[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Notices]
[Pages 67067-67068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25605]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request Investigational 
Agent Accountability Record Forms and International Investigator 
Statement in the Conduct of Investigational Trials for the Treatment of 
Cancer (National Cancer Institute)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication.

[[Page 67068]]


ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Charles Hall, Chief, Pharmaceutical Management 
Branch, Cancer Therapy Evaluation Program, Division of Cancer Diagnosis 
and Treatment, National Cancer Institute, 9609 Medical Center Drive, 
Bethesda, Maryland, 20892 or call non-toll-free number (240) 276-6575 
or email your request, including your address to: [email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on September 14, 2021 
(Vol. 86 FR 51168) and allowed 60 days for public comment. No public 
comments were received. The purpose of this notice is to allow an 
additional 30 days for public comment. The National Cancer Institute 
(NCI), National Institutes of Health, may not conduct or sponsor, and 
the respondent is not required to respond to, an information collection 
that has been extended, revised, or implemented on or after October 1, 
1995, unless it displays a currently valid OMB control number.
    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction 
Act of 1995, the National Institutes of Health (NIH) has submitted to 
the Office of Management and Budget (OMB) a request for review and 
approval of the information collection listed below.
    Proposed Collection: Investigational Agent Accountability Record 
Forms and International Investigator Statement in the Conduct of 
Investigational Trials for the Treatment of Cancer (National Cancer 
Institute), 0925-0613, Expiration Date 3/31/2022, REVISION, National 
Cancer Institute (NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: The Food and Drug 
Administration (FDA) require Investigational New Drug Application (IND) 
sponsors to maintain adequate records on the shipment and disposition 
of agents to investigators. The agent accountability effort for 
National Cancer Institute/Division of Cancer Treatment and Diagnosis/
Cancer Therapy Evaluation Program (NCI/DCTD/CTEP) is managed by the 
Pharmaceutical Management Branch (PMB) at CTEP. The Investigational 
Agent Accountability Records (a.k.a. Drug Accountability Record Forms--
DARF) are used to provide a standardized method of tracking of agent 
disposition across all institutions participating in trials for which 
the NCI provides agent. Institutional auditors verify information on 
the agent accountability forms for compliance. In addition, PMB staff 
review Investigational Agent Accountability Record Forms against 
records maintained in PMB systems to ensure there is no inappropriate 
use or diversion of investigational agents. Additionally, the 
International Investigator Statement (IIS) will be used by non-U.S. 
investigators, that are unable to sign the FDA 1572 (OMB No. 0925-0753, 
Expiration 05/31/2024) to attest compliance with applicable country-
specific regulations.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden are 4,831 hours.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of     Average time
                   Form name                              Category of respondent             Number of     responses per   per response    Total annual
                                                                                            respondents     respondent      (in hours)     burden hours
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A1: Investigational Agent Accountability Record  Individuals............................             760              20            4/60           1,013
 Form (DARF).
A2: Investigational Agent Accountability Record  Individuals............................           2,280              20            4/60           3,040
 for Oral Agents Form (DARF-Oral).
A3: Electronic Agent Accountability Record Form  Individuals............................             760              20            1/60             253
 (eDARF).
A4: International Investigator Statement (IIS)   Individuals............................           2,100               1           15/60             525
 (Initial Response).
                                                                                         ---------------------------------------------------------------
    Totals.....................................  .......................................           5,900          78,100  ..............           4,831
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    Dated: November 18, 2021.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2021-25605 Filed 11-23-21; 8:45 am]
BILLING CODE 4140-01-P