Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping, 20142-20143 [2019-09425]
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20142
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St,
North Bethesda, MD 20852, 301–796–
3794, 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.
[FR Doc. 2019–09381 Filed 5–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3353]
Antimicrobial Animal Drug
Distribution Reports and
Recordkeeping—21 CFR 514.87
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Antimicrobial
Animal Drug Distribution Reports and
Recordkeeping
AGENCY:
OMB Control Number 0910–0659—
Extension
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 June 7,
2019.
SUMMARY:
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 0910–0659. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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
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.
In the Federal Register of October 1,
2018 (83 FR 49395), 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 REPORTING BURDEN 1
khammond on DSKBBV9HB2PROD with NOTICES
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
Average
burden per
response
Total annual
responses
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.
VerDate Sep<11>2014
16:57 May 07, 2019
Jkt 247001
Total hours
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20143
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
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
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping required by section 512(l)(3) of the FD&C
Act ....................................................................................
27
1
27
2
54
khammond on DSKBBV9HB2PROD with NOTICES
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
§ 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 § 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
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.
VerDate Sep<11>2014
16:57 May 07, 2019
Jkt 247001
Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09425 Filed 5–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–2245]
Classification and Requirements for
Laser Illuminated Projectors (Laser
Notice No. 57); Guidance for Industry
and Food and Drug Administration
Staff; 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 final
guidance entitled ‘‘Classification and
Requirements for Laser Illuminated
Projectors (LIPs) (Laser Notice No. 57).’’
This guidance describes FDA’s policy
with respect to certain LIPs that comply
with International Electrotechnical
Commission (IEC) standards during
laser product classification under the
Electronic Product Radiation Control
provisions of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) that apply
to electronic products.
DATES: The announcement of the
guidance is published in the Federal
Register on May 8, 2019.
ADDRESSES: You may submit either
electronic or written comments on
SUMMARY:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Agency guidances 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
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20142-20143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09425]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3353]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Antimicrobial Animal
Drug Distribution Reports and Recordkeeping
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 June 7,
2019.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0659.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St, North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 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.
In the Federal Register of October 1, 2018 (83 FR 49395), 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 Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section FDA form Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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.
[[Page 20143]]
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 burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping required by section 512(l)(3) of the FD&C Act........ 27 1 27 2 54
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 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: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09425 Filed 5-7-19; 8:45 am]
BILLING CODE 4164-01-P
