Adverse Experience/Events with Approved New Animal Drugs

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 1932a VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT (VOLUNTARY)	Form and Instruction	Modified	Available
Form FDA 2301 Transmittal of Periodic Reports and Promotional Material for New Animal Drugs	Form and Instruction	Modified	Available
Form FDA 1932 VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT	Form and Instruction	Modified	Available
0910-0284 Supporting Statement 05_2026.docx	Supporting Statement A	Uploaded 2026-05-26	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
37624	Animal Drug Adverse Event Information Collection Activities	Form and Instruction	Modified	VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT (VOLUNTARY)
37624	Animal Drug Adverse Event Information Collection Activities	Form and Instruction	Modified	Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
37624	Animal Drug Adverse Event Information Collection Activities	Form and Instruction	Modified	VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT
197284	Recordkeeping requirements under 510.301 and 514.80		Modified

ICR Details

OMB Control No: 0910-0284	ICR Reference No: 202512-0910-008
Status: Received in OIRA	Previous ICR Reference No: 202306-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Adverse Experience/Events with Approved New Animal Drugs
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/26/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2026
Responses	264,004	248,888
Time Burden (Hours)	1,936,481	1,914,412
Cost Burden (Dollars)	0	0

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Abstract: 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. Respondents are those submitting adverse experience reports consistent with the applicable laws and regulations.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 8245	02/20/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 29966	05/21/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Animal Drug Adverse Event Information Collection Activities	FDA 1932, FDA 2301, FDA 1932a	VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT ,   Transmittal of Periodic Reports and Promotional Material for New Animal Drugs ,   VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT (VOLUNTARY)
Recordkeeping requirements under 510.301 and 514.80

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ICR Summary of Burden

table that charts list of burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	264,004	248,888	0	0	15,116	0
Annual Time Burden (Hours)	1,936,481	1,914,412	0	0	22,069	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $3,000,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/26/2026

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