This information collection supports agency regulations at 21 CFR 315.4, 315.5, and 315.6. The regulations require manufacturers of diagnostic radiopharmaceuticals to submit certain information demonstrating safety and effectiveness of these products.
The latest form for Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring expires 2021-05-31 and can be found here.
Document Name |
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Supporting Statement A |
Approved without change |
Extension without change of a currently approved collection | 2024-03-21 | |
Approved without change |
Extension without change of a currently approved collection | 2021-04-14 | |
Approved without change |
Extension without change of a currently approved collection | 2018-04-11 | |
Approved without change |
Extension without change of a currently approved collection | 2015-01-08 | |
Approved without change |
Extension without change of a currently approved collection | 2011-10-05 | |
Approved without change |
Extension without change of a currently approved collection | 2008-10-08 | |
Approved without change |
Revision of a currently approved collection | 2005-08-19 | |
Approved without change |
Extension without change of a currently approved collection | 2002-07-30 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 1999-05-20 |