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
<![CDATA[
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]
-----------------------------------------------------------------------
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
