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


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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.

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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: [email protected].

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 http://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 http://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