[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Page 34354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12684]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Facilitating Antibacterial Drug Development for Patients With
Unmet Need and Developing Antibacterial Drugs That Target a Single
Species Media; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop regarding antibacterial drug development for patients with
unmet need and developing antibacterial drugs that target a single
species. FDA is interested in discussing the scientific challenges
pertaining to such development programs, including enrollment
challenges, clinical trial designs, and trial population. This public
workshop is intended to provide information for and gain perspective
from health care providers, other U.S. government Agencies, public
health organizations, academic experts, and industry on various aspects
of drug development for new antibacterial drugs for patients with unmet
need and new antibacterial drugs that target a single species. The
input from this public workshop will also help in developing topics for
future discussion.
DATES: The public workshop will be held on July 18, 2016, from 8:30
a.m. to 5 p.m. and July 19, 2016, from 8:30 a.m. to 4 p.m. See the
SUPPLEMENTARY INFORMATION section for registration information.
ADDRESSES: The public workshop will be held at FDA's White Oak campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
workshop participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
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 antibacterial drug development for patients with unmet need
and developing antibacterial drugs that target a single species.
Discussions will focus on potential development pathways, aspects of
clinical trials including patient population, trial designs, and
endpoints, and the role of clinical trial networks in antibacterial
drug development.
Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early. Seating will be
available on a first-come, first-served basis. To register
electronically, email registration information (including name, title,
firm name, address, telephone, and fax number) to
[email protected]. Persons without access to the Internet can
call 301-796-1300 to register.
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.
Agenda: The workshop draft Agenda will be made available at: http://wwwfda.gov/Drugs/NewsEvents/ucm497650.htm at least 2 days prior to the
meeting. The Agency encourages individuals, industry, health care
professionals, researchers, public health organizations and other
interested persons to attend this public workshop.
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 (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
http://www.fda.gov. Transcripts will also be available on the Internet
at: http://wwwfda.gov/Drugs/NewsEvents/ucm497650.htm approximately 45
days after the workshop.
Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12684 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P