80_FR_78480 80 FR 78239 - National Center for Advancing Translational Sciences; Notice of Meetings

80 FR 78239 - National Center for Advancing Translational Sciences; Notice of Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 241 (December 16, 2015)

Page Range78239-78240
FR Document2015-31547

Federal Register, Volume 80 Issue 241 (Wednesday, December 16, 2015)
[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Notices]
[Pages 78239-78240]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31547]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Center for Advancing Translational Sciences; Notice of 
Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of meetings of the 
National Center for Advancing Translational Sciences.
    The meetings will be open to the public as indicated below, with 
attendance limited to space available. Individuals who plan to attend 
and need special assistance, such as sign language interpretation or 
other reasonable accommodations, should notify the Contact Person 
listed below in advance of the meeting.
    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: Cures Acceleration Network Review Board.
    Date: January 14, 2016.
    Time: 8:30 a.m. to 4:30 p.m.
    Agenda: Report from the Institute Director.
    Place: National Institutes of Health, Building 31, Conference 
Room 10, 31 Center Drive, Bethesda, MD 20892.
    Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive 
Secretary, National Center for Advancing Translational Sciences, 1 
Democracy Plaza, Room 1072, Bethesda, MD 20892, 301-435-0809, 
[email protected].

    Name of Committee: National Center for Advancing Translational 
Sciences Advisory Council.
    Date: January 14, 2016.
    Open: 8:30 a.m. to 4:30 p.m.
    Agenda: Report from the Institute Director and other staff.
    Place: National Institutes of Health, Building 31, Conference 
Room 10, 31 Center Drive, Bethesda, MD 20892.
    Closed: 3:00 p.m. to 4:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Building 31, Conference 
Room 10, 31 Center Drive, Bethesda, MD 20892.
    Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive 
Secretary, National Center for Advancing Translational Sciences, 1 
Democracy Plaza, Room 1072, Bethesda, MD 20892, 301-435-0809, 
[email protected].

    In the interest of security, NIH has instituted stringent 
procedures for entrance onto the NIH campus. All visitor vehicles, 
including taxicabs, hotel, and airport shuttles will be inspected 
before being allowed on campus. Visitors will be asked to show one 
form of identification (for example, a government-issued photo ID, 
driver's license, or passport) and to state the purpose of their 
visit.

(Catalogue of Federal Domestic Assistance Program Nos. 93.859, 
Pharmacology,

[[Page 78240]]

Physiology, and Biological Chemistry Research; 93.350, B--
Cooperative Agreements; 93.859, Biomedical Research and Research 
Training, National Institutes of Health, HHS)

    Dated: December 10, 2015.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-31547 Filed 12-15-15; 8:45 am]
BILLING CODE 4140-01-P



                                                                       Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Notices                                               78239

                                              manner detailed (see ‘‘Written/Paper                    electronic and written/paper comments                 Center for Advancing Translational
                                              Submissions’’ and ‘‘Instructions’’).                    received, go to http://                               Sciences.
                                                                                                      www.regulations.gov and insert the                       The meetings will be open to the
                                              Written/Paper Submissions
                                                                                                      docket number, found in brackets in the               public as indicated below, with
                                                 Submit written/paper submissions as                  heading of this document, into the                    attendance limited to space available.
                                              follows:                                                ‘‘Search’’ box and follow the prompts                 Individuals who plan to attend and
                                                 • Mail/Hand delivery/Courier (for                    and/or go to the Division of Dockets                  need special assistance, such as sign
                                              written/paper submissions): Division of                 Management, 5630 Fishers Lane, Rm.                    language interpretation or other
                                              Dockets Management (HFA–305), Food                      1061, Rockville, MD 20852.                            reasonable accommodations, should
                                              and Drug Administration, 5630 Fishers                                                                         notify the Contact Person listed below
                                              Lane, Rm. 1061, Rockville, MD 20852.                    FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                            in advance of the meeting.
                                                 • For written/paper comments                         Janet Donnelly, Office of Good Clinical
                                                                                                                                                               The meetings will be closed to the
                                              submitted to the Division of Dockets                    Practice, Food and Drug Administration,
                                                                                                                                                            public in accordance with the
                                              Management, FDA will post your                          10903 New Hampshire Ave., Bldg. 32,
                                                                                                                                                            provisions set forth in sections
                                              comment, as well as any attachments,                    Rm. 5167, Silver Spring, MD 20993–
                                                                                                                                                            552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                              except for information submitted,                       0002, 301–796–4187; or Irene Stith-
                                                                                                                                                            as amended. The grant applications and
                                              marked and identified, as confidential,                 Coleman, Office for Human Research
                                                                                                                                                            the discussions could disclose
                                              if submitted as detailed in                             Protections, 1101 Wootton Pkwy., Suite
                                                                                                                                                            confidential trade secrets or commercial
                                              ‘‘Instructions.’’                                       200, Rockville, MD 20852, 240–453–
                                                 Instructions: All submissions received                                                                     property such as patentable material,
                                                                                                      6900.
                                              must include the Docket No. FDA–                                                                              and personal information concerning
                                              2015–D–3638 for ‘‘Minutes of                            SUPPLEMENTARY INFORMATION:      In the                individuals associated with the grant
                                              Institutional Review Board Meetings:                    Federal Register of November 5, 2015                  applications, the disclosure of which
                                              Guidance for Institutions and                           (80 FR 68545), OHRP and FDA                           would constitute a clearly unwarranted
                                              Institutional Review Boards; Draft                      published a notice of availability with a             invasion of personal privacy.
                                              Guidance; Availability’’ publicly                       60-day comment period to request                        Name of Committee: Cures Acceleration
                                              viewable at http://www.regulations.gov                  comments on a draft guidance                          Network Review Board.
                                              or at the Division of Dockets                           document entitled ‘‘Minutes of                          Date: January 14, 2016.
                                              Management between 9 a.m. and 4 p.m.,                   Institutional Review Board Meetings:                    Time: 8:30 a.m. to 4:30 p.m.
                                                                                                      Guidance for Institutions and                           Agenda: Report from the Institute Director.
                                              Monday through Friday.                                                                                          Place: National Institutes of Health,
                                                 • Confidential Submissions—To                        Institutional Review Boards; Draft
                                                                                                                                                            Building 31, Conference Room 10, 31 Center
                                              submit a comment with confidential                      Guidance; Availability.’’ The Agencies
                                                                                                                                                            Drive, Bethesda, MD 20892.
                                              information that you do not wish to be                  are taking the initiative to extend the                 Contact Person: Anna L. Ramsey-Ewing,
                                              made publicly available, submit your                    comment period for an additional 30                   Ph.D., Executive Secretary, National Center
                                              comments only as a written/paper                        days because the timing of the due date               for Advancing Translational Sciences, 1
                                              submission. You should submit two                       for comments intersects with comment                  Democracy Plaza, Room 1072, Bethesda, MD
                                              copies total. One copy will include the                 periods on other Federal Register                     20892, 301–435–0809, anna.ramseyewing@
                                              information you claim to be confidential                documents requiring review by the same                nih.gov.
                                              with a heading or cover note that states                group of stakeholders. We believe that a                Name of Committee: National Center for
                                              ‘‘THIS DOCUMENT CONTAINS                                30-day extension allows adequate time                 Advancing Translational Sciences Advisory
                                              CONFIDENTIAL INFORMATION.’’ The                         for interested persons to submit                      Council.
                                                                                                      comments without significantly                          Date: January 14, 2016.
                                              Agency will review this copy, including                                                                         Open: 8:30 a.m. to 4:30 p.m.
                                              the claimed confidential information, in                delaying finalizing the guidance on
                                                                                                                                                              Agenda: Report from the Institute Director
                                              its consideration of comments. The                      these important issues.                               and other staff.
                                              second copy, which will have the                          Dated: December 9, 2015.                              Place: National Institutes of Health,
                                              claimed confidential information                        Leslie Kux,                                           Building 31, Conference Room 10, 31 Center
                                              redacted/blacked out, will be available                                                                       Drive, Bethesda, MD 20892.
                                                                                                      Associate Commissioner for Policy, U.S. Food
                                              for public viewing and posted on http://                                                                        Closed: 3:00 p.m. to 4:30 p.m.
                                                                                                      and Drug Administration.
                                              www.regulations.gov. Submit both                                                                                Agenda: To review and evaluate grant
                                                                                                        Dated: December 4, 2015.                            applications.
                                              copies to the Division of Dockets                       Karen B. DeSalvo,                                       Place: National Institutes of Health,
                                              Management. If you do not wish your                                                                           Building 31, Conference Room 10, 31 Center
                                                                                                      Acting Assistant Secretary for Health, U.S.
                                              name and contact information to be                      Department of Health and Human Services.              Drive, Bethesda, MD 20892.
                                              made publicly available, you can                                                                                Contact Person: Anna L. Ramsey-Ewing,
                                                                                                      [FR Doc. 2015–31593 Filed 12–15–15; 8:45 am]
                                              provide this information on the cover                                                                         Ph.D., Executive Secretary, National Center
                                                                                                      BILLING CODE 4164–01–P
                                              sheet and not in the body of your                                                                             for Advancing Translational Sciences, 1
                                              comments and you must identify this                                                                           Democracy Plaza, Room 1072, Bethesda, MD
                                              information as ‘‘confidential.’’ Any                                                                          20892, 301–435–0809, anna.ramseyewing@
                                                                                                      DEPARTMENT OF HEALTH AND                              nih.gov.
                                              information marked as ‘‘confidential’’
                                                                                                      HUMAN SERVICES                                          In the interest of security, NIH has
                                              will not be disclosed except in
                                              accordance with 21 CFR 10.20 and other                                                                        instituted stringent procedures for entrance
                                                                                                      National Institutes of Health                         onto the NIH campus. All visitor vehicles,
                                              applicable disclosure law. For more
                                                                                                                                                            including taxicabs, hotel, and airport shuttles
                                              information about FDA’s posting of                      National Center for Advancing                         will be inspected before being allowed on
tkelley on DSK9F6TC42PROD with NOTICES




                                              comments to public dockets, see 80 FR                   Translational Sciences; Notice of                     campus. Visitors will be asked to show one
                                              56469, September 18, 2015, or access                    Meetings                                              form of identification (for example, a
                                              the information at: http://www.fda.gov/                                                                       government-issued photo ID, driver’s license,
                                              regulatoryinformation/dockets/                            Pursuant to section 10(d) of the                    or passport) and to state the purpose of their
                                              default.htm.                                            Federal Advisory Committee Act, as                    visit.
                                                 Docket: For access to the docket to                  amended (5 U.S.C. App.), notice is                    (Catalogue of Federal Domestic Assistance
                                              read background documents or the                        hereby given of meetings of the National              Program Nos. 93.859, Pharmacology,



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                                              78240                    Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Notices

                                              Physiology, and Biological Chemistry                    DEPARTMENT OF HEALTH AND                              Phone: 301–443–6040, Email:
                                              Research; 93.350, B—Cooperative                         HUMAN SERVICES                                        IACCPublicInquiries@mail.nih.gov.
                                              Agreements; 93.859, Biomedical Research
                                              and Research Training, National Institutes of           National Institutes of Health                         Public Comments
                                              Health, HHS)                                                                                                     Any member of the public interested
                                                Dated: December 10, 2015.                             National Institute of Mental Health;                  in presenting oral comments to the
                                              David Clary,                                            Notice of Meeting                                     Committee must notify the Contact
                                              Program Analyst, Office of Federal Advisory                                                                   Person listed on this notice by 5:00 p.m.
                                                                                                         Pursuant to section 10(a) of the
                                              Committee Policy.                                                                                             ET on Monday, January 4, 2016, with
                                                                                                      Federal Advisory Committee Act, as                    their request to present oral comments
                                              [FR Doc. 2015–31547 Filed 12–15–15; 8:45 am]
                                                                                                      amended (5 U.S.C. App.), notice is                    at the meeting. Interested individuals
                                              BILLING CODE 4140–01–P
                                                                                                      hereby given of an Interagency Autism                 and representatives of organizations
                                                                                                      Coordinating Committee (IACC or                       must submit a written/electronic copy
                                                                                                      Committee) meeting.                                   of the oral presentation/statement
                                              DEPARTMENT OF HEALTH AND
                                                                                                         The purpose of the IACC meeting is                 including a brief description of the
                                              HUMAN SERVICES
                                                                                                      to discuss business, agency updates and               organization represented by 5:00 p.m.
                                              National Institutes of Health                           issues related to autism spectrum                     ET on Tuesday, January 5, 2016.
                                                                                                      disorder (ASD) research and services                  Statements submitted will become a
                                              National Institute of Allergy and                       activities. The committee will discuss                part of the public record. Only one
                                              Infectious Diseases; Notice of Closed                   the next update of the IACC Strategic                 representative of an organization will be
                                              Meeting                                                 Plan. The meeting will be open to the                 allowed to present oral comments and
                                                                                                      public and will be accessible by webcast              presentations will be limited to three to
                                                Pursuant to section 10(d) of the
                                                                                                      and conference call.                                  five minutes per speaker, depending on
                                              Federal Advisory Committee Act, as
                                                                                                         Name of Committee: Interagency                     the number of speakers to be
                                              amended (5 U.S.C. App.), notice is
                                                                                                      Autism Coordinating Committee (IACC).                 accommodated within the allotted time.
                                              hereby given of the following meeting.
                                                The meeting will be closed to the                        Type of meeting: Open Meeting.                     Speakers will be assigned a time to
                                              public in accordance with the                              Date: January 12, 2016.                            speak in the order of the date and time
                                              provisions set forth in sections                           Time: 9:00 a.m. to 5:00 p.m.* Eastern              when their request to speak is received,
                                              552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              Time * Approximate end time.                          along with the required submission of
                                              as amended. The grant applications and                     Agenda: To discuss business, updates               the written/electronic statement by the
                                              the discussions could disclose                          and issues related to ASD research and                specified deadline.
                                              confidential trade secrets or commercial                services activities. The committee will                  In addition, any interested person
                                              property such as patentable material,                   discuss the next update of the IACC                   may submit written public comments to
                                              and personal information concerning                     Strategic Plan.                                       the IACC prior to the meeting by
                                              individuals associated with the grant                      Place: National Institutes of Health,              sending the comments to the Contact
                                              applications, the disclosure of which                   31 Center Drive, Building 31, C Wing,                 Person listed on this notice by 5:00 p.m.
                                              would constitute a clearly unwarranted                  6th Floor, Conference Room 6,                         ET on Tuesday, January 5, 2016. The
                                              invasion of personal privacy.                           Bethesda, MD 20892.                                   comments should include the name,
                                                                                                         Webcast Live: http://                              address, telephone number and when
                                                Name of Committee: National Institute of              videocast.nih.gov/.
                                              Allergy and Infectious Diseases Special                                                                       applicable, the business or professional
                                              Emphasis Panel; NIAID Peer Review Meeting.
                                                                                                         Conference Call Access: Dial: 800–                 affiliation of the interested person.
                                                Date: January 5, 2016.                                988–9744, Access code: 3700810.                       NIMH anticipates written public
                                                Time: 10:00 a.m. to 5:00 p.m.                            Cost: The meeting is free and open to              comments received by 5:00 p.m. ET,
                                                Agenda: To review and evaluate grant                  the public.                                           Tuesday, January 5, 2016 will be
                                              applications.                                              Registration: Pre-registration is                  presented to the Committee prior to the
                                                Place: National Institutes of Health, Room            recommended to expedite check-in.                     meeting for the Committee’s
                                              3F30A, 5601 Fishers Lane, Rockville, MD                 Seating in the meeting room is limited                consideration. Any written comments
                                              20892, (Telephone Conference Call).                     to room capacity and on a first come,
                                                Contact Person: Ellen S. Buczko, Ph.D.,                                                                     received after the 5:00 p.m. EST,
                                              Scientific Review Officer, Scientific Review            first served basis. To register, please               January 5, 2016 deadline through
                                              Program, Division of Extramural Activities,             visit: www.iacc.hhs.gov.                              January 11, 2016 will be provided to the
                                              Room # 3F30A, National Institutes of Health/               Deadlines: Notification of intent to               Committee either before or after the
                                              NIAID, 5601 Fishers Lane, MSC 9823,                     present oral comments: Monday,                        meeting, depending on the volume of
                                              Bethesda, MD 20892–9823, (240) 669–5028,                January 4, 2016 by 5:00 p.m. ET.                      comments received and the time
                                              ebuczko1@niaid.nih.gov.                                 Submission of written/electronic                      required to process them in accordance
                                                This notice is being published less than 15           statement for oral comments: Tuesday,                 with privacy regulations and other
                                              days prior to the meeting due to the timing             January 5, 2016 by 5:00 p.m. ET.                      applicable Federal policies. All written
                                              limitations imposed by the review and                   Submission of written comments:
                                              funding cycle.
                                                                                                                                                            public comments and oral public
                                                                                                      Tuesday, January 5, 2016 by 5:00 p.m.                 comment statements received by the
                                              (Catalogue of Federal Domestic Assistance
                                              Program Nos. 93.855, Allergy, Immunology,
                                                                                                      ET. For IACC Public Comment                           deadlines for both oral and written
                                              and Transplantation Research; 93.856,                   guidelines please see: http://                        public comments will be provided to
                                              Microbiology and Infectious Diseases                    iacc.hhs.gov/public-comment/                          the IACC for their consideration and
                                              Research, National Institutes of Health, HHS)           index.shtml.                                          will become part of the public record.
tkelley on DSK9F6TC42PROD with NOTICES




                                                                                                         Access: Medical Center Metro Station                  In the 2009 IACC Strategic Plan, the
                                                Dated: December 10, 2015.                             (Red Line).                                           IACC listed the ‘‘Spirit of Collaboration’’
                                              Natasha M. Copeland,                                       Contact Person: Ms. Lina Perez, Office             as one of its core values, stating that,
                                              Program Analyst, Office of Federal Advisory             of Autism Research Coordination,                      ‘‘We will treat others with respect, listen
                                              Committee Policy.                                       National Institute of Mental Health,                  to diverse views with open minds,
                                              [FR Doc. 2015–31549 Filed 12–15–15; 8:45 am]            NIH, 6001 Executive Boulevard, Room                   discuss submitted public comments,
                                              BILLING CODE 4140–01–P                                  6182A, Bethesda, MD 20892–9669,                       and foster discussions where


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Document Created: 2015-12-16 01:01:28
Document Modified: 2015-12-16 01:01:28
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
DatesJanuary 14, 2016.
FR Citation80 FR 78239 

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