Financial Disclosure by Clinical Investigators

ICR 200602-0910-004

OMB: 0910-0396

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
6057 Migrated
ICR Details
0910-0396 200602-0910-004
Historical Active 200301-0910-001
HHS/FDA
Financial Disclosure by Clinical Investigators
Extension without change of a currently approved collection   No
Regular
Approved without change 04/21/2006
Retrieve Notice of Action (NOA) 02/16/2006
  Inventory as of this Action Requested Previously Approved
04/30/2009 04/30/2009 04/30/2006
1 0 1
18,750 0 18,750
0 0 0

The collection require sponsors of any drug, biologic or device marketing application to certify to the absence of clinical investigators and/or disclose those financial interests as required, when covered clinical studies are submitted to FDA in support of product marketing.

None
None


No

1
IC Title Form No. Form Name
Financial Disclosure by Clinical Investigators 3454, 3455

  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 1 0 0 0 0
Annual Time Burden (Hours) 18,750 18,750 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.
02/16/2006


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