New Animal Drug Application, 21 CFR Part 514

Forms and Documents

Document Name	Status
Form 356 V 514.5(b)(d)(f) Form and Instruction	Modified
Form 356 V FDA FORM 356V Form and Instruction	New
Form 356 V 514.1(b)(8) and 514.8(c)(1) Form and Instruction	New
Form 356 V 558.5(i) Form and Instruction	New
Form 356 V 514.11 Form and Instruction	New
Form 356 V 514.8(c)(2)(3) Form and Instruction	New
Form 356 V 514.8(c)(1) Form and Instruction	New
Form 356 V 514.8(b) Form and Instruction	New
Form 356 V 514.1 and 514.6 Form and Instruction	New
0910-0032 - Supporting Statement A.doc Supporting Statement A	2011-04-12

IC Document Collections

IC ID	Document Title	Status
5688	514.5(b)(d)(f) Form and Instruction	Modified
197519	FDA FORM 356V Form and Instruction	New
197518	514.1(b)(8) and 514.8(c)(1) Form and Instruction	New
197517	558.5(i) Form and Instruction	New
197516	514.11 Form and Instruction	New
197515	514.8(c)(2)(3) Form and Instruction	New
197514	514.8(c)(1) Form and Instruction	New
197513	514.8(b) Form and Instruction	New
197512	514.1 and 514.6 Form and Instruction	New

ICR Details

OMB Control No: 0910-0032	ICR Reference No: 201104-0910-011
Status: Historical Active	Previous ICR Reference No: 200803-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: New Animal Drug Application, 21 CFR Part 514
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: 06/27/2011
	Date Received in OIRA: 04/28/2011
Terms of Clearance: In accordance with 5 CFR 1320, OMB approves this collection for a period of two years. FDA states that it is developing a method of electronic collection of this information but that no such method currently exists. Before resubmitting this ICR for extension, FDA should implement an electronic form of collection to reduce burden on the public.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2013	36 Months From Approved	06/30/2011
Responses	1,517	0	1,412
Time Burden (Hours)	33,146	0	30,421
Cost Burden (Dollars)	0	0	0

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Abstract: This clearance submission is a consolidation of information collection activities associated with approval of new animal drugs. To gain approval to market an animal drug, the applicant must file a New Animal Drug Application containing data to support the safety and effectiveness of the drug, appropriate labeling, product manufacturing information, and where applicable, methods to determine residues of the drug in edible tissue from food producing animals; file a petition to obtain a waiver from labeling requirements for certain drugs intended for use in animal feed or drinking water.

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Authorizing Statute(s): US Code: 21 USC 512 Name of Law: null
   US Code: 21 USC 379 j-11 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:
	76 FR 6798	03/08/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 20684	04/13/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
514.5(b)(d)(f)	356 V	Application for Approval of A New Animal Drug
514.1 and 514.6	356 V	Application for Approval of A New Animal Drug
514.8(b)	356 V	Application for Approval of A New Animal Drug
514.8(c)(1)	356 V	Application for Approval of A New Animal Drug
514.8(c)(2)(3)	356 V	Application for Approval of A New Animal Drug
514.11	356 V	Application for Approval of A New Animal Drug
558.5(i)	356 V	Application for Approval of A New Animal Drug
514.1(b)(8) and 514.8(c)(1)	356 V	Application for Approval of A New Animal Drug
FDA FORM 356V	356 V	Application for Approval of A New Animal Drug

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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	1,517	1,412	0	0	105	0
Annual Time Burden (Hours)	33,146	30,421	0	0	2,725	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: $11,271,514

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: 04/28/2011

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