Proposed Collection; 60-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), 51168-51169 [2021-19741]

Download as PDF 51168 Federal Register / Vol. 86, No. 175 / Tuesday, September 14, 2021 / Notices Dated: September 8, 2021. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2021–19761 Filed 9–13–21; 8:45 am] National Heart, Lung, and Blood Institute; Notice of Closed Meeting BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. tkelley on DSK125TN23PROD with NOTICES Name of Committee: Heart, Lung, and Blood Initial Review Group; NHLBI Mentored Clinical and Basic Science Study Section. Date: October 28–29, 2021. Time: 10:30 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6705 Rockledge Drive, Bethesda, MD 20817 (Virtual Meeting). Contact Person: Rajiv Kumar, Ph.D., Chief Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6705 Rockledge Drive, Bethesda, MD 20892, (301) 827–4612, rajiv.kumar@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: September 8, 2021. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–19708 Filed 9–13–21; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Heart, Lung, and Blood Initial Review Group; NHLBI SingleSite and Pilot Clinical Trials Study Section. Date: October 27–28, 2021. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6705 Rockledge Drive, Bethesda, MD 20817 (Virtual Meeting). Contact Person: YingYing Li-Smerin, M.D., Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6705 Rockledge Drive, Room 207–P, Bethesda, MD 20892– 7924, 301–827–7942, lismerin@nhlbi.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: September 8, 2021. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–19760 Filed 9–13–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-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. VerDate Sep<11>2014 21:55 Sep 13, 2021 Jkt 253001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 ACTION: Notice. In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. SUMMARY: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, 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: HallCh@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimizes the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: Investigational Agent Accountability Record Forms and International Investigator Statement in the Conduct of Investigational Trials for the Treatment of Cancer, 0925–0613, Expiration Date 3/31/2022, REVISION, National Cancer FOR FURTHER INFORMATION CONTACT: E:\FR\FM\14SEN1.SGM 14SEN1 51169 Federal Register / Vol. 86, No. 175 / Tuesday, September 14, 2021 / Notices Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: 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 (aka. Drug Accountability Record Forms—DARF) 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. 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. 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 Category of respondent Form name A1: Investigational Agent Accountability Record Form (DARF) ............................................................................. A2: Investigational Agent Accountability Record for Oral Agents Form (DARF-Oral) ............................................... A3: Electronic Agent Accountability Record Form (eDARF) A4: International Investigator Statement (IIS) (Initial Response) ............................................................................. Totals ............................................................................ Dated: September 8, 2021. Diane Kreinbrink, Project Clearance Liaison, National Cancer Institute, National Institutes of Health. Number of respondents 20 4/60 1,013 Individuals Individuals 2,280 760 20 20 4/60 1/60 3,040 253 Individuals 2,100 1 15/60 525 ........................ 5,900 78,100 ........................ 4,831 Comments must reach the Coast Guard on or before November 15, 2021. You may submit comments identified by Coast Guard docket number [USCG–2021–0736] to the Coast Guard using the Federal eRulemaking Portal at https://www.regulations.gov. See the ‘‘Public participation and request for comments’’ portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments. A copy of the ICR is available through the docket on the internet at https:// www.regulations.gov. Additionally, copies are available from: Commandant (CG–6P), Attn: Paperwork Reduction Act Manager, U.S. Coast Guard, 2703 Martin Luther King Jr. Ave., SE, Stop 7710, Washington, DC 20593–7710. ADDRESSES: DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–2021–0736] Information Collection Request to Office of Management and Budget; OMB Control Number: 1625–0029 Coast Guard, Homeland Security (DHS). ACTION: Sixty-day notice requesting comments. AGENCY: In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of an extension for the following collection of information: 1625–0029, Self-propelled Liquefied Gas Vessels; without change. Our ICR describes the information we seek to tkelley on DSK125TN23PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:55 Sep 13, 2021 Jkt 253001 A.L. Craig, Office of Privacy Management, telephone 202–475–3528, or fax 202– 372–8405, for questions on these documents. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: PO 00000 Total annual burden hours 760 DATES: BILLING CODE 4140–01–P Average time per response (in hours) Individuals collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below. [FR Doc. 2021–19741 Filed 9–13–21; 8:45 am] Number of responses per respondent Frm 00072 Fmt 4703 Sfmt 4703 Public Participation and Request for Comments This notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection’s purpose, the Collection’s likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek E:\FR\FM\14SEN1.SGM 14SEN1

Agencies

[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Notices]
[Pages 51168-51169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19741]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-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 requirement of the Paperwork Reduction 
Act of 1995 to provide opportunity for public comment on proposed data 
collection projects, the National Cancer Institute (NCI) will publish 
periodic summaries of proposed projects to be submitted to the Office 
of Management and Budget (OMB) for review and approval.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 60 days of the date of 
this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project, 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]. Formal 
requests for additional plans and instruments must be requested in 
writing.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 requires: Written comments and/or suggestions 
from the public and affected agencies are invited to address one or 
more of the following points: (1) Whether the proposed collection of 
information is necessary for the proper performance of the function of 
the agency, including whether the information will have practical 
utility; (2) The accuracy of the agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) Ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) Ways 
to minimizes the burden of the collection of information on those who 
are to respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.
    Proposed Collection Title: Investigational Agent Accountability 
Record Forms and International Investigator Statement in the Conduct of 
Investigational Trials for the Treatment of Cancer, 0925-0613, 
Expiration Date 3/31/2022, REVISION, National Cancer

[[Page 51169]]

Institute (NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: 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 (aka. Drug 
Accountability Record Forms--DARF) 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. 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.
    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      Number of     responses per   per response    Total annual
                                    respondent      respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
A1: Investigational Agent            Individuals             760              20            4/60           1,013
 Accountability Record Form
 (DARF).........................
A2: Investigational Agent            Individuals           2,280              20            4/60           3,040
 Accountability Record for Oral
 Agents Form (DARF-Oral)........
A3: Electronic Agent                 Individuals             760              20            1/60             253
 Accountability Record Form
 (eDARF)........................
A4: International Investigator       Individuals           2,100               1           15/60             525
 Statement (IIS) (Initial
 Response)......................
                                                 ---------------------------------------------------------------
    Totals......................  ..............           5,900          78,100  ..............           4,831
----------------------------------------------------------------------------------------------------------------


    Dated: September 8, 2021.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2021-19741 Filed 9-13-21; 8:45 am]
BILLING CODE 4140-01-P