Information Collection

54.4(b)--Clinical Investigators Third Party Disclosure

IC 188972 under ICR 202504-0910-011 · OMB 0910-0396.

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Information Collection (IC) Details

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IC Title:	54.4(b)--Clinical Investigators Third Party Disclosure	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 54.4

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: 13,646	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 10 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	13,646	564	13,082
Annual IC Time Burden (Hours)	2,320	96	2,224
Annual IC Cost Burden (Dollars)	0	0	0

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