Orphan Drugs

OMB 0910-0167

OMB 0910-0167

This information is required in the implementation and administration of the Orphan Drug Act, 21 U.S.C., Sections 526-528. The information is necessary to show that applicants qualify and continue to qualify for the incentives and assistance provided by the statute and regulations.

The latest form for Orphan Drugs expires 2021-01-31 and can be found here.

All Historical Document Collections
Revision of a currently approved collection 2020-12-29
Approved without change
Revision of a currently approved collection 2017-12-19
Approved without change
Revision of a currently approved collection 2014-10-27
Approved without change
Extension without change of a currently approved collection 2011-06-29
Improperly submitted and continue
Extension without change of a currently approved collection 2011-05-19
Approved without change
Extension without change of a currently approved collection 2008-05-13
Approved without change
Revision of a currently approved collection 2007-11-09
Approved without change
Extension without change of a currently approved collection 2007-07-02
Approved without change
Extension without change of a currently approved collection 2004-05-28
Approved without change
Extension without change of a currently approved collection 2001-05-01
Approved without change
Reinstatement without change of a previously approved collection 1998-05-11
Approved without change
Reinstatement with change of a previously approved collection 1993-02-16
Approved without change
Reinstatement with change of a previously approved collection 1989-07-21
Approved without change
Reinstatement with change of a previously approved collection 1984-06-01
Approved without change
Reinstatement with change of a previously approved collection 1984-05-09
Approved without change
New collection (Request for a new OMB Control Number) 1983-08-29
OMB Details

Written recommendations; content and format of a request, the providing of; refusal to provide

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