National Heart, Lung, and Blood Institute; Notice of Closed Meetings, 11924-11925 [2017-03704]

Download as PDF mstockstill on DSK3G9T082PROD with NOTICES 11924 Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993–0002, 301– 796–1300. SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop regarding animal model development for infectious diseases. FDA is conducting this workshop in order to facilitate the development of narrowspectrum antibacterial drugs, such as those that are active against only a single species of bacteria that may not occur frequently. When the species occurs infrequently, performing clinical trials can be extremely challenging. Therefore, animal models of infection may be useful to explore the activity of a candidate antibacterial drug and may help to predict whether the drug will be efficacious in humans. A discussion of the additional scientific work needed to evaluate current animal models of infection and evaluate potential animal VerDate Sep<11>2014 20:23 Feb 24, 2017 Jkt 241001 models that may predict response in humans could advance the development of antibacterial drugs targeting a single species. FDA is particularly interested in infections due to Acinetobacter baumannii and Pseudomonas aeruginosa as pathogens because there are limited therapeutic options to treat patients with serious infections caused by these bacteria, including those resistant to currently available antibacterial drugs. In addition, it is difficult to enroll an adequate number of patients to conduct clinical trials since the frequency with which these organisms cause clinical disease is sufficiently low. Discussions will focus on the current state of animal models of serious infections, lessons learned from the development efforts for past and current animal models of infection, and scientific challenges and future direction and next steps in animal model development. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. Government Agencies, academic experts, contract research organizations, and industry on various aspects of development efforts pertaining to animal models of serious infections. The input from this public workshop will also help FDA in developing topics for future discussion. The Agency encourages health care providers, other U.S. Government Agencies, academic experts, contract research organizations, industry, and other interested persons to attend this public workshop. Registration: Interested parties are encouraged to register early. To register electronically, email registration information (including name, title, firm name, address, telephone, and fax number) to AnimalModelsInfection Workshop2017@fda.hhs.gov. Persons without access to the Internet can call 301–796–1300 to register. Registration is free and will be on a first-come, firstserved basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations due to a disability, please contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance. Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session, and which topic(s) you wish to address. We will do PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. All requests to make oral presentations must be received by February 27, 2017. We will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants on or before February 28, 2017. If selected for presentation, any presentation materials must be emailed to AnimalModels InfectionWorkshop2017@fda.hhs.gov no later than February 28, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency’s Web site at https://www.fda.gov. Transcripts will also be available on the Internet at: https://www.fda.gov/Drugs/NewsEvents/ ucm534031.htm approximately 45 days after the workshop. Dated: February 21, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–03751 Filed 2–24–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meetings 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 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 E:\FR\FM\27FEN1.SGM 27FEN1 Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI Clinical Trial Pilot Studies (R34). Date: March 17, 2017. Time: 8:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: YingYing Li-Smerin, MD, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7184, Bethesda, MD 20892– 7924, 301–827–7942, lismerin@nhlbi.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Collaborative Projects in Organ Fibrosis. Date: March 21, 2017. Time: 8:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Courtyard by Marriott, 5520 Wisconsin Avenue, Chevy Chase, MD 20815. Contact Person: Kristen Page, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7185, Bethesda, MD 20892, 301–827–7953, kristen.page@ 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: February 21, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–03704 Filed 2–24–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health mstockstill on DSK3G9T082PROD with NOTICES National Library of Medicine; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of a meeting of the Board of Scientific Counselors, National Center for Biotechnology Information. The meeting 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. VerDate Sep<11>2014 20:23 Feb 24, 2017 Jkt 241001 The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL LIBRARY OF MEDICINE, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors, National Center for Biotechnology Information. Date: May 2, 2017. Open: 8:30 a.m. to 12:00 p.m. Agenda: Program Discussion. Place: National Library of Medicine, Building 38, 2nd Floor, The Lindberg Room, 8600 Rockville Pike, Bethesda, MD 20892. Closed: 12:00 p.m. to 2:00 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Library of Medicine, Building 38, 2nd Floor, The Lindberg Room, 8600 Rockville Pike, Bethesda, MD 20892. Open: 2:00 p.m. to 3:00 p.m. Agenda: Program Discussion. Place: National Library of Medicine, Building 38, 2nd Floor, The Lindberg Room, 8600 Rockville Pike, Bethesda, MD 20892. Contact Person: David J. Lipman, MD, Director, National Center for Biotechnology Information, National Library of Medicine, Building 38A, Room 8N805, Bethesda, MD 20892, 301–435–5985, dlipman@ mail.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. 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 No. 93.879, Medical Library Assistance, National Institutes of Health, HHS) Dated: February 21, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–03702 Filed 2–24–17; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 11925 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; 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: National Institute of General Medical Sciences Special Emphasis Panel Review of U54 Application. Date: March 30, 2017. Time: 8:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Garden Inn Bethesda, 7301 Waverly Street, Bethesda, MD 20814. Contact Person: Lisa A. Dunbar, Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3AN12, Bethesda, MD 20892, 301–594–2849, dunbarl@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: February 22, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–03822 Filed 2–24–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Sickle Cell Disease Advisory Committee. E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)]
[Notices]
[Pages 11924-11925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03704]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

    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 
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

[[Page 11925]]

would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Heart, Lung, and Blood Institute 
Special Emphasis Panel; NHLBI Clinical Trial Pilot Studies (R34).
    Date: March 17, 2017.
    Time: 8:30 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 
Wisconsin Avenue, Bethesda, MD 20814.
    Contact Person: YingYing Li-Smerin, MD, Ph.D., Scientific Review 
Officer, Office of Scientific Review/DERA, National Heart, Lung, and 
Blood Institute, 6701 Rockledge Drive, Room 7184, Bethesda, MD 
20892-7924, 301-827-7942, lismerin@nhlbi.nih.gov.

    Name of Committee: National Heart, Lung, and Blood Institute 
Special Emphasis Panel; Collaborative Projects in Organ Fibrosis.
    Date: March 21, 2017.
    Time: 8:30 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Courtyard by Marriott, 5520 Wisconsin Avenue, Chevy 
Chase, MD 20815.
    Contact Person: Kristen Page, Ph.D., Scientific Review Officer, 
Office of Scientific Review/DERA, National Heart, Lung, and Blood 
Institute, National Institutes of Health, 6701 Rockledge Drive, Room 
7185, Bethesda, MD 20892, 301-827-7953, kristen.page@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: February 21, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-03704 Filed 2-24-17; 8:45 am]
 BILLING CODE 4140-01-P
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