STATEMENT OF INVESTIGATOR (CLINICAL PHARMACOLOGY)

ICR 198204-0910-007

OMB: 0910-0015

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
109325 Migrated
ICR Details
0910-0015 198204-0910-007
Historical Active 197705-0910-008
HHS/FDA
STATEMENT OF INVESTIGATOR (CLINICAL PHARMACOLOGY)
Revision of a currently approved collection   No
Regular
Approved without change 07/19/1982
Retrieve Notice of Action (NOA) 04/29/1982
  Inventory as of this Action Requested Previously Approved
06/30/1983 06/30/1983 05/31/1982
1,000 0 300
233,826 0 900
0 0 0

FORM FDA 1572 IS UTILIZED UNDER 505(B) OF THE FOOD, DRUG AND COSMETIC ACT FOR POTENTIAL INVESTIGATORS WHO WISH TO PERFORM CLINICAL PHARMACOLOGY STUDIES ON DRUGS LIMITED TO INVESTIGATIONAL USE IN THE UNITED STATES TO SEEK APPROVAL FOR THEIR STUDY.

None
None


No

1
IC Title Form No. Form Name
STATEMENT OF INVESTIGATOR (CLINICAL PHARMACOLOGY) FD 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 1,000 300 0 0 700 0
Annual Time Burden (Hours) 233,826 900 0 0 232,926 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.
04/29/1982


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