Information Collection

PDUFA Pilot Project Proprietary Name Review

IC 189782 under ICR 200907-0910-001 · OMB 0910-0648.

Documents and Forms

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Document Name	Document Type

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IC Title:

PDUFA Pilot Project Proprietary Name Review

Agency IC Tracking Number:

Is this a Common Form?

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: 20

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
	Approved	Program Change Due to New Statute
Annual Number of Responses for this IC	20	20
Annual IC Time Burden (Hours)	9,600	9,600
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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