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 2009_register executive 2009-10-20 article Notices D09002ee1c8033453 D09002ee1c80334c5 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 and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications," dated October 2009. In this draft guidance, we refer to these products for hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C). This draft guidance provides advice to potential sponsors (e.g., generally cord blood banks, or registries, and individual physicians serving as sponsor- investigators) to assist in the submission of an IND for certain HPC- Cs, when such HPC-Cs are not licensed in accordance with certain FDA regulations, and when a suitable human leukocyte antigen (HLA) matched cord blood transplant is needed for treatment of a patient with a serious or life-threatening disease or condition and there is no satisfactory alternative treatment. This draft guidance document is applicable only to HPC-Cs intended for hematopoietic reconstitution in patients with the clinical indications listed in the guidance entitled "Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications" (HPC-C licensure guidance), published elsewhere in this issue of the Federal Register. FDA is also announcing that it no longer intends to exercise enforcement discretion with respect to the IND and biologics license application (BLA) requirements for minimally manipulated, unrelated allogeneic hematopoietic stem/progenitor cell products and the phase-in implementation period for IND and license application requirements will end as of October 20, 2011. 74 FR 53751 https://www.govinfo.gov/app/details/FR-2009-10-20/E9-25136 E9-25136 FR20OC09-67 4160-01-S Docket No. FDA-2009-D-0490 https://www.govinfo.gov/app/details/FR-2009-10-20/E9-25136 https://www.govinfo.gov/content/pkg/FR-2009-10-20/html/E9-25136.htm https://www.govinfo.gov/content/pkg/FR-2009-10-20/pdf/E9-25136.pdf 2 p. 53751 53752 74 FR 53751 Draft Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications; Availability; Federal Register Vol. 74, Issue NOTICE E9-25136 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2009-D-0490 4160-01-S E9-25136 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications," dated October 2009. In this draft guidance, we refer to these products for hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C). This draft guidance provides advice to potential sponsors (e.g., generally cord blood banks, or registries, and individual physicians serving as sponsor- investigators) to assist in the submission of an IND for certain HPC- Cs, when such HPC-Cs are not licensed in accordance with certain FDA regulations, and when a suitable human leukocyte antigen (HLA) matched cord blood transplant is needed for treatment of a patient with a serious or life-threatening disease or condition and there is no satisfactory alternative treatment. This draft guidance document is applicable only to HPC-Cs intended for hematopoietic reconstitution in patients with the clinical indications listed in the guidance entitled "Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications" (HPC-C licensure guidance), published elsewhere in this issue of the Federal Register. FDA is also announcing that it no longer intends to exercise enforcement discretion with respect to the IND and biologics license application (BLA) requirements for minimally manipulated, unrelated allogeneic hematopoietic stem/progenitor cell products and the phase-in implementation period for IND and license application requirements will end as of October 20, 2011.

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 electronic or written comments on the draft guidance by January 19, 2010. 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. Draft Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug 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. 74, no. 201 Office of the Federal Register, National Archives and Records Administration 2009-10-20 continuing daily deposited born digital 251 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2009-10-20 P0b002ee1800d6305 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:FR20OC09 https://www.govinfo.gov/app/details/FR-2009-10-20 https://www.govinfo.gov/content/pkg/FR-2009-10-20/pdf/FR-2009-10-20.pdf https://www.govinfo.gov/content/pkg/FR-2009-10-20/xml/FR-2009-10-20.xml fdlp 53639 53879 DGPO 2009-10-20 2024-06-04 FR-2009-10-20 machine generated eng FR FR-2009-10-20 74 201