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 (NCI), 57157-57158 [2024-15352]
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Federal Register / Vol. 89, No. 134 / Friday, July 12, 2024 / Notices
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While these guidances contain no
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OMB control
No.
Topic
807, subpart E ............................................................................
812 ..............................................................................................
‘‘Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program’’.
800, 801, 809, and 830 ..............................................................
Premarket notification ................................................................
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Protection of Human Subjects and Institutional Review Boards
50, 56 ..........................................................................................
Dated: July 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–15337 Filed 7–11–24; 8:45 am]
BILLING CODE 4164–01–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 (NCI)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide an
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 Tali Johnson, Chief,
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
refer to previously approved FDA
collections of information. The
previously approved collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521). The collections of information in
the following table have been approved
by OMB:
21 CFR part or guidance
820 ..............................................................................................
VerDate Sep<11>2014
16:35 Jul 11, 2024
Jkt 262001
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:
tmjohnson@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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
57157
0910–0120
0910–0078
0910–0756
0910–0485
0910–0073
0910–0130
1/31/2025, REVISION, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: This is a request for OMB to
approve the revision of the collection
titled ‘‘Investigational Agent
Accountability Record Forms in the
Conduct of Investigational Trials for the
Treatment of Cancer National Cancer
Institute (NCI)’’ for an additional three
years of data 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 investigators in its clinical
trials program are maintaining systems
for accountability. 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 tracking
investigational agents under an
Investigational New Drug Application
are outlined in title 21 Code of Federal
Regulations (CFR) part 312. NCI and/or
its auditors use this information to
ensure compliance with federal
regulations and NCI policies. This
revision removes the International
Investigator Statement (IIS) form as it
was transitioned to the CTEP Branch
and Support Contracts Forms and
Surveys (OMB#0925–0753) submission.
OMB approval is requested for 3
years. There are no costs to respondents
E:\FR\FM\12JYN1.SGM
12JYN1
57158
Federal Register / Vol. 89, No. 134 / Friday, July 12, 2024 / Notices
other than their time. The total
estimated annualized burden is 4,166
hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
burden hours
Category of respondent
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).
Individuals .....................
1,000
20
4/60
1,333
Individuals .....................
1,500
20
4/60
2,000
Individuals .....................
2,500
20
1/60
833
Totals .............................................................
.......................................
5,000
100,000
........................
4,166
Dated: July 9, 2024.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2024–15352 Filed 7–11–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Joint Meeting of the National Advisory
Councils
Substance Abuse and Mental
Health Services Administration.
ACTION: Notice.
AGENCY:
Notice is hereby given of the
combined (joint) meeting on August 28,
2024, of the Substance Abuse and
Mental Health Services
Administration’s (SAMHSA) national
advisory councils: the SAMHSA
National Advisory Council (NAC), the
Center for Mental Health Services NAC,
the Center for Substance Abuse
Prevention NAC, the Center for
Substance Abuse Treatment NAC; and
the two SAMHSA advisory committees:
Advisory Committee for Women’s
Services (ACWS) and the Tribal
Technical Advisory Committee (TTAC).
SUPPLEMENTARY INFORMATION: The
meeting will include remarks from the
Assistant Secretary for Mental Health
and Substance Use; follow up from the
JNAC meeting of February 28, 2024;
updates from the individual council
meetings of August 27, 2024;
presentations and discussions on the
following topics: Youth Engagement
Efforts, Criminal Justice, Suicide
Prevention, general Council discussion
and Public Comments.
The meeting is open to the public and
will be held at the Hubert H. Humphrey
Building, 200 Independence Ave. SW,
Washington, DC 20201, Room 505A.
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Number of
respondents
Form name
VerDate Sep<11>2014
16:35 Jul 11, 2024
Jkt 262001
Attendance by the public will be limited
to space availability. Interested persons
may present data, information, or views
orally or in writing, on issues pending
before the Council. Written submissions
should be forwarded to the contact
person by August 21, 2024. Oral
presentations from the public will be
scheduled at the conclusion of the
meeting. Individuals interested in
making oral presentations must notify
the contact by August 21, 2024. Up to
three minutes will be allotted for each
presentation, as time permits.
The meeting may be accessed via
telephone and remotely via Zoom
platform and callers must register. To
attend on site, obtain the call-in
number, access code, and/or web access
link; submit written or brief oral
comments; or request special
accommodations for persons with
disabilities, please register on-line at:
https://snacregister.samhsa.gov, or
communicate with SAMHSA’s
Committee Management Officer, Carlos
Castillo (see contact information below).
Meeting agenda with call-in
information will be posted before the
meeting, and additional information
may be obtained by accessing the
SAMHSA advisory councils web page:
https://www.samhsa.gov/about-us/
advisory-councils.
Council Names:
Substance Abuse and Mental Health
Services
Administration National Advisory
Council
Center for Mental Health Services
National Advisory Council
Center for Substance Abuse Prevention
National Advisory Council
Center for Substance Abuse Treatment
National Advisory Council
Advisory Committee for Women’s
Services
Tribal Technical Advisory Committee
Date/Time/Type: August 28, 2024,
9:00 a.m. to 4:30 p.m. EDT, Open.
PO 00000
Frm 00036
Fmt 4703
Sfmt 9990
Place: 200 Independence Ave. SW,
Washington, DC 20201, Room 505A.
Contact: Carlos Castillo, Committee
Management Officer, 5600 Fishers Lane,
Rockville, Maryland 20857 (mail),
Telephone: (240) 276–2787, Email:
carlos.castillo@samhsa.hhs.gov.
SAMHSA’s National Advisory
Councils were established to advise the
Secretary, Department of Health and
Human Services (HHS); the Assistant
Secretary for Mental Health and
Substance Use, SAMHSA; and
SAMHSA’s Center Directors concerning
matters relating to the activities carried
out by and through the Centers and the
policies respecting such activities.
Under section 501 of the Public
Health Service Act, the ACWS is
statutorily mandated to advise the
SAMHSA Assistant Secretary for Mental
Health and Substance Use and the
Associate Administrator for Women’s
Services on appropriate activities to be
undertaken by SAMHSA and its Centers
with respect to women’s substance
abuse and mental health services.
Pursuant to Presidential Executive
Order No. 13175, November 6, 2000,
and the Presidential Memorandum of
September 23, 2004, SAMHSA
established the TTAC for working with
Federally recognized Tribes to enhance
the government-to-government
relationship, and honor Federal trust
responsibilities and obligations to
Tribes and American Indian and Alaska
Natives. The SAMHSA TTAC serves as
an advisory body to SAMHSA.
Authority: Public Law 92–463.
Dated: July 8, 2024.
Carlos Castillo,
Committee Management Officer, SAMHSA.
[FR Doc. 2024–15311 Filed 7–11–24; 8:45 am]
BILLING CODE 4162–20–P
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]]>Agencies
[Federal Register Volume 89, Number 134 (Friday, July 12, 2024)]
[Notices]
[Pages 57157-57158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15352]
-----------------------------------------------------------------------
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 (NCI)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide an 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 Tali Johnson,
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 1/31/2025, REVISION, National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information Collection: This is a request for OMB
to approve the revision of the collection titled ``Investigational
Agent Accountability Record Forms in the Conduct of Investigational
Trials for the Treatment of Cancer National Cancer Institute (NCI)''
for an additional three years of data 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 investigators in its clinical trials program are maintaining
systems for accountability. 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 tracking investigational
agents under an Investigational New Drug Application are outlined in
title 21 Code of Federal Regulations (CFR) part 312. NCI and/or its
auditors use this information to ensure compliance with federal
regulations and NCI policies. This revision removes the International
Investigator Statement (IIS) form as it was transitioned to the CTEP
Branch and Support Contracts Forms and Surveys (OMB#0925-0753)
submission.
OMB approval is requested for 3 years. There are no costs to
respondents
[[Page 57158]]
other than their time. The total estimated annualized burden is 4,166
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 Individuals................................ 1,000 20 4/60 1,333
Record Form (DARF).
A2: Investigational Agent Accountability Individuals................................ 1,500 20 4/60 2,000
Record for Oral Agents Form (DARF-Oral).
A3: Electronic Agent Accountability Record Individuals................................ 2,500 20 1/60 833
Form (eDARF).
---------------------------------------------------------------
Totals................................. ........................................... 5,000 100,000 .............. 4,166
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: July 9, 2024.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2024-15352 Filed 7-11-24; 8:45 am]
BILLING CODE 4140-01-P
