Information Collection

Supplements to Applications Approved 6/30/01 to Effective Date

IC 185243 under ICR 201412-0910-008 · OMB 0910-0624.

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Information Collection (IC) Details

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IC Title:	Supplements to Applications Approved 6/30/01 to Effective Date	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 601.12(f)(1) 21 CFR 314.70(b)

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: 390	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	Program Change Due to New Statute	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	10,140	1,613	8,527
Annual IC Time Burden (Hours)	1,216,800	32,260	1,184,540
Annual IC Cost Burden (Dollars)	0	0	0

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