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

ICR 202111-0925-005

OMB: 0925-0613

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
New
Form and Instruction
New
Form and Instruction
Modified
Form and Instruction
Modified
Supplementary Document
2021-11-24
Supporting Statement A
2021-11-22
Supplementary Document
2021-11-22
Supplementary Document
2021-11-22
ICR Details
0925-0613 202111-0925-005
Received in OIRA 201901-0925-002
HHS/NIH 18857
Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials in Cancer Treatment (NCI)
Revision of a currently approved collection   No
Regular 11/29/2021
  Requested Previously Approved
36 Months From Approved 03/31/2022
78,100 45,504
4,831 3,033
0 0

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.

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
  
None

Not associated with rulemaking

  86 FR 51168 09/14/2021
86 FR 67067 11/24/2021
No

  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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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).

$23,782
No
    Yes
    Yes
No
No
No
No
Tawanda Abdelmouti 240 276-5530 ta401@nih.gov

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
11/29/2021


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