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 2018-02-14 article Notices D09002ee1c7f31b0f D09002ee1c7f31ba6 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 "A Wearable Alcohol Biosensor: A Second Challenge" (the "Challenge"), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a component of the National Institutes of Health (NIH), is building upon the success of the previous challenge and searching for a wearable or otherwise discreet device capable of measuring blood alcohol level in real time. The advent of alcohol biosensors that can be worn discreetly and used by individuals in the course of their daily lives will advance the mission of the NIAAA in the arenas of research, treatment, and rehabilitation. Current technological developments in electronics, miniaturization, wireless technology, and biophysical techniques of alcohol detection in humans increase the likelihood of successful development of a useful alcohol biosensor in the near future. The NIH believes that this Challenge will further stimulate investment from public and private sectors in the development of functional alcohol biosensors that will be appealing to individuals, treatment providers, and researchers and will continue to further the NIAAA's mission. 81 FR 89119 https://www.govinfo.gov/app/details/FR-2016-12-09/2016-29436 2016-29436 fr09de16-91 4140-01-P https://www.govinfo.gov/app/details/FR-2016-12-09/2016-29436 https://www.govinfo.gov/content/pkg/FR-2016-12-09/html/2016-29436.htm https://www.govinfo.gov/content/pkg/FR-2016-12-09/pdf/2016-29436.pdf 4 p. 89119 89122 81 FR 89119 Announcement of Requirements and Registration for “A Wearable Alcohol Biosensor: A Second Challenge”; Federal Register Vol. 81, Issue NOTICE 2016-29436 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 4140-01-P 2016-29436

Through the "A Wearable Alcohol Biosensor: A Second Challenge" (the "Challenge"), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a component of the National Institutes of Health (NIH), is building upon the success of the previous challenge and searching for a wearable or otherwise discreet device capable of measuring blood alcohol level in real time. The advent of alcohol biosensors that can be worn discreetly and used by individuals in the course of their daily lives will advance the mission of the NIAAA in the arenas of research, treatment, and rehabilitation. Current technological developments in electronics, miniaturization, wireless technology, and biophysical techniques of alcohol detection in humans increase the likelihood of successful development of a useful alcohol biosensor in the near future. The NIH believes that this Challenge will further stimulate investment from public and private sectors in the development of functional alcohol biosensors that will be appealing to individuals, treatment providers, and researchers and will continue to further the NIAAA's mission.

Submission period begins December 9, 2016, 9:00 a.m. ET. M. Katherine Jung, Ph.D., Acting Director, Division of Metabolism and Health Effects, National Institute on Alcohol Abuse and Alcoholism, Phone: 301-443-8744, Email Kathy.jung@nih.gov. F.L. Dammann, M.P.A., Management Analyst and Special Assistant to the Executive, National Institute on Alcohol Abuse and Alcoholism, Phone: 301-480-9433, Email: fl.dammann@nih.gov. All questions and answers regarding the Challenge will be posted and updated as necessary at https://stage.niaaa.nih.gov/research/challenge- prize under Frequently Asked Questions. Questions from Solvers that may reveal proprietary information related to solutions under development Challenges: A Wearable Alcohol BiosensorA Second Challenge; Requirements and Registration Announcements , fl.dammann@nih.gov Kathy.jung@nih.gov Challenge.gov http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018191 http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm http://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html http://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html http://www.hhs.gov/hipaa/index.html http://www.hhs.gov/ohrp/ http://www.hhs.gov/ohrp/assurances/index.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html https://oig.hhs.gov/exclusions/ https://stage.niaaa.nih.gov/research/challenge-prize https://www.ftc.gov/tips-advice/business-center/privacy-and-security www.challenge.gov Vol. 81, no. 237 Office of the Federal Register, National Archives and Records Administration 2016-12-09 continuing daily deposited born digital 392 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-12-09 P0b002ee198681d9b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr09de16 https://www.govinfo.gov/app/details/FR-2016-12-09 https://www.govinfo.gov/content/pkg/FR-2016-12-09/pdf/FR-2016-12-09.pdf https://www.govinfo.gov/content/pkg/FR-2016-12-09/xml/FR-2016-12-09.xml fdlp 88973 89356 DGPO 2018-02-14 2024-06-01 FR-2016-12-09 machine generated eng FR FR-2016-12-09 81 237