Information Collection

Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products

IC 188614 under ICR 200903-0910-009 · OMB 0910-0429.

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IC Title:

Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 301

Information Collection Instruments:

table that charts list of 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: 120

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	198	198
Annual IC Time Burden (Hours)	3,564	3,564
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.

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