Financial Disclosure by Clinical Investigators

ICR 201901-0910-004

OMB: 0910-0396

Federal Form Document

Forms and Documents
ICR Details
0910-0396 201901-0910-004
Active 201510-0910-002
HHS/FDA CDRH
Financial Disclosure by Clinical Investigators
Extension without change of a currently approved collection   No
Regular
Approved without change 04/16/2019
Retrieve Notice of Action (NOA) 03/14/2019
  Inventory as of this Action Requested Previously Approved
04/30/2022 36 Months From Approved 04/30/2019
10,099 0 9,206
3,180 0 2,958
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 Name of Law: FFDCA
  
None

Not associated with rulemaking

  83 FR 48819 09/27/2018
84 FR 7388 03/04/2019
No

  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 10,099 9,206 0 0 893 0
Annual Time Burden (Hours) 3,180 2,958 0 0 222 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$285,890
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  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.
03/14/2019


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