Abbreviated New Animal Drug Applications

Forms and Documents

Document Name	Status
Form 356v FD&C ACT/ Section 512(n)(1) - Phased Review Submission with Administrative ANADA Form and Instruction	New
Form 356v FD&C Act/ Section 512(n)(1) - Submission of a " Complete" ANADA by an Applicant Form and Instruction	New
SS-ANADA #2.doc Supporting Statement A	2010-03-23

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	New
192778	FD&C Act/ Section 512(n)(1) - Submission of a " Complete" ANADA by an Applicant Form and Instruction	New

ICR Details

OMB Control No: 0910-0669	ICR Reference No: 201004-0910-009
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Abbreviated New Animal Drug Applications
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/11/2010
	Date Received in OIRA: 04/30/2010
Terms of Clearance:

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

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Abstract: On November 16,1998, the President signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA) Public Law 100-670). Under Section 512 (n)(1) of the Federal Food, Drug and Cosmetic Act (the act)as amended by GADPTRA, any person may file an abbreviated new animal drug application (ANADA)seekinf approval of a generic copy of an approved new animal drug. Among other things, an ANADA is 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 abbreviated application.FDA permits applicants to submit a complete ANADA or to submit information in support of an ANADA for phased review followed by the submission of an administrative ANADA when FDA finds that all the technical sections for an ANADA are complete.Form FDA 356V must be filled out and accompamy each request.

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Authorizing Statute(s): US Code: 21 USC 360b(b)(2) Name of Law: null
  

Citations for New Statutory Requirements: US Code: 21 USC 360b(b)(2) 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:
	74 FR 56643	11/02/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 12759	03/17/2010
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) - Phased Review Submission with Administrative ANADA	356v	Application for Approval of a New Animal Drug ( or Submission to Support New Animal Drug Approval)
FD&C Act/ Section 512(n)(1) - Submission of a " Complete" ANADA by an Applicant	356v	Application for Approval of A New Animal Drug ( or Submission to Support New Animal Drug Approval.)

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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	42	0	42	0	0	0
Annual Time Burden (Hours)	3,498	0	3,498	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: This is a new information collection.

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Annual Cost to Federal Government: $2,476,203

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: 04/30/2010

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