Information Collection

RECORDKEEPING: One-Time Preparation of SOP

IC 187821 under ICR 202208-0910-003 · OMB 0910-0045.

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Documents and Forms

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Information Collection (IC) Details

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IC Title:	RECORDKEEPING: One-Time Preparation of SOP	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR CFR Part 207 (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: 1,000	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Previously Approved
Annual Number of Responses for this IC	1,000	1,000
Annual IC Time Burden (Hours)	40,000	40,000
Annual IC Cost Burden (Dollars)	0	0

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