LEADER 06690nam 2200721 a 450 001 9910960557803321 005 20251017110105.0 010 $a9786610191970 010 $a9780309175326 010 $a0309175321 010 $a9781280191978 010 $a128019197X 010 $a9780309589505 010 $a0309589509 010 $a9780585155494 010 $a0585155496 035 $a(CKB)110986584751860 035 $a(OCoLC)614658933 035 $a(CaPaEBR)ebrary10055095 035 $a(SSID)ssj0000113226 035 $a(PQKBManifestationID)11131423 035 $a(PQKBTitleCode)TC0000113226 035 $a(PQKBWorkID)10099198 035 $a(PQKB)10885190 035 $a(MiAaPQ)EBC3376101 035 $a(Au-PeEL)EBL3376101 035 $a(CaPaEBR)ebr10055095 035 $a(OCoLC)923261160 035 $a(Perlego)4733859 035 $a(DNLM)815860 035 $a(BIP)47222221 035 $a(EXLCZ)99110986584751860 100 $a19960705d1996 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aBlood banking and regulation $eprocedures, problems, and alternatives /$fForum on Blood Safety and Blood Availability, Division of Health Sciences Policy, Institute of Medicine ; Edward A. Dauer, editor 205 $a1st ed. 210 $aWashington, D.C. $cNational Academy Press$dc1996 215 $a1 online resource (137 p.) 300 $a"The talks summarized in this document were originally given at workshops on Alter[n]ative Regulatory Models (January, 1995); CBER Compliance Acivity, Theory and Practice (September, 1995); and Managing Threats to the Blood Supply (September, 1995)"--P. vii. 311 08$a9780309055468 311 08$a0309055466 327 $aBlood 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. 327 $aRECENT 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. 327 $a568. 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. 330 $aThis 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. 606 $aBlood banks$xSafety regulations$zUnited States 606 $aBlood$xTransfusion$xSafety regulations$zUnited States 615 0$aBlood banks$xSafety regulations 615 0$aBlood$xTransfusion$xSafety regulations 676 $a362.1/784/0973 701 $aDauer$b Edward A$01810349 712 02$aForum on Blood Safety and Blood Availability. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910960557803321 996 $aBlood banking and regulation$94361665 997 $aUNINA