Reporting Associated with New Animal Drug Applications and Veterinary Master Files

Forms and Documents

Document Name	Status
Form 356V Reporting Associated with New Animal Drug Applications Form and Instruction	Modified
0032 NADAs and Vet Master Files SSA 2022 Ext.docx Supporting Statement A	2022-06-29

IC Document Collections

IC ID	Document Title	Status
5688	Reporting Associated with New Animal Drug Applications Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0032	ICR Reference No: 202206-0910-006
Status: Received in OIRA	Previous ICR Reference No: 201905-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Reporting Associated with New Animal Drug Applications and Veterinary Master Files
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: 06/29/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2022
Responses	7,628	1,008
Time Burden (Hours)	38,849	22,083
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports New Animal Drug Applications and Veterinary Mater Files. The information is submitted to FDA consistent with requirements found in applicable regulations.

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Authorizing Statute(s): US Code: 21 USC 512 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 11713	03/02/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 34880	06/08/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Reporting Associated with New Animal Drug Applications	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	7,628	1,008	0	0	6,620	0
Annual Time Burden (Hours)	38,849	22,083	0	0	16,766	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: We have adjusted the information collection to reflect an increase in respondents, resulting in 6,620 additional responses and 16,766 additional hours annually.

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Annual Cost to Federal Government: $11,110,880

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: 06/29/2022

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