OMB control number
Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs
OMB 0910-0667 · HHS/FDA.
OMB 0910-0667
This information collection supports information collection requirements under the Current Good Manufacturing Practice regulations for Positron Emission Tomography (PET) drugs. The regulations establish recordkeeping requirements that include: Batch Production and Control Records; Equipment and Facilities Records; Records of Components, Containers, and Closures; Process Vertification; Laboratory Testing Records; Sterility Test Failure Notices; Conditional Final Releases; Out-of-Specification Investigations; Reprocessing Procedures; Distribution Records; and Complaints. The regulations also require 3rd Party Disclosure requirements regarding specific notices. Respondents to the collection are manufacturers of PET drugs.
The latest form for Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs expires 2029-06-30 and is listed under ICR 202509-0910-003.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0667 PET drugs part 212 SSA 2025 Ext.docx | Supporting Statement A |
 3rd PARTY DISCLOSURE: Sterility Test Failure Notices |
Information collection |
| RECORDKEEPING for PET Drugs |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202509-0910-003 | Extension without change of a currently approved collection | 2025-12-30 | ||
| 202202-0910-019 | Extension without change of a currently approved collection | 2022-10-13 | Approved without change | |
| 201908-0910-015 | Extension without change of a currently approved collection | 2019-09-12 | Approved without change | |
| 201608-0910-007 | Extension without change of a currently approved collection | 2016-08-04 | Approved without change | |
| 201307-0910-007 | Extension without change of a currently approved collection | 2013-07-30 | Approved without change | |
| 201001-0910-008 | New collection (Request for a new OMB Control Number) | 2010-01-28 | Approved without change |
OMB Details
RECORDKEEPING for PET Drugs
Federal Enterprise Architecture: Health - Consumer Health and Safety