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

Forms and Documents

Document Name	Status
0581 ss 12-31-08.doc Supporting Statement A	2009-03-02

IC Document Collections

IC ID	Document Title	Status
6304	Guidance for Industry: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees Other-guidance document	Modified

ICR Details

OMB Control No: 0910-0581	ICR Reference No: 200903-0910-008
Status: Historical Active	Previous ICR Reference No: 200512-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance for Industry: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/09/2009
	Date Received in OIRA: 03/30/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2012	36 Months From Approved	06/30/2009
Responses	1,148	0	1,148
Time Burden (Hours)	1,795	0	1,795
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 21 USC 355(i) Name of Law: FFDCA
   US Code: 21 USC 360j(g) Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 58970	09/18/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 10253	03/10/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Guidance for Industry: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $27,084

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 03/30/2009

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