United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2016-09-16 article Notices D09002ee1c7f3e8b7 D09002ee1c7f3e988 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 81 FR 63774 https://www.govinfo.gov/app/details/FR-2016-09-16/2016-22352 2016-22352 fr16se16-74 4164-01-P Docket No. FDA-2016-N-0001 https://www.govinfo.gov/app/details/FR-2016-09-16/2016-22352 https://www.govinfo.gov/content/pkg/FR-2016-09-16/html/2016-22352.htm https://www.govinfo.gov/content/pkg/FR-2016-09-16/pdf/2016-22352.pdf 2 p. 63774 63775 81 FR 63774 Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Federal Register Vol. 81, Issue NOTICE 2016-22352 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2016-N-0001 4164-01-P 2016-22352 Notice of public workshop.

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 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. 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. Meetings: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices: Public Workshop , AntimicrobialSusceptibilitytestingWorkshop2016@fda.hhs.gov http://www.fda.gov http://www.fda.gov/Drugs/NewsEvents/ucm512519.htm http://www.regulations.gov Vol. 81, no. 180 Office of the Federal Register, National Archives and Records Administration 2016-09-16 continuing daily deposited born digital 389 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-09-16 P0b002ee191308d9d 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr16se16 https://www.govinfo.gov/app/details/FR-2016-09-16 https://www.govinfo.gov/content/pkg/FR-2016-09-16/pdf/FR-2016-09-16.pdf https://www.govinfo.gov/content/pkg/FR-2016-09-16/xml/FR-2016-09-16.xml fdlp 63671 64047 DGPO 2016-09-16 2024-06-01 FR-2016-09-16 machine generated eng FR FR-2016-09-16 81 180