Prescription Drug User Fee Program

OMB 0910-0297

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.

OMB Details

Prescription Drug User Fee Cover Sheet

Federal Enterprise Architecture: Health - Public Health Monitoring


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