User Fee Cover Sheet

ICR 200012-0910-002

OMB: 0910-0297

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
5860 Migrated
ICR Details
0910-0297 200012-0910-002
Historical Active 199802-0910-001
HHS/FDA
User Fee Cover Sheet
Extension without change of a currently approved collection   No
Regular
Approved without change 02/02/2001
Retrieve Notice of Action (NOA) 12/18/2000
  Inventory as of this Action Requested Previously Approved
02/29/2004 02/29/2004 04/30/2001
2,921 0 1,888
876 0 283
0 0 0

The Prescription Drug User Fee Act of 1992 as amended by the Food and Drug Administration Modernization Act of 1997 (PDUFA 1992/FDAMA 1997) reauthorizes the assessment and use of fees relating to human drugs and licensed biologic products. The User Fee Cover Sheet, Form FDA 3397, is used to account for and track User Fees reauthorized by PDUFA 1992/FDAMA 1997. 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. Respondents are manufacturers of human drug and licensed biologic products.

None
None


No

1
IC Title Form No. Form Name
User Fee Cover Sheet FDA-3397

  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 2,921 1,888 0 0 1,033 0
Annual Time Burden (Hours) 876 283 0 0 593 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
12/18/2000


© 2024 OMB.report | Privacy Policy