Center for Scientific Review; Notice of Closed Meetings, 12977-12978 [2017-04500]

Download as PDF Federal Register / Vol. 82, No. 44 / Wednesday, March 8, 2017 / Notices SUPPLEMENTARY INFORMATION: Technology description follows. AMA1–RON2 Complex-Based Vaccine Against Malaria Description of Technology This technology relates to a malaria vaccine composed of a protein complex of Apical Membrane Antigen (AMA1) and rhoptry neck protein 2 (RON2) with an adjuvant. AMA1 is a crucial component of the Plasmodium invasion machinery and is a leading candidate for antimalarial vaccine development. AMA1-based vaccines have shown ability to block red cell invasion in in vitro assays, but protection has so far not translated to in vivo human infections. NIAID investigators have demonstrated that interaction between AMA1 and RON2 (or peptide thereof) is essential for malaria parasites to successfully enter human red blood cells (RBCs). Vaccination with uncomplexed AMA1 and RON2 did not protect against lethal malaria. However, vaccination with a pre-formed AMA1– RON2 complex, highlighted in this technology, produced antibodies that protected against lethal malaria in an in vivo mouse model (P. yoelli) and blocked the entry of human malaria parasites into RBCs in vitro. Additionally, the inhibitory antibody response induced by the AMA1–RON2 complex was greater than AMA1 alone or when AMA1 and RON2 proteins were administered in a un-complexed form. Immunization using the AMA1–RON2 complex of this technology represents a candidate for an effective malaria vaccine against multiple Plasmodium species. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration. Potential Commercial Applications • Malaria vaccine Competitive Advantages Lower-cost malarial prevention for developing/developed countries. mstockstill on DSK3G9T082PROD with NOTICES Development Stage • Early-stage. • In vitro data available. • In vivo data available (animal). Inventors: Prakash Srinivasan and Louis Miller (NIAID). 1. Publications: Srinivasan P, et al. Binding of Plasmodium merozoite proteins RON2 and AMA1 triggers commitment to invasion. Proc Natl VerDate Sep<11>2014 17:34 Mar 07, 2017 Jkt 241001 Acad Sci U S A. 2011 Aug 9;108(32):13275–80. [PMID 21788485]. 2. Srinivasan P, et al. Disrupting malaria parasite AMA1–RON2 interaction with a small molecule prevents erythrocyte invasion. Nat Commun. 2013;4:2261. [PMID 23907321]. Intellectual Property: HHS Reference No. E–066–2013/0—U.S. Provisional Application No. 61/841,479 filed 01 Jul 2013; PCT Application No. PCT/ US2014/045065, filed July 1, 2014; European Application No. 14742116.8, filed July 1, 2014 (pending); U.S. Application No. 14/902,117, filed August December 30, 2015 (pending); and Chinese Application No. 201480037643.1, filed December 31, 2015 (pending). Licensing Contact: Peter Tung, 240– 669–5483; peter.tung@nih.gov. Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability and interest from parties interested in collaborative research to further develop, evaluate or commercialize AMA1–RON2 vaccine by providing well established human adjuvants and clinical trial funding. For collaboration opportunities, please contact Peter Tung, 240–669–5483; peter.tung@nih.gov. Dated: February 24, 2017. Suzanne Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2017–04501 Filed 3–7–17; 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 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. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 12977 Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR–16– 115: Optimization of Monoclonal Antibodies for Eliminating the HIV Reservoir. Date: March 28, 2017. Time: 10:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Barna Dey, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3184, Bethesda, MD 20892, 301–451–2796, bdey@ mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Basic Research on HIV Persistence. Date: March 28, 2017. Time: 1:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Contact Person: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Barna Dey, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3184, Bethesda, MD 20892, 301–451–2796, bdey@ mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cancer Research. Date: March 29, 2017. Time: 11:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: C–L Albert Wang, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4146, MSC 7806, Bethesda, MD 20892, 301–435– 1016, wangca@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Vaccine, Host Defense and Inflammation. Date: March 29, 2017. Time: 3:00 p.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6705 Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: Betty Hayden, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4206, MSC 7812, Bethesda, MD 20892, 301–435– 1223, haydenb@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) E:\FR\FM\08MRN1.SGM 08MRN1 12978 Federal Register / Vol. 82, No. 44 / Wednesday, March 8, 2017 / Notices Dated: March 2, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–04500 Filed 3–7–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings 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. mstockstill on DSK3G9T082PROD with NOTICES Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Program Project Grant P01. Date: March 24, 2017. Time: 11:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Video Conference Meeting). Contact Person: Ana Olariu, Ph.D., Scientific Review Officer, Scientific Review Branch, NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., Suite 3204, MSC 9529, Bethesda, MD 20892–9529, (301) 496–9223, Ana.Olariu@nih.gov. Name of Committee: National Institute of Neurological Disorder and Stroke, Special Emphasis Panel; R21: Rapid Assessment of Zika Virus (ZIKV) Complications. Date: April 5, 2017. Time: 11:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Ana Olariu, Ph.D., Scientific Review Officer, Scientific Review Branch, NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., Suite 3204, MSC 9529, Bethesda, MD 20892–9529, (301) 496–9223, Ana.Olariu@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: March 1, 2017. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–04485 Filed 3–7–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276– 1243. Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Number of respondents Purpose of submission Notification of Intent for Qualifying Other Practitioner to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction by a ‘‘Qualifying Other Practitioner’’ under 21 USC § 823(g)(2)—Nurse Practitioners .................................................................. VerDate Sep<11>2014 17:34 Mar 07, 2017 Jkt 241001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Proposed Project: Notification of Intent To Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction by a ‘‘Qualifying Other Practitioner’’—(OMB No. 0930–0369)— Extension The Substance Abuse and Mental Health Services Administration (SAMHSA) is requesting an extension from the Office of Management and Budget (OMB) for approval of the Notification of Intent to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction by a ‘‘Qualifying Other Practitioner. The Notification of Intent would allow SAMHSA to determine whether other practitioners are eligible to prescribe certain approved narcotic treatment medications for the maintenance or detoxification treatment of opioid addiction. This Notification of Intent is a result of the Comprehensive Addiction and Recovery Act (PL 114–198), which was signed into law on July 22, 2016. The law establishes criteria for nurse practitioners (NPs) and physician assistants (PAs) to qualify for a waiver to prescribe covered medications. To be eligible for a waiver, the NP or PA must: Be licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain; fulfill qualification requirements in the law for training and experience; and fulfill qualification requirements in the law for appropriate supervision by a qualifying physician. SAMHSA has the responsibility to receive, review, approve, or deny waiver requests. Practitioners who meet the statutory requirements will be eligible to prescribe only those opioid treatment medications that are controlled in Schedules III, IV, or V, under the Controlled Substance Act (CSA), that are specifically approved by the Food and Drug Administration (FDA) for the treatment of opioid addiction, and are not the subject of an ‘‘adverse determination.’’ The only medications that currently fulfill these requirements are ones that contain the active ingredient buprenorphine. The following table is the estimated hour burden: Responses/ respondent 816 E:\FR\FM\08MRN1.SGM Burden hours 1 08MRN1 .066 Total burden hours 54

Agencies

[Federal Register Volume 82, Number 44 (Wednesday, March 8, 2017)]
[Notices]
[Pages 12977-12978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04500]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meetings

    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: Center for Scientific Review Special Emphasis 
Panel; PAR-16-115: Optimization of Monoclonal Antibodies for 
Eliminating the HIV Reservoir.
    Date: March 28, 2017.
    Time: 10:00 a.m. to 1:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892.
    Contact Person: Barna Dey, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 3184, Bethesda, MD 20892, 301-451-2796, 
bdey@mail.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; PAR Panel: Basic Research on HIV Persistence.
    Date: March 28, 2017.
    Time: 1:00 p.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Contact Person: National Institutes of Health, 6701 Rockledge 
Drive, Bethesda, MD 20892.
    Contact Person: Barna Dey, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 3184, Bethesda, MD 20892, 301-451-2796, 
bdey@mail.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Cancer Research.
    Date: March 29, 2017.
    Time: 11:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892, (Telephone Conference Call).
    Contact Person: C-L Albert Wang, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4146, MSC 7806, Bethesda, MD 
20892, 301-435-1016, wangca@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Vaccine, Host Defense and Inflammation.
    Date: March 29, 2017.
    Time: 3:00 p.m. to 7:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6705 Rockledge Drive, 
Bethesda, MD 20817 (Telephone Conference Call).
    Contact Person: Betty Hayden, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 4206, MSC 7812, Bethesda, MD 20892, 301-435-
1223, haydenb@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)


[[Page 12978]]


    Dated: March 2, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-04500 Filed 3-7-17; 8:45 am]
BILLING CODE 4140-01-P