Notice2022-27817
Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports
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Published
December 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 245 (Thursday, December 22, 2022)</title>
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[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Pages 78694-78696]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27817]
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#2a7a786b795e4b4c4c6a4c4e4b04424259044d455c"><span class="__cf_email__" data-cfemail="da8a889b89aebbbcbc9abcbebbf4b2b2a9f4bdb5ac">[email protected]</span></a>.
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
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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\
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Number of
21 CFR section FDA form Number of responses per Total annual Average burden per response Total hours
No. respondents respondent responses
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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\
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Number of Average
21 CFR section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
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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
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