82 FR 12977 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 44 (March 8, 2017)

Page Range		12977-12978
FR Document		2017-04500

Federal Register, Volume 82 Issue 44 (Wednesday, March 8, 2017)

[Federal Register Volume 82, Number 44 (Wednesday, March 8, 2017)]
[Notices]
[Pages 12977-12978]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04500]


-----------------------------------------------------------------------

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, 
[email protected].

    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, 
[email protected].

    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, [email protected].

    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, [email protected].

(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

Federal Register / Vol. 82, No. 44 / Wednesday, March 8, 2017 / Notices 12977

SUPPLEMENTARY INFORMATION: Acad Sci U S A. 2011 Aug Name of Committee: Center for Scientific
Technology description follows. 9;108(32):13275–80. [PMID 21788485]. Review Special Emphasis Panel; PAR–16–
2. Srinivasan P, et al. Disrupting 115: Optimization of Monoclonal Antibodies
AMA1–RON2 Complex-Based Vaccine for Eliminating the HIV Reservoir.
Against Malaria malaria parasite AMA1–RON2
Date: March 28, 2017.
interaction with a small molecule
Description of Technology Time: 10:00 a.m. to 1:00 p.m.
prevents erythrocyte invasion. Nat
Agenda: To review and evaluate grant
This technology relates to a malaria Commun. 2013;4:2261. [PMID applications.
vaccine composed of a protein complex 23907321]. Place: National Institutes of Health, 6701
of Apical Membrane Antigen (AMA1) Intellectual Property: HHS Reference Rockledge Drive, Bethesda, MD 20892.
and rhoptry neck protein 2 (RON2) with No. E–066–2013/0—U.S. Provisional Contact Person: Barna Dey, Ph.D.,
an adjuvant. AMA1 is a crucial Application No. 61/841,479 filed 01 Jul Scientific Review Officer, Center for
component of the Plasmodium invasion 2013; PCT Application No. PCT/ Scientific Review, National Institutes of
machinery and is a leading candidate US2014/045065, filed July 1, 2014; Health, 6701 Rockledge Drive, Room 3184,
for antimalarial vaccine development. European Application No. 14742116.8, Bethesda, MD 20892, 301–451–2796, bdey@
AMA1-based vaccines have shown filed July 1, 2014 (pending); U.S. mail.nih.gov.
ability to block red cell invasion in in Application No. 14/902,117, filed Name of Committee: Center for Scientific
vitro assays, but protection has so far August December 30, 2015 (pending); Review Special Emphasis Panel; PAR Panel:
not translated to in vivo human and Chinese Application No. Basic Research on HIV Persistence.
infections. NIAID investigators have 201480037643.1, filed December 31, Date: March 28, 2017.
demonstrated that interaction between 2015 (pending). Time: 1:00 p.m. to 6:00 p.m.
AMA1 and RON2 (or peptide thereof) is Licensing Contact: Peter Tung, 240– Agenda: To review and evaluate grant
applications.
essential for malaria parasites to 669–5483; peter.tung@nih.gov.
Contact Person: National Institutes of
successfully enter human red blood Collaborative Research Opportunity:
Health, 6701 Rockledge Drive, Bethesda, MD
cells (RBCs). Vaccination with un- The National Institute of Allergy and 20892.
complexed AMA1 and RON2 did not Infectious Diseases is seeking statements Contact Person: Barna Dey, Ph.D.,
protect against lethal malaria. However, of capability and interest from parties Scientific Review Officer, Center for
vaccination with a pre-formed AMA1– interested in collaborative research to Scientific Review, National Institutes of
RON2 complex, highlighted in this further develop, evaluate or Health, 6701 Rockledge Drive, Room 3184,
technology, produced antibodies that commercialize AMA1–RON2 vaccine by Bethesda, MD 20892, 301–451–2796, bdey@
protected against lethal malaria in an in providing well established human mail.nih.gov.
vivo mouse model (P. yoelli) and adjuvants and clinical trial funding. For Name of Committee: Center for Scientific
blocked the entry of human malaria collaboration opportunities, please Review Special Emphasis Panel; Member
parasites into RBCs in vitro. contact Peter Tung, 240–669–5483; Conflict: Cancer Research.
Additionally, the inhibitory antibody peter.tung@nih.gov. Date: March 29, 2017.
response induced by the AMA1–RON2 Dated: February 24, 2017. Time: 11:00 a.m. to 6:00 p.m.
complex was greater than AMA1 alone Suzanne Frisbie, Agenda: To review and evaluate grant
or when AMA1 and RON2 proteins applications.
Deputy Director, Technology Transfer and
were administered in a un-complexed Intellectual Property Office, National Institute
Place: National Institutes of Health, 6701
form. Rockledge Drive, Bethesda, MD 20892,
of Allergy and Infectious Diseases.
Immunization using the AMA1–RON2 (Telephone Conference Call).
[FR Doc. 2017–04501 Filed 3–7–17; 8:45 am]
complex of this technology represents a Contact Person: C–L Albert Wang, Ph.D.,
BILLING CODE 4140–01–P Scientific Review Officer, Center for
candidate for an effective malaria
vaccine against multiple Plasmodium Scientific Review, National Institutes of
species. Health, 6701 Rockledge Drive, Room 4146,
DEPARTMENT OF HEALTH AND MSC 7806, Bethesda, MD 20892, 301–435–
This technology is available for HUMAN SERVICES 1016, wangca@csr.nih.gov.
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37 Name of Committee: Center for Scientific
National Institutes of Health
CFR part 404, as well as for further Review Special Emphasis Panel; Member
Center for Scientific Review; Notice of Conflict: Vaccine, Host Defense and
development and evaluation under a
Inflammation.
research collaboration. Closed Meetings
Date: March 29, 2017.
Potential Commercial Applications Pursuant to section 10(d) of the Time: 3:00 p.m. to 7:00 p.m.
Federal Advisory Committee Act, as Agenda: To review and evaluate grant
• Malaria vaccine applications.
amended (5 U.S.C. App.), notice is
Competitive Advantages hereby given of the following meetings. Place: National Institutes of Health, 6705
Rockledge Drive, Bethesda, MD 20817
Lower-cost malarial prevention for The meetings will be closed to the (Telephone Conference Call).
developing/developed countries. public in accordance with the Contact Person: Betty Hayden, Ph.D.,
provisions set forth in sections Scientific Review Officer, Center for
Development Stage
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Scientific Review, National Institutes of
• Early-stage. as amended. The grant applications and Health, 6701 Rockledge Drive, Room 4206,
• In vitro data available. the discussions could disclose
mstockstill on DSK3G9T082PROD with NOTICES

MSC 7812, Bethesda, MD 20892, 301–435–
• In vivo data available (animal). confidential trade secrets or commercial 1223, haydenb@csr.nih.gov.
Inventors: Prakash Srinivasan and property such as patentable material, (Catalogue of Federal Domestic Assistance
Louis Miller (NIAID). and personal information concerning Program Nos. 93.306, Comparative Medicine;
1. Publications: Srinivasan P, et al. individuals associated with the grant 93.333, Clinical Research, 93.306, 93.333,
Binding of Plasmodium merozoite applications, the disclosure of which 93.337, 93.393–93.396, 93.837–93.844,
proteins RON2 and AMA1 triggers would constitute a clearly unwarranted 93.846–93.878, 93.892, 93.893, National
commitment to invasion. Proc Natl invasion of personal privacy. Institutes of Health, HHS)

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12978 Federal Register / Vol. 82, No. 44 / Wednesday, March 8, 2017 / Notices

Dated: March 2, 2017. Contact Person: Ana Olariu, Ph.D., Proposed Project: Notification of Intent
Michelle Trout, Scientific Review Officer, Scientific Review To Use Schedule III, IV, or V Opioid
Program Analyst, Office of Federal Advisory Branch, NINDS/NIH/DHHS, Neuroscience Drugs for the Maintenance and
Committee Policy. Center, 6001 Executive Blvd., Suite 3204, Detoxification Treatment of Opiate
MSC 9529, Bethesda, MD 20892–9529, (301)
[FR Doc. 2017–04500 Filed 3–7–17; 8:45 am] Addiction by a ‘‘Qualifying Other
496–9223, Ana.Olariu@nih.gov.
BILLING CODE 4140–01–P Practitioner’’—(OMB No. 0930–0369)—
(Catalogue of Federal Domestic Assistance
Extension
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854, The Substance Abuse and Mental
DEPARTMENT OF HEALTH AND Biological Basis Research in the Health Services Administration
HUMAN SERVICES Neurosciences, National Institutes of Health, (SAMHSA) is requesting an extension
HHS) from the Office of Management and
National Institutes of Health
Dated: March 1, 2017. Budget (OMB) for approval of the
National Institute of Neurological Sylvia L. Neal, Notification of Intent to Use Schedule
Disorders and Stroke; Notice of Closed Program Analyst, Office of Federal Advisory III, IV, or V Opioid Drugs for the
Meetings Committee Policy. Maintenance and Detoxification
[FR Doc. 2017–04485 Filed 3–7–17; 8:45 am] Treatment of Opiate Addiction by a
Pursuant to section 10(d) of the ‘‘Qualifying Other Practitioner. The
BILLING CODE 4140–01–P
Federal Advisory Committee Act, as Notification of Intent would allow
amended (5 U.S.C. App.), notice is SAMHSA to determine whether other
hereby given of the following meetings. practitioners are eligible to prescribe
The meetings will be closed to the DEPARTMENT OF HEALTH AND
HUMAN SERVICES certain approved narcotic treatment
public in accordance with the medications for the maintenance or
provisions set forth in sections Substance Abuse and Mental Health detoxification treatment of opioid
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Services Administration addiction.
as amended. The grant applications and This Notification of Intent is a result
the discussions could disclose Agency Information Collection of the Comprehensive Addiction and
confidential trade secrets or commercial Activities: Proposed Collection; Recovery Act (PL 114–198), which was
property such as patentable material, Comment Request signed into law on July 22, 2016. The
and personal information concerning law establishes criteria for nurse
individuals associated with the grant In compliance with Section practitioners (NPs) and physician
applications, the disclosure of which 3506(c)(2)(A) of the Paperwork assistants (PAs) to qualify for a waiver
would constitute a clearly unwarranted Reduction Act of 1995 concerning to prescribe covered medications. To be
invasion of personal privacy. opportunity for public comment on eligible for a waiver, the NP or PA must:
Name of Committee: National Institute of proposed collections of information, the Be licensed under State law to prescribe
Neurological Disorders and Stroke Special Substance Abuse and Mental Health schedule III, IV, or V medications for the
Emphasis Panel; Program Project Grant P01. Services Administration (SAMHSA) treatment of pain; fulfill qualification
Date: March 24, 2017. will publish periodic summaries of
Time: 11:00 a.m. to 6:00 p.m.
requirements in the law for training and
proposed projects. To request more experience; and fulfill qualification
Agenda: To review and evaluate grant
information on the proposed projects or requirements in the law for appropriate
applications.
Place: National Institutes of Health, to obtain a copy of the information supervision by a qualifying physician.
Neuroscience Center, 6001 Executive collection plans, call the SAMHSA SAMHSA has the responsibility to
Boulevard, Rockville, MD 20852, (Video Reports Clearance Officer on (240) 276– receive, review, approve, or deny waiver
Conference Meeting). 1243. requests.
Contact Person: Ana Olariu, Ph.D., Comments are invited on: (a) Whether Practitioners who meet the statutory
Scientific Review Officer, Scientific Review
Branch, NINDS/NIH/DHHS, Neuroscience the proposed collections of information requirements will be eligible to
Center, 6001 Executive Blvd., Suite 3204, are necessary for the proper prescribe only those opioid treatment
MSC 9529, Bethesda, MD 20892–9529, (301) performance of the functions of the medications that are controlled in
496–9223, Ana.Olariu@nih.gov. agency, including whether the Schedules III, IV, or V, under the
Name of Committee: National Institute of information shall have practical utility; Controlled Substance Act (CSA), that
Neurological Disorder and Stroke, Special (b) the accuracy of the agency’s estimate are specifically approved by the Food
Emphasis Panel; R21: Rapid Assessment of of the burden of the proposed collection and Drug Administration (FDA) for the
Zika Virus (ZIKV) Complications. of information; (c) ways to enhance the treatment of opioid addiction, and are
Date: April 5, 2017. quality, utility, and clarity of the not the subject of an ‘‘adverse
Time: 11:00 a.m. to 4:00 p.m. determination.’’ The only medications
information to be collected; and (d)
Agenda: To review and evaluate grant
applications. ways to minimize the burden of the that currently fulfill these requirements
Place: National Institutes of Health, collection of information on are ones that contain the active
Neuroscience Center, 6001 Executive respondents, including through the use ingredient buprenorphine.
Boulevard, Rockville, MD 20852, (Telephone of automated collection techniques or The following table is the estimated
Conference Call). other forms of information technology. hour burden:
mstockstill on DSK3G9T082PROD with NOTICES

Number of Responses/ Total burden
Purpose of submission Burden hours
respondents respondent hours

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 .................................................................. 816 1 .066 54

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Document Created: 2017-03-08 05:06:40
Document Modified: 2017-03-08 05:06:40

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		March 28, 2017.
FR Citation		82 FR 12977

82 FR 12977 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 44 (March 8, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health