User Fee Cover Sheet

Forms and Documents

Document Name	Status
Form FDA 3397 User Fee Cover Sheet; Form FDA 3397 Form	Modified
UserFeeCoverSheetBackInstructions 11 2009.doc Supplementary Document	2009-11-10
SupportStateUserFeeCoverSheet 11 2009.doc Supporting Statement A	2009-11-10

IC Document Collections

IC ID	Document Title	Status
5861	User Fee Cover Sheet; Form FDA 3397 Form	Modified

ICR Details

OMB Control No: 0910-0297	ICR Reference No: 200911-0910-003
Status: Historical Active	Previous ICR Reference No: 200612-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: User Fee Cover Sheet
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: 01/26/2010
	Date Received in OIRA: 11/27/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2013	36 Months From Approved	01/31/2010
Responses	3,917	0	3,762
Time Burden (Hours)	1,959	0	1,129
Cost Burden (Dollars)	0	0	0

---

Abstract: The PDUFA of 1992 as amended by FDAMA 1997 and the PHS and Bioterrorism Preparedness and Response Act of 2002 which includes the Prescription Drug User Fee Amendments of 2002 reauthorizes the assessment and use of fees relating to human drugs and licensed biologic products. Form FDA 3397 is used to account for and track user fees reauthorized by PDUFA 1992/FDAMA 1997/FDUFA 2002. The form requests the minimum information necessary to determine whether a fee is required for review of human drug or licensed biologic product applications and supplements. Respodents are manufacturers of human drug and licensed biologic products.

---

Authorizing Statute(s): US Code: 21 USC 379 Name of Law: Federal Food Drug and Cosmetic Act
  

Citations for New Statutory Requirements: None

---

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:
	74 FR 27145	06/08/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 59555	11/18/2009
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
User Fee Cover Sheet; Form FDA 3397	FDA 3397	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	3,917	3,762	0	155	0	0
Annual Time Burden (Hours)	1,959	1,129	0	830	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: The estimated total annual burden for this information collection requirement was 1,128 hours in 2006. The current increase to 1,959 burden hours is attributed to the increase in the hours per response from 0.3 hours to 0.5 hours. The hours per response were revised for consistency with theh OMB statement on the form. The total annual responses slightly in creased from 3,761 in FY 2005 to 3,917 in FY 2008.

---

Annual Cost to Federal Government: $180,182

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

---

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: 11/27/2009

---