Establishment and Operation of Clinical Trial Data Monitoring Committees

ICR 202108-0910-007

OMB: 0910-0581

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0581 202108-0910-007
Received in OIRA 201809-0910-002
HHS/FDA CBER
Establishment and Operation of Clinical Trial Data Monitoring Committees
Extension without change of a currently approved collection   No
Regular 09/30/2021
  Requested Previously Approved
36 Months From Approved 10/31/2021
1,185 1,185
1,795 1,795
0 0

This information collection supports the Food and Drug Administration guidance document entitled, “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees.” The guidance is intended to assist sponsors of clinical trials in determining when a Data Monitoring Committee (DMC) is needed for monitoring a study and how such committees should operate.

None
None

Not associated with rulemaking
Other Documents for OIRA Review

  86 FR 22690 04/29/2021
86 FR 47505 08/25/2021
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 1,185 1,185 0 0 0 0
Annual Time Burden (Hours) 1,795 1,795 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 [email protected]

  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.
09/30/2021


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