- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance describes the circumstances under which user fees will not be assessed under the Prescription Drug User Fee Act (PDUFA) for some applications for fixed dose combination (FDC) and co-packaged versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV). The guidance also describes circumstances under which many of the applications, products, and establishments that will be assessed fees may be eligible for a public health or a barrier-to-innovation waiver. We expect that most of the applications, products, and establishments for FDC and co-packaged HIV therapies proposed for use in the President's Emergency Plan for AIDs Relief (PEPFAR) will either not be assessed fees in the first instance or will qualify for a waiver under the "other circumstances" part of the barrier-to-innovation user fee waiver. See the Attachment at the end of the guidance for a summary of available exemptions and waivers.
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-2005-D-0083.