Announcement of Workshops for the Development of New Antibacterial Products, 37334-37335 [2014-15436]

Download as PDF emcdonald on DSK67QTVN1PROD with NOTICES 37334 Federal Register / Vol. 79, No. 126 / Tuesday, July 1, 2014 / Notices Time: 10:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Ping Wu, Ph.D., Scientific Review Officer, HDM IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3166, Bethesda, MD 20892, 301–615–7401, wup4@ csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; HIV/AIDS Innovative Research Applications. Date: July 23–24, 2014. Time: 10:00 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: Kenneth A. Roebuck, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5106, MSC 7852, Bethesda, MD 20892, (301) 435– 1166, roebuckk@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflicts: Continuous Submissions: Respiratory Diseases. Date: July 24–25, 2014. Time: 11:00 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: Yuanna Cheng, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4138, MSC 7814, Bethesda, MD 20892, (301) 435– 1195, Chengy5@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Urology and Nephrology. Date: July 24, 2014. Time: 1:00 p.m. to 3:00 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: Patricia Greenwel, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2178, MSC 7818, Bethesda, MD 20892, 301–435– 1169, greenwep@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: June 23, 2014. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Amended Notice of Meeting Announcement of Workshops for the Development of New Antibacterial Products Notice is hereby given of a change in the meeting of the National Institute of Child Health and Human Development Special Emphasis Panel, June 17, 2014, 08:30 a.m. to June 17, 2014, 12:00 p.m., Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD, 20814 which was published in the Federal Register on May 19, 2014, 79 FR 28740. The meeting notice is amended to change the date of the ZHD1 Special Emphasis Panel meeting from June 17, 2014 to July 8, 2014. The meeting will now be a telephone conference call and will be closed to the public. Dated: June 25, 2014. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–15299 Filed 6–30–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Cancellation of Meeting Notice is hereby given of the cancellation of the National Children’s Study Advisory Committee, July 11, 2014, 9:00 a.m. to July 11, 2014, 4:45 p.m., National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 which was published in the Federal Register on June 16, 2014, 79 FR 34332. The meeting of the National Children’s Study Advisory Committee is cancelled for July 11, 2014, 9:00 a.m. to 4:45 p.m. Dated: June 24, 2014. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–15296 Filed 6–30–14; 8:45 am] BILLING CODE 4140–01–P [FR Doc. 2014–15295 Filed 6–30–14; 8:45 am] BILLING CODE 4140–01–P VerDate Mar<15>2010 19:00 Jun 30, 2014 Jkt 232001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 National Institutes of Health, Department of Health and Human Services. ACTION: Notice of Public Workshop. AGENCY: The National Institutes of Health (NIH), Office of the Director, Office of Science Policy, and the Food and Drug Administration (FDA), Office of the Commissioner, are announcing a public workshop titled ‘‘The Development of New Antibacterial Products: Charting a Course for the Future.’’ The workshop is being held to: (1) Examine key issues and challenges related to antibacterial product development, (2) discuss regulatory pathways for bringing new antibacterial drugs to market, (3) identify strategies for promoting clinical trials for antibacterial drugs, and (4) encourage partnerships to accelerate the development of new antibacterial drugs. The workshop is open to the public and is free of charge. DATES: The workshop will be held on July 30 and 31, 2014, from 8:00 a.m. to 5:15 p.m. and from 8:00 a.m. to 1:00 p.m., respectively. The registration deadline is July 14, 2014. ADDRESSES: The workshop will be held at the Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, Maryland 20852. FOR FURTHER INFORMATION CONTACT: Kelly Fennington, NIH, Office of Science Policy, 6705 Rockledge Drive, Room 750, Bethesda, MD 20892–7985; 301–496–9838; email: FenningK@ mail.nih.gov. SUMMARY: Specific issues to be discussed at this workshop include: (1) Priorities and strategic approaches to conducting clinical trials for antibacterial drugs; (2) regulatory pathways, including streamlined programs for the development of antibacterial drugs for patients with limited or no treatment options; (3) clinical trial design, including the development of a common clinical protocol, use of common control groups, statistical design, data sharing across trial, clinical trial endpoints, and lessons learned from other therapeutic areas; and (4) the role of public-private partnerships in advancing the development of antibacterial drugs. Participants will include individuals SUPPLEMENTARY INFORMATION: E:\FR\FM\01JYN1.SGM 01JYN1 Federal Register / Vol. 79, No. 126 / Tuesday, July 1, 2014 / Notices from the professional and scientific societies, academia, patient communities, pharmaceutical and biotechnology sectors, diagnostic development community, foundations, NIH, FDA, Biomedical Advanced Research and Development Authority (BARDA), and the general public. The meeting agenda can be accessed at https://osp.od.nih.gov/officebiotechnology-activities/event/2014-0730-120000-2014-07-31-170000/ development-new-antibacterialproducts-charting-course-future. You are encouraged to pre-register for the meeting due to space limitations at https://palladianpartners.cvent.com/ AMRWorkshopJuly2014, and the deadline for registration is July 14, 2014. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the contact person listed above in advance of the meeting. Dated: June 25, 2014. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health. [FR Doc. 2014–15436 Filed 6–30–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting emcdonald on DSK67QTVN1PROD with NOTICES 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 Child Health and Human Development Special Emphasis Panel. Date: July 24, 2014. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852, (Telephone Conference Call). VerDate Mar<15>2010 19:00 Jun 30, 2014 Jkt 232001 Contact Person: Michele C. HindiAlexander, Ph.D., Scientific Review Branc, National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 1600 Executive Boulevard, Rm. 5B01, Bethesda, MD 20892, (301) 435–8382, hindialm@ mail.nih.gov. (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). 37335 Dated: June 25, 2014. Carolyn A. Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–15298 Filed 6–30–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Dated: June 25, 2014. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies [FR Doc. 2014–15294 Filed 6–30–14; 8:45 am] AGENCY: BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; 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 Mental Health Special Emphasis Panel; BrainSpan RNA-seq Browser (R24). Date: July 22, 2014. Time: 12:00 p.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: David W. Miller, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6140, MSC 9608, Bethesda, MD 20892–9608, 301–443–9734, millerda@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS). PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHScertified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov. FOR FURTHER INFORMATION CONTACT: Giselle Hersh, Division of Workplace Programs, SAMHSA/CSAP, Room 7– 1051, One Choke Cherry Road, Rockville, Maryland 20857; 240–276– 2600 (voice), 240–276–2610 (fax). SUPPLEMENTARY INFORMATION: The Mandatory Guidelines were initially SUMMARY: E:\FR\FM\01JYN1.SGM 01JYN1

Agencies

[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Notices]
[Pages 37334-37335]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15436]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Announcement of Workshops for the Development of New 
Antibacterial Products

AGENCY: National Institutes of Health, Department of Health and Human 
Services.

ACTION: Notice of Public Workshop.

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

SUMMARY: The National Institutes of Health (NIH), Office of the 
Director, Office of Science Policy, and the Food and Drug 
Administration (FDA), Office of the Commissioner, are announcing a 
public workshop titled ``The Development of New Antibacterial Products: 
Charting a Course for the Future.'' The workshop is being held to: (1) 
Examine key issues and challenges related to antibacterial product 
development, (2) discuss regulatory pathways for bringing new 
antibacterial drugs to market, (3) identify strategies for promoting 
clinical trials for antibacterial drugs, and (4) encourage partnerships 
to accelerate the development of new antibacterial drugs. The workshop 
is open to the public and is free of charge.

DATES: The workshop will be held on July 30 and 31, 2014, from 8:00 
a.m. to 5:15 p.m. and from 8:00 a.m. to 1:00 p.m., respectively. The 
registration deadline is July 14, 2014.

ADDRESSES: The workshop will be held at the Bethesda North Marriott 
Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, 
Maryland 20852.

FOR FURTHER INFORMATION CONTACT: Kelly Fennington, NIH, Office of 
Science Policy, 6705 Rockledge Drive, Room 750, Bethesda, MD 20892-
7985; 301-496-9838; email: FenningK@mail.nih.gov.

SUPPLEMENTARY INFORMATION: Specific issues to be discussed at this 
workshop include: (1) Priorities and strategic approaches to conducting 
clinical trials for antibacterial drugs; (2) regulatory pathways, 
including streamlined programs for the development of antibacterial 
drugs for patients with limited or no treatment options; (3) clinical 
trial design, including the development of a common clinical protocol, 
use of common control groups, statistical design, data sharing across 
trial, clinical trial endpoints, and lessons learned from other 
therapeutic areas; and (4) the role of public-private partnerships in 
advancing the development of antibacterial drugs. Participants will 
include individuals

[[Page 37335]]

from the professional and scientific societies, academia, patient 
communities, pharmaceutical and biotechnology sectors, diagnostic 
development community, foundations, NIH, FDA, Biomedical Advanced 
Research and Development Authority (BARDA), and the general public.
    The meeting agenda can be accessed at https://osp.od.nih.gov/office-biotechnology-activities/event/2014-07-30-120000-2014-07-31-170000/development-new-antibacterial-products-charting-course-future.
    You are encouraged to pre-register for the meeting due to space 
limitations at https://palladianpartners.cvent.com/AMRWorkshopJuly2014, 
and the deadline for registration is July 14, 2014. Individuals who 
plan to attend and need special assistance, such as sign language 
interpretation or other reasonable accommodations, should notify the 
contact person listed above in advance of the meeting.

    Dated: June 25, 2014.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2014-15436 Filed 6-30-14; 8:45 am]
BILLING CODE 4140-01-P
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