Information Collection Request

Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Medical Gases and Active Pharmaceutical Ingredients)

ICR 202304-0910-008 · OMB 0910-0139 · Received in OIRA

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0139 can be found here:

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
37604	Recordkeeping CGMP for Finished Pharmaceuticals	Unchanged
259864	Pharmaceutical Voluntary Consensus Standard Recognition Other-Agency Guidance	New
248022	Recordkeeping CGMP APIs	Unchanged
215453	Recordkeeping CGMP for Medical Gases, Containers, and Closures Other-Agency Guidance	Unchanged

ICR Details

Status	Received in OIRA
Agency/Subagency	HHS/FDA
OMB Control No	0910-0139
Type of Information Collection	Revision of a currently approved collection
Previous ICR Reference No	202105-0910-004
Agency Tracking No	CDER
Date Submitted to OIRA	1969-12-31
Requested Expiration Date	1969-12-31