Information Collection

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

IC 6046 under ICR 199812-0910-001 · OMB 0910-0392.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0392 can be found here:

Documents and Forms

Document Name Document Type

No indexed documents/forms are available for this IC yet. A refresh has been queued.

Information Collection (IC) Details

View Information Collection (IC)

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: 2,645	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
Annual Number of Responses for this IC	2,663	2,663
Annual IC Time Burden (Hours)	40,571	40,571
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded

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