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 2015_register executive 2015-05-22 article Part III Rules and Regulations D09002ee1c7f78fa4 D09002ee1c7f790e0 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 amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. In order to better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture. FDA is also requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process. Accordingly, these regulations establish requirements for donor education, donor history, and donor testing. These regulations also implement a flexible framework to help both FDA and industry to more effectively respond to new or emerging infectious agents that may affect blood product safety. 80 FR 29842 https://www.govinfo.gov/app/details/FR-2015-05-22/2015-12228 2015-12228 fr22my15-9 RIN 0910-AG87 4164-01-P Docket No. FDA-2006-N-0040 (formerly Docket No. 2006N-0221) https://www.govinfo.gov/app/details/FR-2015-05-22/2015-12228 https://www.govinfo.gov/content/pkg/FR-2015-05-22/html/2015-12228.htm https://www.govinfo.gov/content/pkg/FR-2015-05-22/pdf/2015-12228.pdf Blood Labeling Laboratories Reporting and Recordkeeping Requirements Biologics Medical Devices 65 p. 29842 29906 80 FR 29842 Title 21 Part 606 21 CFR Part 606 Title 21 Part 610 21 CFR Part 610 Title 21 Part 630 21 CFR Part 630 Title 21 Part 640 21 CFR Part 640 Title 21 Part 660 21 CFR Part 660 Title 21 Part 820 21 CFR Part 820 RIN 0910-AG87 Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Federal Register Vol. 80, Issue RULE 2015-12228 III DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-05-23 Docket No. FDA-2006-N-0040 (formerly Docket No. 2006N-0221) 4164-01-P 2015-12228 Final rule.

The Food and Drug Administration (FDA) is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. In order to better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture. FDA is also requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process. Accordingly, these regulations establish requirements for donor education, donor history, and donor testing. These regulations also implement a flexible framework to help both FDA and industry to more effectively respond to new or emerging infectious agents that may affect blood product safety.

This rule is effective May 23, 2016. Valerie A. Butler, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Jonathan R. McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Blood Labeling Laboratories Reporting and Recordkeeping Requirements Biologics Medical Devices Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use , http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/ExceptionsandAlternativeProcedures/default.htm http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm073382.htm http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm073445.htm http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm076756.htm http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm170786.htm http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm235855.htm http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm351107.htm http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm268757.htm http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/TransfusionDonationFatalities/ucm346639.htm http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM155628.pdf http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM218990.pdf http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM251509.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/UCM341088.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm062638.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm062905.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080286.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080301.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080375.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080393.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM190373.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM210268.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM213415.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/OtherRecommendationsforManufacturers/MemorandumtoBloodEstablishments/UCM062626.pdf http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/otherrecommendationsformanufacturers/memorandumtobloodestablishments/ucm062811.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/OtherRecommendationsforManufacturers/MemorandumtoBloodEstablishments/UCM062813.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/OtherRecommendationsforManufacturers/MemorandumtoBloodEstablishments/UCM062834.pdf http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5204.pdf http://www.fda.gov/ohrms/dockets/ac/00/agenda/3649a1.pdf http://www.fda.gov/ohrms/dockets/ac/08/agenda/2008-4379A http://www.gao.gov/archive/1998/he98205.pdf http://www.gao.gov/products/PEMD-97-1 http://www.gpo.gov/fdsys/pkg/CRPT-104hrpt746/html/CRPT-104hrpt746.htm http://www.hhs.gov/ash/bloodsafety/advisorycommittee/minutes/dec2008_minutes.pdf http://www.hhs.gov/ash/bloodsafety/summaries/sumapr99.html Vol. 80, no. 99 Office of the Federal Register, National Archives and Records Administration 2015-05-22 continuing daily deposited born digital 418 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-05-22 P0b002ee18c752e4f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr22my15 https://www.govinfo.gov/app/details/FR-2015-05-22 https://www.govinfo.gov/content/pkg/FR-2015-05-22/pdf/FR-2015-05-22.pdf https://www.govinfo.gov/content/pkg/FR-2015-05-22/xml/FR-2015-05-22.xml fdlp 29529 29935 DGPO 2015-05-22 2024-06-02 FR-2015-05-22 machine generated eng FR FR-2015-05-22 80 99