[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]
-----------------------------------------------------------------------
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: [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