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Cliff

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Files posted by Cliff

  1. Investigational COVID-19 Convalescent Plasma

    Docket Number: FDA-2020-D-1825 Issued by: Center for Biologics Evaluation and Research FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic.  FDA is committed to providing timely guidance to support response efforts to emerging threats. 
    On August 23, 2020, FDA issued an Emergency Use Authorization (EUA)  for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19.  FDA subsequently reissued this EUA with revisions.  Most recently, FDA revised the EUA to limit authorization to the use of COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting.   FDA recognizes that while COVID-19 convalescent plasma may be used under an EUA consistent with the authorization, COVID-19 convalescent plasma may also be used under an investigational new drug application (IND).  For the purposes of this guidance, the term “COVID-19 convalescent plasma” refers to the convalescent plasma authorized under the EUA, while the term “investigational convalescent plasma” refers to convalescent plasma that does not meet all the conditions of the EUA and/or is being used under an IND.
    FDA is issuing this guidance to provide recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma.  The guidance also provides recommendations to blood establishments on collection.  This document supersedes the guidance of the same title issued in January 2022 (previous versions February 2021, January 2021, November 2020, September 2020, May 2020, and April 2020).  The recommendations in this guidance are unchanged from the January 2022 guidance.  However, we have removed the language limiting the duration of the policy in the guidance to the public health emergency related to COVID-19 declared by HHS in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)), which expired on May 11, 2023.

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  2. Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements

    Docket Number: FDA-2022-D-0588 Issued by: Center for Biologics Evaluation and Research This guidance addresses certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma.  Specifically, the guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment’s failure to comply with certain requirements in Title 21 of the Code of Federal Regulations 630.30 (21 CFR 630.30) regarding donation suitability; 21 CFR 630.10(c)(2) regarding donor eligibility; and 21 CFR 640.69(f) regarding quarantine hold for Source Plasma.  
    This guidance finalizes the draft guidance of the same title, dated May 2022, and supersedes the guidance entitled, “Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry,” dated April 2020.    

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  3. Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical

    Docket Number: FDA-2023-D-2034 Issued by: Center for Biologics Evaluation and Research FDA (we) is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in Title 21 of the Code of Federal Regulations (CFR) regarding blood and blood components.  This notice is being issued under 21 CFR 640.120(b) to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical.  Maintaining platelet availability in the face of logistical challenges (e.g., in military, prehospital, or austere settings) or other threats to blood availability (e.g., mass casualty events or public health emergencies) is critical to assure that platelets are available to patients with active bleeding.

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  4. Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma

    Docket Number: FDA-2016-D-1342 Issued by: Center for Biologics Evaluation and Research This guidance recognizes, as acceptable, the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 3.0 dated June 2023, prepared by the Plasma Protein Therapeutics Association (PPTA).   This guidance also advises Source Plasma manufacturers on how to report implementation of the acceptable PPTA Source Plasma donor history questionnaires and accompanying materials (SPDHQ documents) under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12).
    The SPDHQ documents provide establishments that collect Source Plasma with a specific process for administering questions to donors to determine their eligibility to donate.  Acceptable SPDHQ documents are those documents that FDA has determined provide Source Plasma collection establishments with one means of obtaining donor history information to determine if a donor is eligible, consistent with FDA requirements and recommendations.  The SPDHQ documents have been updated to align with FDA’s current requirements and recommendations for donor eligibility. 
    This guidance supersedes the document entitled “Implementation of an Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma” dated May 2020.

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  5. Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components

    Docket Number: FDA-2016-D-1342 Issued by: Center for Biologics Evaluation and Research This guidance recognizes, as acceptable, the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 4.0 dated May 2023, prepared by the AABB Donor History Task Force .  This guidance also provides recommendations to licensed establishments on how to report implementation of the acceptable AABB donor history questionnaires and accompanying materials (DHQ documents) under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12). 

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  6. Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

    Docket Number: FDA-2015-D-1211 Issued by: Center for Biologics Evaluation and Research We, FDA, are issuing this guidance to provide recommendations for evaluating donor eligibility using individual risk-based questions.  This guidance provides you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection.  We also recommend that you make corresponding revisions to your donor educational materials, donor history questionnaires and accompanying materials, along with revisions to your donor requalification and product management procedures.  This guidance supersedes the guidance entitled, “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” dated April 2020, updated August 2020 (April 2020 guidance).  The recommendations contained in this guidance apply to the collection of blood and blood components, including Source Plasma.

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  7. Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria

    Docket Number: FDA-2000-D-0187 Issued by: Center for Biologics Evaluation and Research This guidance document provides you, blood establishments that collect blood and blood components, with FDA’s recommendations to reduce the risk of transfusion-transmitted malaria (TTM).  The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma.  Blood establishments are not required to assess Source Plasma donors for malaria risk (21 CFR 630.15(b)(8)).  This guidance supersedes the guidance titled “Revised Recommendations to Replace the Risk of Transfusion-Transmitted Malaria; Guidance for Industry” dated April 2020 (April 2020 guidance).  
    To address the urgent and immediate need for blood and blood components during the Coronavirus Disease 2019 (COVID-19) public health emergency, in April 2020 FDA (we) issued revised recommendations to reduce the risk of TTM during the public health emergency.  The recommendations in the April 2020 guidance were based on the Agency’s evaluation of the available scientific and epidemiological data on malaria risk, and data on FDA-approved pathogen reduction devices.  As stated in the April 2020 guidance, FDA expected implementation of the revised recommendations would not be associated with any adverse effect on the safety of the blood supply and that early implementation of the recommendations may help to address significant blood shortages that occurred as a result of the COVID-19 public health emergency.  Further, the guidance explained that we expected that the recommendations set forth in the revised guidance would continue to apply outside the context of the COVID-19 public health emergency, and that FDA would replace the April 2020 guidance with an updated guidance that incorporates any appropriate changes based on public comments and our experience with implementation.

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  8. Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy

    Docket Number: FDA-2002-D-0362 Issued by: Center for Biologics Evaluation and Research This guidance addresses the regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components (blood establishments) for transfusion or for further manufacturing use, including Source Plasma.  In the final rule dated May 22, 2015 (Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use (donor eligibility rule)) (Ref. 1), FDA (we) amended the regulations applicable to blood establishments for determining donor eligibility and testing blood and blood components.  The revised requirements were implemented in order to assure the safety of the blood supply and to protect donor health.  The donor eligibility rule became effective on May 23, 2016.

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  9. Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components

    Docket Number: FDA-2012-D-0307 Issued by: Center for Biologics Evaluation and Research We, FDA, are issuing this guidance document to provide you, blood establishments that collect blood and blood components, with recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components.  The recommendations in this guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma.  
    This guidance supersedes the guidance of the same title dated April 2020 and updated August 2020 (2020 guidance).  We removed the recommendations to defer indefinitely blood donors for: 1) geographic risk of possible exposure to bovine spongiform encephalopathy for time spent in the United Kingdom (U.K.) from 1980-1996 and for time spent in France and Ireland from 1980-2001, and 2) receipt of a blood transfusion in the U.K., France, and Ireland from 1980-present.  We also provide recommendations for requalification of individuals previously deferred for these geographic risk factors, provided they meet all other eligibility requirements.

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  10. An Acceptable Circular of Information for the Use of Human Blood and Blood Components

    Docket Number: FDA-2002-D-0223 Issued by: Center for Biologics Evaluation and Research We, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, are recognizing as acceptable for use by you, manufacturers of blood and blood components intended for transfusion, the document entitled “Circular of Information for the Use of Human Blood and Blood Components,” dated December 2021 (December 2021 Circular).  The December 2021 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion.  We believe that the December 2021 Circular will assist you in complying with labeling requirements under 21 CFR 606.122.  The requirements under 21 CFR 606.122 specify that a circular of information must be available for distribution with blood and blood components intended for transfusion.  Section 606.122 further specifies the information that is required in the circular of information.  This guidance supersedes the guidance of the same title updated December 2017

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  11. Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers

    Docket Number: FDA-2017-D-6784 Issued by: Center for Biologics Evaluation and Research We, FDA, are providing you, blood establishments that collect or process blood and blood components, with recommendations for implementing a pathogen reduction device for the manufacture of pathogen-reduced blood components.  We have received specific questions from blood establishments who have chosen to use the INTERCEPT® Blood System for Platelets and Plasma and who have questions on implementation of this pathogen reduction device.  As a result, we are providing guidance in a question and answer format, addressing the most frequently asked questions.

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  12. Notifying FDA of Fatalities Related to Blood Collection or Transfusion

    Docket Number: 2002D-0124 Issued by: Center for Biologics Evaluation and Research This document’s goal is to help you, a blood collection or transfusion facility, report fatalities related to blood and blood component (blood) collection or transfusion to us, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER).  This guidance updates the guidance of the same title dated September 2003.
    The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.  This document is intended only to provide clarity to the public regarding existing requirements under the law.  FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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  13. Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection

    Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection
    Withdrawal of Guidance titled “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components”
    FDA requires blood establishments to test blood donations for new or emerging infectious agents that may affect blood product safety if certain conditions outlined in FDA regulations are met.  Specifically, if a transfusion-transmitted infection “may have sufficient incidence and/or prevalence to affect the potential donor population” and meets certain other criteria described in FDA’s regulations, then FDA may determine the transfusion-transmitted infection is a “relevant transfusion-transmitted infection” (RTTI).  Testing for an RTTI is required under FDA’s regulations if FDA-licensed, approved, or cleared screening tests are available and testing is necessary to reduce adequately and appropriately the risk of transmission.  
    FDA has determined Zika virus (ZIKV) is no longer an RTTI under FDA’s regulations because, as discussed further below, the available evidence demonstrates that ZIKV no longer has sufficient incidence and/or prevalence to affect the potential donor population.  Accordingly, FDA withdrew the guidance titled, “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components,” dated July 2018.  Because ZIKV is no longer an RTTI, blood establishments may discontinue testing for ZIKV.  Licensed blood establishments that discontinue testing blood donations for ZIKV must report this change to FDA in the annual report under 21 CFR 601.12(d), noting the date testing was discontinued. Corresponding changes to the circular of information must also be reported in the annual report under 21 CFR 601.12(d)

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  14. Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis

    Docket Number: FDA-2003-D-0128 Issued by: Center for Biologics Evaluation and Research We, FDA, are providing you, blood establishments that collect Whole Blood or blood components, including Source Plasma, with recommendations for screening and testing of donors and management of donations based on screening tests for syphilis.  Syphilis is a relevant transfusion-transmitted infection (Title 21 Code of Federal Regulations (CFR) 630.3 (h)(1)(v)).  Licensed blood establishments must report the implementation of the recommendations contained in this guidance in accordance with 21 CFR 601.12.  
    This guidance updates the guidance of the same title dated September 2014.  The September 2014 guidance finalized the draft guidance of the same title dated March 2013, and superseded the memorandum dated December 12, 1991, entitled “Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing.”

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  15. Testing for Biotin Interference in In Vitro Diagnostic Devices

    Docket Number: FDA-2019-D-1876 Issued by: Center for Biologics Evaluation and Research         Center for Devices and Radiological Health The Food the Drug Administration (FDA or we) is providing recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs).  This guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing be performed, and how the results of the testing should be communicated to end-users, including clinical laboratories and clinicians.  The recommendations apply to IVDs, including devices that are licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) and used in donor screening, that use biotin technology.  This guidance finalizes the draft guidance of the same title dated June 2019.

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  16. Biological Product Deviation Reporting for Blood and Plasma Establishments

    Docket Number: FDA-2001-D-0007 Issued by: Center for Biologics Evaluation and Research We, FDA, are providing you, a blood or plasma establishment, with revised recommendations related to biological product deviation (BPD) reporting.  This guidance document is intended to assist blood and plasma establishments in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report.  The revised guidance explains that we do not consider post donation information (PDI) events to require BPD reports.

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  17. Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II)

    Docket Number: FDA-2018-D-3324 Issued by: Center for Biologics Evaluation and Research We, FDA, are providing you, blood collection establishments, with recommendations regarding the use of serological tests to reduce the risk of transmission of human T-lymphotropic virus type I (HTLV-I) and type II (HTLV-II), collectively referred to as HTLV-I/II, by blood and blood components.  These recommendations apply to the collection of Whole blood and blood components, except Source Plasma.

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  18. Considerations for the Development of Dried Plasma Products Intended for Transfusion

    Docket Number: FDA-2018-D-3759 Issued by: Center for Biologics Evaluation and Research We, FDA, are providing recommendations intended to assist manufacturers, sponsors, and applicants developing dried plasma products intended for transfusion in order to facilitate the availability of safe and effective dried plasma products in the United States (U.S.).  This guidance provides considerations for the successful development and licensing of dried plasma products and for the approval of devices used to manufacture dried plasma.  The guidance includes recommendations on optimal sources of input plasma;  manufacturing and product quality, including product characterization; packaging and reconstitution; clinical studies; and device submissions.  This guidance finalizes the draft guidance of the same title dated October 2018.

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  19. Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus

    Docket Number: FDA-2018-D-3197 Issued by: Center for Biologics Evaluation and Research We, the Food and Drug Administration (FDA), are providing you, blood establishments that collect Whole Blood and blood components, including Source Plasma, with recommendations for further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus (anti-HCV), as required under 21 CFR 610.40(e).  We are also providing guidance to blood establishments on how to report the implementation of these recommendations. 

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  20. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion

    Docket Number: FDA-2014-D-1814 Issued by: Center for Biologics Evaluation and Research We, FDA, are issuing this guidance document to provide you, blood collection establishments and transfusion services, with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion.   The recommendations in this guidance apply to all platelet products stored at room temperature in plasma or additive solutions, including platelets manufactured by automated methods (apheresis platelets), and Whole Blood derived (WBD) single and pooled (pre-storage and post-storage) platelets. 
    Additionally, this guidance provides licensed blood establishments with recommendations on how to report implementation of manufacturing and labeling changes under Title 21 of the Code of Federal Regulations (CFR) 601.12. 
    This guidance updates the final guidance of the same title dated September 2019.  The September 2019 guidance finalized the draft guidance of the same title dated December 2018.

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  21. Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis

    Docket Number: FDA-2018-D-2478 Issued by: Center for Biologics Evaluation and Research We, the Food and Drug Administration (FDA), are notifying you, blood establishments that collect blood and blood components, that we have determined babesiosis to be a relevant transfusion-transmitted infection (RTTI) under 21 CFR 630.3(h)(2).1 Accordingly, we are providing recommendations for donor screening, donation testing, donor deferral and product management to reduce the risk of transfusion-transmitted babesiosis (TTB). The recommendations contained in this guidance apply to the collection of blood and blood components, except Source Plasma.2
    This guidance finalizes the draft guidance of the same title dated July 2018.

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  22. Labeling of Red Blood Cell Units with Historical Antigen Typing Results

    Docket Number: FDA-2016-D-4308 Issued by: Center for Biologics Evaluation and Research We, FDA, are issuing this guidance document to provide you, establishments that collect blood and blood components for transfusion, with recommendations for labeling Red Blood Cell (RBC) units with non-ABO/Rh(D) antigen typing results obtained from previous donations (historical antigen typing results). This guidance provides recommendations to transfusion services for managing RBC units labeled with historical antigen typing results. This guidance also provides licensed blood collection establishments that choose to implement labeling of RBC units with historical antigen typing results instructions regarding how to report the manufacturing and labeling changes under 21 CFR 601.12. This guidance does not apply to test results for ABO and Rh(D) antigens. For ABO and Rh(D) antigens, you must follow FDA requirements in 21 CFR 640.5(b) and (c), and 606.121(c)(9) and (13), as well as all other applicable requirements.

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  23. Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV)- Testing, Product Disposition, and Donor Deferral and Reentry

    Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV)- Testing, Product Disposition, and Donor Deferral and Reentry

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  24. Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components

    Docket Number: FDA-2009-D-0137 Issued by: Center for Biologics Evaluation and Research We, FDA, are providing you, blood collection establishments, with recommendations regarding the use of serological tests to reduce the risk of transmission of Trypanosoma cruzi (T. cruzi) infection in blood and blood components. These recommendations apply to the collection of blood and blood components, except Source Plasma, for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device.

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  25. Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday

    Docket Number: FDA-2017-D-5152 Issued by: Center for Biologics Evaluation and Research We, FDA, are issuing this guidance to provide you, establishments that collect Whole Blood or blood components intended for transfusion or for further manufacture, including Source Plasma and Source Leukocytes, with recommendations for a requalification method under Title 21 of the Code of Federal Regulations (CFR) 630.35(b) (21 CFR 630.35(b)) for donors who had been indefinitely deferred for a history of viral hepatitis after the 11th birthday, prior to the elimination of the donor suitability requirement under 21 CFR 640.3(c)(1) and 21 CFR 640.63(c)(11).

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