Investigational New Drug Regulations

ICR 200602-0910-005

OMB: 0910-0014

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
5669 Migrated
ICR Details
0910-0014 200602-0910-005
Historical Active 200211-0910-004
HHS/FDA
Investigational New Drug Regulations
Extension without change of a currently approved collection   No
Regular
Approved with change 05/12/2006
Retrieve Notice of Action (NOA) 02/17/2006
  Inventory as of this Action Requested Previously Approved
05/31/2009 05/31/2009 05/31/2006
1,277,517 0 541,986
71,369,525 0 36,040,829
0 0 0

Information collection from applicants who apply for approval of an investigational new drug application in order to develop a drug for marketing.

None
None


No

1
IC Title Form No. Form Name
Investigational New Drug Regulations 1571, 1572

  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 1,277,517 541,986 0 0 735,531 0
Annual Time Burden (Hours) 71,369,525 36,040,829 0 0 35,328,696 0
Annual Cost Burden (Dollars) 0 0 0 0 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.
02/17/2006


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