View Information Collection Request (ICR) Package

OMB Control No: 0925-0613	ICR Reference No: 201302-0925-005
Status: Historical Active	Previous ICR Reference No: 201001-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No: 18857
Title: Investigator Registration and Financial Disclosure for Investigational Trials in Cancer Treatment (NCI)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/25/2013
	Date Received in OIRA: 02/15/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2016	36 Months From Approved	03/31/2013
Responses	123,724	0	51,384
Time Burden (Hours)	14,328	0	8,564
Cost Burden (Dollars)	0	0	0

Abstract: The U.S. Food and Drug Administration (FDA) holds the National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis/Cancer Therapy Evaluation Program (NCI/DCTD/CTEP) and the Division of Cancer Prevention (DCP) responsible, as a sponsor of investigational drug trials, for the collection of information about the clinical investigators who participate in these trials and to assure the FDA that systems for accountability are being maintained by investigators in its clinical trials program. The information collected is used to identify qualified investigators and to facilitate the submission and distribution of important information relative to the investigational drug and the response of the patient to that drug. Investigators are physicians who specialize in the treatment of patients with cancer. Data obtained from the Drug Accountability Record is used to track the dispensing of investigational anticancer agents from receipt from the NCI to dispensing or administration to patients. NCI and/or its auditors use this information for compliance purposes.

Authorizing Statute(s): US Code: 21 USC 312.64 Name of Law: Public Health Service Act
   US Code: 21 USC 312.58 Name of Law: Public Health Service Act
   US Code: 21 USC 312.62 Name of Law: Public Health Service Act
   US Code: 21 USC 312.53 Name of Law: Public Health Service Act

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:
	77 FR 58401	09/20/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 11210	02/15/2013
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	123,724	51,384	62,512	9,828
Annual Time Burden (Hours)	14,328	8,564	4,168	1,596
Annual Cost Burden (Dollars)	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a request for a program change, considered a revision, which includes the logical combination of previously two OMB submissions into one. The U.S. Food and Drug Administration (FDA) holds the National Cancer Institute (NCI) responsible, as a sponsor of investigational drug trials, for the collection of information about clinical investigators who participate in trials and to assure the FDA that systems for accountability are being maintained by investigators in its clinical trials program. The increase in burden is primarily a reflection of the combination of these two submissions. This submission also includes the addition of the DCP information collection for investigator registration and the electronic mechanism for investigator registration information collection, NCI OCR. Additionally, the burden has increased as a result of actively accruing investigational studies and a greater number of patients participating in studies.

Annual Cost to Federal Government: $812,500

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

Agency Contact: Saleda Perryman

View ICR - OIRA Conclusion