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 2017_register executive 2017-12-13 article Notices D09002ee1c7eea79b D09002ee1c7eea8e4 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, the Agency, or we) is announcing the establishment of the Susceptibility Test Interpretive Criteria Website. The Susceptibility Test Interpretive Criteria Website will help to efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health and may allow for more efficient development and evaluation of antimicrobial susceptibility test (AST) devices. These changes may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act). 82 FR 58617 https://www.govinfo.gov/app/details/FR-2017-12-13/2017-26790 2017-26790 fr13de17-58 4164-01-P Docket No. FDA-2017-N-5925 https://www.govinfo.gov/app/details/FR-2017-12-13/2017-26790 https://www.govinfo.gov/content/pkg/FR-2017-12-13/html/2017-26790.htm https://www.govinfo.gov/content/pkg/FR-2017-12-13/pdf/2017-26790.pdf 2 p. 58617 58618 82 FR 58617 21st Century Cures Act: Announcing the Establishment of the Susceptibility Test Interpretive Criteria Website; Federal Register Vol. 82, Issue NOTICE 2017-26790 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2017-N-5925 4164-01-P 2017-26790 Notice.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of the Susceptibility Test Interpretive Criteria Website. The Susceptibility Test Interpretive Criteria Website will help to efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health and may allow for more efficient development and evaluation of antimicrobial susceptibility test (AST) devices. These changes may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).

Katherine Schumann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301- 796-1182, Katherine.Schumann@fda.hhs.gov. 21st Century Cures Act: Announcing the Establishment of the Susceptibility Test Interpretive Criteria Website , Katherine.Schumann@fda.hhs.gov https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm Vol. 82, no. 238 Office of the Federal Register, National Archives and Records Administration 2017-12-13 continuing daily deposited born digital 181 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-12-13 P0b002ee197c2e22e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13de17 https://www.govinfo.gov/app/details/FR-2017-12-13 https://www.govinfo.gov/content/pkg/FR-2017-12-13/pdf/FR-2017-12-13.pdf https://www.govinfo.gov/content/pkg/FR-2017-12-13/xml/FR-2017-12-13.xml fdlp 58533 58705 DGPO 2017-12-13 2024-06-01 FR-2017-12-13 machine generated eng FR FR-2017-12-13 82 238