Information Collection

Medical Devices; Exception from General Requirements for Informed Consent

IC 6309 under ICR 201106-0910-006 · OMB 0910-0586.

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Information Collection (IC) Details

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IC Title:	Medical Devices; Exception from General Requirements for Informed Consent	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 50.50.23

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: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 300	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	1,350	450	900
Annual IC Time Burden (Hours)	1,463	113	1,350
Annual IC Cost Burden (Dollars)	200	100	100

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