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 2013_register executive 2013-06-15 article Notices D09002ee1c7fb5bb4 D09002ee1c7fb5c4c 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 draft 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 June 2013. The draft guidance document provides recommendations for manufacturers, generally cord blood banks, to apply for licensure of minimally manipulated, unrelated allogeneic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. The guidance document is intended to assist manufacturers obtain 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 The draft guidance, when finalized, is intended to supersede the guidance entitled "Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications" dated October 2009. 78 FR 36196 https://www.govinfo.gov/app/details/FR-2013-06-17/2013-14097 2013-14097 fr17jn13-67 4160-01-P Docket No. FDA-2006-D-0157 https://www.govinfo.gov/app/details/FR-2013-06-17/2013-14097 https://www.govinfo.gov/content/pkg/FR-2013-06-17/html/2013-14097.htm https://www.govinfo.gov/content/pkg/FR-2013-06-17/pdf/2013-14097.pdf 2 p. 36196 36197 78 FR 36196 Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and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. 78, Issue NOTICE 2013-14097 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2006-D-0157 4160-01-P 2013-14097 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft 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 June 2013. The draft 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. The guidance document is intended to assist manufacturers obtain 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 draft guidance, when finalized, is intended to supersede the guidance entitled "Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications" dated October 2009.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 16, 2013. Valerie A. Butler, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852- 1448, 301-827-6210. Draft Guidance for Industry; Availability: 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. 78, no. 116 Office of the Federal Register, National Archives and Records Administration 2013-06-17 continuing daily deposited born digital 334 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-06-17 P0b002ee184fec833 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr17jn13 https://www.govinfo.gov/app/details/FR-2013-06-17 https://www.govinfo.gov/content/pkg/FR-2013-06-17/pdf/FR-2013-06-17.pdf https://www.govinfo.gov/content/pkg/FR-2013-06-17/xml/FR-2013-06-17.xml fdlp 36083 36406 DGPO 2013-06-15 2024-06-03 FR-2013-06-17 machine generated eng FR FR-2013-06-17 78 116