Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products

OMB 0910-0693

OMB 0910-0693

The information collection supports agency guidance. The guidance provides recommendations for applicants planning to request waivers or reductions in user fees under the Prescription Drug User Fee Act, and describes the types of waivers and reductions permitted under the user fee provisions of the FD&C Act and the procedures for submitting requests for waivers or reductions.

The latest form for Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products expires 2020-10-31 and can be found here.

OMB Details

Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form Form FDA 3971SMALL BUSINESS WAIVER AND REFUND REQUESTFillable FileableForm and instruction

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