Financial Disclosure by Clinical Investigations - Final Rule

ICR 200207-0910-001

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
ICR Details
0910-0396 200207-0910-001
Historical Inactive 199901-0910-003
HHS/FDA
Financial Disclosure by Clinical Investigations - Final Rule
Reinstatement without change of a previously approved collection   No
Regular
Withdrawn 09/12/2002
Retrieve Notice of Action (NOA) 07/08/2002
Withdrawn to give FDA additional time to respond to OMB questions on this collection. FDA may resubmit this with responses as soon as they are ready (no additional Federal Register notice re- quired).
  Inventory as of this Action Requested Previously Approved
0 0 0
0 0 0
0 0 0

The collection require sponsores of any drug, biologic or device marketing application to certify to the absence of clinical investigators and/or disclose those financial interest 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 Investigations - Final Rule 3454

No
No

$0
Yes Part B of Supporting Statement
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.
07/08/2002


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