OMB control number
Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products
OMB 0910-0759 · HHS/FDA.
OMB 0910-0759
This information collection was established to help prevent and reduce current and future disruptions in the supply of lifesaving medicines, as well as to ensure that both FDA and the public receive adequate advance notice of shortages whenever possible. Early notifications of potential shortages enables us to work with manufacturers and other stakeholders to help prevent such shortages.
The latest form for Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products expires 2021-08-31 and can be found here.
Latest Forms, Documents, and Supporting Material
0759 SSA Perm Discontinuation 2018 Ext.pdf
Notifications Required Under Sections 310.306 (unapproved drugs); 314.81(b)(3)(iii) (products approved under an NDA or ANDA); and 600.82 (products approved under a BLA) All Historical Document Collections
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Approved without change |
Extension without change of a currently approved collection | 2018-07-26 | |
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Approved without change |
New collection (Request for a new OMB Control Number) | 2015-07-15 | |
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Comment filed on proposed rule |
New collection (Request for a new OMB Control Number) | 2013-12-10 |