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

ICR 200207-0910-007

OMB: 0910-0392

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0392 200207-0910-007
Historical Active 199812-0910-001
HHS/FDA
Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients
Extension without change of a currently approved collection   No
Regular
Approved with change 10/01/2002
Retrieve Notice of Action (NOA) 07/31/2002
Approved consistent with clarifications and changes in FDA memos of 9-23-02 and 9-25-02. The additional $80 million in costs associated with this collection reflects the costs of conducting the studies required by this regulation. It had previously been omitted from this icr.
  Inventory as of this Action Requested Previously Approved
10/31/2005 10/31/2005 09/30/2002
64 0 2,663
18,557 0 40,571
80,000,000 0 0

Requires pediatric studies of certain n4w drugs and biological products to ensure that those products that are likely to be commonly used in children or that represent a meaningful therapeutic benefit over existing treatments contain adequate pediatric labeling for the approved indications at the time of, or soon after, approval.

None
None


No

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 64 2,663 0 0 -2,599 0
Annual Time Burden (Hours) 18,557 40,571 0 0 -22,014 0
Annual Cost Burden (Dollars) 80,000,000 0 0 80,000,000 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
07/31/2002


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