FDA Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Develop- ment of Fast Track Products Under PDUFA

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IC Title:	FDA Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Develop- ment of Fast Track Products Under PDUFA	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Migrated

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

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Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 114	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 35 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	125	125
Annual IC Time Burden (Hours)	10,000	10,000
Annual IC Cost Burden (Dollars)	0	0

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