Guidance for Industry: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees

ICR 201509-0910-004

OMB: 0910-0581

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-09-16
ICR Details
0910-0581 201509-0910-004
Historical Active 201204-0910-002
HHS/FDA CBER
Guidance for Industry: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees
Extension without change of a currently approved collection   No
Regular
Approved without change 12/09/2015
Retrieve Notice of Action (NOA) 09/22/2015
  Inventory as of this Action Requested Previously Approved
12/31/2018 36 Months From Approved 12/31/2015
1,185 0 1,185
1,795 0 1,795
0 0 0

The collection of information includes the following reporting, recordkeeping, and third-party disclosure provisions for sponsors and data monitoring committees (DMCs): (1) Sponsor reporting to FDA on DMC recommendations related to safety; (2) standard operating procedures (SOPs) for DMCs; (3) DMC meeting records; (4) sponsor notification to the DMC regarding waivers; and (5) DMC reports of meeting minutes to the sponsor. The submission of the requested information provides the appropriate parties with essential information regarding the clinical trial upon which they may base their recommendations. The SOPs ensure that established written procedures are followed and proper recordkeeping is performed.

None
None

Not associated with rulemaking

  80 FR 16402 03/27/2015
80 FR 54297 09/09/2015
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 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

$29,748
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [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.
09/22/2015


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