80_FR_79297 80 FR 79054 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings

80 FR 79054 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 243 (December 18, 2015)

Page Range79054-79055
FR Document2015-31769

Federal Register, Volume 80 Issue 243 (Friday, December 18, 2015)
[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)]
[Notices]
[Pages 79054-79055]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31769]


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

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

[[Page 79055]]

would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Neurological Disorders 
and Stroke Initial Review Group; Neurological Sciences and Disorders 
A.
    Date: February 22-23, 2016.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Best Western Tuscan Inn, 425 North Point Street, San 
Francisco, CA 94133.
    Contact Person: Natalia Strunnikova, Ph.D., Scientific Review 
Officer, Scientific Review Branch, Division of Extramural Research, 
NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 
3208, MSC 9529, Bethesda, MD 20892-9529, 301-402-0288, 
[email protected].

    Name of Committee: National Institute of Neurological Disorders 
and Stroke Initial Review Group; Neurological Sciences and Disorders 
C.
    Date: February 23-24, 2016.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: JW Marriott New Orleans, 614 Canal Street, New Orleans, 
LA 70130.
    Contact Person: William C. Benzing, Ph.D., Scientific Review 
Officer, Scientific Review Branch, Division of Extramural Research, 
NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 
3204, MSC 9529, Bethesda, MD 20892-9529, 301-496-0660, 
[email protected].

    Name of Committee: National Institute of Neurological Disorders 
and Stroke Initial Review Group; Neurological Sciences and Disorders 
B.
    Date: February 25, 2016.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: JW Marriott New Orleans, 614 Canal Street, New Orleans, 
LA 70130,
    Contact Person: Birgit Neuhuber, Ph.D., Scientific Review 
Officer, Scientific Review Branch, Division of Extramural Research, 
NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 
3208, MSC 9529, Bethesda, MD 20892-9529, [email protected].

    Name of Committee: Neurological Sciences Training Initial Review 
Group; NST-1 Subcommittee.
    Date: March 7-8, 2016.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hyatt Arlington, 1325 Wilson Boulevard, Arlington, VA 
22209.
    Contact Person: William C. Benzing, Ph.D., Scientific Review 
Officer, Scientific Review Branch, Division of Extramural Research, 
NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 
3204, MSC 9529, Bethesda, MD 20892-9529, 301-496-0660, 
[email protected].

    Name of Committee: Neurological Sciences Training Initial Review 
Group; NST-2 Subcommittee.
    Date: March 14-15, 2016.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Pier 2620 Hotel, 2620 Jones Street, San Francisco, CA 
94133.
    Contact Person: Elizabeth A Webber, Ph.D., Scientific Review 
Officer, Scientific Review Branch, Division of Extramural Research, 
NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 
3208, MSC 9529, Bethesda, MD 20892-9529, 301-496-1917, 
[email protected].

(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: December 14, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-31769 Filed 12-17-15; 8:45 am]
BILLING CODE 4140-01-P



                                                  79054                       Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Notices

                                                    Meeting Registration: Registration is                 workshop include definition of                        Individuals with disabilities who need
                                                  open through April 12, 2016;                            important chemical and biological                     accommodation to participate in this
                                                  registration will close earlier if space                activity features, statistical methods for            event should contact Dr. Rider at
                                                  capacity is reached. Registration to view               comparing across complex mixtures,                    telephone: (919) 541–7638 or email:
                                                  the workshop via webcast is required.                   and how to define ‘‘similarity’’ across               cynthia.rider@nih.gov. TTY users
                                                  ADDRESSES: Meeting Location: Lister                     botanicals (i.e., how similar do                      should contact the Federal TTY Relay
                                                  Hill Auditorium, National Library of                    botanicals have to be in order to apply               Service at 800–877–8339. Requests
                                                  Medicine, 8600 Rockville Pike, NIH                      safety data from a reference botanical to             should be made at least five business
                                                  Building 38A, Bethesda, MD 20894                        nominally-related botanicals).                        days in advance of the event.
                                                    Meeting Web page: The preliminary                        Botanicals are often perceived to have
                                                                                                          significant health benefits with low risk             Background Information on the NTP
                                                  agenda and registration are at (http://
                                                  ntp.niehs.nih.gov/go/workshop_                          of harm. Since botanicals are complex                    NTP is an interagency program
                                                  botanicals).                                            natural products, the particular                      established in 1978 (43 FR 53060) to
                                                    Webcast: The meeting will be                          constituent(s) responsible for biological             strengthen the Department of Health
                                                  webcast; the URL will be provided to                    activity, as related to efficacy or toxicity,         and Human Services’ activities in
                                                  those who register to view.                             is often unknown. Participants at the                 toxicology research and testing, and
                                                                                                          workshop will discuss the relative                    develop and validate new and better
                                                  FOR FURTHER INFORMATION CONTACT: Dr.
                                                                                                          merits of dedicating scientific attention             testing methods. Other activities of the
                                                  Cynthia Rider, NTP Toxicologist,
                                                                                                          to identifying the active constituent(s)              program focus on strengthening the
                                                  NIEHS, P.O. Box 12233, MD K2–12,
                                                                                                          in botanicals and identifying biological              science base in toxicology and
                                                  Research Triangle Park, NC 27709.
                                                                                                          signatures that are predictive of adverse             providing information about potentially
                                                  Telephone: (919) 541–7638, email:
                                                                                                          events (biomarkers of effect).                        toxic chemicals to health regulatory and
                                                  cynthia.rider@nih.gov.
                                                                                                          Furthermore, presentations will address               research agencies, scientific and
                                                  SUPPLEMENTARY INFORMATION:                              promising approaches (e.g., high                      medical communities, and the public.
                                                  Background                                              throughput screening, computational                   NTP is located administratively at the
                                                                                                          tools) and accompanying challenges for                National Institute of Environmental
                                                     The safety of botanical dietary                      using these approaches to advance our
                                                  supplements, hereafter referred to as                                                                         Health Sciences (NIEHS). Information
                                                                                                          understanding of the risks associated                 about NTP and NIEHS is found at http://
                                                  botanicals, is an important public health               with botanical use.
                                                  issue. According to the 2012 National                                                                         ntp.niehs.nih.gov and http://
                                                                                                             Understanding the ADME of                          www.niehs.nih.gov, respectively.
                                                  Health Interview Survey, 17.7 percent of                botanicals is critical to evaluating their
                                                  Americans reported having used                          safety. However, evaluating ADME in                   Reference
                                                  nonvitamin, nonmineral dietary                          humans and animal models is
                                                  supplements (including botanicals) in                                                                           Clarke, T.C. et al. Trends in the use of
                                                                                                          complicated in the case of botanicals by              complementary health approaches among
                                                  the past 12 months (Clarke et al., 2015).               the large number of constituents, the                 adults: United States, 2002–2012, in National
                                                  Botanicals pose several unique                          wide range of concentrations, potential               health statistics reports. 2015. National
                                                  challenges to efficacy and safety                       interactions (botanical-botanical and                 Center for Health Statistics: Hyattsville, MD.
                                                  evaluation because of their inherent                    botanical-drug interactions), as well as                Dated: December 15, 2015.
                                                  complexity and potential for wide                       interindividual and animal-to-human
                                                  variability in nominally related                                                                              John R. Bucher,
                                                                                                          differences in pharmacokinetics. The
                                                  products. The interrelated challenges                                                                         Associate Director, National Toxicology
                                                                                                          workshop will include discussion of                   Program.
                                                  associated with the evaluation of                       knowledge gaps and available options
                                                  botanicals include: (1) Developing                                                                            [FR Doc. 2015–31833 Filed 12–17–15; 8:45 am]
                                                                                                          for assessing ADME of botanicals to
                                                  methods and criteria for assessing                      inform future safety evaluations.                     BILLING CODE 4140–01–P
                                                  phytoequivalence (i.e., similarity in
                                                  chemical composition and biological                     Meeting and Registration
                                                  activity) of botanicals, (2) identifying                   This meeting is open to the public,                DEPARTMENT OF HEALTH AND
                                                  the active constituent(s) or patterns of                free of charge, with attendance limited               HUMAN SERVICES
                                                  biological response of botanicals, and                  only by the space available. Individuals              National Institutes of Health
                                                  (3) assessing absorption, distribution,                 who plan to attend in person should
                                                  metabolism, and elimination (ADME) of                   register at (http://ntp.niehs.nih.gov/go/             National Institute of Neurological
                                                  botanicals. This workshop will engage                   workshop_botanicals) by April 12, 2016,               Disorders and Stroke; Notice of Closed
                                                  experts from multiple disciplines to                    to facilitate meeting planning.                       Meetings
                                                  focus on practical approaches for                       Registration will close earlier if space
                                                  addressing these challenges.                            capacity is reached. Registration is                    Pursuant to section 10(d) of the
                                                     Multiple factors contribute to the                   required to view the Webcast; the URL                 Federal Advisory Committee Act, as
                                                  variability in botanicals including                     for the Webcast will be provided in the               amended (5 U.S.C. App.), notice is
                                                  complex and inconsistent source                         email confirming registration. A                      hereby given of the following meetings.
                                                  material, manufacturing processes,                      preliminary agenda and additional                       The meetings will be closed to the
                                                  formulation, and storage. Botanicals in                 information are available at (http://                 public in accordance with the
                                                  commerce often display a wide range in                  ntp.niehs.nih.gov/go/workshop_                        provisions set forth in sections
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                                                  the concentration of known                              botanicals). Interested individuals are               552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
                                                  constituents. Robust procedures for                     encouraged to access the Web site to                  as amended. The grant applications and
                                                  comparing constituent profiles across                   stay abreast of the most current                      the discussions could disclose
                                                  multiple botanicals are needed to                       information regarding the workshop.                   confidential trade secrets or commercial
                                                  determine how broadly safety or                            Visitor and security information for               property such as patentable material,
                                                  efficacy evaluations with a specific                    those attending in person is available at             and personal information concerning
                                                  product can be applied to related                       https://www.nih.gov/about-nih/visitor-                individuals associated with the grant
                                                  products. Topics for discussion at the                  information/campus-access-security.                   applications, the disclosure of which


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                                                                              Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Notices                                         79055

                                                  would constitute a clearly unwarranted                    Agenda: To review and evaluate grant                DATES:  Comments must be submitted to
                                                  invasion of personal privacy.                           applications.                                         the online docket via http://
                                                                                                            Place: Pier 2620 Hotel, 2620 Jones Street,          www.regulations.gov, or reach the
                                                    Name of Committee: National Institute of              San Francisco, CA 94133.
                                                  Neurological Disorders and Stroke Initial                 Contact Person: Elizabeth A Webber, Ph.D.,
                                                                                                                                                                Docket Management Facility, on or
                                                  Review Group; Neurological Sciences and                 Scientific Review Officer, Scientific Review          before January 19, 2016.
                                                  Disorders A.                                            Branch, Division of Extramural Research,                Synopses of proposals regarding
                                                    Date: February 22–23, 2016.                           NINDS/NIH/DHHS/Neuroscience Center,                   future CRADAs must reach the Coast
                                                    Time: 8:00 a.m. to 6:00 p.m.                          6001 Executive Boulevard, Suite 3208, MSC             Guard (see FOR FURTHER INFORMATION
                                                    Agenda: To review and evaluate grant                  9529, Bethesda, MD 20892–9529, 301–496–               CONTACT) on or before January 19, 2016.
                                                  applications.                                           1917, webbere@mail.nih.gov.
                                                    Place: Best Western Tuscan Inn, 425 North                                                                   ADDRESSES: Submit comments online at
                                                                                                          (Catalogue of Federal Domestic Assistance
                                                  Point Street, San Francisco, CA 94133.                  Program Nos. 93.853, Clinical Research                http://www.regulations.gov following
                                                    Contact Person: Natalia Strunnikova,                  Related to Neurological Disorders; 93.854,            Web site instructions.
                                                  Ph.D., Scientific Review Officer, Scientific            Biological Basis Research in the                      FOR FURTHER INFORMATION CONTACT: If
                                                  Review Branch, Division of Extramural                   Neurosciences, National Institutes of Health,         you have questions on this notice or
                                                  Research, NINDS/NIH/DHHS/Neuroscience                   HHS)
                                                  Center, 6001 Executive Boulevard, Suite                                                                       wish to submit proposals for future
                                                                                                            Dated: December 14, 2015.                           CRADAs, contact LT Keely Higbie,
                                                  3208, MSC 9529, Bethesda, MD 20892–9529,
                                                  301–402–0288, Natalia.strunnikova@nih.gov.              Melanie J. Gray,                                      Project Official, Surface Branch, U.S.
                                                    Name of Committee: National Institute of              Program Analyst, Office of Federal Advisory           Coast Guard Research and Development
                                                  Neurological Disorders and Stroke Initial               Committee Policy.                                     Center, 1 Chelsea Street, New London,
                                                  Review Group; Neurological Sciences and                 [FR Doc. 2015–31769 Filed 12–17–15; 8:45 am]          CT 06320, telephone 860–271–2815,
                                                  Disorders C.                                            BILLING CODE 4140–01–P                                email Keely.J.Higbie@uscg.mil.
                                                    Date: February 23–24, 2016.                                                                                 SUPPLEMENTARY INFORMATION:
                                                    Time: 8:00 a.m. to 6:00 p.m.
                                                    Agenda: To review and evaluate grant
                                                                                                          DEPARTMENT OF HOMELAND                                Public Participation and Request for
                                                  applications.                                                                                                 Comments
                                                    Place: JW Marriott New Orleans, 614 Canal             SECURITY
                                                  Street, New Orleans, LA 70130.                                                                                   We request public comments on this
                                                    Contact Person: William C. Benzing, Ph.D.,            Coast Guard                                           notice. Although we do not plan to
                                                  Scientific Review Officer, Scientific Review            [Docket No. USCG–2015–1050]                           respond to comments in the Federal
                                                  Branch, Division of Extramural Research,                                                                      Register, we will respond directly to
                                                  NINDS/NIH/DHHS/Neuroscience Center,                     Cooperative Research and                              commenters and may modify our
                                                  6001 Executive Boulevard, Suite 3204, MSC               Development Agreement: Diesel                         proposal in light of comments.
                                                  9529, Bethesda, MD 20892–9529, 301–496–
                                                                                                          Outboard Engine Development                              Comments should be marked with
                                                  0660, benzingw@mail.nih.gov.
                                                                                                                Coast Guard, DHS.
                                                                                                          AGENCY:
                                                                                                                                                                docket number USCG–2015–1050 and
                                                    Name of Committee: National Institute of
                                                  Neurological Disorders and Stroke Initial                                                                     should provide a reason for each
                                                                                                                Notice of intent; request for
                                                                                                          ACTION:
                                                  Review Group; Neurological Sciences and                                                                       suggestion or recommendation. You
                                                                                                          comments.
                                                  Disorders B.                                                                                                  should provide personal contact
                                                    Date: February 25, 2016.                              SUMMARY:    The Coast Guard announces                 information so that we can contact you
                                                    Time: 8:00 a.m. to 6:00 p.m.                          its intent to enter into a Cooperative                if we have questions regarding your
                                                    Agenda: To review and evaluate grant                  Research and Development Agreement                    comments; but please note that all
                                                  applications.                                                                                                 comments will be posted to the online
                                                                                                          (CRADA) with Mercury Marine
                                                    Place: JW Marriott New Orleans, 614 Canal                                                                   docket without change and that any
                                                  Street, New Orleans, LA 70130,                          (Mercury) to evaluate and test the
                                                                                                          advantages, disadvantages, required                   personal information you include can be
                                                    Contact Person: Birgit Neuhuber, Ph.D.,
                                                  Scientific Review Officer, Scientific Review            technology enhancements, performance,                 searchable online (see the Federal
                                                  Branch, Division of Extramural Research,                costs, and other issues associated with               Register Privacy Act notice regarding
                                                  NINDS/NIH/DHHS/Neuroscience Center,                     diesel outboard engine technology. A                  our public dockets, 73 FR 3316, Jan. 17,
                                                  6001 Executive Boulevard, Suite 3208, MSC               test schedule has been proposed in                    2008). We also accept anonymous
                                                  9529, Bethesda, MD 20892–9529, neuhuber@                which Mercury will provide and install                comments.
                                                  ninds.nih.gov.                                          two of their diesel outboard engines                     We encourage you to submit
                                                    Name of Committee: Neurological Sciences              onto a selected Coast Guard boat                      comments through the Federal
                                                  Training Initial Review Group; NST–1                    platform; the Coast Guard Research and                eRulemaking Portal at http://
                                                  Subcommittee.                                                                                                 www.regulations.gov. If your material
                                                                                                          Development Center (R&D Center) will
                                                    Date: March 7–8, 2016.
                                                                                                          outfit the platform with the necessary                cannot be submitted using http://
                                                    Time: 8:00 a.m. to 6:00 p.m.
                                                    Agenda: To review and evaluate grant                  instrumentation to monitor power,                     www.regulations.gov, contact the Coast
                                                  applications.                                           speed, and fuel consumption; and a                    Guard (see FOR FURTHER INFORMATION
                                                    Place: Hyatt Arlington, 1325 Wilson                   Coast Guard field unit will operate the               CONTACT). Documents mentioned in this
                                                  Boulevard, Arlington, VA 22209.                         boat for performance testing over a six-              notice, and all public comments, are in
                                                    Contact Person: William C. Benzing, Ph.D.,            month period to collect information on                our online docket at http://
                                                  Scientific Review Officer, Scientific Review            reliability, maintenance requirements,                www.regulations.gov and can be viewed
                                                  Branch, Division of Extramural Research,                and availability data. While the Coast                by following that Web site’s
                                                  NINDS/NIH/DHHS/Neuroscience Center,                                                                           instructions. Additionally, if you go to
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                                                                          Guard is currently considering
                                                  6001 Executive Boulevard, Suite 3204, MSC
                                                                                                          partnering with Mercury, the agency is                the online docket and sign up for email
                                                  9529, Bethesda, MD 20892–9529, 301–496–
                                                  0660, benzingw@mail.nih.gov.                            soliciting public comment on the                      alerts, you will be notified when
                                                                                                          possible nature of and participation of               comments are posted or a final rule is
                                                    Name of Committee: Neurological Sciences
                                                  Training Initial Review Group; NST–2                    other parties in the proposed CRADA. In               published.
                                                  Subcommittee.                                           addition, the Coast Guard also invites                   Do not submit detailed proposals for
                                                    Date: March 14–15, 2016.                              other potential non-Federal participants              future CRADAs to the Docket
                                                    Time: 8:00 a.m. to 6:00 p.m.                          to propose similar CRADAs.                            Management Facility. Instead, submit


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Document Created: 2015-12-18 01:38:31
Document Modified: 2015-12-18 01:38:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesFebruary 22-23, 2016.
FR Citation80 FR 79054 

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