Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials in Cancer Treatment (NCI)

Forms and Documents

Document Name	Status
Form 2 Drug Accountability Record Form - Oral Version (DARF- Oral) Form and Instruction	New
Form 1 Drug Accountability Record Form (DARF) Form and Instruction	New
Form 3 Supplemental Investigator Data Form (Attachment 4) Form and Instruction	Removed
Form 1 Statement of Investigator Attachments 3A or 3B Form and Instruction	Removed
Form 7 Drug Accountability Record Form (DARF and DARF-Oral) Form and Instruction	Removed
Form 5 Financial Disclosure Form (Attachments 5A or 5B) Form and Instruction	Removed
Attach3-PIA-CTEP-ESYS-9453-09-25-2018-1.docx Supplementary Document	2019-02-26
30day FRN2019-00447.pdf Supplementary Document	2019-01-31
Attach4-Privacy Act Memo-Dec2018.pdf Supplementary Document	2019-01-31
Attach3-PIA-CTEP-ESYS-9453-09-25-2018-1.pdf Supplementary Document	2019-01-31
SSA_PMB_1-4-19.docx Supporting Statement A	2019-01-31

IC Document Collections

IC ID	Document Title	Status
234814	Drug Accountability Record Form - Oral Version (DARF- Oral) Form and Instruction	New
234813	Drug Accountability Record Form (DARF) Form and Instruction	New
219968	Supplemental Investigator Data Form (Attachment 4) Form and Instruction	Removed
219967	Statement of Investigator Attachments 3A or 3B Form and Instruction	Removed
205830	Drug Accountability Record Form (DARF and DARF-Oral) Form and Instruction	Removed
190377	Financial Disclosure Form (Attachments 5A or 5B) Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0613	ICR Reference No: 201901-0925-002
Status: Active	Previous ICR Reference No: 201602-0925-006
Agency/Subagency: HHS/NIH	Agency Tracking No: 18857
Title: Investigational Agent Accountability Record Forms in the Conduct of 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 without change	Conclusion Date: 03/14/2019
	Date Received in OIRA: 02/01/2019
Terms of Clearance: OMB is approving this information collection request for a period of three years during which time the agency will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2022	36 Months From Approved	03/31/2019
Responses	45,504	0	119,457
Time Burden (Hours)	3,033	0	14,649
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection is a revision for a three-year period. 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, to assure the FDA that systems for accountability are being maintained by investigators in its clinical trials program. Data obtained from the Investigational Agent Accountability Record Forms are used to track the dispensing of investigational anticancer agents from receipt from the NCI to dispensing or administration to patients.

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Authorizing Statute(s): US Code: 21 USC 312.62 Name of Law: Public Health Service Act
   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 312.53 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:
	83 FR 53885	10/25/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 785	01/31/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Drug Accountability Record Form - Oral Version (DARF- Oral)	2	Investig Agent-Oral Account Record
Statement of Investigator Attachments 3A or 3B	1, 2	Attach 3A NCI Modified FDA form 1572 ,   Attach 3B Statement of Investigator DCP copy
Supplemental Investigator Data Form (Attachment 4)	3	Attach 4 Supplemental Investigator data form
Drug Accountability Record Form (DARF)	1	Investig Agent Account Record
Drug Accountability Record Form (DARF and DARF-Oral)	7, 8	Attach 1 DARF Agent accountability ,   Attach 2 DARF Oral agent agent accountability
Financial Disclosure Form (Attachments 5A or 5B)	6, 5	Attach 5 Financial Disclosure Form ,   Attach 5B Financial Disclosure DCP

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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	45,504	119,457	0	-73,953	0	0
Annual Time Burden (Hours)	3,033	14,649	0	-11,616	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The investigator registration process underwent a technology change from paper data collection to electronic data collection. The use of the electronic forms for investigator registration information collection were approved under the CTEP Branch and Support Contracts Forms and Surveys submission (OMB No. 0925-0753) with an expiration date of 7/31/2021. Therefore, removing the investigator registration forms from this submission has decreased the total burden by 11,142 hours. In addition, this submission requests a reduction of 474 fewer burden hours than the 2016 submission because there is a year to year variation in the number of active studies (and subsequently the number of patients enrolled in those studies).

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Annual Cost to Federal Government: $23,524

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

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: 02/01/2019

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