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Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients
Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients
OMB: 0910-0392
IC ID: 6047
OMB.report
HHS/FDA
OMB 0910-0392
ICR 200207-0910-007
IC 6047
( )
Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
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
Federal Enterprise Architecture Business Reference Module
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 New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
64
0
0
-2,599
0
2,663
Annual IC Time Burden (Hours)
18,557
0
0
-22,014
0
40,571
Annual IC Cost Burden (Dollars)
80,000,000
0
80,000,000
0
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.