Abbreviated New Animal Drug Applications

Forms and Documents

Document	Type	Status	Availability
Form 356v Phased Review with Administrative ANADA	Form and Instruction	Modified	Repair queued
Form 356v Abbreviated New Animal Drug Applications	Form and Instruction	Modified	Repair queued
0669 SUPPORTING STATEMENT FINAL 8-15-2016.doc	Supporting Statement A	Uploaded 2016-08-16	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
192779	Phased Review with Administrative ANADA	Form and Instruction	Modified
192778	Abbreviated New Animal Drug Applications	Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0669	ICR Reference No: 201608-0910-009
Status: Historical Active	Previous ICR Reference No: 201309-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Abbreviated New Animal Drug Applications
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: 10/14/2016
	Date Received in OIRA: 09/07/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2019	36 Months From Approved	10/31/2016
Responses	33	0	33
Time Burden (Hours)	3,339	0	3,339
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from animal drug manufacturers who seek approval of a generic copy of an approved new animal drug. The information required to be submitted as part of an abbreviated new animal drug application (ANADA) is described in section 512(n)(1) of the FD&C Act (21 U.S.C. 360b(n)(1)). Among other things, an ANADA is required to contain information to show that the proposed generic drug is bioequivalent to, and has the same labeling as, the approved new animal drug. We allow applicants to submit a complete ANADA or to submit information in support of an ANADA for phased review. We have developed Form FDA 356v to facilitate a complete ANADA or a phased review submission to ensure efficient and accurate processing of information.

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Authorizing Statute(s): US Code: 21 USC 360b(b)(2) Name of Law: FD&C Act
  

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:
	81 FR 29273	05/11/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 60705	09/02/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Abbreviated New Animal Drug Applications	356v	Application for Approval of a New Animal Drug
Phased Review with Administrative ANADA	356v	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	33	33	0	0	0	0
Annual Time Burden (Hours)	3,339	3,339	0	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:

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Annual Cost to Federal Government: $2,248,206

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: 09/07/2016

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