of responses per
respondent in table 1 on a review of our
records of sponsors with active and
inactive applications. We estimate that
20 sponsors will have active
applications and we assume that half of
the respondents will report
electronically, while the other half will
report on paper. We estimate that 10
sponsors with active applications will
spend 62 hours annually to assemble
the necessary information, prepare, and
submit an annual antimicrobial animal
drug sales and distribution report on
paper and 10 sponsors with active
applications will spend 52 hours
annually to assemble the necessary
information, prepare, and electronically
submit an annual antimicrobial animal
drug sales and distribution report. We
estimate that seven sponsors will have
inactive applications and we assume
that half of these respondents will
report electronically, while the other
half will report on paper. We estimate
that sponsors with inactive applications
will spend 2 hours to prepare their
annual antimicrobial animal drug sales
and distribution reports, whether
electronically or on paper.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Recordkeeping required by section 512(l)(3) of the FD&C
Act ....................................................................................
amozie on DSK3GDR082PROD with NOTICES
1 There
Number of
records per
recordkeeper
27
Total
annual
records
1
Average
burden per
recordkeeping
27
2
Total hours
54
are no capital costs or operating and maintenance costs associated with this collection of information.
Animal drug manufacturers are
already required to maintain
distribution records for their animal
drug products to comply with FDA’s
current good manufacturing regulations
for periodic drug reports under
§ 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)),
approved under OMB control number
0910–0284. Section 512(l)(3) of the
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Jkt 247001
FD&C Act differs from § 514.80(b)(4)(i)
in that it requires that records include
separate information for each month of
the calendar year. In addition, under 21
CFR 211.196 (approved under OMB
control number 0910–0139),
manufacturers currently are required to
maintain distribution records that
include dosage form and the date the
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Sfmt 4703
drug is distributed. Based on these
requirements, FDA believes that
manufacturers already keep detailed
records of the dates when antimicrobial
drugs are distributed for marketing and
recall purposes from which monthly
reports can be prepared as part of usual
and customary business practices.
However, FDA estimates an additional
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Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
recordkeeping burden of 54 hours for
further compliance with section
512(l)(3) of the FD&C Act, as detailed in
table 2.
Based on a review of the information
collection since our last request for
OMB approval, which was submitted
with a final rule, we have made no
adjustments to our burden estimates as
reported in tables 1 and 2, other than to
remove the one-time burden of 787
hours, which represented the time
needed to review the provisions of the
final rule and develop a compliance
plan in the first year of compliance.
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21208 Filed 9–28–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3292]
Master Protocols: Efficient Clinical
Trial Design Strategies To Expedite
Development of Oncology Drugs and
Biologics; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Master
Protocols: Efficient Clinical Trial Design
Strategies to Expedite Development of
Oncology Drugs and Biologics.’’ This
guidance provides advice to sponsors of
drugs and biologics for cancer treatment
regarding the design and conduct of
clinical trials, other than first-in-human
(FIH) trials, intended to simultaneously
evaluate more than one investigational
drug and/or more than one cancer type
within the same overall trial structure
(master protocols) in adult and pediatric
cancers. In contrast to traditional trial
designs, where a single drug is tested in
a single disease population in one
clinical trial, master protocols use a
single infrastructure, trial design, and
protocol to simultaneously evaluate
multiple drugs and/or disease
populations in multiple substudies,
allowing for efficient and accelerated
drug development.
DATES: Submit either electronic or
written comments on the draft guidance
by November 30, 2018 to ensure that the
Agency considers your comment on this
amozie on DSK3GDR082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:50 Sep 28, 2018
Jkt 247001
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time 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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2018–D–3292 for Master Protocols:
Efficient Clinical Trial Design Strategies
to Expedite Development of Oncology
Drugs and Biologics. 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 Dockets Management Staff
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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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 Dockets Management
Staff. 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 information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002 or the Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Lee
Pai-Scherf, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49395-49398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21208]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3353]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Antimicrobial Animal Drug Distribution Reports and
Recordkeeping
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 information collection
provisions of our reporting and recordkeeping requirements for
antimicrobial animal drug sales and distribution.
DATES: Submit either electronic or written comments on the collection
of information by November 30, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 30, 2018.
[[Page 49396]]
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2018-N-3353 for ``Antimicrobial Animal Drug Distribution Reports
and Recordkeeping.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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 information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: 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.
Antimicrobial Animal Drug Distribution Reports and Recordkeeping--21
CFR 514.87
OMB Control Number 0910-0659--Extension
Sponsors of approved or conditionally approved applications for new
animal drugs containing an antimicrobial active ingredient are required
by section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360b) to submit to FDA an annual report on the amount of
each such ingredient in the drug that is sold or distributed for use in
food-producing animals. Sponsors are also required to maintain
distribution records for their animal drug products, including separate
information for each month of the calendar year, under section
512(l)(3) of the FD&C Act. These provisions were enacted to assist FDA
in our continuing analysis of the interactions (including drug
resistance), efficacy, and safety of antimicrobials approved for use in
both humans and food-producing animals for the purpose of mitigating
the public health risk associated with antimicrobial resistance.
Section 514.87 of our regulations (21 CFR 514.87) codifies the
reporting requirements established in the FD&C Act. Sponsors submit
antimicrobial animal drug sales and distribution reports to the Agency
on Form FDA 3744. Each report must specify: (1) The amount of each
antimicrobial active ingredient by container size, strength, and dosage
form; (2) quantities distributed domestically and quantities
[[Page 49397]]
exported; and (3) a listing of the target animals, indications, and
production classes that are specified on the approved label of the
product. The report must cover the period of the preceding calendar
year and include separate information for each month of the calendar
year. Each report must also provide a species-specific estimate of the
percentage of each product that was sold or distributed domestically in
the reporting year for use in cattle, swine, chickens, or turkeys for
such species that appear on the approved label.
Collection of information on the amount of animal antimicrobials
being distributed, including species-specific information, is necessary
to support our ongoing efforts to encourage the judicious use of
antimicrobials in food-producing animals to help ensure the continued
availability of safe and effective antimicrobials for animals and
humans. We intend to use these data to supplement existing information,
including data collected under the National Animal Health Monitoring
System and the National Antimicrobial Resistance Monitoring System
programs. Data from multiple sources are needed to provide a
comprehensive and science-based picture of antimicrobial drug use and
resistance in animal agriculture.
Description of Respondents: Animal drug manufacturers (sponsors).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section FDA Form Number of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.87(a) through (e)--Annual Reports for Sponsors With 3744 10 7.5 75 62 4,650
Active Applications--Paper Submission..................
514.87(a) through (e)--Annual Reports for Sponsors With 3744 10 7.5 75 52 3,900
Active Applications--Electronic Submission.............
514.87(a) through (e)--Annual Reports for Sponsors With 3744 4 26.5 106 2 212
Inactive Applications--Paper Submission................
514.87(a) through (e)--Annual Reports for Sponsors With 3744 3 35 105 2 210
Inactive Applications--Electronic Submission...........
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. 8,972
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the average burden per response on our
recent experience with the existing antimicrobial animal drug
distribution reports program. We base our estimate of the number of
affected respondents reported in tables 1 and 2 and the average number
of responses per respondent in table 1 on a review of our records of
sponsors with active and inactive applications. We estimate that 20
sponsors will have active applications and we assume that half of the
respondents will report electronically, while the other half will
report on paper. We estimate that 10 sponsors with active applications
will spend 62 hours annually to assemble the necessary information,
prepare, and submit an annual antimicrobial animal drug sales and
distribution report on paper and 10 sponsors with active applications
will spend 52 hours annually to assemble the necessary information,
prepare, and electronically submit an annual antimicrobial animal drug
sales and distribution report. We estimate that seven sponsors will
have inactive applications and we assume that half of these respondents
will report electronically, while the other half will report on paper.
We estimate that sponsors with inactive applications will spend 2 hours
to prepare their annual antimicrobial animal drug sales and
distribution reports, whether electronically or on paper.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Recordkeeping required by 27 1 27 2 54
section 512(l)(3) of the FD&C
Act............................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Animal drug manufacturers are already required to maintain
distribution records for their animal drug products to comply with
FDA's current good manufacturing regulations for periodic drug reports
under Sec. 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)), approved under
OMB control number 0910-0284. Section 512(l)(3) of the FD&C Act differs
from Sec. 514.80(b)(4)(i) in that it requires that records include
separate information for each month of the calendar year. In addition,
under 21 CFR 211.196 (approved under OMB control number 0910-0139),
manufacturers currently are required to maintain distribution records
that include dosage form and the date the drug is distributed. Based on
these requirements, FDA believes that manufacturers already keep
detailed records of the dates when antimicrobial drugs are distributed
for marketing and recall purposes from which monthly reports can be
prepared as part of usual and customary business practices. However,
FDA estimates an additional
[[Page 49398]]
recordkeeping burden of 54 hours for further compliance with section
512(l)(3) of the FD&C Act, as detailed in table 2.
Based on a review of the information collection since our last
request for OMB approval, which was submitted with a final rule, we
have made no adjustments to our burden estimates as reported in tables
1 and 2, other than to remove the one-time burden of 787 hours, which
represented the time needed to review the provisions of the final rule
and develop a compliance plan in the first year of compliance.
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21208 Filed 9-28-18; 8:45 am]
BILLING CODE 4164-01-P
