Prescription Drug User Fee Program

OMB 0910-0297

This information collection supports implementation of the Food and Drug Administration (FDA, us or we) Prescription Drug User Fee program. Under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (sections 735 and 736 (21 U.S.C. 379g and 379h)), as amended, we have the authority to assess and collect user fees for certain new drug applications (NDAs) and new biologics license applications (BLAs)

The latest form for Prescription Drug User Fee Program expires 2022-03-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0297 PDUFA SSA 2022 Rev.docx Supporting Statement A
0297 PDUFA Non sub to include refund waiver reduction requests AUG 2020.pdf Justification for No Material/Nonsubstantive Change
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All Historical Document Collections

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