New Animal Drug Applications; Abbreviated New Animal Drug Applications; and Veterinary Master Files

Forms and Documents

Document Name	Status
Form 356V New Animal Drug Application Submissions Form and Instruction	Modified
83C 0032 to add 0669 ANDA activity.docx Justification for No Material/Nonsubstantive Change	2025-12-01
0032 NADAs and Vet Master Files SSA 2025 Ext.docx Supporting Statement A	2025-07-31

IC Document Collections

IC ID	Document Title	Status
5688	New Animal Drug Application Submissions Form and Instruction	Modified
278264	Biowaiver requests Other-Agency Guidance	New
278263	Abbreviated New Animal Drug Application Submissions Other-Agency Guidance	New

ICR Details

OMB Control No: 0910-0032	ICR Reference No: 202512-0910-001
Status: Received in OIRA	Previous ICR Reference No: 202411-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: New Animal Drug Applications; Abbreviated New Animal Drug Applications; and Veterinary Master Files
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/01/2025

	Requested	Previously Approved
Expiration Date	09/30/2028	09/30/2028
Responses	8,674	8,556
Time Burden (Hours)	41,053	36,243
Cost Burden (Dollars)	0	0

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Abstract: FDA is requesting to include abbreviated new animal drug application information collection activity into the collection for efficiency of agency operations and because activities are conducted under related statutory authorities.

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Authorizing Statute(s): US Code: 21 USC 512 Name of Law: FD&C 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:
	89 FR 106493	12/20/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 25335	06/16/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Abbreviated New Animal Drug Application Submissions
Biowaiver requests
New Animal Drug Application Submissions	356V	Application for Approval of a New Animal Drug (or Submission to Support New Animal Drug Approval)

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ICR Summary 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	8,674	8,556	0	118	0	0
Annual Time Burden (Hours)	41,053	36,243	0	4,810	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: The estimated increase reflects the inclusion of related information collection activities attributable to abbreviated new animal drug application submissions. We have provided updated figures reflecting an increase in submissions since our last review (+ 55 responses; + 511 hours), for a total of 118 responses and 4,810 hours. We intend on discontinuing OMB control no. upon approval of this request.

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Annual Cost to Federal Government: $12,173,920

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.     Yes

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: 12/01/2025

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