82 FR 35978 - National Cancer Institute; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 147 (August 2, 2017)

Page Range		35978-35979
FR Document		2017-16190

Federal Register, Volume 82 Issue 147 (Wednesday, August 2, 2017)

[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35978-35979]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

    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, 
[email protected].

(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]
 BILLING CODE 4140-01-P

35978 Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices

template to identify aMOIs for 4. Applications that have not been DEPARTMENT OF HEALTH AND
submission to MATCHbox. submitted within 3 months of HUMAN SERVICES
Æ Laboratory results of NGS assays done notification of acceptance will be de-
for clinical care will be the subject of activated, and a new LOI must then be National Institutes of Health
this initiative. There is no funding for submitted if the laboratory wishes to
‘‘screening’’ a patient for MATCH. National Cancer Institute; Notice of
participate in NCI MATCH.
Æ Laboratories must notify NCI MATCH Closed Meeting
5. DO NOT send a full application
sites that the laboratory results would
until you are invited to do so. Pursuant to section 10(d) of the
potentially allow the patient to be
Review criteria for LOI: Federal Advisory Committee Act, as
eligible for NCI MATCH.
Æ Laboratories must track how many amended (5 U.S.C. Appendix 2); notice
• Laboratory is a CLIA certified or is hereby given of the following
assays per week detect rare variants accredited laboratory within the United
that could make a patient eligible for meeting.
States. The meeting will be closed to the
NCI MATCH.
Æ If the clinician presents the • Academic laboratories must have public in accordance with the
MATCH study and the patient is NCI MATCH open at their site. provisions set forth in sections 552b(c)
eligible and desires to enter the • Laboratory has adequate sensitivity, (4) and 552b(c) (6), Title 5 U.S.C., as
study, the laboratory must agree to specificity. amended. The purpose of this meeting
fill out a spreadsheet that can be is to evaluate requests for preclinical
• Laboratory tests tumor tissue for development resources for potential
used to put the results into the
rare variants as described in NCI new therapeutics for the treatment of
informatics system that assigns
treatment in NCI MATCH MATCH. cancer. The outcome of the evaluation
(MATCHbox). • Laboratory agrees to provide needed will provide information to internal NCI
Æ Laboratories must have a way to information for evaluation of the committees that will decide whether
answer questions from NCI MATCH analytical validity of the test. NCI should support requests and make
sites about their assay and must • Laboratory is likely to refer at least available contract resources for
have a contact person for optimal development of the potential
100 patients to NCI MATCH based on
communication with the NCI therapeutic to improve the treatment of
detection of rare variants in the past.
MATCH team. various forms of cancer. The research
• Prior to participation, laboratories • Laboratory agrees to contact sites proposals and the discussions could
must enter into a collaboration regarding NCI MATCH eligibility. disclose confidential trade secrets or
agreement with NCI. A sample • Laboratory agrees to a collaboration commercial property such as patentable
agreement is available upon request. As with NCI as detailed above. material, and personal information
part of such a collaboration agreement, concerning individuals associated with
laboratories must agree to provide the Review criteria for full application:
the proposed research projects, the
licensing rights described in the CTEP • Laboratory NGS assay interrogates disclosure of which would constitute a
IP Option to the Pharmaceutical inclusionary and all exclusionary clearly unwarranted invasion of
Collaborators who provided agents for variants for arms in which the personal privacy.
the NCI MATCH trial (https:// laboratory will participate. Name of Committee: National Cancer
ctep.cancer.gov/branches/rab/ • Laboratory supplies evidence that Institute Special Emphasis Panel; Jun2017
intellectual_property_optionto_ the assay meets analytical requirements Cycle 26 NExT SEP Committee Meeting.
collaborators.htm), as well as agree to as detailed above. Date: August 31, 2017.
the data sharing and publication rights Time: 8:30 a.m. to 4:30 p.m.
consistent with those agreements. • Laboratories are capable of Agenda: To evaluate the NCI Experimental
• No reimbursement for these contacting clinical sites, tracking Therapeutics Program Portfolio.
activities (testing or notification of sites activity, and of referring at least 100 Place: National Institutes of Health, 9000
of NCI MATCH eligibility) exists. patients to the study based on detection Rockville Pike, Building 31, Wing C, 6th
Floor, Conference Room 10, Bethesda, MD
Qualified laboratories serving of rare variants in the past. 20892.
underserved populations are • Laboratories agree to execute a Contact Persons: Barbara Mroczkowski,
encouraged to participate. collaboration agreement with NCI, as Ph.D., Executive Secretary, Discovery
How to apply: Experimental Therapeutics Program,
1. Submit letter of interest (LOI) as well as to data sharing and sharing
National Cancer Institute, NIH, 31 Center
described above under ‘‘Letter of publication rights.
Drive, Room 3A44, Bethesda, MD 20817
Interest and Collaboration Agreement’’ • Laboratories agree to abide by the (301) 496–4291, mroczkoskib@mail.nih.gov.
to NCIMATCHLabApps@nih.gov. procedures in place for the MATCH Toby Hecht, Ph.D., Executive Secretary,
2. LOIs will be accepted until January study and to collaborate fully with the Development Experimental Therapeutics
31, 2018 at 5:00 p.m. Eastern Time. LOIs MATCH team. Program, National Cancer Institute, NIH,
will be reviewed on a monthly basis, 9609 Medical Center Drive, Room 3W110,
For more information, contact Rockville, MD 20850, (240) 276–5683,
with those arriving by the 15th day of
NCIMATCHLabApps@nih.gov. toby.hecht2@nih.gov.
the month being reviewed and answered
by the 15th day of the following month. Dated: July 20, 2017. (Catalogue of Federal Domestic Assistance
3. Notification of acceptance, non- Program Nos. 93.392, Cancer Construction;
sradovich on DSKBCFCHB2PROD with NOTICES

James V. Tricoli,
acceptance or questions from Steering 93.393, Cancer Cause and Prevention
Chief, Diagnostic Biomarkers and Technology Research; 93.394, Cancer Detection and
Committee will be sent to the Development Branch, Cancer Diagnosis Diagnosis Research; 93.395, Cancer
designated contact person as soon as the Program, Division of Cancer Treatment and Treatment Research; 93.396, Cancer Biology
LOI has been reviewed. This Diagnosis, National Cancer Institute. Research; 93.397, Cancer Centers Support;
notification will include further [FR Doc. 2017–16203 Filed 8–1–17; 8:45 am] 93.398, Cancer Research Manpower; 93.399,
instructions if a full application is BILLING CODE 4140–01–P
Cancer Control, National Institutes of Health,
invited. HHS)

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Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices 35979

Dated: July 27, 2017. Dated: July 27, 2017. SAMHSA Committees’ Web https://
Melanie J. Pantoja, Michelle Trout, www.samhsa.gov/about-us/advisory-
Program Analyst, Office of Federal Advisory Program Analyst, Office of Federal Advisory councils/meetings, or by contacting Ms.
Committee Policy. Committee Policy. Benton.
[FR Doc. 2017–16190 Filed 8–1–17; 8:45 am] [FR Doc. 2017–16191 Filed 8–1–17; 8:45 am] Committee Name: Substance Abuse
BILLING CODE 4140–01–P BILLING CODE 4140–01–P and Mental Health Services
Administration Advisory Committee for
Women’s Services (ACWS).
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Date/Time/Type: Thursday, August 2,
HUMAN SERVICES HUMAN SERVICES 2017, from: 9:00 a.m. to 4:45 p.m. EDT.
Open:
National Institutes of Health Substance Abuse and Mental Health Place: SAMHSA, 5600 Fishers Lane,
Services Administration Conference Room 5N76, Rockville,
National Heart, Lung, and Blood Maryland 20857.
Institute; Notice of Closed Meetings Advisory Committee for Women’s Contact: Nadine Benton, Designated
Pursuant to section 10(d) of the Services; Notice of Meeting Federal Official, SAMHSA’s Advisory
Federal Advisory Committee Act, as Committee for Women’s Services, 5600
Pursuant to Public Law 92–463,
amended (5 U.S.C. App.), notice is Fishers Lane, Rockville, MD 20857,
notice is hereby given of a meeting of
hereby given of the following meetings. Telephone: (240) 276–0127, Fax: (240)
the Substance Abuse and Mental Health
The meetings will be closed to the 276–2252, Email: nadine.benton@
Services Administration’s (SAMHSA)
public in accordance with the samhsa.hhs.gov.
Advisory Committee for Women’s
provisions set forth in sections Services (ACWS) on August 10, 2017. Brian Makela,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., The meeting will include discussions Chemist, Substance Abuse and Mental Health
as amended. The grant applications and on the role of SAMHSA’s Office of the Services Administration.
the discussions could disclose Chief Medical Officer and emerging [FR Doc. 2017–16217 Filed 8–1–17; 8:45 am]
confidential trade secrets or commercial issues for women; a follow-up BILLING CODE 4162–20–P
property such as patentable material, discussion on the Office of Women’s
and personal information concerning Health Report on Women and Opioids;
individuals associated with the grant the invisibility of American Indian/ DEPARTMENT OF HOMELAND
applications, the disclosure of which American Native women; Legislative SECURITY
would constitute a clearly unwarranted updates, including the Cures Act and
invasion of personal privacy. the Comprehensive Addiction Recovery Coast Guard
Name of Committee: National Heart, Lung, Act; and a conversation with the Deputy
and Blood Institute Special Emphasis Panel; [Docket No. USCG–2017–0105]
Assistant Secretary for Mental Health
HIV-Related Comorbidities Systems Biology. and Substance Use.
Date: August 25, 2017. Information Collection Request to
The meeting is open to the public and Office of Management and Budget;
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
will be held at SAMHSA, 5600 Fishers OMB Control Number: 1625–0002
applications. Lane, Rockville, MD, 20857, in
Place: National Institutes of Health, 6701 Conference Room 5E45. Attendance by AGENCY:Coast Guard, DHS.
Rockledge Drive, Suite 7180, Bethesda, MD the public will be limited to space Sixty-day notice requesting
ACTION:
20892 (Telephone Conference Call). available. Interested persons may comments.
Contact Person: Tony L. Creazzo, Ph.D., present data, information, or views,
Scientific Review Officer, Office of Scientific orally or in writing, on issues pending SUMMARY: In compliance with the
Review/DERA National Heart, Lung, and Paperwork Reduction Act of 1995, the
before the committee. Written
Blood Institute, 6701 Rockledge Drive, Room U.S. Coast Guard intends to submit an
7180, Bethesda, MD 20892–7924, 301–827– submissions should be forwarded to the
contact person (below) by August 2, Information Collection Request (ICR) to
7913, creazzotl@mail.nih.gov.
2017. Oral presentations from the public the Office of Management and Budget
Name of Committee: National Heart, Lung, (OMB), Office of Information and
and Blood Institute Special Emphasis Panel; will be scheduled at the conclusion of
Opportunities for Collaborative Research at the meeting. Individuals interested in Regulatory Affairs (OIRA), requesting
the NIH Clinical Center. making oral presentations are approval for reinstatement, without
Date: August 30, 2017. encouraged to notify the contact person change, of the following collection of
Time: 1:00 p.m. to 5:00 p.m. on or before August 2, 2017. Five information: 1625–0002, Application for
Agenda: To review and evaluate grant minutes will be allotted for each Vessel Inspection, Waiver, and
applications. Continuous Synopsis Record without
Place: National Institutes of Health, 6701
presentation.
The meeting may be accessed via change. Our ICR describes the
Rockledge Drive, Room 7178, Bethesda, MD information we seek to collect from the
20892 (Telephone Conference Call). telephone. To attend on site, obtain the
Contact Person: William J. Johnson, Ph.D., call-in number and access code, submit public. Before submitting this ICR to
Scientific Review Officer, Office of Scientific written or brief oral comments, or OIRA, the Coast Guard is inviting
Review/DERA, National Heart, Lung, and request special accommodations for comments as described below.
Blood Institute, 6701 Rockledge Drive, Room persons with disabilities, please register DATES: Comments must reach the Coast
7178, Bethesda, MD 20892–7924, 301–827– on-line at http://nac.samhsa.gov/ Guard on or before October 2, 2017.
sradovich on DSKBCFCHB2PROD with NOTICES

7938, johnsonwj@nhlbi.nih.gov.
Registration/meetingsRegistration.aspx, ADDRESSES: You may submit comments
(Catalogue of Federal Domestic Assistance or communicate with SAMHSA’s identified by Coast Guard docket
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Designated Federal Officer, Ms. Nadine number [USCG–2017–0105] to the Coast
Vascular Diseases Research; 93.838, Lung Benton (see contact information below). Guard using the Federal eRulemaking
Diseases Research; 93.839, Blood Diseases Substantive meeting information and Portal at http://www.regulations.gov.
and Resources Research, National Institutes a roster of Committee members may be See the ‘‘Public participation and
of Health, HHS) obtained either by accessing the request for comments’’ portion of the

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Document Created: 2017-08-02 07:09:33
Document Modified: 2017-08-02 07:09:33

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		August 31, 2017.
FR Citation		82 FR 35978

82 FR 35978 - National Cancer Institute; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 147 (August 2, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health