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 2013-11-05 article Notices D09002ee1c7fad11e D09002ee1c7fad1a6 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: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis)," dated October 2013. The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The draft guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The recommendations in this guidance, when finalized, will supersede those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled "Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)," dated August 2007. 78 FR 66366 https://www.govinfo.gov/app/details/FR-2013-11-05/2013-26397 2013-26397 fr05no13-65 4160-01-P Docket No. FDA-2013-D-1213 https://www.govinfo.gov/app/details/FR-2013-11-05/2013-26397 https://www.govinfo.gov/content/pkg/FR-2013-11-05/html/2013-26397.htm https://www.govinfo.gov/content/pkg/FR-2013-11-05/pdf/2013-26397.pdf 2 p. 66366 66367 78 FR 66366 Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis); Availability; Federal Register Vol. 78, Issue NOTICE 2013-26397 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2013-D-1213 4160-01-P 2013-26397 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis)," dated October 2013. The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The draft guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The recommendations in this guidance, when finalized, will supersede those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled "Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)," dated August 2007.

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 February 3, 2014. Paul E. Levine, Jr., 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: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis) , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 78, no. 214 Office of the Federal Register, National Archives and Records Administration 2013-11-05 continuing daily deposited born digital 382 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-11-05 P0b002ee1864f55ba 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr05no13 https://www.govinfo.gov/app/details/FR-2013-11-05 https://www.govinfo.gov/content/pkg/FR-2013-11-05/pdf/FR-2013-11-05.pdf https://www.govinfo.gov/content/pkg/FR-2013-11-05/xml/FR-2013-11-05.xml fdlp 66249 66620 DGPO 2013-11-05 2024-06-03 FR-2013-11-05 machine generated eng FR FR-2013-11-05 78 214