User Fee Waivers, Reductions, and Refunds for Drug and Biological Products September 2011
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This guidance provides recommendations to applicants regarding requests for waivers, refunds, and reductions of user fees assessed under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (the Act) for drugs, including biological drug products. This guidance is a revision of the draft guidance entitled Draft Interim Guidance Document for Waivers of and Reductions in User Fees (1993 interim guidance), issued July 16, 1993.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-D-0108.