INVESTIGATIONAL NEW DRUG APPLICATION - 21 CFR 312

ICR 198906-0910-007

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
165348 Migrated
ICR Details
0910-0014 198906-0910-007
Historical Active 198801-0910-002
HHS/FDA
INVESTIGATIONAL NEW DRUG APPLICATION - 21 CFR 312
No material or nonsubstantive change to a currently approved collection   No
Emergency 06/05/1989
Approved with change 06/05/1989
Retrieve Notice of Action (NOA) 06/05/1989
  Inventory as of this Action Requested Previously Approved
06/30/1989 06/30/1989 06/30/1989
4,300 0 4,300
627,752 0 627,752
0 0 0

PROVIDES DATA NEEDED BY FDA MEDICAL OFFICERS IN DETERMININ WHETHER AND HOW A PROPOSED NEW DRUG MAY BE TESTED FOR SAFETY AND EFFECTIVENESS. THIS REVISION ADDS THE INFORMATION COLLECTION REQUIREMENTS OF THE "TREATMENT USE OF AN INVESTIGATIONAL NEW DRUG" WHI AFFECTS THE AVAILABILITY OF UNAPPROVED DRUGS FOR USE IN THE TREATMENT OF LIFE THREATENING DISEASES FOR WHICH THERE IS NO KNOWN EFFECTIVE

None
None


No

1
IC Title Form No. Form Name
INVESTIGATIONAL NEW DRUG APPLICATION - 21 CFR 312 FDA-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 4,300 4,300 0 0 0 0
Annual Time Burden (Hours) 627,752 627,752 0 0 0 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.
06/05/1989


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