Information Collection

312.23 and 312.120(b)(c)(2)(c)(3). Biologics; Investigational New Drug Submission

IC 189341 under ICR 201105-0910-011 · OMB 0910-0014.

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Information Collection (IC) Details

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IC Title:	312.23 and 312.120(b)(c)(2)(c)(3). Biologics; Investigational New Drug Submission	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.30(a) - (f) 21 CFR 312.120(b)(c)(2)(c)(3)

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: 433	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	563	307	256
Annual IC Time Burden (Hours)	1,017,904	608,304	409,600
Annual IC Cost Burden (Dollars)	0	0	0

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