Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports, 78694-78696 [2022-27817]
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78694
Federal Register / Vol. 87, No. 245 / Thursday, December 22, 2022 / Notices
section 207 of the FDA Reauthorization
Act of 2017 (Pub. L. 115–52), and
consistent with the Medical Device User
Fee Amendments 2017 (MDUFA IV)
Commitment Letter and the FDA
guidance document entitled ‘‘Providing
Regulatory Submissions for Medical
Devices in Electronic Format—
Submissions Under Section 745A(b) of
the Federal Food, Drug, and Cosmetic
Act’’ (https://www.fda.gov/media/
131064/download), FDA has developed
an ‘‘electronic Submission Template
and Resource’’ (eSTAR) for Qsubmissions to facilitate the preparation
of submissions in electronic format
(https://www.fda.gov/medical-devices/
how-study-and-market-your-device/
voluntary-estar-program). The use of
eSTAR for Q-Submissions is currently
voluntary. We assume approximately 40
percent of Q-Submissions will use
eSTAR and that preparation using
eSTAR will take approximately half the
time of preparing a submission without
using eSTAR.
We estimate a setup burden of 5
minutes for new eSTAR users.
Respondents will only need to set up
eSTAR the first time they use it. We
note that because some respondents
may have already undergone eSTAR set
up for other types of submission, e.g.,
premarket notification, fewer
respondents may need to undergo
eSTAR setup than estimated.
In the Federal Register of August 9,
2022 (87 FR 48488), 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
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’
Q-Submissions:
CDRH ......................................................................
CBER ......................................................................
2,160
60
1
1
2,160
60
137 .....................
137 .....................
295,920
8,220
Q-Submissions using eSTAR (21 CFR part 814, subparts A through E; section 745A(b) of the FD&C Act)
CDRH ......................................................................
CBER ......................................................................
eSTAR setup ...........................................................
Manufacturer request to participate in EPFP .........
1,440
40
1,480
30
1
1
1
1
1,440
40
1,480
30
69 .......................
69 .......................
0.08 (5 minutes)
2 .........................
99,360
2,760
118
60
Total .................................................................
........................
........................
........................
............................
406,438
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Including the EPFP form represents a
revision to this information collection
request. Our estimated burden for the
information collection reflects the
availability of eSTAR to assist electronic
preparation of Q-submissions and
addition of the EPFP form, resulting in
an overall decrease of 85,803 hours.
Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27815 Filed 12–21–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
lotter on DSK11XQN23PROD with NOTICES1
[Docket No. FDA–2022–N–3208]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Records and
Reports Concerning Experiences With
Approved New Animal Drugs: Adverse
Event Reports
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
18:01 Dec 21, 2022
Jkt 259001
The Food and Drug
Administration (FDA or Agency) 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 adverse event
reporting by FDA on new animal drugs
and product manufacturing defects.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
February 21, 2023.
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
February 21, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
SUMMARY:
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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
E:\FR\FM\22DEN1.SGM
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Federal Register / Vol. 87, No. 245 / Thursday, December 22, 2022 / Notices
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
lotter on DSK11XQN23PROD with NOTICES1
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–
2022–N–3208 for ‘‘Records and Reports
Concerning Experiences with Approved
New Animal Drugs: Adverse Event
Reports.’’ 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.
VerDate Sep<11>2014
18:01 Dec 21, 2022
Jkt 259001
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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
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78695
Records and Reports Concerning
Experiences With Approved New
Animal Drugs: Adverse Event Reports
OMB Control Number 0910–0284—
Extension
This information collection supports
statutory and regulatory requirements
governing reporting associated with
certain animal drug products. With
regard to adverse events and product/
manufacturing defects associated with
approved new animal drugs, section
512(l) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360b(l)) requires applicants with
approved new animal drug applications
(NADAs) and abbreviated new animal
drug applications (ANADAs) to
establish and maintain records and
reports of data relating to experience
with uses of such drug, or with respect
to animal feeds bearing or containing
such drug, to facilitate a determination
under section 512(e) as to whether there
may be grounds for suspending or
withdrawing approval of the NADA or
ANADA under section 512(e) or
512(m)(4).
In 2020, FDA amended § 514.80 (21
CFR 514.80) to require electronic
submission of certain postmarketing
safety reports for approved new animal
drugs and to provide a procedure for
requesting a temporary waiver of the
requirement. We, therefore, retain use of
certain paper-based forms. Section
514.80 requires applicants and
nonapplicants to keep records of and
report to us data, studies, and other
information concerning experience with
new animal drugs for each approved
NADA and ANADA. Following
complaints from animal owners or
veterinarians, or following their own
detection of a problem, applicants or
nonapplicants are required to submit
adverse event reports and product/
manufacturing defect reports under
§ 514.80(b)(1), (b)(2)(i) and (ii), (b)(3),
and (b)(4)(iv)(A) and (C) on Form FDA
1932.
The information collection includes
electronic submission of adverse event
reports and product/manufacturing
defect reports under § 514.80(b)(1),
(b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A)
and (C) using Form FDA 1932.
The information collection also
includes submissions under
§ 514.80(d)(2), by an applicant or
nonapplicant requesting, in writing, a
temporary waiver of the electronic
submission requirements. The initial
request may be by telephone or email to
CVM’s Division of Pharmacovigilance
and Surveillance, with prompt written
follow-up submitted as a letter to the
application(s). FDA will grant waivers
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78696
Federal Register / Vol. 87, No. 245 / Thursday, December 22, 2022 / Notices
on a limited basis for good cause shown.
If FDA grants a waiver, the applicant or
nonapplicant must comply with the
conditions for reporting specified by
FDA upon granting the waiver.
Description of Respondents:
Respondents to this collection of
information are applicants and
nonapplicants as defined in 21 CFR
514.3. Respondents include individuals
and the private sector (for-profit
businesses).
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA form
No.
21 CFR section
Medicated feed reports, 510.301(a) and
(b).
Submission of postmarketing safety reports under § 514.80(b)(1), (2)(i) and (ii),
(3), and (4)(iv)(A) and (C).
Voluntary reporting FDA Form 1932a for
the public.
514.80(b)(4) Periodic Drug Experience
Reports.
514.80(b)(5)(i) Special Drug Experience
Reports.
514.80(b(5)(ii) Advertisement and Promotional labeling.
514.80(b)(5)(iii) Distributor’s Statements ...
514.80(d)(2) ...............................................
Total ....................................................
1 There
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden
per response
Total hours
N/A
8
1
8
.25 (15 minutes) ..
2
1932
85
1249
98,639
1 ...........................
98,639
1932a
106
1
106
1 ...........................
106
2301
79
20
1,582
16 .........................
25,312
2301
78
215
16,790
2 ...........................
33,580
2301
38
192
7,282
2 ...........................
14,564
2301
N/A
22
1
2
1
36
1
2 ...........................
1 ...........................
72
1
....................
........................
........................
........................
..............................
172,276
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping, 510.301 2 ....................................................
Recordkeeping, 21 U.S.C. 360b(1) and 514.80(e) 3 ...........
8
79
1
1,575.14
8
124,436
4
14
32
1,742,104
Total ..............................................................................
........................
........................
........................
........................
1,742,136
1 There
2 This
3 This
are no capital costs or operating and maintenance costs associated with this collection of information.
estimate includes all recordkeeping by licensed medicated feed manufacturers under § 510.301.
estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and conditional NADAs under § 514.80(e).
Upon review of the information
collection, we have adjusted our
estimated burden to reflect an overall
increase of 136,029.75 hours and
1,677,019 responses/records, annually.
Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27817 Filed 12–21–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–3054]
M11 Clinical Electronic Structured
Harmonised Protocol; International
Council for Harmonisation; Draft
Guidance for Industry; Draft Template;
and Technical Specification;
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 ‘‘M11
Clinical Electronic Structured
Harmonised Protocol (CeSHarP),’’ and
two supplemental documents entitled
‘‘M11 Template,’’ and ‘‘M11 Technical
Specification.’’ The draft guidance,
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SUMMARY:
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18:01 Dec 21, 2022
Jkt 259001
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template, and technical specification
were prepared under the auspices of the
International Council for Harmonisation
of Technical Requirements for
Pharmaceuticals for Human Use (ICH),
formerly the International Conference
on Harmonisation. The draft guidance
provides recommendations for a
harmonized clinical trial protocol
including the organization of
standardized content and formatting.
The draft template identifies headers,
common text, and a set of data fields
and terminologies that will be the basis
for efficiencies in data exchange. The
technical specification recommends the
use of an open, non-proprietary
standard to enable electronic exchange
of clinical protocol information. The
intent of the draft guidance and
supporting documents is to create an
international standard for the content
and exchange of clinical trial protocol
information facilitating review and
assessment by regulators, sponsors,
E:\FR\FM\22DEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Pages 78694-78696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27817]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-3208]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Records and Reports Concerning Experiences With
Approved New Animal Drugs: Adverse Event Reports
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 adverse event reporting by FDA on new
animal drugs and product manufacturing defects.
DATES: Either electronic or written comments on the collection of
information must be submitted by February 21, 2023.
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 February 21, 2023. 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
[[Page 78695]]
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-2022-N-3208 for ``Records and Reports Concerning Experiences with
Approved New Animal Drugs: Adverse Event Reports.'' 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.
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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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.
Records and Reports Concerning Experiences With Approved New Animal
Drugs: Adverse Event Reports
OMB Control Number 0910-0284--Extension
This information collection supports statutory and regulatory
requirements governing reporting associated with certain animal drug
products. With regard to adverse events and product/manufacturing
defects associated with approved new animal drugs, section 512(l) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(l))
requires applicants with approved new animal drug applications (NADAs)
and abbreviated new animal drug applications (ANADAs) to establish and
maintain records and reports of data relating to experience with uses
of such drug, or with respect to animal feeds bearing or containing
such drug, to facilitate a determination under section 512(e) as to
whether there may be grounds for suspending or withdrawing approval of
the NADA or ANADA under section 512(e) or 512(m)(4).
In 2020, FDA amended Sec. 514.80 (21 CFR 514.80) to require
electronic submission of certain postmarketing safety reports for
approved new animal drugs and to provide a procedure for requesting a
temporary waiver of the requirement. We, therefore, retain use of
certain paper-based forms. Section 514.80 requires applicants and
nonapplicants to keep records of and report to us data, studies, and
other information concerning experience with new animal drugs for each
approved NADA and ANADA. Following complaints from animal owners or
veterinarians, or following their own detection of a problem,
applicants or nonapplicants are required to submit adverse event
reports and product/manufacturing defect reports under Sec.
514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and (C) on
Form FDA 1932.
The information collection includes electronic submission of
adverse event reports and product/manufacturing defect reports under
Sec. 514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and
(C) using Form FDA 1932.
The information collection also includes submissions under Sec.
514.80(d)(2), by an applicant or nonapplicant requesting, in writing, a
temporary waiver of the electronic submission requirements. The initial
request may be by telephone or email to CVM's Division of
Pharmacovigilance and Surveillance, with prompt written follow-up
submitted as a letter to the application(s). FDA will grant waivers
[[Page 78696]]
on a limited basis for good cause shown. If FDA grants a waiver, the
applicant or nonapplicant must comply with the conditions for reporting
specified by FDA upon granting the waiver.
Description of Respondents: Respondents to this collection of
information are applicants and nonapplicants as defined in 21 CFR
514.3. Respondents include individuals and the private sector (for-
profit businesses).
We estimate 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 per response Total hours
No. respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicated feed reports, 510.301(a) and N/A 8 1 8 .25 (15 minutes)................... 2
(b).
Submission of postmarketing safety 1932 85 1249 98,639 1.................................. 98,639
reports under Sec. 514.80(b)(1),
(2)(i) and (ii), (3), and (4)(iv)(A) and
(C).
Voluntary reporting FDA Form 1932a for 1932a 106 1 106 1.................................. 106
the public.
514.80(b)(4) Periodic Drug Experience 2301 79 20 1,582 16................................. 25,312
Reports.
514.80(b)(5)(i) Special Drug Experience 2301 78 215 16,790 2.................................. 33,580
Reports.
514.80(b(5)(ii) Advertisement and 2301 38 192 7,282 2.................................. 14,564
Promotional labeling.
514.80(b)(5)(iii) Distributor's 2301 22 2 36 2.................................. 72
Statements.
514.80(d)(2)............................. N/A 1 1 1 1.................................. 1
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Total................................ ........... .............. .............. .............. ................................... 172,276
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Recordkeeping, 510.301 \2\...... 8 1 8 4 32
Recordkeeping, 21 U.S.C. 360b(1) 79 1,575.14 124,436 14 1,742,104
and 514.80(e) \3\..............
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Total....................... .............. .............. .............. .............. 1,742,136
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ This estimate includes all recordkeeping by licensed medicated feed manufacturers under Sec. 510.301.
\3\ This estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and conditional NADAs
under Sec. 514.80(e).
Upon review of the information collection, we have adjusted our
estimated burden to reflect an overall increase of 136,029.75 hours and
1,677,019 responses/records, annually.
Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27817 Filed 12-21-22; 8:45 am]
BILLING CODE 4164-01-P
