Abbreviated New Animal Drug Applications

Forms and Documents

Document Name	Status
Form FDA 356v Phased Review with Administrative ANADA Form and Instruction	Modified
Form FDA 356v Abbreviated New Animal Drug Applications Form and Instruction	Modified
0669 ss 8-14-2019.pdf Supporting Statement A	2019-08-14

IC Document Collections

IC ID	Document Title	Status
237372	Biowaiver request: Type A medicated article, using same API/solubility approach Other-guidance	New
237371	Biowaiver request: Type A medicated article, same formulation/manufacturing process approach Other-guidance	New
237370	Biowaiver request: powder oral dosage form, using same API/solubility approach Other-guidance	New
237367	Biowaiver request: powder oral dosage form, same formulation/manufacturing process approach Other-guidance	New
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: 201908-0910-009
Status: Active	Previous ICR Reference No: 201608-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Abbreviated New Animal Drug Applications
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: 10/08/2019
	Date Received in OIRA: 09/09/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2022	36 Months From Approved	10/31/2019
Responses	51	0	33
Time Burden (Hours)	3,604	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.

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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:
	84 FR 16270	04/18/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 46543	09/04/2019
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
Phased Review with Administrative ANADA	FDA 356v	Application for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval)
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: powder oral dosage form, same formulation/manufacturing process approach
Biowaiver request: Type A medicated article, same formulation/manufacturing process approach
Biowaiver request: powder oral dosage form, using same API/solubility approach
Biowaiver request: Type A medicated article, using same API/solubility approach

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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	51	33	0	18	0	0
Annual Time Burden (Hours)	3,604	3,339	0	265	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our previous estimate of the number of respondents submitting generic drug applications. However, as discussed, the burden for this information collection (a program change) was increased by 265 hours and 18 responses since the last OMB approval. This is due to adding to this collection burden hours and responses for biowaiver requests. We have also added to this collection a discussion of the use of veterinary master files by the animal pharmaceutical industry in support of information being submitted for NADAs, ANADAs, INAD files, and JINAD files.

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Annual Cost to Federal Government: $4,995,680

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? 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: 09/09/2019

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