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

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.

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

All Historical Document Collections

201706-0910-016 Approved without change	Extension without change of a currently approved collection	2017-08-17
201503-0910-011 Approved without change	No material or nonsubstantive change to a currently approved collection	2015-03-26
201407-0910-012 Approved with change	Revision of a currently approved collection	2014-07-25
201108-0910-004 Approved without change	New collection (Request for a new OMB Control Number)	2011-08-04

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 3971

SMALL BUSINESS WAIVER AND REFUND REQUEST

Fillable Fileable

Form and instruction

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