Information Collection

Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program

IC 5890 under ICR 199603-0910-001 · OMB 0910-0318.

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Information Collection (IC) Details

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IC Title:	Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program	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

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 15	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 1 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	532	532
Annual IC Time Burden (Hours)	20,836	20,836
Annual IC Cost Burden (Dollars)	86,000	86,000

Documents for IC

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