Information Collection

Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients

IC 6047 under ICR 200207-0910-007 · OMB 0910-0392.

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Information Collection (IC) Details

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IC Title:	Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Migrated

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 119	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	64	0	-2,599	2,663
Annual IC Time Burden (Hours)	18,557	0	-22,014	40,571
Annual IC Cost Burden (Dollars)	80,000,000	80,000,000	0	0

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