Proposed Collection; 60-Day Comment Request; NCI Genomic Data Commons (GDC) Data Submission Request Form (National Cancer Institute), 67049-67050 [2022-24186]
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Federal Register / Vol. 87, No. 214 / Monday, November 7, 2022 / Notices
distribution requirements under section
582(g) of the FD&C Act.
• Steps taken by the pharmaceutical
distribution supply chain to build
capacity for package-level tracing,
including the ability of the healthcare
system to maintain patient access to
medicines, scalability of DSCSA
requirements, and best practices.
• Technical capabilities and legal
authorities, if any, needed to establish
interoperable, electronic product tracing
at the package level.
• General impact that the DSCSA
requirements would have on public
health, including patient safety and
access to prescription drugs, and on
stakeholders, in terms of costs, benefits,
and regulatory burden.
If other topics are identified as
appropriate, FDA will post these on the
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Other Issues for Consideration: FDA
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at https://www.fda.gov/drugs/drugsupply-chain-security-act-dscsaimplementation-and-readiness-efforts2023-12072022 after the public meeting.
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If you need special accommodations
due to a disability, please contact Kristle
Green (see FOR FURTHER INFORMATION
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group discussions must register by
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the public meeting must register by
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Dated: November 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
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.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Pathway to Independence Awards (K99/R00).
Date: December 2, 2022.
Time: 9:30 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Nicholas Gaiano, Ph.D.,
Review Branch Chief, Division of Extramural
Activities, National Institute of Mental
Health, National Institutes of Health,
PO 00000
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Neuroscience Center/Room 6150/MSC 9606,
6001 Executive Boulevard, Bethesda, MD
20892–9606, 301–443–2742, nick.gaiano@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: November 1, 2022.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–24115 Filed 11–4–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; NCI Genomic Data Commons
(GDC) Data Submission Request Form
(National Cancer Institute)
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: Zhining Wang, Ph.D., Project
Officer, Center for Cancer Genomics
(CCG), National Cancer Institute,
Building 31, Room 3A20, 31 Center
Drive, Bethesda, MD 20814 or call nontoll-free number 301–402–1892 or Email
your request, including your address to:
zhining.wang@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 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
SUMMARY:
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Federal Register / Vol. 87, No. 214 / Monday, November 7, 2022 / Notices
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 minimize 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: NCI
Genomic Data Commons (GDC) Data
obtaining information from investigators
that: (1) would like to submit data about
their study into the GDC, (2) are
affiliated with studies that adhere to
GDC data submission conditions. The
benefits of the collection are that it
provides the needed information for
investigators to understand the types of
studies and data that the GDC supports
and that it provides a standard
mechanism for the GDC to assess
incoming data submission requests.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
50 hours.
Submission Request Form, 0925–0752,
Expiration Date 03/31/2023,
EXTENSION, National Cancer Institute
(NCI), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The purpose of the NCI
Genomic Data Commons (GDC) Data
Submission Request Form is to provide
a vehicle for investigators to request the
submission of their cancer genomic data
into the GDC in support of data sharing.
The purpose is also to provide a
mechanism for the GDC Data
Submission Review Committee to
review and assess the data submission
request for applicability to the GDC
mission. The scope of the form involves
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Number of
respondents
Investigator ......................................................................................................
Total ..........................................................................................................
200
........................
Dated: November 2, 2022.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2022–24186 Filed 11–4–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
khammond on DSKJM1Z7X2PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel; RFA:
Countermeasures Against Chemical Threats
Exploratory/Developmental Projects.
Date: December 5, 2022.
Time: 8:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
VerDate Sep<11>2014
16:45 Nov 04, 2022
Jkt 259001
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jodie Michelle Fleming,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 812R,
Bethesda, MD 20892, (301) 867–5309,
flemingjm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Microbial Vaccine Development.
Date: December 5–6, 2022.
Time: 10:00 a.m. to 8:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Subhamoy Pal, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 594–0926, subhamoy.pal@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Oncology.
Date: December 6–7, 2022.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Nywana Sizemore, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6189,
MSC 7804, Bethesda, MD 20892, 301–408–
9916, sizemoren@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Epigenomics of Neurodevelopment.
PO 00000
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Number of
responses per
respondent
1
200
Average time
per response
(in hours)
Total annual
burden hour
15/60
........................
50
50
Date: December 6, 2022.
Time: 2:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Mary G Schueler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5214,
MSC 7846, Bethesda, MD 20892, 301–915–
6301, marygs@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 2, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–24204 Filed 11–4–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the Sleep Disorders
Research Advisory Board, December 01,
2022, 12 p.m. to December 01, 2022, 4
p.m., National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD, 20892 which was
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[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67049-67050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24186]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; NCI Genomic Data
Commons (GDC) Data Submission Request Form (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 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: Zhining
Wang, Ph.D., Project Officer, Center for Cancer Genomics (CCG),
National Cancer Institute, Building 31, Room 3A20, 31 Center Drive,
Bethesda, MD 20814 or call non-toll-free number 301-402-1892 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 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
[[Page 67050]]
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 minimize 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: NCI Genomic Data Commons (GDC) Data
Submission Request Form, 0925-0752, Expiration Date 03/31/2023,
EXTENSION, National Cancer Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information Collection: The purpose of the NCI
Genomic Data Commons (GDC) Data Submission Request Form is to provide a
vehicle for investigators to request the submission of their cancer
genomic data into the GDC in support of data sharing. The purpose is
also to provide a mechanism for the GDC Data Submission Review
Committee to review and assess the data submission request for
applicability to the GDC mission. The scope of the form involves
obtaining information from investigators that: (1) would like to submit
data about their study into the GDC, (2) are affiliated with studies
that adhere to GDC data submission conditions. The benefits of the
collection are that it provides the needed information for
investigators to understand the types of studies and data that the GDC
supports and that it provides a standard mechanism for the GDC to
assess incoming data submission requests.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 50 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
Investigator.................................... 200 1 15/60 50
Total....................................... .............. 200 .............. 50
----------------------------------------------------------------------------------------------------------------
Dated: November 2, 2022.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2022-24186 Filed 11-4-22; 8:45 am]
BILLING CODE 4140-01-P
