82_FR_14960 82 FR 14905 - Center for Scientific Review; Notice of Closed Meeting

82 FR 14905 - Center for Scientific Review; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 55 (March 23, 2017)

Page Range14905-14906
FR Document2017-05750

Federal Register, Volume 82 Issue 55 (Thursday, March 23, 2017)
[Federal Register Volume 82, Number 55 (Thursday, March 23, 2017)]
[Notices]
[Pages 14905-14906]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meeting

    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 
meeting.
    The meeting 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; Member Conflict: Oncology 1 Basic Translational.
    Date: April 6, 2017.
    Time: 1:00 p.m. to 5:00 p.m.

[[Page 14906]]

    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Amy L. Rubinstein, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5152, MSC 7844, Bethesda, MD 
20892, 301-408-9754, [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)

    Dated: March 17, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-05750 Filed 3-22-17; 8:45 am]
 BILLING CODE 4140-01-P



                                                                             Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices                                                  14905

                                                instructions for submitting comments.                   the claimed confidential information, in              practices regulation (21 CFR 10.115).
                                                Comments submitted electronically,                      its consideration of comments. The                    The draft guidance, when finalized, will
                                                including attachments, to http://                       second copy, which will have the                      represent the current thinking of FDA
                                                www.regulations.gov will be posted to                   claimed confidential information                      on developing drugs for the prevention
                                                the docket unchanged. Because your                      redacted/blacked out, will be available               of DGF in kidney transplant. It does not
                                                comment will be made public, you are                    for public viewing and posted on http://              establish any rights for any person and
                                                solely responsible for ensuring that your               www.regulations.gov. Submit both                      is not binding on FDA or the public.
                                                comment does not include any                            copies to the Division of Dockets                     You can use an alternative approach if
                                                confidential information that you or a                  Management. If you do not wish your                   it satisfies the requirements of the
                                                third party may not wish to be posted,                  name and contact information to be                    applicable statutes and regulations.
                                                such as medical information, your or                    made publicly available, you can
                                                anyone else’s Social Security number, or                provide this information on the cover                 II. The Paperwork Reduction Act of
                                                confidential business information, such                 sheet and not in the body of your                     1995
                                                as a manufacturing process. Please note                 comments and you must identify this                      This guidance refers to previously
                                                that if you include your name, contact                  information as ‘‘confidential.’’ Any                  approved collections of information that
                                                information, or other information that                  information marked as ‘‘confidential’’                are subject to review by the Office of
                                                identifies you in the body of your                      will not be disclosed except in                       Management and Budget (OMB) under
                                                comments, that information will be                      accordance with 21 CFR 10.20 and other                the Paperwork Reduction Act of 1995
                                                posted on http://www.regulations.gov.                   applicable disclosure law. For more                   (44 U.S.C. 3501–3520). The collections
                                                  • If you want to submit a comment                     information about FDA’s posting of                    of information in 21 CFR parts 312 and
                                                with confidential information that you                  comments to public dockets, see 80 FR                 314 have been approved under OMB
                                                do not wish to be made available to the                 56469, September 18, 2015, or access                  control numbers 0910–0014 and 0910–
                                                public, submit the comment as a                         the information at: http://www.fda.gov/               0001, respectively.
                                                written/paper submission and in the                     regulatoryinformation/dockets/
                                                manner detailed (see ‘‘Written/Paper                    default.htm.                                          III. Electronic Access
                                                Submissions’’ and ‘‘Instructions’’).                       Docket: For access to the docket to                   Persons with access to the Internet
                                                                                                        read background documents or the                      may obtain the draft guidance at either
                                                Written/Paper Submissions
                                                                                                        electronic and written/paper comments                 http://www.fda.gov/Drugs/
                                                   Submit written/paper submissions as                  received, go to http://                               GuidanceCompliance
                                                follows:                                                www.regulations.gov and insert the                    RegulatoryInformation/Guidances/
                                                   • Mail/Hand delivery/Courier (for                    docket number, found in brackets in the               default.htm or http://
                                                written/paper submissions): Division of                 heading of this document, into the                    www.regulations.gov.
                                                Dockets Management (HFA–305), Food                      ‘‘Search’’ box and follow the prompts                   Dated: March 20, 2017.
                                                and Drug Administration, 5630 Fishers                   and/or go to the Division of Dockets
                                                Lane, Rm. 1061, Rockville, MD 20852.                                                                          Leslie Kux,
                                                                                                        Management, 5630 Fishers Lane, Rm.
                                                   • For written/paper comments                         1061, Rockville, MD 20852.                            Associate Commissioner for Policy.
                                                submitted to the Division of Dockets                       Submit written requests for single                 [FR Doc. 2017–05818 Filed 3–22–17; 8:45 am]
                                                Management, FDA will post your                          copies of the draft guidance to the                   BILLING CODE 4164–01–P
                                                comment, as well as any attachments,                    Division of Drug Information, Center for
                                                except for information submitted,                       Drug Evaluation and Research, Food
                                                marked and identified, as confidential,                 and Drug Administration, 10001 New                    DEPARTMENT OF HEALTH AND
                                                if submitted as detailed in                             Hampshire Ave., Hillandale Building,                  HUMAN SERVICES
                                                ‘‘Instructions.’’                                       4th Floor, Silver Spring, MD 20993–
                                                   Instructions: All submissions received               0002. Send one self-addressed adhesive                National Institutes of Health
                                                must include the Docket No. FDA–                        label to assist that office in processing             Center for Scientific Review; Notice of
                                                2017–D–0198 for ‘‘Delayed Graft                         your requests. See the SUPPLEMENTARY                  Closed Meeting
                                                Function in Kidney Transplantation:                     INFORMATION section for electronic
                                                Developing Drugs for Prevention; Draft                  access to the draft guidance document.                  Pursuant to section 10(d) of the
                                                Guidance for Industry; Availability.’’                  FOR FURTHER INFORMATION CONTACT:                      Federal Advisory Committee Act, as
                                                Received comments will be placed in                     Ozlem Belen, Center for Drug                          amended (5 U.S.C. App.), notice is
                                                the docket and, except for those                        Evaluation and Research, Food and                     hereby given of the following meeting.
                                                submitted as ‘‘Confidential                             Drug Administration, 10903 New                          The meeting will be closed to the
                                                Submissions,’’ publicly viewable at                     Hampshire Ave, Bldg. 22, Rm. 6118,                    public in accordance with the
                                                http://www.regulations.gov or at the                    Silver Spring, MD 20993–0002, 301–                    provisions set forth in sections
                                                Division of Dockets Management                          796–0676.                                             552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                between 9 a.m. and 4 p.m., Monday                       SUPPLEMENTARY INFORMATION:                            as amended. The grant applications and
                                                through Friday.                                                                                               the discussions could disclose
                                                   • Confidential Submissions—To                        I. Background                                         confidential trade secrets or commercial
                                                submit a comment with confidential                         FDA is announcing the availability of              property such as patentable material,
                                                information that you do not wish to be                  a draft guidance for industry entitled                and personal information concerning
                                                made publicly available, submit your                    ‘‘Delayed Graft Function in Kidney                    individuals associated with the grant
                                                comments only as a written/paper
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                        Transplantation: Developing Drugs for                 applications, the disclosure of which
                                                submission. You should submit two                       Prevention.’’ The purpose of this                     would constitute a clearly unwarranted
                                                copies total. One copy will include the                 guidance is to assist sponsors in the                 invasion of personal privacy.
                                                information you claim to be confidential                clinical development of drugs for the                   Name of Committee: Center for Scientific
                                                with a heading or cover note that states                prevention of DGF in kidney                           Review Special Emphasis Panel; Member
                                                ‘‘THIS DOCUMENT CONTAINS                                transplantation.                                      Conflict: Oncology 1 Basic Translational.
                                                CONFIDENTIAL INFORMATION.’’ The                            This draft guidance is being issued                  Date: April 6, 2017.
                                                Agency will review this copy, including                 consistent with FDA’s good guidance                     Time: 1:00 p.m. to 5:00 p.m.



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                                                14906                        Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices

                                                  Agenda: To review and evaluate grant                  Research; 93.862, Genetics and                        Health, 6701 Rockledge Drive, Room 5216,
                                                applications.                                           Developmental Biology Research; 93.88,                MSC 7852, Bethesda, MD 20892, 301–435–
                                                  Place: National Institutes of Health, 6701            Minority Access to Research Careers; 93.96,           1050, freundr@csr.nih.gov.
                                                Rockledge Drive, Bethesda, MD 20892                     Special Minority Initiatives; 93.859,                   This notice is being published less than 15
                                                (Virtual Meeting).                                      Biomedical Research and Research Training,            days prior to the meeting due to the timing
                                                  Contact Person: Amy L. Rubinstein, Ph.D.,             National Institutes of Health, HHS)                   limitations imposed by the review and
                                                Scientific Review Officer, Center for                                                                         funding cycle.
                                                Scientific Review, National Institutes of                 Dated: March 15, 2017.                                Name of Committee: Center for Scientific
                                                Health, 6701 Rockledge Drive, Room 5152,                Melanie J. Pantoja,                                   Review Special Emphasis Panel; Voice
                                                MSC 7844, Bethesda, MD 20892, 301–408–                  Program Analyst, Office of Federal Advisory           Production.
                                                9754, rubinsteinal@csr.nih.gov.                         Committee Policy.                                       Date: April 11, 2017.
                                                (Catalogue of Federal Domestic Assistance               [FR Doc. 2017–05587 Filed 3–22–17; 8:45 am]             Time: 2:00 p.m. to 3:00 p.m.
                                                Program Nos. 93.306, Comparative Medicine;                                                                      Agenda: To review and evaluate grant
                                                                                                        BILLING CODE 4140–01–P
                                                93.333, Clinical Research, 93.306, 93.333,                                                                    applications.
                                                93.337, 93.393–93.396, 93.837–93.844,                                                                           Place: National Institutes of Health, 6701
                                                93.846–93.878, 93.892, 93.893, National                                                                       Rockledge Drive, Bethesda, MD 20892
                                                Institutes of Health, HHS)                              DEPARTMENT OF HEALTH AND                              (Telephone Conference Call).
                                                                                                        HUMAN SERVICES                                          Contact Person: Biao Tian, Ph.D., Scientific
                                                  Dated: March 17, 2017.
                                                                                                                                                              Review Officer, Center for Scientific Review,
                                                Michelle Trout,                                         National Institutes of Health                         National Institutes of Health, 6701 Rockledge
                                                Program Analyst, Office of Federal Advisory                                                                   Drive, Room 3089B, MSC 7848, Bethesda,
                                                Committee Policy.                                       Center for Scientific Review; Notice of               MD 20892, (301) 402–4411, tianbi@
                                                [FR Doc. 2017–05750 Filed 3–22–17; 8:45 am]             Closed Meetings                                       csr.nih.gov.
                                                BILLING CODE 4140–01–P                                    Pursuant to section 10(d) of the                      Name of Committee: Center for Scientific
                                                                                                        Federal Advisory Committee Act, as                    Review Special Emphasis Panel; Member
                                                                                                                                                              Conflict: Neurodevelopmental Disorders.
                                                                                                        amended (5 U.S.C. App.), notice is
                                                DEPARTMENT OF HEALTH AND                                                                                        Date: April 13, 2017.
                                                                                                        hereby given of the following meetings.                 Time: 10:00 a.m. to 12:01 p.m.
                                                HUMAN SERVICES                                            The meetings will be closed to the                    Agenda: To review and evaluate grant
                                                                                                        public in accordance with the                         applications.
                                                National Institutes of Health
                                                                                                        provisions set forth in sections                        Place: National Institutes of Health, 6701
                                                National Institute of General Medical                   552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            Rockledge Drive, Bethesda, MD 20892
                                                Sciences; Notice of Closed Meeting                      as amended. The grant applications and                (Telephone Conference Call).
                                                                                                        the discussions could disclose                          Contact Person: Samuel C. Edwards, Ph.D.,
                                                  Pursuant to section 10(d) of the                      confidential trade secrets or commercial              Chief, Brain Disorders and Clinical
                                                Federal Advisory Committee Act, as                      property such as patentable material,                 Neuroscience, Center for Scientific Review,
                                                amended (5 U.S.C. App.), notice is                                                                            National Institutes of Health, 6701 Rockledge
                                                                                                        and personal information concerning
                                                hereby given of the following meeting.                                                                        Drive, Room 5210, MSC 7846, Bethesda, MD
                                                                                                        individuals associated with the grant                 20892, (301) 435–1246, edwardss@
                                                  The meeting will be closed to the                     applications, the disclosure of which                 csr.nih.gov.
                                                public in accordance with the                           would constitute a clearly unwarranted                  Name of Committee: Center for Scientific
                                                provisions set forth in sections                        invasion of personal privacy.                         Review Special Emphasis Panel; Member
                                                552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                                                                    Conflict: Neuroendocrinology, Sleep, Stress,
                                                                                                          Name of Committee: Center for Scientific
                                                as amended. The grant applications and                  Review Special Emphasis Panel; Member                 and Alcohol.
                                                the discussions could disclose                          Conflict: International and Cooperative                 Date: April 14, 2017.
                                                confidential trade secrets or commercial                Projects 1.                                             Time: 9:00 a.m. to 6:00 p.m.
                                                property such as patentable material,                     Date: April 6, 2017.                                  Agenda: To review and evaluate grant
                                                and personal information concerning                       Time: 9:00 a.m. to 10:00 a.m.                       applications.
                                                individuals associated with the grant                     Agenda: To review and evaluate grant                  Place: National Institutes of Health, 6701
                                                applications, the disclosure of which                   applications.                                         Rockledge Drive, Bethesda, MD 20892
                                                                                                          Place: National Institutes of Health, 6701          (Virtual Meeting).
                                                would constitute a clearly unwarranted
                                                                                                        Rockledge Drive, Bethesda, MD 20892                     Contact Person: Nicholas Gaiano, Ph.D.,
                                                invasion of personal privacy.                           (Telephone Conference Call).                          Scientific Review Officer, Center for
                                                  Name of Committee: National Institute of                Contact Person: Brian H. Scott, Ph.D.,              Scientific Review, National Institutes of
                                                General Medical Sciences Special Emphasis               Scientific Review Officer, National Institutes        Health, 6701 Rockledge Drive, Room 5178,
                                                Panel; Loan Repayment Program.                          of Health, Center for Scientific Review, 6701         MSC 7844, Bethesda, MD 20892–7844, 301–
                                                  Date: April 18, 2017.                                 Rockledge Drive, Bethesda, MD 20892, 301–             435–1033, gaianonr@csr.nih.gov.
                                                  Time: 12:00 p.m. to 3:00 p.m.                         827–7490, brianscott@mail.nih.gov.                      Name of Committee: Center for Scientific
                                                  Agenda: To review and evaluate grant                    This notice is being published less than 15         Review Special Emphasis Panel; Member
                                                applications.                                           days prior to the meeting due to the timing           Conflict: Aging Related Discords, Human and
                                                  Place: National Institutes of Health,                 limitations imposed by the review and                 Animal Studies.
                                                Natcher Building, Room 3An.12N, 45 Center               funding cycle.                                          Date: April 14, 2017.
                                                Drive, Bethesda, MD 20892.                                Name of Committee: Center for Scientific              Time: 11:00 a.m. to 1:00 p.m.
                                                  Contact Person: Manas Chattopadhyay,                  Review Special Emphasis Panel; Member                   Agenda: To review and evaluate grant
                                                Ph.D., Scientific Review Officer, National              Conflict: AIDS and Related Research.                  applications.
                                                Institute of General Medical Sciences,                    Date: April 7, 2017.                                  Place: National Institutes of Health, 6701
                                                National Institute of Health, Building 45,                Time: 1:00 p.m. to 4:00 p.m.                        Rockledge Drive, Bethesda, MD 20892
sradovich on DSK3GMQ082PROD with NOTICES




                                                Room 3An12N, 45 Center Drive, Bethesda,                   Agenda: To review and evaluate grant                (Telephone Conference Call).
                                                MD 20892, 301–827–5320, manasc@                         applications.                                           Contact Person: Samuel C. Edwards, Ph.D.,
                                                mail.nih.gov.                                             Place: National Institutes of Health, 6701          Chief, Brain Disorders and Clinical
                                                (Catalogue of Federal Domestic Assistance               Rockledge Drive, Bethesda, MD 20892                   Neuroscience, Center for Scientific Review,
                                                Program Nos. 93.375, Minority Biomedical                (Telephone Conference Call).                          National Institutes of Health, 6701 Rockledge
                                                Research Support; 93.821, Cell Biology and                Contact Person: Robert Freund, Ph.D.,               Drive, Room 5210, MSC 7846, Bethesda, MD
                                                Biophysics Research; 93.859, Pharmacology,              Scientific Review Officer, Center for                 20892, (301) 435–1246, edwardss@
                                                Physiology, and Biological Chemistry                    Scientific Review, National Institutes of             csr.nih.gov.



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Document Created: 2017-03-23 02:45:46
Document Modified: 2017-03-23 02:45:46
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
DatesApril 6, 2017.
FR Citation82 FR 14905 

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