Agency Emergency Processing Under Office of Management and Budget Review; Guidance for Industry : Animal Generic Drug User Fees and Fee Waivers and Reductions

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
SS AGDUFA Waiver-Red..doc	Supporting Statement A	Uploaded 2009-03-27	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
188573	Agency Emergency Processing Under Office of Management and Budget Review; Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers and Reductions	Other-Guidance with specific instructions on submission of fee w	New

ICR Details

OMB Control No:	ICR Reference No: 200903-0910-004
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Agency Emergency Processing Under Office of Management and Budget Review; Guidance for Industry : Animal Generic Drug User Fees and Fee Waivers and Reductions
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 04/10/2009
OIRA Conclusion Action: Withdrawn	Conclusion Date: 04/15/2009
	Date Received in OIRA: 03/27/2009
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		6 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Federal Food, drug and Cosmetic Act (the act) as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA) signed by the President August 14, 2008 authorize FDA to collect user fees for certain: (1) Abbreviated applications for generic new animal drugs (2) new animal drug products and (3) sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for new animal drugs. AGDUFA contains a specific provision under which a fee waiver or reduction may be requested for any or all of these fees. Under Section 741(d) of the Act, the Agency intends to waive or reduce sponsor and application fees only if the application provides exclusively for minor species or minor use indication. Further, the Agency intends to waive or reduce the product fee only if the animal drug product is exclusively labeled for a minor species or minor use indication.

Emergency Justfication: The Animal Generic Drug User Fee Act of 2008(AGDUFA), enacted August 14, 2008, amends the Federal, Food, Drug and Cosmetic Act (FD&C Act) and requires FDA to assess and collect user fees for certain generic applications, products, establishments and sponsors. It also requires the Agency to grant a waiver from or a reduction of fees in certain circunstances. However, FDA may not receive fee waiver and reduction requests for processing, and collect user until enactment of appropriation for these fees. The previous Federal Government appropriation by continuing resolution was in effect until March 6, 2009 and no appropriation had yet been made as to these fees. Subsquent to the March 6, 2009 date Congress has enacted appropriation for these fees so that to comply with the fee waiver and reduction provisions of ADFUFA, it is imperative that the collection of information requirements for the guidance developed by the Center for Veterinary Medicine (CVM) be approved. OMB has approved justification for this request.

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Authorizing Statute(s): US Code: 21 USC 741 ( d ) Name of Law: null
  

Citations for New Statutory Requirements: US Code: 21 USC 741 (d) 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 13213	03/26/2009
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Agency Emergency Processing Under Office of Management and Budget Review; Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers and Reductions

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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 statutory requirement.

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Annual Cost to Federal Government: $9,272

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 03/27/2009

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