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2014-10-07
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Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis; Availability
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,'' dated September 2014. The guidance document provides recommendations for screening and testing of donors and management of donations based on screening tests for syphilis. The guidance is intended for blood establishments that collect Whole Blood or blood components, including Source Plasma. The guidance announced in this notice finalizes the draft guidance of the same title, dated March 2013 (2013 draft guidance), and supersedes the memorandum of December 12, 1991, entitled ``Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing.''
79 FR 51341
https://www.govinfo.gov/app/details/FR-2014-08-28/2014-20483
2014-20483
fr28au14-61
4164-01-P
Docket No. FDA-2003-D-0128 (Legacy ID: FDA-2003D-0236)
https://www.govinfo.gov/app/details/FR-2014-08-28/2014-20483
https://www.govinfo.gov/content/pkg/FR-2014-08-28/html/2014-20483.htm
https://www.govinfo.gov/content/pkg/FR-2014-08-28/pdf/2014-20483.pdf
2 p.
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79 FR 51341
Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis; Availability; Federal Register Vol. 79, Issue
NOTICE
2014-20483
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2003-D-0128 (Legacy ID: FDA-2003D-0236)
4164-01-P
2014-20483
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,'' dated September 2014. The guidance document provides recommendations for screening and testing of donors and management of donations based on screening tests for syphilis. The guidance is intended for blood establishments that collect Whole Blood or blood components, including Source Plasma. The guidance announced in this notice finalizes the draft guidance of the same title, dated March 2013 (2013 draft guidance), and supersedes the memorandum of December 12, 1991, entitled ``Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing.''
Submit either electronic or written comments on Agency guidances at any time.
Paul E. Levine, Jr., Center for Biologics Evaluation and Research, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002, 240-402-7911.
Guidance:
Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 79, no. 167
Office of the Federal Register, National Archives and Records Administration
2014-08-28
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232 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-2014-08-28
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https://www.govinfo.gov/app/details/FR-2014-08-28
https://www.govinfo.gov/content/pkg/FR-2014-08-28/pdf/FR-2014-08-28.pdf
https://www.govinfo.gov/content/pkg/FR-2014-08-28/xml/FR-2014-08-28.xml
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