Orphan Drug Credit

OMB 1545-1505

OMB 1545-1505

Filers use this form to elect to claim the orphan drug credit, which is 25% of the qualified clinical testing expenses paid or incurred with respect to low or unprofitable drugs for rare diseases and conditions, as designated under section 526 of the Federal Food, Drug, and Cosmetic Act.

The latest form for Orphan Drug Credit expires 2021-12-31 and can be found here.

Latest Forms, Documents, and Supporting Material
All Historical Document Collections
Approved without change
Extension without change of a currently approved collection 2021-12-31
Approved without change
Revision of a currently approved collection 2018-07-24
Approved without change
Extension without change of a currently approved collection 2015-05-29
Approved without change
Revision of a currently approved collection 2012-02-27
Approved without change
Extension without change of a currently approved collection 2008-12-09
Approved without change
No material or nonsubstantive change to a currently approved collection 2006-12-06
Approved without change
Extension without change of a currently approved collection 2006-01-06
Approved without change
No material or nonsubstantive change to a currently approved collection 2004-09-23
Approved without change
Extension without change of a currently approved collection 2002-12-05
Approved without change
No material or nonsubstantive change to a currently approved collection 2001-12-12
Approved without change
No material or nonsubstantive change to a currently approved collection 2000-08-31
Approved without change
Extension without change of a currently approved collection 1999-11-19
Approved without change
No material or nonsubstantive change to a currently approved collection 1998-09-18
Approved without change
No material or nonsubstantive change to a currently approved collection 1997-10-22
Approved without change
Extension without change of a currently approved collection 1997-03-04
Approved without change
New collection (Request for a new OMB Control Number) 1996-11-18

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