[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Notices]
[Pages 63774-63775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22352]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Coordinated Development of Antimicrobial Drugs and Antimicrobial
Susceptibility Test Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public workshop regarding ``Coordinated Development of Antimicrobial
Drugs and Antimicrobial Susceptibility Test Devices (ASTs).'' This
public workshop is intended to facilitate discussion between drug
sponsors and device manufacturers who are planning to develop new
antimicrobial drugs or ASTs and who wish to coordinate development of
these products, such that the AST device could be cleared either at the
time of new drug approval or shortly thereafter. The input from this
public workshop will also help in developing topics for future
discussion.
DATES: Dates and Times: The public workshop will be held on September
29, 2016, from 9 a.m. to 4 p.m. See the SUPPLEMENTARY INFORMATION
section for registration information.
ADDRESSES: Location: The public workshop will be held at the Sheraton
Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The
hotel's phone number is 301-589-0800.
FOR FURTHER INFORMATION CONTACT:
Contact Persons: 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.
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 your registration information (including name,
title, firm name, address, telephone number, 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 Contact Persons above) at
least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop
pertaining to the coordinated development of antimicrobial drugs and
ASTs. Discussions will focus on assisting drug sponsors and device
manufacturers who are planning to develop new antimicrobial drugs or
ASTs and who seek to coordinate development of these products.
The goals of the workshop are to: (1) Outline the regulatory
considerations for submitting separate applications to the Center for
Drug Evaluation and Research and the Center for Devices and
Radiological Health for antimicrobial drugs and ASTs, respectively; (2)
identify the challenges related to obtaining data supporting the
clearance of an AST device coincident with or soon after antimicrobial
drug approval; and (3) discuss ideas for addressing these challenges.
[[Page 63775]]
The Agency encourages individuals, industry, device manufacturers,
health care professionals, researchers, public health organizations and
other interested persons to attend this public workshop. Workshop
updates will be made available on the internet at http://www.fda.gov/Drugs/NewsEvents/ucm512519.htm.
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. A
transcript will also be available either in 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://www.fda.gov/Drugs/NewsEvents/ucm512519.htm approximately 45
days after the workshop.
Dated: September 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22352 Filed 9-15-16; 8:45 am]
BILLING CODE 4164-01-P