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 2016-02-10 article Notices D09002ee1c7f6930a D09002ee1c7f69382 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) is announcing the following public workshop entitled, "Advancing the Development of Biomarkers in Traumatic Brain Injury." This workshop aims to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for traumatic brain injury (TBI). By convening the relevant stakeholders, the goal is to obtain input on the scientific, clinical, patient, and regulatory considerations associated with TBI biomarker development to improve diagnosis and clinical utility for TBI. 81 FR 7128 https://www.govinfo.gov/app/details/FR-2016-02-10/2016-02592 2016-02592 fr10fe16-66 4164-01-P Docket No. FDA-2016-N-0343 https://www.govinfo.gov/app/details/FR-2016-02-10/2016-02592 https://www.govinfo.gov/content/pkg/FR-2016-02-10/html/2016-02592.htm https://www.govinfo.gov/content/pkg/FR-2016-02-10/pdf/2016-02592.pdf 3 p. 7128 7130 81 FR 7128 Advancing the Development of Biomarkers in Traumatic Brain Injury; Public Workshop; Request for Comments; Federal Register Vol. 81, Issue NOTICE 2016-02592 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-05-03 Docket No. FDA-2016-N-0343 4164-01-P 2016-02592 Notice of public workshop; request for comments.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled, "Advancing the Development of Biomarkers in Traumatic Brain Injury." This workshop aims to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for traumatic brain injury (TBI). By convening the relevant stakeholders, the goal is to obtain input on the scientific, clinical, patient, and regulatory considerations associated with TBI biomarker development to improve diagnosis and clinical utility for TBI.

The public workshop will be held on March 3, 2016, from 8 a.m. to 5 p.m. Submit either electronic or written comments on the public workshop by May 3, 2016. Allison Kumar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5408, Silver Spring, MD 20993, 301-796-6369, email: Allison.Kumar@fda.hhs.gov; or Lakshmi Kannan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5402, Silver Spring, MD 20993, 240-402-7735, email: Lakshmi.Kannan@fda.hhs.gov. Meetings: Advancing the Development of Biomarkers in Traumatic Brain Injury; Public Workshop , Allison.Kumar@fda.hhs.gov Lakshmi.Kannan@fda.hhs.gov susan.monahan@fda.hhs.gov http://www.adobe.com/go/connectpro_overview http://www.fda.gov http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov https://collaboration.fda.gov/common/help/en/support/meeting_test.htm Vol. 81, no. 27 Office of the Federal Register, National Archives and Records Administration 2016-02-10 continuing daily deposited born digital 179 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-02-10 P0b002ee18e783a31 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10fe16 https://www.govinfo.gov/app/details/FR-2016-02-10 https://www.govinfo.gov/content/pkg/FR-2016-02-10/pdf/FR-2016-02-10.pdf https://www.govinfo.gov/content/pkg/FR-2016-02-10/xml/FR-2016-02-10.xml fdlp 7025 7193 DGPO 2016-02-10 2024-06-02 FR-2016-02-10 machine generated eng FR FR-2016-02-10 81 27