Description
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 This guidance is a revision of the draft guidance entitled Draft Interim Guidance Document for Waivers of and Reductions in User Fees (1993 interim guidance), issued July 16, 1993.
Scope & Applicability
Product Classes
5Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
Exemptions for orphan drugs
The term final dosage form means, with respect to a prescription drug product...
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
A drug intended for use in a rare disease or condition
Stakeholders
8Entity submitting development data and knowledge; Entity performing the work process for change
Authorized to reject a gift; such a decision is final.
Receives copies of requests for appeal and comments on burden estimates.
FDA official in the Office of the Chief Scientist for final user fee reviews
Authorized to reject a gift; such a decision is final.
Reviews and grants/denies user fee waivers for CDER
Target audience for the compliance guide
An entity whose sales must be included in the calculation if it is related to the facility.; Facility that controls, is controlled by, or is under common control with another facility
Regulatory Context
Attributes
5Status that does not exempt a drug from pediatric investigation requirements under certain conditions.
required for full application fee assessment
Has the drug product been granted fast track status.
Objective measure of resources available to the applicant
Indicator of whether user fees are a barrier to innovation
Related CFR Sections (1)
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
See Also (8)
- Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry: Guidance for Industry (Status: Final)
- Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product: Guidance for Industry and FDA Staff (Status: Final)
- Early Development Considerations for Innovative Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- Cellular Therapy for Cardiac Disease: Guidance for Industry (Status: Final)
- How to Write a Request for Designation (RFD): Guidance for Industry (Status: Final)
- Clinical Considerations for Therapeutic Cancer Vaccines: Guidance for Industry (Status: Final)
- The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff (Status: Draft)