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 2014_register executive 2014-03-05 article Notices D09002ee1c7fa5b8d D09002ee1c7fa5c05 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 availability of a document entitled "Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System" dated March 2014. The guidance document provides recommendations for manufacturers, generally cord blood banks, to apply for licensure of minimally manipulated, unrelated allogeneic placental/ umbilical cord blood, for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. The guidance document is intended to assist manufacturers in obtaining a biologics license. The guidance contains information about the manufacture of minimally manipulated, unrelated allogeneic placental/ umbilical cord blood and how to comply with applicable regulatory requirements. The guidance announced in this document finalizes the draft guidance of the same title dated June 2013 and supersedes the guidance entitled "Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications" dated October 2009. 79 FR 12508 https://www.govinfo.gov/app/details/FR-2014-03-05/2014-04813 2014-04813 fr05mr14-69 4160-01-P Docket No. FDA-2006-D-0157 https://www.govinfo.gov/app/details/FR-2014-03-05/2014-04813 https://www.govinfo.gov/content/pkg/FR-2014-03-05/html/2014-04813.htm https://www.govinfo.gov/content/pkg/FR-2014-03-05/pdf/2014-04813.pdf 2 p. 12508 12509 79 FR 12508 Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System; Availability; Federal Register Vol. 79, Issue NOTICE 2014-04813 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2006-D-0157 4160-01-P 2014-04813 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System" dated March 2014. The guidance document provides recommendations for manufacturers, generally cord blood banks, to apply for licensure of minimally manipulated, unrelated allogeneic placental/ umbilical cord blood, for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. The guidance document is intended to assist manufacturers in obtaining a biologics license. The guidance contains information about the manufacture of minimally manipulated, unrelated allogeneic placental/ umbilical cord blood and how to comply with applicable regulatory requirements. The guidance announced in this document finalizes the draft guidance of the same title dated June 2013 and supersedes the guidance entitled "Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications" dated October 2009.

Submit either electronic or written comments on Agency guidances at any time. Tami Belouin, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210. Guidance for Industry and Staff: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood, etc. , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 79, no. 43 Office of the Federal Register, National Archives and Records Administration 2014-03-05 continuing daily deposited born digital 311 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-03-05 P0b002ee187889dc0 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr05mr14 https://www.govinfo.gov/app/details/FR-2014-03-05 https://www.govinfo.gov/content/pkg/FR-2014-03-05/pdf/FR-2014-03-05.pdf https://www.govinfo.gov/content/pkg/FR-2014-03-05/xml/FR-2014-03-05.xml fdlp 12353 12654 DGPO 2014-03-05 2024-06-03 FR-2014-03-05 machine generated eng FR FR-2014-03-05 79 43