Records and Reports Concerning Experience with Approved New Animal Drugs

Forms and Documents

Document Name	Status
Form Form FDA 1932 Mandatory adverse event reporting Form and Instruction	Modified
Form 2301 Reporting: Requirement for submitting Distributor statements - Form FDA 2301 Form and Instruction	Removed
Form 2301 Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301 Form and Instruction	Removed
Form 2301 Drug experience reports; advertisements and promotional labeling; distributor statements Form and Instruction	Modified
Form 1932a Voluntary adverse event reporting Form and Instruction	Modified
0284 AER Animal Drugs SSA 2018 Ext.pdf Supporting Statement A	2018-02-10

IC Document Collections

IC ID	Document Title	Status
37624	Mandatory adverse event reporting Form and Instruction	Modified
230017	Medicated feed reports	New
197284	Recordkeeping requirements under 510.301 and 514.80	Modified
197283	Reporting: Requirement for submitting Distributor statements - Form FDA 2301 Form and Instruction	Removed
197282	Reporting: Requirement for Submitting Advertisement & Promotional Material - Form FDA 2301 Other-Screenshots - Proposed Electronic Submitter System	Removed
197281	Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301 Form and Instruction	Removed
197280	Drug experience reports; advertisements and promotional labeling; distributor statements Form and Instruction	Modified
197279	Voluntary adverse event reporting Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0284	ICR Reference No: 201801-0910-008
Status: Historical Active	Previous ICR Reference No: 201703-0910-012
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: 03/08/2018
	Date Received in OIRA: 02/13/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2021	36 Months From Approved	03/31/2018
Responses	12,418	0	12,410
Time Burden (Hours)	101,363	0	101,365
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:
	82 FR 32829	07/18/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 5107	02/05/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301	2301	Transmittal of Periodic Reports and Promotional Material
Reporting: Requirement for submitting Distributor statements - Form FDA 2301	2301	Transmittal of Periodic reports and Promotional Material
Reporting: Requirement for Submitting Advertisement & Promotional Material - Form FDA 2301	2301	Transmittal of Periodic Reports and Promotional Material forNew Animal Drugs
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	Form FDA 1932	Veterinary Adverse Drug Reaction; Lack of Effectiveness or Product Defect Report

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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	12,418	12,410	0	0	8	0
Annual Time Burden (Hours)	101,363	101,365	0	0	-2	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: $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? Uncollected

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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: 02/13/2018

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