Information Collection

312.54(a) and (b) Biologics; Submissions concerning exception from informed consent under 50.24

IC 189354 under ICR 201503-0910-002 · OMB 0910-0014.

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Information Collection (IC) Details

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IC Title:	312.54(a) and (b) Biologics; Submissions concerning exception from informed consent under 50.24	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Removed

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.54(a) and (b)

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: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	-1	1
Annual IC Time Burden (Hours)	-48	48
Annual IC Cost Burden (Dollars)	0	0

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