NEW DRUGS FOR INVESTIGATIONAL USE - 21 CFR 312

ICR 198611-0910-001

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
109320 Migrated
ICR Details
0910-0014 198611-0910-001
Historical Active 198507-0910-006
HHS/FDA
NEW DRUGS FOR INVESTIGATIONAL USE - 21 CFR 312
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 01/15/1987
Retrieve Notice of Action (NOA) 11/06/1986
  Inventory as of this Action Requested Previously Approved
09/30/1987 09/30/1987
73,100 0 0
654,701 0 0
0 0 0

PROVIDES DATA NEED BY FDA MEDICAL OFFICERS IN DETERMINING WHETHER AND HOW A PROPOSED NEW DRUG MAY BE TESTED FOR SAFETY AND EFFECTIVENESS.

None
None


No

1
IC Title Form No. Form Name
NEW DRUGS FOR INVESTIGATIONAL USE - 21 CFR 312 FDA-1571, 1572, 1573

  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 73,100 0 0 0 73,100 0
Annual Time Burden (Hours) 654,701 0 0 0 654,701 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.
11/06/1986


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