Financial Disclosure by Clinical Investigators

ICR 200904-0910-010

OMB: 0910-0396

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2009-07-30
ICR Details
0910-0396 200904-0910-010
Historical Active 200602-0910-004
HHS/FDA
Financial Disclosure by Clinical Investigators
Extension without change of a currently approved collection   No
Regular
Approved with change 08/06/2009
Retrieve Notice of Action (NOA) 04/28/2009
This ICR is approved consistent with revised supporting statement.
  Inventory as of this Action Requested Previously Approved
08/31/2012 36 Months From Approved 08/31/2009
13,600 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.

US Code: 21 USC 54.4 Name of Law: FFDCA
   US Code: 21 USC 54.1 Name of Law: FFDCA
   US Code: 21 USC 54.6 Name of Law: FFDCA
  
None

Not associated with rulemaking

  73 FR 79493 12/29/2008
74 FR 18385 04/22/2009
Yes

  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 13,600 1 0 0 13,599 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

$63,536
No
No
Uncollected
Uncollected
No
Uncollected
Eliazabeth Berbakos 3018271482

  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.
04/27/2009


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