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

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 0581 9-16-15.docx Supporting Statement A	2015-09-16

IC Document Collections

IC ID	Document Title	Status
6304	Sponsor Reporting to FDA on DMC Recommendations Other-Guidance	Modified
203249	DMC reports of meeting minutes to the sponsor Other-Guidance	Modified
203248	Sponsor notification to the DMC regarding waivers Other-Guidance	Modified
203247	DMC Meeting Records Other-Guidance	Modified
203246	Standard Operating Procuedres for Data Monitoring Committees Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0581	ICR Reference No: 201509-0910-004
Status: Historical Active	Previous ICR Reference No: 201204-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
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: 12/09/2015
	Date Received in OIRA: 09/22/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved	12/31/2015
Responses	1,185	0	1,185
Time Burden (Hours)	1,795	0	1,795
Cost Burden (Dollars)	0	0	0

---

Abstract: 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.

---

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 16402	03/27/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 54297	09/09/2015
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Sponsor Reporting to FDA on DMC Recommendations
Standard Operating Procuedres for Data Monitoring Committees
DMC Meeting Records
Sponsor notification to the DMC regarding waivers
DMC reports of meeting minutes to the sponsor

---

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	1,185	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

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:

---

Annual Cost to Federal Government: $29,748

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

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

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  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:

(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: 09/22/2015

---