Financial Disclosure by Clinical Investigators

ICR 202110-0910-010

OMB: 0910-0396

Federal Form Document

ICR Details
0910-0396 202110-0910-010
Received in OIRA 201901-0910-004
HHS/FDA CROSS CENTER
Financial Disclosure by Clinical Investigators
Extension without change of a currently approved collection   No
Regular 03/31/2022
  Requested Previously Approved
36 Months From Approved 04/30/2022
14,584 10,099
3,478 3,180
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

  86 FR 68500 12/02/2021
87 FR 18371 03/30/2022
No

  Total Request 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 14,584 10,099 0 0 4,485 0
Annual Time Burden (Hours) 3,478 3,180 0 0 298 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Our estimated burden for the information collection reflects an overall increase of 298 hours and a corresponding increase of 4,485 responses/records. We attribute this adjustment to an increase in the number of affected applications and the number of investigators. The estimated number of respondents has decreased from 1,050 to 715 for Certification, from 105 to 72 for Disclosure, and from 1,050 to 715 for Recordkeeping due to a decrease in the estimated number of affected applications. The estimated number of respondents for third-party disclosure has increased from 7,894 to 13,082 due to adjustments in the number of affected applications and the number of investigators. No program changes were made. Upon review, we have corrected an inadvertent omission with regard to the number of biologics license applications (BLAs) and BLA efficacy supplements received by our Center for Drug Evaluation and Research (CDER) and used, in part, as a basis for calculating the cumulative burden estimate.

$211,819
No
    Yes
    No
No
No
No
No
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.
03/31/2022


© 2024 OMB.report | Privacy Policy