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 |
|---|---|
| Applications: | |
| Abbreviated New Drug Application (ANDA) | $ 225,712 |
| Drug Master File (DMF) | 74,952 |
| Facilities: | |
| 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 |
|---|---|
| Application: | |
| 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 |
| Applications: | |
| 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.