Adverse Experience/Events with Approved New Animal Drugs

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 2301 TRANSMITTAL OF PERIODIC REPORTS AND PROMOTIONAL MATERIAL FOR NEW ANIMAL DRUGS	Form and Instruction	Modified	Available
Form FDA 1932a VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, OR PRODUCT DEFECT REPORT (voluntary reporting)	Form and Instruction	Modified	Available
Form FDA 1932 VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT	Form and Instruction	Modified	Available
Form FDA 1932 Animal Drug Adverse Event Information Collection Activities	Form and Instruction	Modified	Repair queued
Form 2301 Transmittal of Periodic Reports and Promotional Material	Form and Instruction	Removed	Available
Form 2301 Drug experience reports; advertisements and promotional labeling; distributor statements	Form and Instruction	Removed	Repair queued
Form 1932a Veterinary Adverse Drug Reaction, Lack of Effectiveness	Form and Instruction	Removed	Available
Form 1932a Voluntary adverse event reporting	Form and Instruction	Removed	Repair queued
0284 CVM AER SSA 2023 REV.docx	Supporting Statement A	Uploaded 2023-06-30	Repair queued

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	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, OR PRODUCT DEFECT REPORT (voluntary reporting)
37624	Animal Drug Adverse Event Information Collection Activities	Form and Instruction	Modified	VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT
37624	Animal Drug Adverse Event Information Collection Activities	Form and Instruction	Modified
239296	One time recordkeeping resulting from implementation of new requirements (New SOPs and training)		Removed
239295	Request for waiver from electronic reporting requirement		Removed
230017	Medicated feed reports		Removed
197284	Recordkeeping requirements under 510.301 and 514.80		Modified
197280	Drug experience reports; advertisements and promotional labeling; distributor statements	Form and Instruction	Removed	Transmittal of Periodic Reports and Promotional Material
197280	Drug experience reports; advertisements and promotional labeling; distributor statements	Form and Instruction	Removed
197280	Drug experience reports; advertisements and promotional labeling; distributor statements	Other-Screenshots - Proposed Electronic Submitter System	Removed
197279	Voluntary adverse event reporting	Form and Instruction	Removed	Veterinary Adverse Drug Reaction, Lack of Effectiveness
197279	Voluntary adverse event reporting	Form and Instruction	Removed

ICR Details

OMB Control No: 0910-0284	ICR Reference No: 202306-0910-009
Status: Active	Previous ICR Reference No: 202001-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Adverse Experience/Events with Approved New Animal Drugs
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/01/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/30/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2026	36 Months From Approved	07/31/2023
Responses	248,888	0	10,937
Time Burden (Hours)	1,914,412	0	99,882
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports FDA regulations regarding records and reports concerning experience with approved new animal drugs. Respondents to the collection are animal drug manufacturers with approved new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), or conditionally approved new animal drug applications (CNADAs), as well as licensed commercial feed mills and licensed mixer-feeders. The reporting and recordkeeping elements implement public health protection provisions provided for in the Federal Food, Drug and Cosmetic.

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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:
	87 FR 78694	12/22/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 26318	04/28/2023
Did the Agency receive public comments on this ICR? Yes

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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 2301, FDA 1932a, FDA 1932	VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT ,   VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, OR PRODUCT DEFECT REPORT (voluntary reporting) ,   TRANSMITTAL OF PERIODIC REPORTS AND PROMOTIONAL MATERIAL FOR NEW ANIMAL DRUGS
Drug experience reports; advertisements and promotional labeling; distributor statements	2301	Transmittal of Periodic Reports and Promotional Material
Medicated feed reports
One time recordkeeping resulting from implementation of new requirements (New SOPs and training)
Recordkeeping requirements under 510.301 and 514.80
Request for waiver from electronic reporting requirement
Voluntary adverse event reporting	1932a	Veterinary Adverse Drug Reaction, Lack of Effectiveness

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	248,888	10,937	0	0	237,951	0
Annual Time Burden (Hours)	1,914,412	99,882	0	0	1,814,530	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: Upon review of the information collection, we have adjusted our estimated burden to reflect an overall increase of 1,814,530 hours and 248,888 responses/records, annually to correspond with current submission data.

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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: 06/30/2023

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