[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average time
Form name Category of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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