Abbreviated New Animal Drug Applications

Forms and Documents

Document Name	Status
Form FDA 356v FD&C ACT/ Section 512(n)(1) - Phased Review Submission with Administrative ANADA Form and Instruction	Modified
Form FDA 356v FD&C Act/ Section 512(n)(1) - Submission of a " Complete" ANADA by an Applicant Form and Instruction	Modified
0669 SS Part A 2013.doc Supporting Statement A	2013-09-12

IC Document Collections

IC ID	Document Title	Status
192779	FD&C ACT/ Section 512(n)(1) - Phased Review Submission with Administrative ANADA Form and Instruction	Modified
192778	FD&C Act/ Section 512(n)(1) - Submission of a " Complete" ANADA by an Applicant Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0669	ICR Reference No: 201309-0910-007
Status: Historical Active	Previous ICR Reference No: 201004-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: 20483
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: 10/23/2013
	Date Received in OIRA: 09/17/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2016	36 Months From Approved	10/31/2013
Responses	33	0	42
Time Burden (Hours)	3,339	0	3,498
Cost Burden (Dollars)	0	0	0

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Abstract: Respondents to this information collection are sponsors of abbreviated animal drug applications (ANADA) seeking approval of a generic copy of an approved new animal drug. These applications are required to contain information to demonstrate that the proposed generic drug is bioequivalent to, and has the same labeling as, the approved drug referenced in the application. Form FDA 356V must also be completed and accompamy each submission.

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Authorizing Statute(s): US Code: 21 USC 360b(b)(2) 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:
	78 FR 25279	04/30/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 52772	08/26/2013
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
FD&C Act/ Section 512(n)(1) - Submission of a " Complete" ANADA by an Applicant	FDA 356v	Application for Approval of a New Animal Drug
FD&C ACT/ Section 512(n)(1) - Phased Review Submission with Administrative ANADA	FDA 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	42	0	0	-9	0
Annual Time Burden (Hours)	3,339	3,498	0	0	-159	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: Extension of a currently approved collection.

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Annual Cost to Federal Government: $2,203,707

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: 09/17/2013

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