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 Requirements for Submitting Distributor Statements- Form FDA 2301 Form and Instruction	New
Form 2301 Requirements for Submitting Advetisement & Promotional Labeling- Form FDA 2301 Form and Instruction	New
Form 2301 Requirements 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 first 2 years)- Paper Form FDA 2301 Form and Instruction	New
Form 1932a AdverseDrug Experiences & Product /Manufacturing Defects Voluntary Reporting Using Form FDA 1932a Form and Instruction	New
SS-0910-0284.doc Supporting Statement A	2010-01-26

IC Document Collections

IC ID	Document Title	Status
37624	Adverse Drug Experiences & Product / Manufacturing Defects Reporting Using FDA Form 1932 Form and Instruction	Modified
191902	Requirement for Applicants & NonApplicants to Establish and Maintain Records & files of New Animal Drug Data That Had Not Been Submitted As Part of the Application	New
191901	Requirements for Submitting Distributor Statements- Form FDA 2301 Form and Instruction	New
191900	Requirements for Submitting Advetisement & Promotional Labeling- Form FDA 2301 Form and Instruction	New
191899	Requirements for Submission of Special Drug Experience Reports More Frequently - Form FDA 2301 Form and Instruction	New
191898	Six Month Periodic Drug Experience Report ( submit annually after first 2 years)- Paper Form FDA 2301 Form and Instruction	New
191897	AdverseDrug Experiences & Product /Manufacturing Defects Voluntary Reporting Using Form FDA 1932a Form and Instruction	New

ICR Details

OMB Control No: 0910-0284	ICR Reference No: 201001-0910-012
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 03/29/2010
	Date Received in OIRA: 01/29/2010
Terms of Clearance: This collection has been improperly submitted under the terms set out by 5 CFR 1320. The collection is incorrectly listed as an extension when it includes discretionary changes that impact the burden. Please resubmit this collection as a revision.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2010	36 Months From Approved	03/31/2010
Responses	43,518	0	43,518
Time Burden (Hours)	83,555	0	83,555
Cost Burden (Dollars)	0	0	0

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

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Authorizing Statute(s): None

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 52967	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
AdverseDrug Experiences & Product /Manufacturing Defects Voluntary Reporting Using Form FDA 1932a	1932a	Veteinay Adverse Drug Reaction Lack of Effectiveness
Six Month Periodic Drug Experience Report ( submit annually after first 2 years)- Paper Form FDA 2301	2301	Transmittal of Periodic Reports and Promotional Material
Requirements for Submission of Special Drug Experience Reports More Frequently - Form FDA 2301	2301	Transmittal of Periodic Reports and Promotional Material
Requirements for Submitting Advetisement & Promotional Labeling- Form FDA 2301	2301	Tansmittal of Periodic Reports and Promotional Material
Requirements for Submitting Distributor Statements- Form FDA 2301	2301	Transmittal of Periodic Reports and Promotional Material
Requirement for Applicants & NonApplicants to Establish and Maintain Records & files of New Animal Drug Data That Had Not Been Submitted As Part of the Application

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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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: In response to comments received for the 60 day Federal register notice that published May 19,2006,(71 FR 29157 ), FDA made an adjustment for its reporting and recordkeeping burden estimates. The reporting estimate increased from 34,827 hours to 40,957 hours and the recordkeeping burden estimate increased from 34,316 hours to 43,013 hours (Refer to 30 day Federal Register notice; September 22,2006 (71 FR 55484)

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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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 01/29/2010

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