Fees for certifying insulin drugs--FDA. Interim rule; opportunity for public comment.
The Food and Drug Administration (FDA) is issuing interim regulations to revise the fee schedule for insulin certification services. Under the revision, FDA will charge a fixed fee for each master lot or batch submitted for certification. The changes in fee schedule reflect a change in agency testing policy for certification and release of batches of insulin. The changes in fees will allow FDA to continue to maintain an adequate insulin certification program as required by the Federal Food, Drug, and Cosmetic Act (the act). The fees are intended to recover the full costs of operation of FDA's insulin certification program, including the unfunded liability of the Civil Service Retirement Fund and appropriate overhead costs of the Public Health Service and Department of Health and Human Services.
D002568:Certification / Q000191:economics*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D005245:Fee Schedules / Q000331:legislation & jurisprudence*; D007328:Insulin / Q000592:standards*; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration
D007328:Insulin