Notice2026-10189
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 21, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 98 (Thursday, May 21, 2026)</title>
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[Federal Register Volume 91, Number 98 (Thursday, May 21, 2026)]
[Notices]
[Pages 29966-29968]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10189]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-1303]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Adverse Experience/
Events With Approved New Animal Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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: Submit written comments (including recommendations) on the
collection of information by June 22, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0284. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Kelly Covington, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 240-402-5661,
<a href="/cdn-cgi/l/email-protection#144446554760757272547270753a7c7c673a737b62"><span class="__cf_email__" data-cfemail="39696b786a4d585f5f795f5d581751514a175e564f">[email protected]</span></a>.
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.
Adverse Experience/Events With Approved New Animal Drugs
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). Regulations in
Sec. 514.80 (21 CFR 514.80) require the electronic submission of
postmarketing safety
[[Page 29967]]
reports for approved new animal drugs but provide a procedure for
requesting a temporary waiver from 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 (to include FDA 1932 and
1932a (e-form). The information collection also includes Form FDA 2301;
Transmittal of Periodic Reports and Promotional Material for New Animal
Drugs.
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 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.
In the Federal Register of February 20, 2026 (91 FR 8245), 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\ \2\
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Number of
21 CFR section Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Medicated feed reports, 510.301(a) N/A 7 1 7 .5 (30 minutes).................. 3.5
and (b).
Submission of postmarketing safety 1932 85 1262.94 107,350 1................................ 107,350
reports under Sec. 514.80(b)(1),
(2)(i) and (ii), (3), and (4)(iv)(A)
and (C).
Voluntary reporting FDA Form 1932a 1932a 217 1 217 1................................ 217
for the public.
514.80(b)(4) Periodic Drug Experience 2301 66 24.68 1,629 16............................... 26,064
Reports.
514.80(b)(5)(i) Special Drug 2301 52 363.2 18,886 2................................ 37,772
Experience Reports.
514.80(b(5)(ii) Advertisement and 2301 35 326.71 11,435 2................................ 22,870
Promotional labeling.
514.80(b)(5)(iii) Distributor's 2301 13 2.77 36 2................................ 72
Statements.
514.80(d)(2)......................... N/A 1 1 1 1................................ 1
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Total............................ .............. .............. .............. 139,561 ................................. 194,349.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Sums may not total due to rounding.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Recordkeeping, 510.301 \2\...... 7 1 7 4 28
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....................... .............. .............. 124443 .............. 1,742,132
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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).
[[Page 29968]]
Our estimated burden for the information collection reflects an
overall increase of 22,073.50 hours and a corresponding increase of
15,117 responses. We attribute this adjustment to an increase in the
number of submissions we received over the last few years. An increase
of safety reports represents a pattern that aligns with expectations--
as product availability and usage expand, adverse event reporting
increases proportionally. The recent three-year increase appears to be
a continuation of this established pattern rather than an indication of
new safety concerns.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10189 Filed 5-20-26; 8:45 am]
BILLING CODE 4164-01-P
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