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 2001_register executive 2010-09-24 article Rules and Regulations D09002ee1c81da0be D09002ee1c81da13f 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 revising the general biological product standards applicable to human blood and blood components by updating the hepatitis B virus (HBV) and human immunodeficiency virus (HIV) testing requirements, by adding testing requirements for hepatitis C virus (HCV), human T-lymphotropic virus (HTLV), and by adding requirements for supplemental (i.e., additional, more specific) testing approved for such use by FDA when a donation is found to be reactive for any of the required screening tests for evidence of infection due to communicable disease agents. The agency also is requiring manufacturers of certain test kits to use reference panels, when available, to verify the acceptable sensitivity and specificity of each lot. This final rule is intended to help protect the safety and ensure the quality of the Nation's blood supply, to enhance the safety of medical devices containing blood or blood components, to provide FDA with clear enforcement authority, and to promote consistency in the industry. Elsewhere in this issue of the Federal Register, FDA is publishing a rule requiring blood and plasma establishments to notify donors, including autologous donors, whenever the donor is deferred or determined not to be suitable for current or future donations of blood and blood components. 66 FR 31146 https://www.govinfo.gov/app/details/FR-2001-06-11/01-14408 01-14408 fr11jn01-13 4160-01-F Docket No. 98N-0581 https://www.govinfo.gov/app/details/FR-2001-06-11/01-14408 https://www.govinfo.gov/content/pkg/FR-2001-06-11/html/01-14408.htm https://www.govinfo.gov/content/pkg/FR-2001-06-11/pdf/01-14408.pdf Blood Labeling Laboratories Reporting and Recordkeeping Requirements 20 p. 31146 31165 66 FR 31146 Title 21 Part 606 21 CFR Part 606 Title 21 Part 607 21 CFR Part 607 Title 21 Part 610 21 CFR Part 610 Title 21 Part 640 21 CFR Part 640 Title 21 Part 660 21 CFR Part 660 Title 21 Part 809 21 CFR Part 809 Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents; Federal Register Vol. 66, Issue RULE 01-14408 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2001-12-10 Docket No. 98N-0581 4160-01-F 01-14408 Final rule.

The Food and Drug Administration (FDA) is revising the general biological product standards applicable to human blood and blood components by updating the hepatitis B virus (HBV) and human immunodeficiency virus (HIV) testing requirements, by adding testing requirements for hepatitis C virus (HCV), human T-lymphotropic virus (HTLV), and by adding requirements for supplemental (i.e., additional, more specific) testing approved for such use by FDA when a donation is found to be reactive for any of the required screening tests for evidence of infection due to communicable disease agents. The agency also is requiring manufacturers of certain test kits to use reference panels, when available, to verify the acceptable sensitivity and specificity of each lot. This final rule is intended to help protect the safety and ensure the quality of the Nation's blood supply, to enhance the safety of medical devices containing blood or blood components, to provide FDA with clear enforcement authority, and to promote consistency in the industry. Elsewhere in this issue of the Federal Register, FDA is publishing a rule requiring blood and plasma establishments to notify donors, including autologous donors, whenever the donor is deferred or determined not to be suitable for current or future donations of blood and blood components.

This rule is effective December 10, 2001. Paula S. McKeever, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852- 1448, 301-827-6210. Blood Labeling Laboratories Reporting and Recordkeeping Requirements Biological products: Human blood donors; testing for evidence of infection due communicable disease agents; requirements, http://www.aabb.org http://www.fda.gov/cber/publications.htm www.cdc.gov/ncidod/diseases/hepatitis” Vol. 66, no. 112 Office of the Federal Register, National Archives and Records Administration 2001-06-11 continuing daily deposited born digital 279 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2001-06-11 P0b002ee180a0e2de 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr11jn01 https://www.govinfo.gov/app/details/FR-2001-06-11 https://www.govinfo.gov/content/pkg/FR-2001-06-11/pdf/FR-2001-06-11.pdf https://www.govinfo.gov/content/pkg/FR-2001-06-11/xml/FR-2001-06-11.xml fdlp 31107 31373 DGPO 2010-09-24 2024-06-08 FR-2001-06-11 machine generated eng FR FR-2001-06-11 66 112