OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Prescription Drug User Fee Program

OMB 0910-0297 ยท HHS/FDA.

OMB 0910-0297

This ICR collects information from certain drug and biologic manufacturers who are subject to Prescription Drug User fees. These fees are related to the submission of certain new drug and biologics license applications as well as for certain approved annual program fees. In addition, the ICR collects information relating to the submission of requests for waivers, exemptions, reductions, or for refunds of these user fees. Manufacturers submit information in accordance with established statutory authorities. Form FDA 3397, Prescription Drug User Fee Cover Sheet, and Form FDA 3971, Small Business Waivers and Refund Requests, were developed to assist respondents with submission of required information.

The latest form for Prescription Drug User Fee Program expires 2029-01-31 and is listed under ICR 202407-0910-006.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
0297PDUFA SSA2025 1-29-25.docxSupporting Statement A
Prescription Drug User Fee Cover Sheet Other-E-form Screenshot
Appeal requests Other-Authority to Assess and Use Drug Fees
Reconsideration requests Other-Authority to Assess and Use Drug Fees
Other waivers, reductions, refunds, exemptions under secs. 735 & 736 Other-Statutory Authority
Small business waiver requests Other-Agency Guidance

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202407-0910-006 Revision of a currently approved collection 2025-06-18
202202-0910-010 Revision of a currently approved collection 2022-02-23 Approved without change
202008-0910-002 No material or nonsubstantive change to a currently approved collection 2020-08-03 Approved without change
201902-0910-014 Extension without change of a currently approved collection 2019-02-28 Approved without change
201708-0910-004 No material or nonsubstantive change to a currently approved collection 2017-08-08 Approved without change
201510-0910-011 Extension without change of a currently approved collection 2015-10-27 Approved without change
201211-0910-001 Extension without change of a currently approved collection 2012-11-06 Approved without change
200911-0910-003 Revision of a currently approved collection 2009-11-27 Approved without change
200612-0910-002 Extension without change of a currently approved collection 2006-12-13 Approved without change
200310-0910-008 Extension without change of a currently approved collection 2003-10-27 Approved without change
200012-0910-002 Extension without change of a currently approved collection 2000-12-18 Approved without change
199802-0910-001 Reinstatement without change of a previously approved collection 1998-02-23 Approved without change
199309-0910-002 New collection (Request for a new OMB Control Number) 1993-09-17 Approved without change

OMB Details

Prescription Drug User Fee Cover Sheet

Federal Enterprise Architecture: Health - Public Health Monitoring

Information collection instruments
FormNameElectronic accessType
Form Form FDA 3397Prescription Drug User Fee Cover SheetFillable FileableForm

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.