Abbreviated New Animal Drug Applications

Forms and Documents

Document	Type	Status	Availability
Form FDA 356v Phased Review with Administrative ANADA	Form and Instruction	Modified	Repair queued
Form FDA 356v Abbreviated New Animal Drug Applications	Form and Instruction	Modified	Repair queued
0910-0669SupportingStatement2022 Final 9-23-22.docx	Supporting Statement A	Uploaded 2022-09-23	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
237372	Biowaiver request: Type A medicated article, using same API/solubility approach	Other-Guidance	Modified
237371	Biowaiver request: Type A medicated article, same formulation/manufacturing process approach	Other-Guidance	Modified
237370	Biowaiver request: powder oral dosage form, using same API/solubility approach	Other-Guidance	Modified
237367	Biowaiver request: powder oral dosage form, same formulation/manufacturing process approach	Other-Guidance	Modified
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: 202202-0910-008
Status: Received in OIRA	Previous ICR Reference No: 201908-0910-009
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	Date Submitted to OIRA: 09/27/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2022
Responses	63	51
Time Burden (Hours)	4,299	3,604
Cost Burden (Dollars)	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. Form FDA 356v facilitates 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
   US Code: 21 USC 512(n)(1) 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:
	87 FR 15436	03/18/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 57905	09/22/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Abbreviated New Animal Drug Applications	FDA 356v	Application for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval)
Biowaiver request: Type A medicated article, same formulation/manufacturing process approach
Biowaiver request: Type A medicated article, using same API/solubility approach
Biowaiver request: powder oral dosage form, same formulation/manufacturing process approach
Biowaiver request: powder oral dosage form, using same API/solubility approach
Phased Review with Administrative ANADA	FDA 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 Request	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	63	51	0	0	12	0
Annual Time Burden (Hours)	4,299	3,604	0	0	695	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: Our estimated burden for the information collection reflects an overall adjustment increase of 695 hours and a corresponding increase of 12 responses, based on an increase in the number of respondents submitting generic drug applications.

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Annual Cost to Federal Government: $5,102,971

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 09/27/2022

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