National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 51637 [2017-24144]

Download as PDF Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices include patients with clinical or laboratory evidence of chronic hepatitis C disease, such as the presence of fibrosis by biopsy or noninvasive tests. • Additional details on DAA drug development in patients with decompensated cirrhosis, including recommendations for a review by an independent adjudication committee for all serious hepatic events, deaths, liver transplantations, and changes in prespecified alanine transaminase, aspartate transaminase, and bilirubin parameters and a recommendation for long-term followup to characterize clinical outcomes such as progression or regression of liver disease, liver-related mortality, occurrence of hepatocellular carcinoma, or liver failure requiring liver transplantation. • Additional clarification on efficacy endpoints, specifically additional posttreatment followup (e.g., 1 year or longer) may be needed if one or more drugs in the regimen has a long plasma or intracellular half-life or prolonged antiviral activity. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Chronic Hepatitis C Virus Infection: Developing DirectActing Antiviral Drugs for Treatment.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001, respectively. 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, hurstj@ nhlbi.nih.gov. (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 ethrower on DSK3G9T082PROD with NOTICES III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. 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 [FR Doc. 2017–24195 Filed 11–6–17; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:29 Nov 06, 2017 Jkt 244001 National Institutes of Health Center for Scientific Review; Notice of Closed Meetings PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 51637 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; PAR Panel: Synthetic Psychoactive Drugs and Strategic Approaches to Counteract their Deleterious Effects. Date: November 30, 2017. Time: 1:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jasenka Borzan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892–7814, 301– 435–1787, borzanj@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Neuroimmunology, Neuroinflammation and Brain Tumor. Date: December 6, 2017. Time: 10:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Nataliya Gordiyenko, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5202, MSC 7846, Bethesda, MD 20892, 301–435– 1265, gordiyenkon@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Retinal Synapses and Circuitry. Date: December 6, 2017. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Afia Sultana, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Room 4189, Bethesda, MD 20892, (301) 827–7083, sultanaa@ mail.nih.gov. (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) E:\FR\FM\07NON1.SGM 07NON1

Agencies

[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Page 51637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24144]


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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, 
hurstj@nhlbi.nih.gov.

(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
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