
[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]


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

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.

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

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 
unmetneed2016@fda.hhs.gov. 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


