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	New
Form 3 Electronic Agent Accountability Record Form (eDARF) Form and Instruction	New
Form 2 Drug Accountability Record Form - Oral Version (DARF- Oral) Form and Instruction	Modified
Form 1 Drug Accountability Record Form (DARF) Form and Instruction	Modified
pub 30day FRN2021-25605.pdf Supplementary Document	2021-11-24
SSA FINAL 11.17.2021.docx Supporting Statement A	2021-11-22
Attachment 6 - Privacy Act Memo.pdf Supplementary Document	2021-11-22
Attachment 5 PIA.pdf Supplementary Document	2021-11-22

IC Document Collections

IC ID	Document Title	Status
250488	International Investigator Statement (IIS) Form and Instruction	New
250487	Electronic Agent Accountability Record Form (eDARF) Form and Instruction	New
234814	Drug Accountability Record Form - Oral Version (DARF- Oral) Form and Instruction	Modified
234813	Drug Accountability Record Form (DARF) Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0613	ICR Reference No: 202111-0925-005
Status: Received in OIRA	Previous ICR Reference No: 201901-0925-002
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: 11/29/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2022
Responses	78,100	45,504
Time Burden (Hours)	4,831	3,033
Cost Burden (Dollars)	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. Two additional forms have been added to this submission. The Electronic Agent Accountability Record Form Report (aka electronic Drug Accountability Record Form-eDARF) will be phased into use to replace two of the currently existing forms and will improve tracking and distribution of investigational agents. A second form, the International Investigator Statement (IIS), will ensure compliance of international investigators’ participation on CTEP studies.

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Authorizing Statute(s): US Code: 21 USC 312.64 Name of Law: Public Health Service Act
   US Code: 21 USC 312.62 Name of Law: Public Health Service Act
   US Code: 21 USC 312.58 Name of Law: Public Health Service Act
   US Code: 21 USC 312.53 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:
	86 FR 51168	09/14/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 67067	11/24/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Drug Accountability Record Form (DARF)	1	Investig Agent Account Record
Drug Accountability Record Form - Oral Version (DARF- Oral)	2	Investig Agent-Oral Account Record
Electronic Agent Accountability Record Form (eDARF)	3	Electronic Agent Accountability Record
International Investigator Statement (IIS)	4	International investigator statement

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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	78,100	45,504	0	32,596	0	0
Annual Time Burden (Hours)	4,831	3,033	0	1,798	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: This revision involves a request for an additional 778 burden hours from the 2019 submission due to the phasing in of two new forms, the eDARF and the IIS. The eDARF will be completed online using the AURORA inventory management system, and will ultimately replace the DARF and DARF-Oral. Full use of the eDARF will be implemented over the next 24-months and the burden is based upon a total percentage of burden for maintaining agent records. The IIS requirement is for non-U.S. investigators who can no longer sign the Form FDA 1572 as part of their RCR registration. The form is completed annually. The Form FDA 1572 and other forms that are part of the RCR registration process are covered under the CTEP Branch and Support Contracts Forms and Surveys (OMB No. 0925-0753, exp. 5/31/2024).

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Annual Cost to Federal Government: $23,782

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: 11/29/2021

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