Information Collection

New Start-up SOPs

IC 215453 under ICR 201502-0910-014 · OMB 0910-0139.

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Information Collection (IC) Details

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IC Title:	New Start-up SOPs	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 210 21 CFR 211

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: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 100	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	2,500	2,500
Annual IC Time Burden (Hours)	50,000	50,000
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.