Records and Reports Concerning Experience with Approved New Animal Drugs

Forms and Documents

Document Name	Status
Form FDA 1932 Mandatory adverse event reporting Form and Instruction	Modified
Form 2301 Drug experience reports; advertisements and promotional labeling; distributor statements Form and Instruction	Unchanged
Form 1932a Voluntary adverse event reporting Form and Instruction	Unchanged
0910-0284 Revision by ADE Electronic Submission FR.pdf Supporting Statement A	2020-01-16

IC Document Collections

IC ID	Document Title	Status
37624	Mandatory adverse event reporting Form and Instruction	Modified
239296	One time recordkeeping resulting from implementation of new requirements (New SOPs and training)	New
239295	Request for waiver from electronic reporting requirement	New
230017	Medicated feed reports	Unchanged
197284	Recordkeeping requirements under 510.301 and 514.80	Unchanged
197280	Drug experience reports; advertisements and promotional labeling; distributor statements Form and Instruction	Unchanged
197279	Voluntary adverse event reporting Form and Instruction	Unchanged

ICR Details

OMB Control No: 0910-0284	ICR Reference No: 202001-0910-009
Status: Active	Previous ICR Reference No: 201801-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Records and Reports Concerning Experience with Approved New Animal Drugs
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/29/2020
	Date Received in OIRA: 01/16/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2023	36 Months From Approved	03/31/2021
Responses	10,937	0	12,418
Time Burden (Hours)	99,882	0	101,363
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:
0910-AH51	Final or interim final rulemaking	85 FR 45505	07/29/2020

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 6480	02/14/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 45505	07/29/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Medicated feed reports
Recordkeeping requirements under 510.301 and 514.80
Voluntary adverse event reporting	1932a	Veterinary Adverse Drug Reaction, Lack of Effectiveness
Drug experience reports; advertisements and promotional labeling; distributor statements	2301	Transmittal of Periodic Reports and Promotional Material
Mandatory adverse event reporting	FDA 1932	Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report
Request for waiver from electronic reporting requirement
One time recordkeeping resulting from implementation of new requirements (New SOPs and training)

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ICR Summary 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	10,937	12,418	0	0	-1,481	0
Annual Time Burden (Hours)	99,882	101,363	0	0	-1,481	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: This rulemaking revises the information collection to require electronic reporting or the granting of a waiver from the requirement. We have updated our mandatory reporting element (IC element 1) to reflect estimates consistent with the final rule, which results in a decrease in both annual responses and burden hours in the amount of 1512. This is because the currently approved estimate was shown to be too high by the FRIA for the final rule. Ultimately, upon approval of the revision, the 270 responses and hours attributable to mandatory electronic reporting will be captured under OMB Control No. 0910-0645, FDA’s Adverse Event Reporting System (which administers our MedWatch Program), however the 1 request for waiver will be retained in this information collection. We have also added a one-time recordkeeping burden in the amount of 30 responses and 30 burden hours to reflect implementation of the new requirements, but we expect this burden to be realized upon the next renewal request for the information collection (currently expires March 31, 2021). Cumulatively, these changes reflect a total decrease of 1481 hours and 1481 responses annually.

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Annual Cost to Federal Government: $700,000

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: 01/16/2020

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