Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 ( 21 U.S.C. 379j - 21) Emergency Request

Forms and Documents

Document Name	Status
Form 3728 Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 ( 21 U.S.C. 379j-21); Emergency Request Form and Instruction	New
SS AGDUFA Cover Sheet.doc Supporting Statement A	2008-11-03

IC Document Collections

IC ID	Document Title	Status
187089	Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 ( 21 U.S.C. 379j-21); Emergency Request Form and Instruction	New

ICR Details

OMB Control No: 0910-0632	ICR Reference No: 200811-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 ( 21 U.S.C. 379j - 21) Emergency Request
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: 11/21/2008
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/14/2008
	Date Received in OIRA: 11/04/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2009	6 Months From Approved
Responses	69	0	0
Time Burden (Hours)	3	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: The Animal Generic drug User Fee Act of 2008 (AGDUFA) (Title II of Public Law 110-316 signed by the President on August 14,2008), authorizes FDA to collect user fees for certain abbreviated applications for a generic new animal drug, om certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. A generic 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 has been paid. AGDUFA requires the submission of the user fees concurrently with applications. If the required fees are not submitted, the review of the application will not begin. The "User Fee Cover Sheet" provides the information to either initiate or defer the application review.

Emergency Justfication: FDA is requesting emergency processing of this information collection request under the PRA of 1995 in order to comply with provisions of the Animal Drug User Fee Act of 2008 (AGDUFA. Under certain provisions of AGDUFA,the FDA is required to implemet a new user fee cover sheet, Form FDA 3728 in collection of user fees for all abbreviated applications for generic new animal drugs. The cover sheet in the AGDUFA User Fee System was scheduled to go into effect October 1, 2008, (assuming the enactment of an appropriation for these fees)

---

Authorizing Statute(s): US Code: 21 USC 379j-21 Name of Law: null
  

Citations for New Statutory Requirements: Statute at Large: 21 Stat. 301 Name of Statute: null

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 65384	11/03/2008
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 ( 21 U.S.C. 379j-21); Emergency Request	3728	Animal Generic Drug User Fee Cover Sheet

---

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	69	0	69	0	0	0
Annual Time Burden (Hours)	3	0	3	0	0	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: This is a new collection.

---

Annual Cost to Federal Government: $42,346

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)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

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: 11/04/2008

---