06690nam 2200721 a 450 991096055780332120251017110105.09786610191970978030917532603091753219781280191978128019197X9780309589505030958950997805851554940585155496(CKB)110986584751860(OCoLC)614658933(CaPaEBR)ebrary10055095(SSID)ssj0000113226(PQKBManifestationID)11131423(PQKBTitleCode)TC0000113226(PQKBWorkID)10099198(PQKB)10885190(MiAaPQ)EBC3376101(Au-PeEL)EBL3376101(CaPaEBR)ebr10055095(OCoLC)923261160(Perlego)4733859(DNLM)815860(BIP)47222221(EXLCZ)9911098658475186019960705d1996 uy 0engurcn|||||||||txtccrBlood banking and regulation procedures, problems, and alternatives /Forum on Blood Safety and Blood Availability, Division of Health Sciences Policy, Institute of Medicine ; Edward A. Dauer, editor1st ed.Washington, D.C. National Academy Pressc19961 online resource (137 p.)"The talks summarized in this document were originally given at workshops on Alter[n]ative Regulatory Models (January, 1995); CBER Compliance Acivity, Theory and Practice (September, 1995); and Managing Threats to the Blood Supply (September, 1995)"--P. vii.9780309055468 0309055466 Blood Banking and Regulation: Procedures, Problems, and Alternatives -- Copyright -- Foreword -- Preface -- Contents -- I Overview of Regulatory and Policy-Making Procedures in Blood Banking -- FDA Policy and Regulation -- THE REGULATORY MANDATE -- REGULATORY MECHANISMS -- LEGAL AUTHORITIES -- REGULATION AND ENFORCEMENT AT FDA -- ENSURING BLOOD SAFETY AND AVAILABILITY IN THE FUTURE -- CDC Recommendations -- CDC'S MISSION -- EFFECTIVENESS OF CDC -- RESEARCH ON HIV -- HOW CDC AFFECTS POLICY -- FORMAL RECOMMENDATIONS -- Blood Banking's Policy Groups and Procedures -- THE TRADITION OF SELF-REGULATION -- STANDARD-SETTING ORGANIZATIONS -- AMERICAN ASSOCIATION OF BLOOD BANKS -- JOINT EFFORTS -- OTHER STANDARDS AND GUIDELINES -- Opportunities and Venues for Dialogue -- THE CHANGING CLIMATE IN BLOOD BANKING -- VENUES FOR DIALOGUE -- THE BLOOD PRODUCTS ADVISORY COMMITTEE -- OTHER VENUES FOR DIALOGUE -- THE VOICE OF BLOOD PRODUCT CONSUMERS -- ATTENDING TO THE DONOR -- REGULATORY DIFFICULTIES -- Discussion -- II Regulatory Enforcement And Compliance -- CBER Compliance Activity -- COORDINATION BETWEEN THE CENTERS AND THE FIELD -- OFFICE OF REGULATORY AFFAIRS -- INSPECTION CONSISTENCY -- INSPECTIONS AND ENFORCEMENT -- FDA Practice in the Field -- TRAINING FOR THE FIELD -- SOURCES OF CONSISTENCY -- Challenges and Questions About Compliance -- IMPROVEMENTS IN SAFETY -- QUESTIONS ABOUT ENFORCEMENT -- Evidence That Compliance Works -- Indirect Effects: "Bulletproofing -- Is Compliance Improving? -- REGULATION AND OTHER FORCES -- Discussion -- III Innovations and Alternatives in Regulation -- Regulatory Alternatives -- REGULATORY DIAGNOSIS AND MISMATCH -- MAXIMIZING EFFECTIVENESS AND EFFICIENCY -- PROPOSED ALTERNATIVES TO COMMAND-AND-CONTROL -- Specific Techniques -- ACUS STUDY AND RECOMMENDATIONS -- THE ADMINISTRATIVE PROCEDURE ACT -- THE ALTERNATIVE: NEGOTIATION.RECENT DEVELOPMENTS AND THE FEDERAL ADVISORY COMMITTEE ACT (FACA) -- AUDITED SELF-REGULATION -- Negotiated Rule-Making -- REG-NEG"-DOES IT WORK? -- THE PUBLIC AT THE NEGOTIATION TABLE -- CONSENSUS -- DECISION-MAKING DYNAMICS -- BENEFITS OF COLLABORATION -- POLITICAL CONSENSUS -- REG-NEG OUTCOMES -- GETTING REG-NEG STARTED -- CHOOSING THE PROBLEM -- OTHER REQUISITES -- CONSTITUENCY PRESSURES -- ACCOUNTABILITY -- REG-NEG PROCESS -- QUESTIONS ABOUT REG-NEG -- Panel Discussion on Applications of Negotiated Rule-Making to Issues in Blood Banking -- Kathryn C. Zoon -- REGULATORY INITIATIVES AT FDA -- FDA IN THE FUTURE -- INITIATIVES AT CBER -- WILLINGNESS TO EXPLORE PILOTS -- Jay Epstein -- INITIATIVES IN BLOOD REGULATION -- PARTICIPATORY DECISION-MAKING -- PUBLIC MEETINGS -- NATIONAL PERFORMANCE REVIEW -- EXPERIMENTS IN REGULATION -- THE FORCES OF CHANGE -- THE ROLE OF THE RULE-MAKING PROCESS -- Toby Simon -- COMMENTS AND QUESTIONS -- General Discussion of Issues for Negotiated Rule-Making -- CRITERIA FOR SELECTING ISSUES -- CANDIDATES FOR REG-NEG -- IV Congressional Oversight and Regulatory Initiatives -- Congressional Oversight of Blood Safety Issues -- THE WORK OF THE SUBCOMMITTEE -- THE QUESTION OF COSTS -- DHHS Task Force on HIV and the Blood Supply -- THE TASK FORCE CHARGE -- BLOOD PRODUCTS ADVISORY COMMITTEE -- DECISION-MAKING -- COST AS A FACTOR -- THE PUBLIC VIEW -- V Postscript -- Investing in Regulatory Quality -- REQUISITES OF REGULATORY PROCEDURES -- PUBLIC PERCEPTIONS -- Appendixes -- A Negotiated Rule-Making Procedure -- Preamble -- 561. Purpose -- 562. Definitions -- 563. Determination of need for negotiated rulemaking committee -- 564. Publication of notice -- applications for membership on committees -- 565. Establishment of committee -- 566. Conduct of committee activity -- 567. Termination of committee.568. Services, facilities, and payment of committee member expenses -- 569. Role of the Administrative Conference of the United States and other entities -- 570. Judicial review -- B Workshop Participants -- WORKSHOP ON RISK AND REGULATION -- WORKSHOP ON MANAGING THREATS TO THE BLOOD SUPPLY -- C Acronyms.This volume examines regulatory and policymaking procedures in blood banking, regulatory enforcement and compliance, innovations and alternatives in regulation, congressional oversight and regulatory initiatives, and investment in regulatory quality.Blood banksSafety regulationsUnited StatesBloodTransfusionSafety regulationsUnited StatesBlood banksSafety regulationsBloodTransfusionSafety regulations362.1/784/0973Dauer Edward A1810349Forum on Blood Safety and Blood Availability.MiAaPQMiAaPQMiAaPQBOOK9910960557803321Blood banking and regulation4361665UNINA