Office of the Director, National Institutes of Health; Notice of Meeting, 39197-39198 [2020-14023]

Download as PDF Federal Register / Vol. 85, No. 126 / Tuesday, June 30, 2020 / Notices Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Time-Sensitive Obesity. Date: July 29, 2020. Time: 1:00 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Video Meeting). Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, Division of Extramural Activities, NIDDK, National Institutes of Health, Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, (301) 594–8898, barnardm@ extra.niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: June 25, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–14059 Filed 6–29–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings khammond on DSKJM1Z7X2PROD with NOTICES 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–RM– 20–003 Real-Time Chromatin Dynamics and Function. Date: July 9, 2020. Time: 1:00 p.m. to 2:30 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: Charles Selden, Ph.D., Scientific Review Officer, Center for VerDate Sep<11>2014 18:18 Jun 29, 2020 Jkt 250001 Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5187, MSC 7840, Bethesda, MD 20892, (301) 451– 3388. seldens@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cognitive, Behavioral and Neuroimaging Signatures in Neurological Disorders. Date: July 23, 2020. Time: 8:30 a.m. to 6:00 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: Seetha Bhagavan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5194, MSC 7846, Bethesda, MD 20892, (301) 237– 9838, bhagavas@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Mechanisms of Disparities in Lung Cancer. Date: July 23, 2020. Time: 11:00 a.m. to 5:00 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: Kate Fothergill, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3142, MSC 7770, Bethesda, MD 20892, (301) 435– 2309, fothergillke@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Emotions, Sleep, Stress, Health, and Psychopathology. Date: July 23, 2020. Time: 2:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Katherine Colona Morasch, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3170, MSC 7848, Bethesda, MD 20892, (301) 594– 9147 moraschkc@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Molecular Immunology. Date: July 24, 2020. Time: 11:00 a.m. to 1:00 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: David B Winter, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4204, MSC 7812, Bethesda, MD 20892, (301) 435– 1152, dwinter@csr.nih.gov. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 39197 (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: June 24, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–14020 Filed 6–29–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, July 20, 2020, 11:00 a.m. to July 20, 2020, 04:00 p.m., National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal Register on June 23, 2020, 85 FR 37684. This notice is being amended to change the meeting time from 11:00 a.m. to 4:00 p.m. to 12:15 p.m. to 5:00 p.m. The meeting is closed to the public. Dated: June 24, 2020. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–14021 Filed 6–29–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the NIH Clinical Center Research Hospital Board. The meeting will be held virtually and is open to the public. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting, should notify the Contact Person listed below in advance of the meeting. Name of Committee: NIH Clinical Center Research Hospital Board. Date: July 17, 2020. Time: 9:00 a.m. to 1:00 p.m. E:\FR\FM\30JNN1.SGM 30JNN1 39198 Federal Register / Vol. 85, No. 126 / Tuesday, June 30, 2020 / Notices Agenda: Discussion of Patient Safety and Clinical Quality, Activities Regarding Novel Coronavirus, and Facility Planning. Place: National Institutes of Health, Building 1, One Center Drive, 9000 Rockville Pike, Bethesda, MD 20892 (Virtual Meeting). Virtual Access: The meeting will be videocast and can be accessed from the NIH Videocast https://videocast.nih.gov/ and the CCRHB website https://ccrhb.od.nih.gov/ meetings.html. Contact Person: Gretchen Wood, Staff Assistant, National Institutes of Health, Office of the Director, One Center Drive, Building 1, Room 126, Bethesda, MD 20892, 301–496–4272, woodgs@od.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) Dated: June 24, 2020. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–14023 Filed 6–29–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Request for Letters of Interest (LOI) for Pediatric Focused NCI-MATCH Laboratories AGENCY: National Institutes of Health, HHS. ACTION: Notice; extension. The National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) is developing a successor precision medicine trial to ‘NCI-Molecular Analysis for Therapy Choice (NCI-MATCH)’ entitled ‘NCIComboMATCH’. The principal of this intiative is to overcome drug resistance to single-agent therapy by developing genomically-directed targeted agent combinations. All combinations must be supported by robust, preclinical in vivo evidence. Due to the coronavirus pandemic the NCI is providing an extension of the previously published notice in the Federal Register on March khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:18 Jun 29, 2020 Jkt 250001 11, 2020, to allow candidate more time to submit LOIs. DATES: The due date for Letters Of Interest (LOIs) has been extended and should now be submitted to the National Cancer Institute (NCI), National Institutes of Health (NIH) on or before 5:00 p.m. EST on September 30, 2020. ADDRESSES: Submit LOIs by email to NCICOMBOMATCHLabApps@nih.gov. 9609 Medical Center Drive, 3 West, Room 526, MSC 9728, Rockville, MD 20892. FOR FURTHER INFORMATION CONTACT: Questions about this request for LOIs should be directed to NCICOMBOMATCHLabApps@nih.gov. James V. Tricoli, at 240–276–5725 or tricolij@mail.nih.gov, can also provide further information. SUPPLEMENTARY INFORMATION: NCIComboMATCH trial leadership invites applications for Clinical Laboratory Improvements Program (CLIA) certified/ accredited laboratories that test tumor specimens from patients utilizing NextGeneration Sequencing (NGS) assays to participate in the NCI-ComboMATCH trial. In order to support this trial, the designated laboratories participating in NCI-ComboMATCH will identify patients for the specific variants needed for trial eligibility. Laboratories will be required to contact any of the NCTN sites that have activated NCIComboMATCH if a specimen sent from one of these sites has a variant(s) that would potentially make the patient eligible for one of the treatment arms. This notice was previously published in the Federal Register on March 11, 2020, page 14208–14210 (85 FR 14208). The purpose of this notice is to allow an additional 90 days for submission of the LOI. The due date for LOI submission has been extended from the previous date of June 30, 2020 to September 30, 2020 to allow more labs to submit. This is necessary due to the impact of the coronavirus pandemic. In accordance with 42 U.S.C. 285, of the Public Health Service Act, as amended. Similar to NCI-MATCH, NCI-ComboMATCH is conceived as a signal-seeking study. The NCI-ComboMATCH team will determine whether patients with tumor mutations, amplifications or translocations in the genetic pathway(s) of interest are likely to derive clinical benefit if treated with a combination of precision medicine agents targeting those specific pathway(s). This recruitment is for pediatric focused labs that can specifically screen 250 pediatric patients seen at NCTN sites per month. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Patients with histologically documented solid tumors, lymphomas and multiple myeloma whose disease has progressed following at least one line of standard systemic therapy or for whom no standard therapy exists are eligible if they meet the eligibility criteria for the trial. The selected collaborating outside laboratories may only act (i.e., refer patients) on any of the variant arms for which their assay reports actionable mutations of interest (aMOIs). The assay must also report all exclusionary variants for the arm unless these occur at a frequency of <1% in cancer patients. Only CLIA accredited/certified laboratories located in the United States may be considered for addition to the laboratory network. Letter of Interest (LOI) and Confidentiality Agreement Candidate laboratories should submit a letter of interest to NCICOMBOMATCHLabApps@nih.gov stating: • Statement of interest in the proposed activity • Laboratory name • Lead contact name, address, email address, and telephone number • CLIA certification number • Assay name • Brief description of assay Æ Sensitivity and specificity for SNVs, indels, CNV, fusions Æ Method of analysis Æ Platform and variant calling • Number of assays on pediatric patients per month • Number assays on patients seen at NCTN study sites per month • What other CLIA approved/certified tests have been validated in your laboratory? • Willingness to contact sites regarding results with a potentially eligible for NCI-ComboMATCH • Willingness to sign a collaboration agreement with NCI (https:// ctep.cancer.gov/branches/rab/ intellectual_property_option_to_ collaborators.htm) and to share data and publication rights Following an acceptable eligibility review to the NCI-ComboMATCH screening committee, the laboratory would execute a confidentiality agreement with the NCI and will be provided with a detailed list of eligibility and exclusion variants for arms (approved at that time). The lab would then be required to submit an application within 2 months for review by the NCI-ComboMATCH review committee. Candidate laboratories will E:\FR\FM\30JNN1.SGM 30JNN1

Agencies

[Federal Register Volume 85, Number 126 (Tuesday, June 30, 2020)]
[Notices]
[Pages 39197-39198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Director, National Institutes of Health; Notice of 
Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of a meeting of the NIH Clinical Center 
Research Hospital Board.
    The meeting will be held virtually and is open to the public. 
Individuals who plan to view the virtual meeting and need special 
assistance or other reasonable accommodations to view the meeting, 
should notify the Contact Person listed below in advance of the 
meeting.

    Name of Committee: NIH Clinical Center Research Hospital Board.
    Date: July 17, 2020.
    Time: 9:00 a.m. to 1:00 p.m.

[[Page 39198]]

    Agenda: Discussion of Patient Safety and Clinical Quality, 
Activities Regarding Novel Coronavirus, and Facility Planning.
    Place: National Institutes of Health, Building 1, One Center 
Drive, 9000 Rockville Pike, Bethesda, MD 20892 (Virtual Meeting).
    Virtual Access: The meeting will be videocast and can be 
accessed from the NIH Videocast https://videocast.nih.gov/ and the 
CCRHB website https://ccrhb.od.nih.gov/meetings.html.
    Contact Person: Gretchen Wood, Staff Assistant, National 
Institutes of Health, Office of the Director, One Center Drive, 
Building 1, Room 126, Bethesda, MD 20892, 301-496-4272, 
[email protected].
    Any interested person may file written comments with the 
committee by forwarding the statement to the Contact Person listed 
on this notice. The statement should include the name, address, 
telephone number and when applicable, the business or professional 
affiliation of the interested person.

(Catalogue of Federal Domestic Assistance Program Nos. 93.14, 
Intramural Research Training Award; 93.22, Clinical Research Loan 
Repayment Program for Individuals from Disadvantaged Backgrounds; 
93.232, Loan Repayment Program for Research Generally; 93.39, 
Academic Research Enhancement Award; 93.936, NIH Acquired 
Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, 
Undergraduate Scholarship Program for Individuals from Disadvantaged 
Backgrounds, National Institutes of Health, HHS)

    Dated: June 24, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-14023 Filed 6-29-20; 8:45 am]
BILLING CODE 4140-01-P

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