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FDA has announced most FY2022 user fee rates this month, conspicuously missing are the OMUFA 2022 user fee rates. We will continue to monitor Federal Register notices and share information as soon as it becomes available.

Federal Register Vol. 86, No. 142 announcing FDA 2022 GDUFA user fee rates

Fee category Fees rates for FY 2022
Abbreviated New Drug Application (ANDA) $ 225,712
Drug Master File (DMF) 74,952
Active Pharmaceutical Ingredient (API)—Domestic 42,557
API—Foreign 57,557
Finished Dosage Form (FDF)—Domestic 195,012
FDF—Foreign 210,012
Contract Manufacturing Organization (CMO)—Domestic 65,004
CMO—Foreign 80,004
GDUFA Program:
Large size operation generic drug applicant 1,536,856
Medium size operation generic drug applicant 614,742
Small business operation generic drug applicant 153,686
Federal Register Vol. 86, No. 155 announcing FDA 2022 PDUFA rates.
Fee category Fees rates for FY 2022
Requiring clinical data $ 3,117,218
Not requiring clinical data 1,558,609
Program 369,413
Federal Register Vol 86, No 145 announces FDA 2022 MDUFA rates. See the Federal Register notice for details on the small business qualification.
Application Type Standard Fee Small Business Fee†
510(k) $ 12,745 $ 3,186
513(g) $ 5,061 $ 2,530
PMA, PDP, PMR, BLA $ 374,858 $ 93,714
De Novo Classification Request $ 112,457 $ 28,114
Panel-track Supplement $ 281,143 $ 70,286
180-Day Supplement $ 56,229 $ 14,057
Real-Time Supplement $ 26,240 $ 6,560
BLA Efficacy Supplement $ 374,858 $ 93,714
30-Day Notice $ 5,998 $ 2,999
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) $ 13,120 $ 3,280
Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business..

All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.

Federal Register Vol 86, No 142 has been published announcing FDA’s Animal Drug User Fee Rates and Payment Procedures for FY 2022. Please see FR notice for full details.
Animal drug user fee category Fees rates for FY 2022
Animal Drug Application Fees:
Animal Drug Application $ 580,569
Supplemental Animal Drug Application for Which Safety or Effectiveness Data are Required or Animal Drug Application Subject to the Criteria Set Forth in Section 512(d)(4) of the FD&C Act 290,284
Animal Drug Product Fee 10,787
Animal Drug Establishment Fee 1 155,220
Animal Drug Sponsor Fee 2 137,791

1 An animal drug establishment is subject to only one such fee each fiscal year.

2 An animal drug sponsor is subject to only one such fee each fiscal year.

Federal Register Vol. 86, No. 142 Announces Biosimilar User Fee Rates for FY 2022
Fee category Fees rates for FY 2022
Initial BPD $ 57,184
Annual BPD 57,184
Reactivation 114,368
Requiring clinical data 1,746,745
Not requiring clinical data 873,373
Program 304,162
FDA Export Certification final guidance for industry has been published in August 2021, superseding the versions issued in July 2004, April 2005, and February 2019. This guidance document is intended to provide a general description of FDA’s export certification to industry and foreign governments. Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the FD&C Act, and other statutes FDA administers.
Recently published Guidance Documents can be searched on the FDA’s website.

Posted in Drug and Device Corner, Drugs, Medical Devices.