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

ICR 200903-0910-008

OMB: 0910-0581

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2009-03-02
ICR Details
0910-0581 200903-0910-008
Historical Active 200512-0910-007
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 without change 06/09/2009
Retrieve Notice of Action (NOA) 03/30/2009
  Inventory as of this Action Requested Previously Approved
06/30/2012 36 Months From Approved 06/30/2009
1,148 0 1,148
1,795 0 1,795
0 0 0

Sponsors are required to monitor studies evaluating new drugs, biologics, and devices (21 CFR 312.50 and 312.56 for drugs and biologics, and 21 CFR 812.40 and 812.46 for devices). One group involved in the clinical trial monitoring is a Data Monitoring Committee (DMC) appointed by the sponsor to evaluate the accumulating outcome data. The guidance document assists sponsors with regard to the roles, responsibilities, operating procedures, and certain reporting and recordkeeping functions of the DMCs.

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

Not associated with rulemaking

  73 FR 58970 09/18/2008
74 FR 10253 03/10/2009
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 1,148 1,148 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

$27,084
No
No
Uncollected
Uncollected
No
Uncollected
Jonnalynn Capezzuto 3018274659

  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.
03/30/2009


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