Information Collection

Recordkeeping CGMP for Medical Gases, Containers, and Closures

IC 215453 under ICR 202309-0910-010 · OMB 0910-0139.

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Information Collection (IC) Details

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IC Title:

Recordkeeping CGMP for Medical Gases, Containers, and Closures

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 225; 226 21 CFR 600 through 680 21 CFR 1271 21 CFR 210; 211 (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Federal Enterprise Architecture Business Reference Module

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 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	639,520	639,520
Annual IC Time Burden (Hours)	396,502	396,502
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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

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