National Cancer Institute; Notice of Closed Meeting, 35978-35979 [2017-16190]
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Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
template to identify aMOIs for
submission to MATCHbox.
Æ Laboratory results of NGS assays done
for clinical care will be the subject of
this initiative. There is no funding for
‘‘screening’’ a patient for MATCH.
Æ Laboratories must notify NCI MATCH
sites that the laboratory results would
potentially allow the patient to be
eligible for NCI MATCH.
Æ Laboratories must track how many
assays per week detect rare variants
that could make a patient eligible for
NCI MATCH.
Æ If the clinician presents the
MATCH study and the patient is
eligible and desires to enter the
study, the laboratory must agree to
fill out a spreadsheet that can be
used to put the results into the
informatics system that assigns
treatment in NCI MATCH
(MATCHbox).
Æ Laboratories must have a way to
answer questions from NCI MATCH
sites about their assay and must
have a contact person for optimal
communication with the NCI
MATCH team.
• Prior to participation, laboratories
must enter into a collaboration
agreement with NCI. A sample
agreement is available upon request. As
part of such a collaboration agreement,
laboratories must agree to provide the
licensing rights described in the CTEP
IP Option to the Pharmaceutical
Collaborators who provided agents for
the NCI MATCH trial (https://
ctep.cancer.gov/branches/rab/
intellectual_property_optionto_
collaborators.htm), as well as agree to
the data sharing and publication rights
consistent with those agreements.
• No reimbursement for these
activities (testing or notification of sites
of NCI MATCH eligibility) exists.
Qualified laboratories serving
underserved populations are
encouraged to participate.
How to apply:
1. Submit letter of interest (LOI) as
described above under ‘‘Letter of
Interest and Collaboration Agreement’’
to NCIMATCHLabApps@nih.gov.
2. LOIs will be accepted until January
31, 2018 at 5:00 p.m. Eastern Time. LOIs
will be reviewed on a monthly basis,
with those arriving by the 15th day of
the month being reviewed and answered
by the 15th day of the following month.
3. Notification of acceptance, nonacceptance or questions from Steering
Committee will be sent to the
designated contact person as soon as the
LOI has been reviewed. This
notification will include further
instructions if a full application is
invited.
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4. Applications that have not been
submitted within 3 months of
notification of acceptance will be deactivated, and a new LOI must then be
submitted if the laboratory wishes to
participate in NCI MATCH.
5. DO NOT send a full application
until you are invited to do so.
Review criteria for LOI:
• Laboratory is a CLIA certified or
accredited laboratory within the United
States.
• Academic laboratories must have
NCI MATCH open at their site.
• Laboratory has adequate sensitivity,
specificity.
• Laboratory tests tumor tissue for
rare variants as described in NCI
MATCH.
• Laboratory agrees to provide needed
information for evaluation of the
analytical validity of the test.
• Laboratory is likely to refer at least
100 patients to NCI MATCH based on
detection of rare variants in the past.
• Laboratory agrees to contact sites
regarding NCI MATCH eligibility.
• Laboratory agrees to a collaboration
with NCI as detailed above.
Review criteria for full application:
• Laboratory NGS assay interrogates
inclusionary and all exclusionary
variants for arms in which the
laboratory will participate.
• Laboratory supplies evidence that
the assay meets analytical requirements
as detailed above.
• Laboratories are capable of
contacting clinical sites, tracking
activity, and of referring at least 100
patients to the study based on detection
of rare variants in the past.
• Laboratories agree to execute a
collaboration agreement with NCI, as
well as to data sharing and sharing
publication rights.
• Laboratories agree to abide by the
procedures in place for the MATCH
study and to collaborate fully with the
MATCH team.
For more information, contact
NCIMATCHLabApps@nih.gov.
Dated: July 20, 2017.
James V. Tricoli,
Chief, Diagnostic Biomarkers and Technology
Development Branch, Cancer Diagnosis
Program, Division of Cancer Treatment and
Diagnosis, National Cancer Institute.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2); 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 purpose of this meeting
is to evaluate requests for preclinical
development resources for potential
new therapeutics for the treatment of
cancer. The outcome of the evaluation
will provide information to internal NCI
committees that will decide whether
NCI should support requests and make
available contract resources for
development of the potential
therapeutic to improve the treatment of
various forms of cancer. The research
proposals and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the proposed research projects, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Jun2017
Cycle 26 NExT SEP Committee Meeting.
Date: August 31, 2017.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: To evaluate the NCI Experimental
Therapeutics Program Portfolio.
Place: National Institutes of Health, 9000
Rockville Pike, Building 31, Wing C, 6th
Floor, Conference Room 10, Bethesda, MD
20892.
Contact Persons: Barbara Mroczkowski,
Ph.D., Executive Secretary, Discovery
Experimental Therapeutics Program,
National Cancer Institute, NIH, 31 Center
Drive, Room 3A44, Bethesda, MD 20817
(301) 496–4291, mroczkoskib@mail.nih.gov.
Toby Hecht, Ph.D., Executive Secretary,
Development Experimental Therapeutics
Program, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 3W110,
Rockville, MD 20850, (240) 276–5683,
toby.hecht2@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
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Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
Dated: July 27, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
Dated: July 27, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–16190 Filed 8–1–17; 8:45 am]
[FR Doc. 2017–16191 Filed 8–1–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Substance Abuse and Mental Health
Services Administration
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
sradovich on DSKBCFCHB2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
HIV-Related Comorbidities Systems Biology.
Date: August 25, 2017.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Suite 7180, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Tony L. Creazzo, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7180, Bethesda, MD 20892–7924, 301–827–
7913, creazzotl@mail.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Opportunities for Collaborative Research at
the NIH Clinical Center.
Date: August 30, 2017.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7178, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: William J. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–827–
7938, johnsonwj@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)
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Advisory Committee for Women’s
Services; Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given of a meeting of
the Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
Advisory Committee for Women’s
Services (ACWS) on August 10, 2017.
The meeting will include discussions
on the role of SAMHSA’s Office of the
Chief Medical Officer and emerging
issues for women; a follow-up
discussion on the Office of Women’s
Health Report on Women and Opioids;
the invisibility of American Indian/
American Native women; Legislative
updates, including the Cures Act and
the Comprehensive Addiction Recovery
Act; and a conversation with the Deputy
Assistant Secretary for Mental Health
and Substance Use.
The meeting is open to the public and
will be held at SAMHSA, 5600 Fishers
Lane, Rockville, MD, 20857, in
Conference Room 5E45. Attendance by
the public will be limited to space
available. Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions should be forwarded to the
contact person (below) by August 2,
2017. Oral presentations from the public
will be scheduled at the conclusion of
the meeting. Individuals interested in
making oral presentations are
encouraged to notify the contact person
on or before August 2, 2017. Five
minutes will be allotted for each
presentation.
The meeting may be accessed via
telephone. To attend on site, obtain the
call-in number and access code, submit
written or brief oral comments, or
request special accommodations for
persons with disabilities, please register
on-line at https://nac.samhsa.gov/
Registration/meetingsRegistration.aspx,
or communicate with SAMHSA’s
Designated Federal Officer, Ms. Nadine
Benton (see contact information below).
Substantive meeting information and
a roster of Committee members may be
obtained either by accessing the
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SAMHSA Committees’ Web https://
www.samhsa.gov/about-us/advisorycouncils/meetings, or by contacting Ms.
Benton.
Committee Name: Substance Abuse
and Mental Health Services
Administration Advisory Committee for
Women’s Services (ACWS).
Date/Time/Type: Thursday, August 2,
2017, from: 9:00 a.m. to 4:45 p.m. EDT.
Open:
Place: SAMHSA, 5600 Fishers Lane,
Conference Room 5N76, Rockville,
Maryland 20857.
Contact: Nadine Benton, Designated
Federal Official, SAMHSA’s Advisory
Committee for Women’s Services, 5600
Fishers Lane, Rockville, MD 20857,
Telephone: (240) 276–0127, Fax: (240)
276–2252, Email: nadine.benton@
samhsa.hhs.gov.
Brian Makela,
Chemist, Substance Abuse and Mental Health
Services Administration.
[FR Doc. 2017–16217 Filed 8–1–17; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2017–0105]
Information Collection Request to
Office of Management and Budget;
OMB Control Number: 1625–0002
Coast Guard, DHS.
Sixty-day notice requesting
comments.
AGENCY:
ACTION:
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 for reinstatement, without
change, of the following collection of
information: 1625–0002, Application for
Vessel Inspection, Waiver, and
Continuous Synopsis Record without
change. Our ICR describes the
information we seek to collect from the
public. Before submitting this ICR to
OIRA, the Coast Guard is inviting
comments as described below.
DATES: Comments must reach the Coast
Guard on or before October 2, 2017.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2017–0105] 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
SUMMARY:
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Agencies
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35978-35979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16190]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2); 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 purpose of this meeting is to evaluate requests
for preclinical development resources for potential new therapeutics
for the treatment of cancer. The outcome of the evaluation will provide
information to internal NCI committees that will decide whether NCI
should support requests and make available contract resources for
development of the potential therapeutic to improve the treatment of
various forms of cancer. The research proposals and the discussions
could disclose confidential trade secrets or commercial property such
as patentable material, and personal information concerning individuals
associated with the proposed research projects, the disclosure of which
would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Cancer Institute Special Emphasis
Panel; Jun2017 Cycle 26 NExT SEP Committee Meeting.
Date: August 31, 2017.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: To evaluate the NCI Experimental Therapeutics Program
Portfolio.
Place: National Institutes of Health, 9000 Rockville Pike,
Building 31, Wing C, 6th Floor, Conference Room 10, Bethesda, MD
20892.
Contact Persons: Barbara Mroczkowski, Ph.D., Executive
Secretary, Discovery Experimental Therapeutics Program, National
Cancer Institute, NIH, 31 Center Drive, Room 3A44, Bethesda, MD
20817 (301) 496-4291, mroczkoskib@mail.nih.gov.
Toby Hecht, Ph.D., Executive Secretary, Development Experimental
Therapeutics Program, National Cancer Institute, NIH, 9609 Medical
Center Drive, Room 3W110, Rockville, MD 20850, (240) 276-5683,
toby.hecht2@nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.392,
Cancer Construction; 93.393, Cancer Cause and Prevention Research;
93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer
Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer
Control, National Institutes of Health, HHS)
[[Page 35979]]
Dated: July 27, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-16190 Filed 8-1-17; 8:45 am]
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