82_FR_51851 82 FR 51637 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

82 FR 51637 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 214 (November 7, 2017)

Page Range51637-51637
FR Document2017-24144

Federal Register, Volume 82 Issue 214 (Tuesday, November 7, 2017) 
[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Page 51637]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24144]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute; Notice of Closed 
Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of the following Heart, Lung, & Blood 
Program Project Review Committee 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: Heart, Lung, and Blood Initial Review Group; 
Heart, Lung, and Blood Program Project Review Committee.
    Date: December 1, 2017.
    Time: 8:00 a.m. to 2:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Sheraton BWI (Baltimore), 1100 Old Elkridge Landing Road, 
Baltimore, MD 21090.
    Contact Person: Jeffrey H. Hurst, Ph.D., Scientific Review 
Officer, Office of Scientific Review/DERA, National Heart, Lung, and 
Blood Institute, National Institutes of Health, 6701 Rockledge 
Drive, Room 7208, Bethesda, MD 20892, 301-435-0303, 
[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.233, 
National Center for Sleep Disorders Research; 93.837, Heart and 
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, 
Blood Diseases and Resources Research, National Institutes of 
Health, HHS)

    Dated: November 1, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-24144 Filed 11-6-17; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51637 include patients with clinical or DEPARTMENT OF HEALTH AND provisions set forth in sections laboratory evidence of chronic hepatitis HUMAN SERVICES 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., C disease, such as the presence of as amended. The grant applications and fibrosis by biopsy or noninvasive tests. National Institutes of Health the discussions could disclose • Additional details on DAA drug confidential trade secrets or commercial development in patients with National Heart, Lung, and Blood property such as patentable material, decompensated cirrhosis, including Institute; Notice of Closed Meeting and personal information concerning recommendations for a review by an Pursuant to section 10(d) of the individuals associated with the grant independent adjudication committee for Federal Advisory Committee Act, as applications, the disclosure of which all serious hepatic events, deaths, liver amended, notice is hereby given of the would constitute a clearly unwarranted transplantations, and changes in following Heart, Lung, & Blood Program invasion of personal privacy. prespecified alanine transaminase, Project Review Committee meeting. aspartate transaminase, and bilirubin The meeting will be closed to the Name of Committee: Center for Scientific parameters and a recommendation for public in accordance with the Review Special Emphasis Panel; PAR Panel: long-term followup to characterize Synthetic Psychoactive Drugs and Strategic provisions set forth in sections clinical outcomes such as progression or Approaches to Counteract their Deleterious 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., regression of liver disease, liver-related Effects. as amended. The grant applications and mortality, occurrence of hepatocellular Date: November 30, 2017. the discussions could disclose carcinoma, or liver failure requiring Time: 1:00 p.m. to 6:00 p.m. confidential trade secrets or commercial liver transplantation. Agenda: To review and evaluate grant property such as patentable material, • Additional clarification on efficacy applications. and personal information concerning Place: National Institutes of Health, 6701 endpoints, specifically additional post- individuals associated with the grant treatment followup (e.g., 1 year or Rockledge Drive, Bethesda, MD 20892 applications, the disclosure of which (Virtual Meeting). longer) may be needed if one or more would constitute a clearly unwarranted Contact Person: Jasenka Borzan, Ph.D., drugs in the regimen has a long plasma invasion of personal privacy. Scientific Review Officer, Center for or intracellular half-life or prolonged Name of Committee: Heart, Lung, and Scientific Review, National Institutes of antiviral activity. Blood Initial Review Group; Heart, Lung, and Health, 6701 Rockledge Drive, Room 4214, This guidance is being issued Blood Program Project Review Committee. MSC 7814, Bethesda, MD 20892–7814, 301– consistent with FDA’s good guidance Date: December 1, 2017. 435–1787, borzanj@csr.nih.gov. practices regulation (21 CFR 10.115). Time: 8:00 a.m. to 2:00 p.m. The guidance represents the current Agenda: To review and evaluate grant Name of Committee: Center for Scientific thinking of FDA on ‘‘Chronic Hepatitis applications. Review Special Emphasis Panel; Member C Virus Infection: Developing Direct- Place: Sheraton BWI (Baltimore), 1100 Old Conflict: Neuroimmunology, Elkridge Landing Road, Baltimore, MD Neuroinflammation and Brain Tumor. Acting Antiviral Drugs for Treatment.’’ 21090. It does not establish any rights for any Date: December 6, 2017. Contact Person: Jeffrey H. Hurst, Ph.D., Time: 10:00 a.m. to 2:00 p.m. person and is not binding on FDA or the Scientific Review Officer, Office of Scientific Agenda: To review and evaluate grant public. You can use an alternative Review/DERA, National Heart, Lung, and applications. approach if it satisfies the requirements Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7208, Bethesda, Place: National Institutes of Health, 6701 of the applicable statutes and MD 20892, 301–435–0303, hurstj@ Rockledge Drive, Bethesda, MD 20892 regulations. This guidance is not subject nhlbi.nih.gov. (Telephone Conference Call). to Executive Order 12866. (Catalogue of Federal Domestic Assistance Contact Person: Nataliya Gordiyenko, II. The Paperwork Reduction Act of Program Nos. 93.233, National Center for Ph.D., Scientific Review Officer, Center for 1995 Sleep Disorders Research; 93.837, Heart and Scientific Review, National Institutes of Vascular Diseases Research; 93.838, Lung Health, 6701 Rockledge Drive, Room 5202, This guidance refers to previously Diseases Research; 93.839, Blood Diseases MSC 7846, Bethesda, MD 20892, 301–435– approved collections of information that and Resources Research, National Institutes 1265, gordiyenkon@csr.nih.gov. are subject to review by the Office of of Health, HHS) Management and Budget (OMB) under Name of Committee: Center for Scientific Dated: November 1, 2017. Review Special Emphasis Panel; Member the Paperwork Reduction Act of 1995 Michelle Trout, (44 U.S.C. 3501–3520). The collections Conflict: Retinal Synapses and Circuitry. Program Analyst, Office of Federal Advisory Date: December 6, 2017. of information in 21 CFR parts 312 and Committee Policy. 314 have been approved under OMB Time: 12:00 p.m. to 4:00 p.m. [FR Doc. 2017–24144 Filed 11–6–17; 8:45 am] Agenda: To review and evaluate grant control numbers 0910–0014 and 0910– BILLING CODE 4140–01–P applications. 0001, respectively. Place: National Institutes of Health, 6701 III. Electronic Access Rockledge Drive, Bethesda, MD 20892 Persons with access to the internet DEPARTMENT OF HEALTH AND (Telephone Conference Call). may obtain the guidance at either HUMAN SERVICES Contact Person: Afia Sultana, Ph.D., https://www.fda.gov/Drugs/Guidance Scientific Review Officer, National Institutes National Institutes of Health of Health, Center for Scientific Review, 6701 ComplianceRegulatoryInformation/ Rockledge Drive, Room 4189, Bethesda, MD Guidances/default.htm or https:// Center for Scientific Review; Notice of 20892, (301) 827–7083, sultanaa@ www.regulations.gov. ethrower on DSK3G9T082PROD with NOTICES Closed Meetings mail.nih.gov. Dated: November 2, 2017. Pursuant to section 10(d) of the (Catalogue of Federal Domestic Assistance Anna K. Abram, Federal Advisory Committee Act, as Program Nos. 93.306, Comparative Medicine; Deputy Commissioner for Policy, Planning, amended, notice is hereby given of the 93.333, Clinical Research, 93.306, 93.333, Legislation, and Analysis. following meetings. 93.337, 93.393–93.396, 93.837–93.844, [FR Doc. 2017–24195 Filed 11–6–17; 8:45 am] The meetings will be closed to the 93.846–93.878, 93.892, 93.893, National BILLING CODE 4164–01–P public in accordance with the Institutes of Health, HHS) VerDate Sep<11>2014 17:29 Nov 06, 2017 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\07NON1.SGM 07NON1


Document Created: 2018-10-25 10:26:53
Document Modified: 2018-10-25 10:26:53
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
DatesDecember 1, 2017.
FR Citation82 FR 51637 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR