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

Forms and Documents

Document Name	Status
Form 4 International Investigator Statement (IIS) Form and Instruction	Removed
Form 1 Electronic Agent Accountability Record Form (eDARF) Form	Modified
Form 1 Investigational Agent Accountability Record for Oral Agents Form (DARF-Oral) Form	Modified
Form 1 Investigational Agent Accountability Record Form (DARF) Form	Modified
SSA 0925-0613.docx Supporting Statement A	2024-09-30
Attachment 5 - Privacy Act Memo.pdf Supplementary Document	2024-09-30
Attachment 4 - Privacy Impact Assessment (PIA).pdf Supplementary Document	2024-09-30
30day 0613.pdf Supplementary Document	2024-09-30

IC Document Collections

IC ID	Document Title	Status
250488	International Investigator Statement (IIS) Form and Instruction	Removed
250487	Electronic Agent Accountability Record Form (eDARF) Form	Modified
234814	Investigational Agent Accountability Record for Oral Agents Form (DARF-Oral) Form	Modified
234813	Investigational Agent Accountability Record Form (DARF) Form	Modified

ICR Details

OMB Control No: 0925-0613	ICR Reference No: 202409-0925-001
Status: Received in OIRA	Previous ICR Reference No: 202111-0925-005
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	Date Submitted to OIRA: 09/30/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2025
Responses	100,000	78,100
Time Burden (Hours)	4,166	4,831
Cost Burden (Dollars)	0	0

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Abstract: This is a request for the Office of Management and Budget (OMB) to approve a Revision of the “Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials for the Treatment of Cancer” for an additional 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 agent trials, to assure the FDA that investigators in its clinical trials program are maintaining systems for accountability. 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. Requirements for the tracking of investigational agents under an Investigational New Drug Application are outlined in Title 21 Code of Federal Regulations (CRF) Part 312. NCI and/or its auditors use this information to ensure compliance with federal regulations and NCI policies

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Authorizing Statute(s): US Code: 21 USC 312.62 Name of Law: Public Health Service Act
   US Code: 21 USC 312.58 Name of Law: Public Health Service Act
   US Code: 21 USC 312.64 Name of Law: Public Health Service Act
   US Code: 21 USC 312.53 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:
	89 FR 57157	07/12/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 79630	09/30/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Electronic Agent Accountability Record Form (eDARF)	1	A3: Electronic Agent Accountability Record Form (eDARF)
International Investigator Statement (IIS)	4	International investigator statement
Investigational Agent Accountability Record Form (DARF)	1	Investigational Agent Accountability Record Form (DARF)
Investigational Agent Accountability Record for Oral Agents Form (DARF-Oral)	1	Investigational Agent Accountability Record for Oral Agents Form (DARF-Oral)

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ICR Summary of Burden

	Total Request	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	100,000	78,100	0	24,000	-2,100	0
Annual Time Burden (Hours)	4,166	4,831	0	-140	-525	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: Changing Forms

Short Statement: This revision removes the International Investigator Statement (IIS) form as it was transitioned to the CTEP Branch and Support Contracts Forms and Surveys (OMB#0925-0753) submission, thereby reducing the burden hours by 665 hours annually. The eDARF will be completed online using the AURORA inventory management system, ultimately replacing the DARF and DARF-Oral. Full use of the eDARF will be implemented over the next 12 months, and the burden is based upon a total percentage of the burden for maintaining agent records.

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Annual Cost to Federal Government: $28,273

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? No

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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: 09/30/2024

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