New Animal Drug Application, 21 CFR Part 514

Forms and Documents

Document Name	Status
Form 356 V New Animal Drug Application, 21 CFR Part 514 Form and Instruction	Modified
guidance 152.doc Supplementary Document	2008-02-04
SS 0910-0032.doc Supporting Statement A	2008-02-01

IC Document Collections

IC ID	Document Title	Status
5688	New Animal Drug Application, 21 CFR Part 514 Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0032	ICR Reference No: 200803-0910-001
Status: Historical Active	Previous ICR Reference No: 200411-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: New Animal Drug Application, 21 CFR Part 514
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: 04/23/2008
	Date Received in OIRA: 03/04/2008
Terms of Clearance: OMB revised the total number of respondents in the ROCIS submission to reflect the estimate provided in the supporting statement. The agency is reminded to ensure that the ROCIS data entry for burden and the information provided in the supporting statement are consistent before submission of an ICR.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2011	36 Months From Approved	04/30/2008
Responses	1,412	0	1,406
Time Burden (Hours)	30,421	0	340,858
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: US Code: 21 USC J - 11 Name of Law: null

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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:
	72 FR 37240	07/09/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 70331	12/11/2007
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
New Animal Drug Application, 21 CFR Part 514	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	1,412	1,406	0	6	0	0
Annual Time Burden (Hours)	30,421	340,858	-310,437	0	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: No

Burden Reduction Due to:

Short Statement: In addition to requesting extension of approval for the subject collection for OMB number 0910-0032, under 21 CFR Part 500, the Center for Veterinary Medicine (CVM) is also consolidating under this collection the following: OMB 0910-0555,0910-0356, 0910-0522, and 0910-0600. These collections are also approved under 21 CFR Part 500 and will be discontinued upon approval of the subject collection. Further, the Animal Drug User Fee Act of 2003 (ADUFA)(P.L. 108-130) (21 U.S.C.J-11), amended the Federal Food,Drug and Cosmetic Acr (FD&C Act) and authorizes FDA to collect fees for certain applications and establishments, product and sponsors.As a result of the ADUFA legislation, CVM recognized a decrease in the number of animal drug sponsors (respondents). Also, CVM has available better metrics with which to estimate paperwork. To comply with this consolidation, CVM has significantly revised the existing Form FDA 356 V which more closely follows the administrative process.This sequence of legislation and regulatory initiatives by CVM has resulted in a significant program change (decrease) for this consolidated collection of information, i.e. 0910-0032.

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Annual Cost to Federal Government: $9,544,675

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: 02/24/2008

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