Financial Disclosure by Clinical Investigators -- 21 CFR Part 54

ICR 199908-0910-012

OMB: 0910-0366

Federal Form Document

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ICR Details
0910-0366 199908-0910-012
Historical Active 199801-0910-004
Financial Disclosure by Clinical Investigators -- 21 CFR Part 54
No material or nonsubstantive change to a currently approved collection   No
Approved without change 08/10/1999
Retrieve Notice of Action (NOA) 08/10/1999
  Inventory as of this Action Requested Previously Approved
08/31/1999 08/31/1999 04/30/2001
1 0 1
6,250 0 6,250
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....



IC Title Form No. Form Name
Financial Disclosure by Clinical Investigators -- 21 CFR Part 54 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 1 0 0 0 0
Annual Time Burden (Hours) 6,250 6,250 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0



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.

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