Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions

Forms and Documents

Document Name	Status
0540 SS Part A 2014.doc Supporting Statement A	2014-07-07

IC Document Collections

IC ID	Document Title	Status
6260	Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions	Modified

ICR Details

OMB Control No: 0910-0540	ICR Reference No: 201407-0910-004
Status: Historical Active	Previous ICR Reference No: 201405-0910-025
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions
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: 08/27/2014
	Date Received in OIRA: 07/08/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved	08/31/2014
Responses	139	0	83
Time Burden (Hours)	277	0	166
Cost Burden (Dollars)	0	0	0

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Abstract: An animal drug application or supplemental animal drug application submitted by a person subject to application fees is considered incomplete and will not be accepted for filing by FDA until all fees owed by such person have been paid. Section 740(e) of the FD&C Act. The purpose of collecting this information is to provide persons subject to fees an opportunity to obtain a waiver or reduction of certain animal drug user fees in advance of the submissin of certain applications or in advance of the invoicing of the other annual fees.

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Authorizing Statute(s): US Code: 21 USC 379b 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:
	79 FR 10532	02/25/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 28523	05/16/2014
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions

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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	139	83	0	56	0	0
Annual Time Burden (Hours)	277	166	0	111	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: There is an increase in burden for this collection of information data as more sponsors are taking advantage of the waiver benefit.

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Annual Cost to Federal Government: $47,485

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: 07/08/2014

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