Records and Reports Concerning Experience with Approved New Animal Drugs

Forms and Documents

Document Name	Status
Form Form FDA 1932 Records and Reports Concerning Experience with Approved New Animal Drugs Form and Instruction	Modified
Covermemo-Records and Reports.doc Supplementary Document	2006-10-02
SSRRpt3.doc Supporting Statement A	2006-10-03

IC Document Collections

IC ID	Document Title	Status
37624	Records and Reports Concerning Experience with Approved New Animal Drugs Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0284	ICR Reference No: 200610-0910-004
Status: Historical Active	Previous ICR Reference No: 200603-0910-013
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: Approved without change	Conclusion Date: 01/04/2007
	Date Received in OIRA: 10/17/2006
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2010	36 Months From Approved	01/31/2007
Responses	43,518	0	45,528
Time Burden (Hours)	83,555	0	138,114
Cost Burden (Dollars)	0	0	0

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Abstract: To facilitate a determination as to whether there may be grounds for suspending or withdrawing approval of the new animal drug application or whether any applicable animal drug regulation should be amended or repealed.

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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:
	71 FR 29157	05/19/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 55482	09/22/2006
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Records and Reports Concerning Experience with Approved New Animal Drugs	FDA 1932a (Voluntary), Form FDA 1932, FDA Form 2301	Veterinary Adverse Drug Reaction; Lack of Effectiveness or Product Defect Report ,   Vet. Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report ,   Transmittal of Periodic reports and Promotional Material for New Animal Drugs

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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	43,518	45,528	0	-2,010	0	0
Annual Time Burden (Hours)	83,555	138,114	0	-54,559	0	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: 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: $0

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)? Uncollected

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: 10/04/2006

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