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 2018-02-09 article Notices D09002ee1c7f42773 D09002ee1c7f42898 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States National Institutes of Health originator org United States Government Agency or Subagency Through the "Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test" Challenge (the "Challenge"), the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR) are searching for novel and innovative in vitro diagnostic tests that would rapidly inform clinical treatment decisions and be of potential significant clinical and public health utility to combat the development and spread of antibiotic resistant bacteria. Tests of interest will provide novel, innovative solutions for use in inpatient and/or outpatient settings. The goal of the challenge is to identify a diagnostic test that when utilized would lead to more rapid clinical decision making such that antibiotic use and/or outcomes of patients infected with resistant pathogens are fundamentally improved compared to current standard of care, and/or reduce transmission of resistant pathogens such that population infection rates significantly decrease. The Challenge competition seeks to incentivize a broad range of scientists, engineers, and innovators to develop diagnostic tests that would enable health care providers to make more informed decisions on appropriate antibiotic use and infection prevention. This Challenge, structured in three steps, will complement existing BARDA and NIH research portfolios by reaching out to a diverse population of innovators and solvers, including not only those from academic institutions, but also those from research and development communities in the private sector and others who are outside biomedical disciplines. The NIH and the BARDA believe this Challenge will stimulate investment from both public and private sectors in rapid, point-of-need in vitro diagnostic assay research and product development, which, in turn, could lead to the development of more sensitive, accurate, robust, and cost-effective assay approaches and devices for clinical diagnosis. 81 FR 62150 https://www.govinfo.gov/app/details/FR-2016-09-08/2016-21328 2016-21328 fr08se16-110 4140-01-P https://www.govinfo.gov/app/details/FR-2016-09-08/2016-21328 https://www.govinfo.gov/content/pkg/FR-2016-09-08/html/2016-21328.htm https://www.govinfo.gov/content/pkg/FR-2016-09-08/pdf/2016-21328.pdf 7 p. 62150 62156 81 FR 62150 Announcement of Requirements and Registration for “Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test” Challenge; Federal Register Vol. 81, Issue NOTICE 2016-21328 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 4140-01-P 2016-21328

Through the "Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test" Challenge (the "Challenge"), the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR) are searching for novel and innovative in vitro diagnostic tests that would rapidly inform clinical treatment decisions and be of potential significant clinical and public health utility to combat the development and spread of antibiotic resistant bacteria. Tests of interest will provide novel, innovative solutions for use in inpatient and/or outpatient settings. The goal of the challenge is to identify a diagnostic test that when utilized would lead to more rapid clinical decision making such that antibiotic use and/or outcomes of patients infected with resistant pathogens are fundamentally improved compared to current standard of care, and/or reduce transmission of resistant pathogens such that population infection rates significantly decrease. The Challenge competition seeks to incentivize a broad range of scientists, engineers, and innovators to develop diagnostic tests that would enable health care providers to make more informed decisions on appropriate antibiotic use and infection prevention. This Challenge, structured in three steps, will complement existing BARDA and NIH research portfolios by reaching out to a diverse population of innovators and solvers, including not only those from academic institutions, but also those from research and development communities in the private sector and others who are outside biomedical disciplines. The NIH and the BARDA believe this Challenge will stimulate investment from both public and private sectors in rapid, point-of-need in vitro diagnostic assay research and product development, which, in turn, could lead to the development of more sensitive, accurate, robust, and cost-effective assay approaches and devices for clinical diagnosis.

Step 1 Submission period begins: September 8, 2016. Step 1 Submission period ends: January 9, 2017, 11:59 p.m. ET Step 1 Judging Period: January 10, 2017, to March 26, 2017 Step 1 Up to 20 highest ranked proposals Semi-finalists Announced: March 27, 2017 Step 2 Submission period begins: March 28, 2017 Step 2 Submission period ends: September 4, 2018, 11:59 p.m. ET Step 2 Judging Period: September 5, 2018-November 30, 2018 Step 2 Up to 10 Semi-finalists Announced: December 3, 2018 Step 3 Submission period begins: December 4, 2018 Step 3 Submission period ends: January 3, 2020, 11:59 p.m. ET Step 3 Judging Period: May 1, 2020-July 1, 2020 Step 3 Winner(s) Announced: July 31, 2020 Robert W. Eisinger, Ph.D., NIH, 301- 496-2229 or by email robert.eisinger@nih.gov. Challenges: Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test; Requirements and Registration Announcements , robert.eisinger@nih.gov http://business.ftc.gov/privacy-and-security http://www.cccinnovationcenter.com/challenges/antimicrobial-resistance-diagnostic-challenge/ http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018191 http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm http://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html http://www.hhs.gov/ocr/privacy/index.html http://www.hhs.gov/ohrp/assurances/index.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.hhs.gov/ohrp/index.html http://www.hhs.gov/ohrp/policy/index.html https://www.epls.gov/ www.challenge.gov Vol. 81, no. 174 Office of the Federal Register, National Archives and Records Administration 2016-09-08 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-2016-09-08 P0b002ee1985ecffc 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr08se16 https://www.govinfo.gov/app/details/FR-2016-09-08 https://www.govinfo.gov/content/pkg/FR-2016-09-08/pdf/FR-2016-09-08.pdf https://www.govinfo.gov/content/pkg/FR-2016-09-08/xml/FR-2016-09-08.xml fdlp 61973 62352 DGPO 2018-02-09 2024-06-01 FR-2016-09-08 machine generated eng FR FR-2016-09-08 81 174