Recordkeeping CGMP APIs

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

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Recordkeeping CGMP APIs	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 225; 226 21 CFR 210; 211 21 CFR 600 through 680 21 CFR 1270 (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,260	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	322,560	322,560
Annual IC Time Burden (Hours)	264,499	264,499
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.