82_FR_46274 82 FR 46084 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings

82 FR 46084 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 190 (October 3, 2017)

Page Range46084-46085
FR Document2017-21139

Federal Register, Volume 82 Issue 190 (Tuesday, October 3, 2017) 
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46084-46085]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21139]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Eunice Kennedy Shriver National Institute of Child Health & Human 
Development; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of the following meetings.
    The meetings will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel NICHD Education Grants.
    Date: November 6, 2017.
    Time: 3:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6710 B Rockledge Drive, 
Bethesda, MD 20892, (Telephone Conference Call).
    Contact Person: Joanna Kubler-Kielb, Scientific Review Officer, 
Scientific Review Branch, Eunice Kennedy Shriver National Institute 
of Child Health and Human Development, 6100 Executive Boulevard, 
Room 5B01, Bethesda, MD 20892-7510, 301-435-6916, 
[email protected].

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel, SPROUTS: Development of eating 
behaviors in early childhood.
    Date: November 13, 2017.
    Time: 1:00 p.m. to 4:00 p.m.
    Agenda: To review and evaluate contract proposals.

[[Page 46085]]

    Place: National Institutes of Health, 6710 B Rockledge Drive, 
Bethesda, MD 20892, (Telephone Conference Call).
    Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review 
Administrator Division of Scientific Review National Institute of 
Child Health and Human D, 6100 Executive Boulevard, Room 5B01, 
Bethesda, MD 20892-9304, (301) 435-6680, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.864, 
Population Research; 93.865, Research for Mothers and Children; 
93.929, Center for Medical Rehabilitation Research; 93.209, 
Contraception and Infertility Loan Repayment Program, National 
Institutes of Health, HHS)


    Dated: September 27, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-21139 Filed 10-2-17; 8:45 am]
 BILLING CODE 4140-01-P

46084 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices docket number, found in brackets in the (3) What standards already exist that enhanced compliance and safer use of heading of this document, into the could be used to address the needs and drugs that have REMS. ‘‘Search’’ box and follow the prompts facilitate the REMS activities described II. Electronic Access and/or go to the Dockets Management in the needs assessment? Staff, 5630 Fishers Lane, Rm. 1061, (4) Where (if at all) do new standards Persons with access to the Internet Rockville, MD 20852. need to be developed? may obtain the needs assessment at (5) What other opportunities exist to https://www.fda.gov/downloads/ FOR FURTHER INFORMATION CONTACT: leverage health IT to facilitate the ForIndustry/UserFees/ Adam Kroetsch, Center for Drug completion of REMS activities? PrescriptionDrugUserFee/ Evaluation and Research, Food and FDA hopes that the needs assessment UCM565594.pdf. Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1168, will help identify areas where standards Dated: September 19, 2017. Silver Spring, MD 20993–0002, 301– development projects to support REMS Leslie Kux, 796–3842, REMS_Standardization@ are already underway, as well as areas Associate Commissioner for Policy. fda.hhs.gov; or Aaron Sherman, Center that are ripe for standards development, [FR Doc. 2017–21218 Filed 10–2–17; 8:45 am] for Drug Evaluation and Research, Food enabling interested stakeholders to BILLING CODE 4164–01–P and Drug Administration, 10903 New engage further in this project. Hampshire Ave., Bldg. 51, Rm. 6366, What is the REMS Platform Standards Silver Spring, MD 20993–0002, 240– Initiative? DEPARTMENT OF HEALTH AND 402–0493, REMS_Standardization@ HUMAN SERVICES fda.hhs.gov. The goal of the REMS Platform Standards Initiative is to leverage National Institutes of Health SUPPLEMENTARY INFORMATION: electronic health data standards to standardize certain activities in REMS Eunice Kennedy Shriver National I. Background with ETASU and integrate them into Institute of Child Health & Human On October 5, 2015, FDA launched health IT systems. Under the initiative, Development; Notice of Closed the REMS Platform Standards Initiative FDA seeks to work with third-party Meetings (previously referred to as the ‘‘Common standards development organizations to Pursuant to section 10(d) of the REMS Platform Initiative’’), with the encourage the development of electronic Federal Advisory Committee Act, as goal of developing and leveraging data standards that may be used to amended, notice is hereby given of the electronic health data standards, facilitate communication between following meetings. referred to as ‘‘REMS platform REMS and their participants. Once the The meetings will be closed to the standards,’’ to further standardize standards are developed, FDA would public in accordance with the certain activities associated with REMS maintain a list of REMS platform provisions set forth in sections with elements to assure safe use standards, encourage their use in REMS 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., (ETASU), and integrate them into with ETASU, and encourage the as amended. The grant applications and existing health care systems. development of tools that use these the discussions could disclose (Information about the initiative can be standards to integrate REMS into health confidential trade secrets or commercial found at: http://www.fda.gov/ care providers’ existing systems. property such as patentable material, downloads/ForIndustry/UserFees/ and personal information concerning PrescriptionDrugUserFee/ Why is FDA launching the REMS Platform Standards Initiative? individuals associated with the grant UCM507451.pdf). Since then, FDA has applications, the disclosure of which been working to determine the most This initiative was launched for a would constitute a clearly unwarranted effective methods for carrying out this number of reasons. Stakeholders have invasion of personal privacy. initiative, including how best to engage requested a centralized method to enroll the public on the project and advance Name of Committee: National Institute of in and interact with REMS with ETASU Child Health and Human Development the development of REMS platform and more fundamental standardization Special Emphasis Panel NICHD Education standards. To achieve these ends, FDA of REMS architecture. There is also a Grants. is publishing the ‘‘REMS Platform need for a comprehensive set of Date: November 6, 2017. Standards Initiative: Needs standards for REMS to help minimize Time: 3:00 p.m. to 5:00 p.m. Assessment,’’ which seeks to provide REMS burden on the health care Agenda: To review and evaluate grant REMS stakeholders, standards delivery system and integrate REMS applications. developers, and health information into health IT systems. Place: National Institutes of Health, 6710 B technology (IT) systems developers with Rockledge Drive, Bethesda, MD 20892, The goal of the REMS Platform (Telephone Conference Call). specific, detailed information on the Standards Initiative is to give all Contact Person: Joanna Kubler-Kielb, areas in which standards development stakeholders—including sponsors, data Scientific Review Officer, Scientific Review is needed and the information that the vendors, clinical decision support Branch, Eunice Kennedy Shriver National data standards would need to system developers (such as those for Institute of Child Health and Human communicate to effectively carry out hospitals, private practices, etc.)—a Development, 6100 Executive Boulevard, REMS activities. FDA seeks comment on ‘‘fixed target’’ for standardization and Room 5B01, Bethesda, MD 20892–7510, 301– the document as a whole, as well as on 435–6916, kielbj@mail.nih.gov. asabaliauskas on DSKBBXCHB2PROD with NOTICES integration. If successful, this will the specific questions that follow. clarify how sponsors can develop Name of Committee: National Institute of (1) Does this needs assessment cover standardized REMS that are more easily Child Health and Human Development all of the REMS activities for which integrated into the health care system Special Emphasis Panel, SPROUTS: standards development would be Development of eating behaviors in early and what health care providers must do childhood. beneficial? to comply with those REMS. Ultimately, Date: November 13, 2017. (2) Which REMS activities should be REMS that are more effectively Time: 1:00 p.m. to 4:00 p.m. given highest priority for standards standardized and integrated into the Agenda: To review and evaluate contract development? health care system should facilitate proposals. VerDate Sep<11>2014 18:17 Oct 02, 2017 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\03OCN1.SGM 03OCN1

Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46085 Place: National Institutes of Health, 6710 B Vascular Diseases Research; 93.838, Lung DEPARTMENT OF HEALTH AND Rockledge Drive, Bethesda, MD 20892, Diseases Research; 93.839, Blood Diseases HUMAN SERVICES (Telephone Conference Call). and Resources Research, National Institutes Contact Person: Sathasiva B. Kandasamy, of Health, HHS) National Institutes of Health Ph.D., Scientific Review Administrator Division of Scientific Review National Dated: September 27, 2017. Center for Scientific Review; Notice of Institute of Child Health and Human D, 6100 Michelle Trout, Closed Meetings Executive Boulevard, Room 5B01, Bethesda, Program Analyst, Office of Federal Advisory MD 20892–9304, (301) 435–6680, skandasa@ Pursuant to section 10(d) of the Committee Policy. mail.nih.gov. Federal Advisory Committee Act, as [FR Doc. 2017–21136 Filed 10–2–17; 8:45 am] (Catalogue of Federal Domestic Assistance amended, notice is hereby given of the Program Nos. 93.864, Population Research; BILLING CODE 4140–01–P following meetings. 93.865, Research for Mothers and Children; The meetings will be closed to the 93.929, Center for Medical Rehabilitation public in accordance with the Research; 93.209, Contraception and DEPARTMENT OF HEALTH AND Infertility Loan Repayment Program, National provisions set forth in sections HUMAN SERVICES Institutes of Health, HHS) 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., National Institutes of Health as amended. The grant applications and Dated: September 27, 2017. the discussions could disclose Michelle Trout, National Institute of Allergy and confidential trade secrets or commercial Program Analyst, Office of Federal Advisory Infectious Diseases; Notice of Closed property such as patentable material, Committee Policy. Meeting and personal information concerning [FR Doc. 2017–21139 Filed 10–2–17; 8:45 am] individuals associated with the grant BILLING CODE 4140–01–P Pursuant to section 10(d) of the applications, the disclosure of which Federal Advisory Committee Act, as would constitute a clearly unwarranted amended, notice is hereby given of the invasion of personal privacy. DEPARTMENT OF HEALTH AND following meeting. Name of Committee: Brain Disorders and HUMAN SERVICES Clinical Neuroscience Integrated Review The meeting will be closed to the Group; Diseases and Pathophysiology of the National Institutes of Health public in accordance with the Visual System Study Section. provisions set forth in sections Date: October 26–27, 2017. National Heart, Lung, and Blood 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 8:00 a.m. to 5:00 p.m. Institute; Notice of Closed Meeting as amended. The contract proposals and Agenda: To review and evaluate grant the discussions could disclose applications. Pursuant to section 10(d) of the Place: Residence Inn Bethesda, 7335 confidential trade secrets or commercial Federal Advisory Committee Act, as Wisconsin Avenue, Bethesda, MD 20814. property such as patentable material, amended, notice is hereby given of the Contact Person: Nataliya Gordiyenko, and personal information concerning Ph.D., Scientific Review Officer, Center for following NHLBI Mentored Clinical and individuals associated with the contract Scientific Review, National Institutes of Basic Science Review Committee proposals, the disclosure of which Health, 6701 Rockledge Drive, Room 5202, meeting. The meeting will be closed to the would constitute a clearly unwarranted MSC 7846, Bethesda, MD 20892, 301–435– invasion of personal privacy. 1265, gordiyenkon@csr.nih.gov. public in accordance with the provisions set forth in sections Name of Committee: National Institute of Name of Committee: Oncology 1—Basic Translational Integrated Review Group; 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Allergy and Infectious Diseases Special Cancer Etiology Study Section. as amended. The grant applications and Emphasis Panel NIAID Peer Review Meeting. Date: October 26–27, 2017. the discussions could disclose Date: October 26–27, 2017. Time: 8:00 a.m. to 4:00 p.m. confidential trade secrets or commercial Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant property such as patentable material, Agenda: To review and evaluate contract applications. and personal information concerning proposals. Place: Marines’ Memorial Club & Hotel, individuals associated with the grant Place: National Institutes of Health, 5601 609 Sutter Street, San Francisco, CA 94102. applications, the disclosure of which Fishers Lane, Rockville, MD 20892, Contact Person: Ola Mae Zack Howard, would constitute a clearly unwarranted (Telephone Conference Call). Ph.D., Scientific Review Officer, Center for Contact Person: Susana Mendez, DVM, Scientific Review, National Institutes of invasion of personal privacy. Health, 6701 Rockledge Dr., Room 4192, MSC Ph.D., Scientific Review Officer, Scientific Name of Committee: Heart, Lung, and 7806, Bethesda, MD 20892, 301–451–4467, Review Program, Division of Extramural Blood Initial Review Group; NHLBI howardz@mail.nih.gov. Mentored Clinical and Basic Science Review Activities, Room 3G53B, National Institutes Name of Committee: Integrative, Committee. of Health, NIAID, 5601 Fishers Lane Dr., Functional and Cognitive Neuroscience Date: October 26–27, 2017. MSC 9823, Bethesda, MD 20892–9823, (240) Integrated Review Group; Neurotoxicology Time: 10:30 a.m. to 3:00 p.m. 669–5077, mendezs@niaid.nih.gov. and Alcohol Study Section. Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance Date: October 26–27, 2017. applications. Program Nos. 93.855, Allergy, Immunology, Time: 8:00 a.m. to 5:00 p.m. Place: Crowne Plaza National Airport, 1480 and Transplantation Research; 93.856, Agenda: To review and evaluate grant Crystal Drive, Arlington, VA 22202. asabaliauskas on DSKBBXCHB2PROD with NOTICES Microbiology and Infectious Diseases applications. Contact Person: Keith A. Mintzer, Ph.D., Place: Residence Inn Washington, DC Research, National Institutes of Health, HHS) Scientific Review Officer, Office of Scientific Downtown, 1199 Vermont Avenue NW., Review/DERA, National Heart, Lung, and Dated: September 27, 2017. Washington, DC 20005. Blood Institute, 6701 Rockledge Drive, Room Natasha M. Copeland, Contact Person: Jana Drgonova, Ph.D., 7186, Bethesda, MD 20892–7924, 301–827– Scientific Review Officer, Center for 7949, mintzerk@nhlbi.nih.gov. Program Analyst, Office of Federal Advisory Scientific Review, National Institutes of Committee Policy. (Catalogue of Federal Domestic Assistance Health, 6701 Rockledge Drive, Room 5213, Program Nos. 93.233, National Center for [FR Doc. 2017–21138 Filed 10–2–17; 8:45 am] Bethesda, MD 20892, 301–827–2549, Sleep Disorders Research; 93.837, Heart and BILLING CODE 4140–01–P jdrgonova@mail.nih.gov. VerDate Sep<11>2014 18:17 Oct 02, 2017 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\03OCN1.SGM 03OCN1


Document Created: 2017-10-03 01:01:41
Document Modified: 2017-10-03 01:01:41
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
DatesNovember 6, 2017.
FR Citation82 FR 46084 
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