Information Collection

Medical Devices; Exception from General Requirements for Informed Consent

IC 6309 under ICR 201407-0910-015 · 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 50.23

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: 60

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

Percentage of Respondents Reporting Electronically: 98 %

	Approved	Previously Approved
Annual Number of Responses for this IC	1,350	1,350
Annual IC Time Burden (Hours)	1,463	1,463
Annual IC Cost Burden (Dollars)	200	200

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