Information Collection

Recordkeeping CGMP APIs

IC 248022 under ICR 202309-0910-010 · OMB 0910-0139.

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Information Collection (IC) Details

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IC Title:

Recordkeeping CGMP APIs

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 600 through 680 21 CFR 1270 21 CFR 225; 226 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: 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 %

table that charts list of burden
	Approved	Previously Approved
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

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Title	Document	Date Uploaded
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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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