Recordkeeping CGMP for Medical Gases, Containers, and Closures

Current Good Manufacturing Practices for Finished Pharmaceuticals and Medical Gases

⚠️ Notice: This information collection may be referencing outdated material.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
GFI for Medical Gases CDER draft.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Recordkeeping CGMP for Medical Gases, Containers, and Closures	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 610.12; 610.13; 610.18 21 CFR 680.2; 680.3 21 CFR 211 21 CFR 210

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			GFI for Medical Gases CDER draft.pdf		Yes	No	Printable Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,284	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	Previously Approved
Annual Number of Responses for this IC	641,094	638,594	2,500
Annual IC Time Burden (Hours)	396,988	346,988	50,000
Annual IC Cost Burden (Dollars)	0	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.