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.
Document Name |
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Supporting Statement A |
Approved without change |
Extension without change of a currently approved collection | 2022-10-13 | |
Approved without change |
Extension without change of a currently approved collection | 2019-09-12 | |
Approved without change |
Extension without change of a currently approved collection | 2016-08-04 | |
Approved without change |
Extension without change of a currently approved collection | 2013-07-30 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 2010-01-28 |
Federal Enterprise Architecture: Health - Consumer Health and Safety