National Cancer Institute; Notice of Closed Meeting, 35978-35979 [2017-16190]

Download as PDF sradovich on DSKBCFCHB2PROD with NOTICES 35978 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. VerDate Sep<11>2014 19:43 Aug 01, 2017 Jkt 241001 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. [FR Doc. 2017–16203 Filed 8–1–17; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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) E:\FR\FM\02AUN1.SGM 02AUN1 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] BILLING CODE 4140–01–P BILLING CODE 4140–01–P 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) VerDate Sep<11>2014 19:43 Aug 01, 2017 Jkt 241001 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 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 35979 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] BILLING CODE 4162–20–P 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: E:\FR\FM\02AUN1.SGM 02AUN1

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]
 BILLING CODE 4140-01-P
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