OMB control number

Prescription Drug User Fee Program

OMB 0910-0297 · 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 can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0297PDUFA SSA2025 1-29-25.docx Supporting 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All Historical Document Collections

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

OMB Details

Prescription Drug User Fee Cover Sheet

Federal Enterprise Architecture: Health - Public Health Monitoring

Form Form FDA 3397

Prescription Drug User Fee Cover Sheet

Fillable Fileable

Form

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