Information Collection Request

Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

ICR 202210-0910-015 · OMB 0910-0800 · Received in OIRA

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0800 can be found here:

Forms and Documents

Document Name	Status
0800 503A 503B SSA 2022 REV.docx Supporting Statement A	2022-10-25

IC Document Collections

IC ID	Document Title	Status
256583	Outsourcing Facilities: Registration and reporting of drugs under 503B(b) Other-Statutory Authority	New
241793	503A; Disclosure Other-Memorandum of Understanding	Unchanged
241792	503A; Recordkeeping Other-Memorandum of Understanding	Unchanged
241791	503A; Reporting Other-Memorandum of Understanding	Unchanged
217572	503B Recordkeeping; AERs Other-Guidance	Unchanged
217571	503B Reporting: AERs Other-Guidance	Unchanged

ICR Details

Status	Received in OIRA
Agency/Subagency	HHS/FDA
OMB Control No	0910-0800
Type of Information Collection	Revision of a currently approved collection
Previous ICR Reference No	202005-0910-004
Agency Tracking No	CDER
Date Submitted to OIRA	1969-12-31
Requested Expiration Date	1969-12-31