Drug Informatio​n Update- Draft Guidance for Industry - User Fee Waivers, Reductions​, and Refunds for Drug and Biological Products

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ‘‘User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.’’ This revised draft guidance provides recommendations to applicants considering whether to request a waiver or reduction in user fees. This guidance is a revision of the draft guidance entitled ‘‘Draft Interim Guidance Document for Waivers of and Reductions in User Fees,’’ issued July 16, 1993.

DATES: Although you can comment on any guidance at any time, to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by June 13, 2011. Submit written comments on the proposed collection of information by May 13, 2011.

Submit electronic comments on the revised draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

To view the draft guidance, please visit: User Fee Guidance
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079298.pdf