INVESTIGATIONAL NEW DRUG APPLICATION

ICR 198401-0910-006

OMB: 0910-0162

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
165452
Migrated
ICR Details
0910-0162 198401-0910-006
Historical Active 198306-0910-004
HHS/FDA
INVESTIGATIONAL NEW DRUG APPLICATION
No material or nonsubstantive change to a currently approved collection   No
Emergency 01/26/1984
Approved with change 01/26/1984
Retrieve Notice of Action (NOA) 01/26/1984
  Inventory as of this Action Requested Previously Approved
06/30/1986 06/30/1986 06/30/1986
50 0 1
500 0 1
0 0 0

THE FOOD AND DRUG ADMINISTRATION (FDA) IS PROPOSING TO REVISE ITS REGULATIONS GOVERNING THE REVIEW OF INVESTIGATIONAL NEW DRUG USE. FDA IS TAKING THIS ACTION TO IMPROVE THE INVESTIGATIONAL DRUG DEVELOPMENT PROCESS WHILE MAINTAINING HIGH STANDARDS OF HUMAN SUBJECT PROTECTION. THE IMPROVEMENTS ARE INTENDED TO ASSIST SPONSORS OF CLINICAL INVESTIGATIONS TO PREPARE & SUBMIT HIGH QUALITY APPLICATIONS & TO PERMIT FDA TO REVIEW THEM EFFICIENTLY & WITH MINIMAL DELAY.

None
None


No

1
IC Title Form No. Form Name
INVESTIGATIONAL NEW DRUG APPLICATION

  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 50 1 0 49 0 0
Annual Time Burden (Hours) 500 1 0 499 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
01/26/1984


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