NOTICE OF CLAIMED INVESTIGATIONAL EXEMPTION FOR A NEW DRUG

ICR 198301-0910-002

OMB: 0910-0014

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0014 198301-0910-002
Historical Active 198205-0910-004
HHS/FDA
NOTICE OF CLAIMED INVESTIGATIONAL EXEMPTION FOR A NEW DRUG
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 03/07/1983
Retrieve Notice of Action (NOA) 01/12/1983
  Inventory as of this Action Requested Previously Approved
06/30/1983 06/30/1983
1,000 0 0
1,247,072 0 0
0 0 0

FORM FDA 1571 IS UTILIZED UNDER 505(B) OF THE FOOD, DRUG AND COSMETIC ACT FOR POTENTIAL INVESTIGATORS OF DRUGS TO APPLY FOR APPROVAL IN A PACKAGE (FORMS 1571, 1572, AND 1573) TO STUDY A DRUG LIMITED TO INVESTIGATIONAL USE IN THE UNITED STATES.

None
None


No

1
IC Title Form No. Form Name
NOTICE OF CLAIMED INVESTIGATIONAL EXEMPTION FOR A NEW DRUG FD-1571

  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 1,000 0 0 1,000 0 0
Annual Time Burden (Hours) 1,247,072 0 0 1,247,072 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.
01/12/1983


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