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

ICR 201204-0910-002

OMB: 0910-0581

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2012-09-19
ICR Details
0910-0581 201204-0910-002
Historical Active 200903-0910-008
HHS/FDA
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 with change 10/02/2012
Retrieve Notice of Action (NOA) 04/23/2012
  Inventory as of this Action Requested Previously Approved
10/31/2015 36 Months From Approved 10/31/2012
1,185 0 1,148
1,795 0 1,795
0 0 0

The purpose of this collection is to provide the data monitoring committees with information regarding clinical trials. The collection of information includes the following reporting, recordkeeping, and third-party provisions for sponsors and data monitoring committees: (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 based on meeting minutes to the sponsor.

US Code: 21 USC 355i(1) Name of Law: FFDCA
   US Code: 21 USC 360j(g)(2)(A) Name of Law: FFDCA
  
None

Not associated with rulemaking

  76 FR 79689 12/22/2011
77 FR 23730 04/20/2012
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 1,148 0 0 37 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
The collection of information includes ICs adjusted by reporting, recordkeeping, and third-party provisions for sponsors and data monitoring committees.

$29,748
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 ila.mizrachi@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.
04/23/2012


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