Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs

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 2022-10-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0667_Supporting Statement_2022.docx Supporting Statement A
3rd PARTY DISCLOSURE: Sterility Test Failure Notices
RECORDKEEPING for PET Drugs

All Historical Document Collections

202202-0910-019 Approved without change	Extension without change of a currently approved collection	2022-10-13
201908-0910-015 Approved without change	Extension without change of a currently approved collection	2019-09-12
201608-0910-007 Approved without change	Extension without change of a currently approved collection	2016-08-04
201307-0910-007 Approved without change	Extension without change of a currently approved collection	2013-07-30
201001-0910-008 Approved without change	New collection (Request for a new OMB Control Number)	2010-01-28

OMB Details

RECORDKEEPING for PET Drugs

Federal Enterprise Architecture: Health - Consumer Health and Safety