Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs

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. 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 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 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, 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. 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 §  514.80 (21 CFR 514.80) require the electronic submission of postmarketing safety 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 §  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 §  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 21 CFR section Form No. Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Medicated feed reports, 510.301(a) and (b) N/A 7 1 7 .5 (30 minutes) 3.5 Submission of postmarketing safety reports under § 514.80(b)(1), (2)(i) and (ii), (3), and (4)(iv)(A) and (C) 1932 85 1262.94 107,350 1 107,350 Voluntary reporting FDA Form 1932a for the public 1932a 217 1 217 1 217 514.80(b)(4) Periodic Drug Experience Reports 2301 66 24.68 1,629 16 26,064 514.80(b)(5)(i) Special Drug Experience Reports 2301 52 363.2 18,886 2 37,772 514.80(b(5)(ii) Advertisement and Promotional labeling 2301 35 326.71 11,435 2 22,870 514.80(b)(5)(iii) Distributor's Statements 2301 13 2.77 36 2 72 514.80(d)(2) N/A 1 1 1 1 1 Total 139,561 194,349.5 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 21 CFR section Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Recordkeeping, 510.301  2 7 1 7 4 28 Recordkeeping, 21 U.S.C. 360b(1) and 514.80(e)  3 79 1,575.14 124,436 14 1,742,104 Total 124443 1,742,132 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 § 510.301. 3  This estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and conditional NADAs under § 514.80(e). 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