Financial Disclosure by Clinical Investigators -- 21 CFR Part 54 (Final Rule)

ICR 199801-0910-004

OMB: 0910-0366

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
0910-0366 199801-0910-004
Historical Active
HHS/FDA
Financial Disclosure by Clinical Investigators -- 21 CFR Part 54 (Final Rule)
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 04/03/1998
Retrieve Notice of Action (NOA) 01/30/1998
This collection is approved on the condition that FDA identify the burden hours on the two forms.
  Inventory as of this Action Requested Previously Approved
04/30/2001 04/30/2001
1 0 0
6,250 0 0
0 0 0

The information collection is needed to assure that data from clinical studies meant to demonstrate safety and efficacy of new products are not compromised by bias based on financial interests of clinical investigators in the tested product. This information will be used to identify potentially biasing financial interests and assess the extent to which they could affect or have affected the reliability of the clinical investigators who submit certain sponsors who submit marketing applications to FDA that require clinical data from covered studies and clinical investigators who submit certain....

None
None


No

1
IC Title Form No. Form Name
Financial Disclosure by Clinical Investigators -- 21 CFR Part 54 (Final Rule) 3454

  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 0 0 1 0 0
Annual Time Burden (Hours) 6,250 0 0 6,250 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.
01/30/1998


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