Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Sales and Distribution, 84887-84889 [2024-24721]
Download as PDF
<![CDATA[
84887
Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices
Annual
number of
respondents
Instrument
Recommended States List (Form L–11) .........................................................
Child Advocate Referral (Form L–12A)-Respondents .....................................
Child Advocate Referral (Form L–12A)-Recordkeepers ..................................
Acknowledgment of Receipt of Legal Resource Guide (LRG–4)-Unaccompanied Children ............................................................................................
Acknowledgment of Receipt of Legal Resource Guide (LRG–4)-Care Providers ............................................................................................................
Notice of Administrative Review (Form P–18) ................................................
Estimated Annual Burden Hours Total .....................................................
Authority: 6 U.S.C. 279; 8 U.S.C.
1232; Flores v. Reno Settlement
Agreement, No. CV85–4544–RJK (C.D.
Cal. 1996).
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–24588 Filed 10–23–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4470]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Antimicrobial
Animal Drug Sales and Distribution
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
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: Either electronic or written
comments on the collection of
information must be submitted by
December 23, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:56 Oct 23, 2024
Jkt 265001
0.33
0.25
0.33
198
1,425
1,848
121,669
2.0
0.25
60,835
300
200
817.0
1.0
0.25
.83
61,275
166
........................
........................
........................
259,664
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
Frm 00026
Fmt 4703
Annual total
burden hours
10.0
19.0
5,601.0
system will accept comments until
11:59 p.m. Eastern Time at the end of
December 23, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
PO 00000
Average
burden hours
per response
60
300
1
Electronic Submissions
BILLING CODE 4184–45–P
AGENCY:
Number of
responses per
respondent
Sfmt 4703
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2024–N–4470 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Antimicrobial Animal Drug Sales and
Distribution.’’ 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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
E:\FR\FM\24OCN1.SGM
24OCN1
84888
Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices
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, 240–402–7500.
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. 3501–3521), 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 Sales and
Distribution—21 CFR 514.87
OMB Control Number 0910–0659—
Extension
This information collection helps
support implementation of Agency
statutory and regulatory requirements
regarding new animal drugs containing
an antimicrobial active ingredient.
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 us 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 speciesspecific 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.
Description of Respondents: Animal
drug manufacturers (sponsors).
Respondents include individuals and
the private sector (for-profit businesses).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
514.87(a)–(e)—Annual Reports for Sponsors With Active
Applications—Paper Submission .....................................
514.87(a)–(e)—Annual Reports for Sponsors With Active
Applications—Electronic Submission ...............................
514.87(a)–(e)—Annual Reports for Sponsors With Inactive
Applications—Paper Submission .....................................
514.87(a)–(e)—Annual Reports for Sponsors With Inactive
Applications—Electronic Submission ...............................
Total ..............................................................................
lotter on DSK11XQN23PROD with NOTICES1
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
1
1
1
62
62
15
10.1
152
52
7,904
2
3.5
7
2
14
10
17.9
179
2
358
........................
........................
........................
........................
8,338
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
VerDate Sep<11>2014
17:56 Oct 23, 2024
Jkt 265001
average number of responses per
respondent in table 1 on a review of our
records of sponsors with active and
inactive applications. We estimate
sponsors with active applications, who
submit an annual antimicrobial annual
drug sales and distribution report on
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
paper, will spend 62 hours to assemble
the necessary information, prepare, and
submit to FDA. We estimate sponsors
with active applications, who submit an
annual antimicrobial animal drug sales
and distribution report electronically,
will spend 52 hours to assemble the
E:\FR\FM\24OCN1.SGM
24OCN1
84889
Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices
necessary information, prepare, and
submit to FDA. We estimate that
sponsors with inactive applications will
spend 2 hours preparing 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 ....................................................................................
23
1
23
2
46
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
lotter on DSK11XQN23PROD with NOTICES1
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 date 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 46 hours for
further compliance with section
512(l)(3), as detailed in table 2.
After a review of the information
collection since our last request for
OMB approval, we have adjusted our
estimates based on our experience with
the antimicrobial animal drug
distribution reports program. Our
estimated burden for the information
collection reflects a decrease of 54
burden hours and a corresponding
decrease of 27 total annual responses.
We attribute this to respondents who
submitted by paper in previous years
and are now reporting electronically.
Dated: October 18, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024–24721 Filed 10–23–24; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:56 Oct 23, 2024
Jkt 265001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3768]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adherence
Potential and Patient Preference in
Prescription Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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: Submit written comments
(including recommendations) on the
collection of information by November
25, 2024.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The title
of this information collection is
‘‘Adherence Potential and Patient
Preference in Prescription Drug
Promotion.’’ 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, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUMMARY:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
collection of information to OMB for
review and clearance.
Adherence Potential and Patient
Preference in Prescription Drug
Promotion
OMB Control Number 0910—NEW
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 393(d)(2)(C)) authorizes
FDA to conduct research relating to
drugs and other FDA-regulated products
in carrying out the provisions of the
FD&C Act.
The mission of the Office of
Prescription Drug Promotion (OPDP) is
to protect the public health by helping
to ensure that prescription drug
promotion is truthful, balanced, and
accurately communicated so that
patients and healthcare providers can
make informed decisions about
treatment options. OPDP’s research
program provides scientific evidence to
help ensure that our policies related to
prescription drug promotion will have
the greatest benefit to public health.
Toward that end, we have consistently
conducted research to evaluate the
aspects of prescription drug promotion
that are most central to our mission,
focusing in particular on three main
topic areas: advertising features,
including content and format; target
populations; and research quality.
Through the evaluation of advertising
features, we assess how elements such
as graphics, format, and the
characteristics of the disease and
product impact the communication and
understanding of prescription drug risks
and benefits. Focusing on target
populations allows us to evaluate how
understanding of prescription drug risks
and benefits may vary as a function of
audience. Our focus on research quality
aims at maximizing the quality of
research data through analytical
methodology development and
investigation of sampling and response
E:\FR\FM\24OCN1.SGM
24OCN1
]]>Agencies
[Federal Register Volume 89, Number 206 (Thursday, October 24, 2024)]
[Notices]
[Pages 84887-84889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24721]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4470]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Antimicrobial Animal Drug Sales and Distribution
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: Either electronic or written comments on the collection of
information must be submitted by December 23, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 23, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2024-N-4470 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Antimicrobial Animal Drug Sales
and Distribution.'' 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, 240-402-7500.
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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
[[Page 84888]]
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, 240-402-7500.
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. 3501-3521), 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 Sales and Distribution--21 CFR 514.87
OMB Control Number 0910-0659--Extension
This information collection helps support implementation of Agency
statutory and regulatory requirements regarding new animal drugs
containing an antimicrobial active ingredient. 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 us 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.
Description of Respondents: Animal drug manufacturers (sponsors).
Respondents include individuals and the private sector (for-profit
businesses).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
514.87(a)-(e)--Annual Reports 1 1 1 62 62
for Sponsors With Active
Applications--Paper Submission.
514.87(a)-(e)--Annual Reports 15 10.1 152 52 7,904
for Sponsors With Active
Applications--Electronic
Submission.....................
514.87(a)-(e)--Annual Reports 2 3.5 7 2 14
for Sponsors With Inactive
Applications--Paper Submission.
514.87(a)-(e)--Annual Reports 10 17.9 179 2 358
for Sponsors With Inactive
Applications--Electronic
Submission.....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 8,338
----------------------------------------------------------------------------------------------------------------
\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 sponsors
with active applications, who submit an annual antimicrobial annual
drug sales and distribution report on paper, will spend 62 hours to
assemble the necessary information, prepare, and submit to FDA. We
estimate sponsors with active applications, who submit an annual
antimicrobial animal drug sales and distribution report electronically,
will spend 52 hours to assemble the
[[Page 84889]]
necessary information, prepare, and submit to FDA. We estimate that
sponsors with inactive applications will spend 2 hours preparing 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........ 23 1 23 2 46
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 date 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 46 hours for
further compliance with section 512(l)(3), as detailed in table 2.
After a review of the information collection since our last request
for OMB approval, we have adjusted our estimates based on our
experience with the antimicrobial animal drug distribution reports
program. Our estimated burden for the information collection reflects a
decrease of 54 burden hours and a corresponding decrease of 27 total
annual responses. We attribute this to respondents who submitted by
paper in previous years and are now reporting electronically.
Dated: October 18, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24721 Filed 10-23-24; 8:45 am]
BILLING CODE 4164-01-P
