Records and Reports Concerning Experience with Approved New Animal Drugs

Forms and Documents

Document Name	Status
Form Form FDA 1932 Adverse Drug Experiences & Product / Manufacturing Defects Reporting Using FDA Form 1932 Form and Instruction	Modified
Form 2301 Requirement for Submitting Distributor Statements - Form FDA 2301 Form and Instruction	New
Form 2301 Requirement for Submitting Advertisement & Promotional Labeling- Form FDA 2301 Form and Instruction	New
Form 2301 Requirement for Submission of Special Drug Experience Reports More Frequently Form FDA 2301 Form and Instruction	New
Form 2301 Six Month Periodic Drug Experience Report( Submit annually after the first 2 years) Form FDA 2301 Form and Instruction	New
Form 1932 A Adverse Drug Experiences & Product / Manufacturing Defects Voluntary Reporting Using Form FDA 1932a Form and Instruction	New
SS-0910-0284[1].doc Supporting Statement A	2010-04-22

IC Document Collections

IC ID	Document Title	Status
37624	Adverse Drug Experiences & Product / Manufacturing Defects Reporting Using FDA Form 1932 Form and Instruction	Modified
192752	Requirement for Applicant & Non Applicant to Establish and Maintain Records & Files of New Animal Drug Data That Had Not Been Submitted As Part of The NADA Application	New
192751	Requirement for Submitting Distributor Statements - Form FDA 2301 Form and Instruction	New
192750	Requirement for Submitting Advertisement & Promotional Labeling- Form FDA 2301 Form and Instruction	New
192749	Requirement for Submission of Special Drug Experience Reports More Frequently Form FDA 2301 Form and Instruction	New
192748	Six Month Periodic Drug Experience Report( Submit annually after the first 2 years) Form FDA 2301 Form and Instruction	New
192747	Adverse Drug Experiences & Product / Manufacturing Defects Voluntary Reporting Using Form FDA 1932a Form and Instruction	New

ICR Details

OMB Control No: 0910-0284	ICR Reference No: 201004-0910-008
Status: Historical Inactive	Previous ICR Reference No: 200610-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Records and Reports Concerning Experience with Approved New Animal Drugs
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn	Conclusion Date: 12/20/2010
	Date Received in OIRA: 04/28/2010
Terms of Clearance: In accordance with 5 CFR 1320, OMB is withdrawing this collection at the request of FDA.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Section 512(I) of the Federal Food, Drug and Cosmetic Act( the act)(21 U.S.C. 360b(1)) and section 514.80( 21 CFR 514.80)of FDA regulations require applicants of approved new animal drug applications ( NADAs) and abbreviated new animal drug applications ( ANADAs)to report adverse drug experience and product / manufacturing defects. This continuous monitoring of approved NADAs and ANADAs affords the primary means by which FDA obtains information regarding potential problems with the satety and efficacy of marketed approved new animal drugs as well as potential product / manufacturing problems.

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Authorizing Statute(s): US Code: 21 USC 360b(1) Name of Law: null
  

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:
	74 FR 5267	10/15/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 2865	01/19/2010
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
Adverse Drug Experiences & Product / Manufacturing Defects Reporting Using FDA Form 1932	Form FDA 1932	Veterinary Adverse Drug Reaction; Lack of Effectiveness or Product Defect Report
Adverse Drug Experiences & Product / Manufacturing Defects Voluntary Reporting Using Form FDA 1932a	1932 A	Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
Six Month Periodic Drug Experience Report( Submit annually after the first 2 years) Form FDA 2301	2301	Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
Requirement for Submission of Special Drug Experience Reports More Frequently Form FDA 2301	2301	Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
Requirement for Submitting Advertisement & Promotional Labeling- Form FDA 2301	2301	Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
Requirement for Submitting Distributor Statements - Form FDA 2301	2301	Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
Requirement for Applicant & Non Applicant to Establish and Maintain Records & Files of New Animal Drug Data That Had Not Been Submitted As Part of The NADA Application

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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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The reporting and recordkeeping burdens for section 514.80 have increased. The increase in burden for submission of adverse drug ereactions on Form FDA 1932 results from greater awareness of the need for veterinarians and consumers to submit this information to the drug manufacturers as well as new approvals.While there is an increase in the estimated burden, the corresponding added information generated by the additional submissions greatly enhances FDAs ability to assess safety and edffectiveness of marketed drugs.

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Annual Cost to Federal Government: $1,079,363

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 04/28/2010

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