Information Collection

New NDAs/ANDAs/BLAs/Efficacy Supplements Submitted on or After Effective Date, Including Amendments to Applications Pending on Effective Date

IC 185245 under ICR 201412-0910-008 · OMB 0910-0624.

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Information Collection (IC) Details

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IC Title:	New NDAs/ANDAs/BLAs/Efficacy Supplements Submitted on or After Effective Date, Including Amendments to Applications Pending on Effective Date	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 601.2 21 CFR 601.12(f)(1) 21 CFR 314.50 21 CFR 314.60 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	3,900	1,789	2,111
Annual IC Time Burden (Hours)	156,000	152,065	3,935
Annual IC Cost Burden (Dollars)	0	0	0

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