81 FR 63774 - Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 180 (September 16, 2016)

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.

[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Notices]
[Pages 63774-63775]
From the Federal Register Online  [www.thefederalregister.org]
[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]
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