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 2012_register executive 2012-12-22 article Notices D09002ee1c7fc09f4 D09002ee1c7fc0ac8 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), in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to that of an efficacy/response biomarker in evaluating new drugs for the treatment of chronic lymphocytic leukemia (CLL). Our objective for the workshop is to provide a venue for an in- depth discussion of potential surrogate endpoints for trials intended to support the approval of new drugs or biologics for the treatment of CLL. Participants in the workshop will examine the advantages and disadvantages of MRD as a surrogate endpoint for approval, identify the preferred technology platform and performance characteristics for the assay of this biomarker, and discuss any issues regarding methodological standardization for the biomarker. The primary focus will be on the biomarkers that are ready for incorporation into clinical trials and the technical and regulatory challenges for use of these markers. 77 FR 76051 https://www.govinfo.gov/app/details/FR-2012-12-26/2012-31044 2012-31044 fr26de12-112 4160-01-P Docket No. FDA-2012-N-0001 https://www.govinfo.gov/app/details/FR-2012-12-26/2012-31044 https://www.govinfo.gov/content/pkg/FR-2012-12-26/html/2012-31044.htm https://www.govinfo.gov/content/pkg/FR-2012-12-26/pdf/2012-31044.pdf 2 p. 76051 76052 77 FR 76051 Public Workshop on Minimal Residual Disease; Public Workshop; Federal Register Vol. 77, Issue NOTICE 2012-31044 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-N-0001 4160-01-P 2012-31044 Notice of public workshop.

The Food and Drug Administration (FDA), in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to that of an efficacy/response biomarker in evaluating new drugs for the treatment of chronic lymphocytic leukemia (CLL). Our objective for the workshop is to provide a venue for an in- depth discussion of potential surrogate endpoints for trials intended to support the approval of new drugs or biologics for the treatment of CLL. Participants in the workshop will examine the advantages and disadvantages of MRD as a surrogate endpoint for approval, identify the preferred technology platform and performance characteristics for the assay of this biomarker, and discuss any issues regarding methodological standardization for the biomarker. The primary focus will be on the biomarkers that are ready for incorporation into clinical trials and the technical and regulatory challenges for use of these markers.

The public workshop will be held on February 27, 2013, from 8 a.m. to 4 p.m. Christine Lincoln, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6413, Silver Spring, MD 20993-0002, 301- 796-2340, email: Christine.Lincoln@fda.hhs.gov. Public Workshops: Minimal Residual Disease , Christine.Lincoln@fda.hhs.gov http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm http://www.fda.gov/AdvisoryCommittees/default.htm http://www.zoomerang.com/Survey/WEB22GPA3U95QX Vol. 77, no. 247 Office of the Federal Register, National Archives and Records Administration 2012-12-26 continuing daily deposited born digital 402 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-12-26 P0b002ee1839c2d36 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr26de12 https://www.govinfo.gov/app/details/FR-2012-12-26 https://www.govinfo.gov/content/pkg/FR-2012-12-26/pdf/FR-2012-12-26.pdf https://www.govinfo.gov/content/pkg/FR-2012-12-26/xml/FR-2012-12-26.xml fdlp 75823 76213 DGPO 2012-12-22 2024-06-03 FR-2012-12-26 machine generated eng FR FR-2012-12-26 77 247