Financial Disclosure by Clinical Investigators

ICR 201510-0910-002

OMB: 0910-0396

Federal Form Document

Forms and Documents
ICR Details
0910-0396 201510-0910-002
Historical Active 201207-0910-012
HHS/FDA CDRH
Financial Disclosure by Clinical Investigators
Extension without change of a currently approved collection   No
Regular
Approved with change 03/22/2016
Retrieve Notice of Action (NOA) 11/06/2015
  Inventory as of this Action Requested Previously Approved
03/31/2019 36 Months From Approved 03/31/2016
9,206 0 12,448
2,958 0 3,372
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 54.4 Name of Law: FFDCA
   US Code: 21 USC 54.1 Name of Law: FFDCA
   US Code: 21 USC 54.6 Name of Law: FFDCA
  
None

Not associated with rulemaking

  80 FR 23803 04/29/2015
80 FR 66542 10/29/2015
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 9,206 12,448 0 0 -3,242 0
Annual Time Burden (Hours) 2,958 3,372 0 0 -414 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The estimated number of respondents has increased from 902 to 1,000 for Certification, from 90 to 100 for Disclosure, and from 902 to 1,000 for Recordkeeping due to an increase in the estimated number of affected applications. The estimated number of respondents for third-party disclosure has decreased from 10,554 to 7,106. The sum of these adjustments has resulted in a 414-hour decrease of the total hour burden. No program changes were made.

$124,454
No
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.
11/06/2015


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