Center for Scientific Review; Notice of Closed Meetings, 2223-2224 [2016-00650]

Download as PDF Federal Register / Vol. 81, No. 10 / Friday, January 15, 2016 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES of safety-related drug marketing withdrawals over the past 50 years and that hepatotoxicity has both limited the use of many drugs that have been approved and prevented the approval of others. Second, this guidance discusses methods of detecting DILI by periodic tests of serum enzyme activities and of bilirubin concentration and how changes in the results of these laboratory tests over time, along with symptoms and physical findings, may be used to estimate the severity of the injury. Third, this guidance suggests some ‘‘stopping rules’’ for interrupting drug treatment and mentions the need to obtain sufficient clinical information to assess causation. FDA published a draft of this guidance in 2006, and comments on that draft were taken into consideration when issuing the final guidance in July 2009. II. Conference Information The purpose of the 2016 conference is to invite participants to present their data and views and to hold an open discussion. The meetings in recent years have been attended by members of industry, regulatory bodies, and academic consultants, and the topics discussed have included several unresolved issues on which consensus was sought. Registration: A registration fee ($650 for industry registrants and $325 for Federal government and academic registrants) will be charged to help defray the cost of renting the meeting space, providing meals and snacks, and covering the travel fees incurred by invited academic (but not government or industry) speakers, as well as any other expenses. The registration process will be handled by C-Path, an independent, nonprofit organization established in 2005 with public and private philanthropic support from the southern Arizona community, Science Foundation Arizona, and FDA. Additional information on the conference, program, and registration procedures may be obtained on the Internet at http://www.c-path.org, and at http://www.fda.gov by typing ‘‘liver toxicity’’ into the search box. (FDA has verified the Web site addresses but is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http:// www.regulations.gov. It may be viewed at the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A transcript will also be available in VerDate Sep<11>2014 20:01 Jan 14, 2016 Jkt 238001 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 http:// www.fda.gov. Materials presented at past programs (from 2007 to 2015) (including copies of slides shown, comments made about the slides, and discussions following the slides) may be accessed at http:// www.aasld.org/events-professionaldevelopment/drug-induced-liver-injury2015-program. (FDA has verified this Web site address but is not responsible for any subsequent changes to it after this document publishes in the Federal Register.) Dated: January 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–00690 Filed 1–14–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting Notice for the President’s Advisory Council on Faith-Based and Neighborhood Partnerships In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the President’s Advisory Council on Faith-based and Neighborhood Partnerships announces the following meetings: Name: President’s Advisory Council on Faith-based and Neighborhood Partnerships Council Meetings. Time and Date: Monday, February 1st, 2016 1:00 p.m.–5:00 p.m. (EST) and Tuesday, February 2nd, 2016 10:00 a.m.–1:00 p.m. (EST). Place: Meeting will be held at a location to be determined in the White House complex, 1600 Pennsylvania Ave NW., Washington, DC. Space is extremely limited. Photo ID and RSVP by January 25, 2016 are required to attend the event. Please RSVP to Ben O’Dell at partnerships@hhs.gov. The meeting will be available to the public through a conference call line. Register to participate in the conference call on Monday, February 1st at the Web site https://attendee.gotowebinar.com/ register/7321886895235169026. Register to participate in the conference call on Tuesday, February 2nd at the Web site https://attendee.gotowebinar.com/ register/4788059050490531842. Status: Open to the public, limited only by space available. Conference call limited only by lines available. Purpose: The Council brings together leaders and experts in fields related to the work of faith-based and PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 2223 neighborhood organizations in order to: Identify best practices and successful modes of delivering social services; evaluate the need for improvements in the implementation and coordination of public policies relating to faith- based and other neighborhood organizations; and make recommendations for changes in policies, programs, and practices. Contact Person for Additional Information: Please contact Ben O’Dell for any additional information about the President’s Advisory Council meeting at partnerships@hhs.gov. Agenda: For February 1, the agenda will begin with an Opening and Welcome from the Chairperson and Executive Director for the President’s Advisory Council for Faith-based and Neighborhood Partnership. Then there will be presentation of any Recommendations for deliberation and vote. Lastly, there will be a discussion of subgroup deliberation as well as elements being considered for recommendations. For February 2, there will presentations on work to address poverty and income inequality after a welcome and opening from the Chairperson and Executive Director for the President’s Advisory Council. Public Comment: There will be an opportunity for public comment at the end of the meeting. Comments and questions can be sent in advance to partnerships@hhs.gov. Dated: January 11, 2016. Ben O’Dell, Associate Director for Center for Faith-based and Neighborhood Partnerships at U.S. Department of Health and Human Services. [FR Doc. 2016–00767 Filed 1–14–16; 8:45 am] BILLING CODE 4154–07–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; 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\15JAN1.SGM 15JAN1 2224 Federal Register / Vol. 81, No. 10 / Friday, January 15, 2016 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–15– 319 Biomedical and Behavioral Research Innovations to Ensure Equity (BRITE). Date: February 3, 2016. Time: 1:00 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: San Diego Marriott Mission Valley, 8757 Rio San Diego Drive, San Diego, CA 92108. Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD 20892, 301–435– 0684, olufokunbisamd@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–15– 279 Strategies to Increase Delivery of Guideline-Based Care to Populations with Health Disparities. Date: February 3, 2016. Time: 2:30 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: San Diego Marriott Mission Valley, 8757 Rio San Diego Drive, San Diego, CA 90108. Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD 20892, 301–435– 0684, olufokunbisamd@csr.nih.gov. Name of Committee: Healthcare Delivery and Methodologies Integrated Review Group; Health Disparities and Equity Promotion Study Section. Date: February 4–5, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: San Diego Marriott Mission Valley, 8757 Rio San Diego Drive, San Diego, CA 92108. Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD 20892, 301–435– 0684, olufokunbisamd@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Physical Activity and Weight Control Interventions Among Cancer Survivors: Effects on Biomarkers of Prognosis. Date: February 4, 2016. Time: 1:30 p.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Denise Wiesch, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3138, MSC 7770, Bethesda, MD 20892, (301) 437– 3478, wieschd@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Academic Research Enhancement Award. VerDate Sep<11>2014 20:01 Jan 14, 2016 Jkt 238001 Date: February 9, 2016. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bahia Resort Hotel, 998 West Mission Bay Drive, San Diego, CA 92109. Contact Person: Inna Gorshkova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301–435–1784, gorshkoi@csr.nih.gov. Name of Committee: Bioengineering Sciences & Technologies Integrated Review Group; Modeling and Analysis of Biological Systems Study Section. Date: February 10–11, 2016. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Renaissance Long Beach Hotel, 111 East Ocean Blvd., Long Beach, CA 90802. Contact Person: Craig Giroux, Ph.D., Scientific Review Officer, BST IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5150, Bethesda, MD 20892, 301–435–2204, girouxcn@csr.nih.gov. Name of Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Xenobiotic and Nutrient Disposition and Action Study Section. Date: February 10, 2016. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. Contact Person: Martha Garcia, Ph.D., Scientific Reviewer Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2186, Bethesda, MD 20892, 301–435–1243, garciamc@nih.gov. Name of Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Kidney Molecular Biology and Genitourinary Organ Development. Date: February 10, 2016. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Crowne Plaza National Airport, 1480 Crystal Drive, Arlington, VA 22202. Contact Person: Ryan G. Morris, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4205, MSC 7814, Bethesda, MD 20892, 301–435– 1501, morrisr@csr.nih.gov. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Vector Biology Study Section. Date: February 10, 2016. Time: 8:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Marines Memorial Club & Hotel, 609 Sutter Street, San Francisco, CA 94102. Contact Person: Liangbiao Zheng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD 20892, 301–402– 5671, zhengli@csr.nih.gov. PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Name of Committee: Center for Scientific Review Special Emphasis Panel; Musculoskeletal, Oral and Skin Sciences AREA review. Date: February 10, 2016. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Yanming Bi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301–451– 0996, ybi@csr.nih.gov. Name of Committee: Oncology 1-Basic Translational Integrated Review Group; Tumor Cell Biology Study Section. Date: February 11–12, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hotel Nikko San Francisco, 222 Mason Street, San Francisco, CA 94102. Contact Person: Charles Morrow, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6202, MSC 7804, Bethesda, MD 20892, 301–408– 9850, morrowcs@csr.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) Dated: January 11, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–00650 Filed 1–14–16; 8:45 am] BILLING CODE 4140–01–P 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; PAR–14– E:\FR\FM\15JAN1.SGM 15JAN1

Agencies

[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Notices]
[Pages 2223-2224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00650]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; 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 2224]]

would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; RFA-15-319 Biomedical and Behavioral Research Innovations to 
Ensure Equity (BRITE).
    Date: February 3, 2016.
    Time: 1:00 p.m. to 2:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: San Diego Marriott Mission Valley, 8757 Rio San Diego 
Drive, San Diego, CA 92108.
    Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD 
20892, 301-435-0684, olufokunbisamd@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; RFA-15-279 Strategies to Increase Delivery of Guideline-Based 
Care to Populations with Health Disparities.
    Date: February 3, 2016.
    Time: 2:30 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: San Diego Marriott Mission Valley, 8757 Rio San Diego 
Drive, San Diego, CA 90108.
    Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD 
20892, 301-435-0684, olufokunbisamd@csr.nih.gov.

    Name of Committee: Healthcare Delivery and Methodologies 
Integrated Review Group; Health Disparities and Equity Promotion 
Study Section.
    Date: February 4-5, 2016.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: San Diego Marriott Mission Valley, 8757 Rio San Diego 
Drive, San Diego, CA 92108.
    Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD 
20892, 301-435-0684, olufokunbisamd@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Physical Activity and Weight Control Interventions Among 
Cancer Survivors: Effects on Biomarkers of Prognosis.
    Date: February 4, 2016.
    Time: 1:30 p.m. to 5:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Denise Wiesch, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 3138, MSC 7770, Bethesda, MD 20892, (301) 437-
3478, wieschd@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Academic Research Enhancement Award.
    Date: February 9, 2016.
    Time: 1:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Bahia Resort Hotel, 998 West Mission Bay Drive, San 
Diego, CA 92109.
    Contact Person: Inna Gorshkova, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301-435-1784, 
gorshkoi@csr.nih.gov.

    Name of Committee: Bioengineering Sciences & Technologies 
Integrated Review Group; Modeling and Analysis of Biological Systems 
Study Section.
    Date: February 10-11, 2016.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Renaissance Long Beach Hotel, 111 East Ocean Blvd., Long 
Beach, CA 90802.
    Contact Person: Craig Giroux, Ph.D., Scientific Review Officer, 
BST IRG, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5150, Bethesda, MD 20892, 301-
435-2204, girouxcn@csr.nih.gov.

    Name of Committee: Digestive, Kidney and Urological Systems 
Integrated Review Group; Xenobiotic and Nutrient Disposition and 
Action Study Section.
    Date: February 10, 2016.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military 
Road, NW., Washington, DC 20015.
    Contact Person: Martha Garcia, Ph.D., Scientific Reviewer 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 2186, Bethesda, MD 20892, 301-
435-1243, garciamc@nih.gov.

    Name of Committee: Digestive, Kidney and Urological Systems 
Integrated Review Group; Kidney Molecular Biology and Genitourinary 
Organ Development.
    Date: February 10, 2016.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Crowne Plaza National Airport, 1480 Crystal Drive, 
Arlington, VA 22202.
    Contact Person: Ryan G. Morris, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4205, MSC 7814, Bethesda, MD 
20892, 301-435-1501, morrisr@csr.nih.gov.

    Name of Committee: Infectious Diseases and Microbiology 
Integrated Review Group; Vector Biology Study Section.
    Date: February 10, 2016.
    Time: 8:30 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Marines Memorial Club & Hotel, 609 Sutter Street, San 
Francisco, CA 94102.
    Contact Person: Liangbiao Zheng, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD 
20892, 301-402-5671, zhengli@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Musculoskeletal, Oral and Skin Sciences AREA review.
    Date: February 10, 2016.
    Time: 9:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Yanming Bi, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301-451-
0996, ybi@csr.nih.gov.

    Name of Committee: Oncology 1-Basic Translational Integrated 
Review Group; Tumor Cell Biology Study Section.
    Date: February 11-12, 2016.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hotel Nikko San Francisco, 222 Mason Street, San 
Francisco, CA 94102.
    Contact Person: Charles Morrow, MD, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 6202, MSC 7804, Bethesda, MD 
20892, 301-408-9850, morrowcs@csr.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)

    Dated: January 11, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-00650 Filed 1-14-16; 8:45 am]
 BILLING CODE 4140-01-P