OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

OMB 0910-0409 · HHS/FDA.

OMB 0910-0409

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 is listed under ICR 201804-0910-006.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
0409 in vivo Pharmaceuticals SSA 2024 EXT.docxSupporting Statement A
In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring Information collection

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202403-0910-007 Extension without change of a currently approved collection 2024-03-21 Approved without change
202103-0910-004 Extension without change of a currently approved collection 2021-04-14 Approved without change
201804-0910-006 Extension without change of a currently approved collection 2018-04-11 Approved without change
201501-0910-002 Extension without change of a currently approved collection 2015-01-08 Approved without change
201110-0910-003 Extension without change of a currently approved collection 2011-10-05 Approved without change
200810-0910-001 Extension without change of a currently approved collection 2008-10-08 Approved without change
200508-0910-002 Revision of a currently approved collection 2005-08-19 Approved without change
200207-0910-005 Extension without change of a currently approved collection 2002-07-30 Approved without change
199905-0910-009 New collection (Request for a new OMB Control Number) 1999-05-20 Approved without change