Investigator Registration and Financial Disclosure for Investigational Trials in Cancer Treatment (NCI)

Forms and Documents

Document Name	Status
Form 8 Drug Accountability Record Form (DARF and DARF-Oral) Form and Instruction	New
Form 7 Electronic Curriculum Vitae (Attachment 11) Form and Instruction	New
Form 5 Financial Disclosure Form (Attachments 5A or 5B) Form and Instruction	Modified
Form 4 Supplemental Investigator Data Form (Attachment 4) Form and Instruction	Modified
Form 1 Statement of Investigator (Attachment 3A, 3B or 10) Form and Instruction	Modified
Attach_9B_PIA_OCR.pdf Supplementary Document	2013-02-15
Attach_9A_PIA_fy12_q2.pdf Supplementary Document	2013-02-15
Attach_8_Privacy Act Memo_InvestRegis.doc Supplementary Document	2013-02-15
Attach_7_OHSR not needed.pdf Supplementary Document	2013-02-15
Attach_6_DARF Working Group.doc Supplementary Document	2013-02-15
SSA_DARFInvestigatorReg_2-5-2013.doc Supporting Statement A	2013-02-15

IC Document Collections

IC ID	Document Title	Status
205830	Drug Accountability Record Form (DARF and DARF-Oral) Form and Instruction	New
205829	Electronic Curriculum Vitae (Attachment 11) Form and Instruction	New
190377	Financial Disclosure Form (Attachments 5A or 5B) Form and Instruction	Modified
190376	Supplemental Investigator Data Form (Attachment 4) Form and Instruction	Modified
190375	Statement of Investigator (Attachment 3A, 3B or 10) Form and Instruction	Modified

ICR Details

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

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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.

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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

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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:
	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

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

IC Title	Form No.	Form Name
Statement of Investigator (Attachment 3A, 3B or 10)	3, 2, 1	Statement of Investigator CTEP ,   Statement of Investigator DCP ,   Statement of Investigator Online
Supplemental Investigator Data Form (Attachment 4)	4	Supplemental Investigator Data Form
Financial Disclosure Form (Attachments 5A or 5B)	5, 6	Financial Disclosure Form_CTEP ,   Financial Disclosure Form_DCP
Electronic Curriculum Vitae (Attachment 11)	7	CV
Drug Accountability Record Form (DARF and DARF-Oral)	8, 9	Drug Accountability Record Form ,   Drug Accountability Record Form_Oral

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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	123,724	51,384	0	62,512	9,828	0
Annual Time Burden (Hours)	14,328	8,564	0	4,168	1,596	0
Annual Cost Burden (Dollars)	0	0	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.

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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

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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: 02/15/2013

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