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Blood Banking and Regulation

Blood Banking and Regulation

Procedures, Problems, and Alternatives

  • Author: Dauer, Edward A.
  • Publisher: National Academies Press
  • ISBN: 9780309055468
  • eISBN Pdf: 9780309589505
  • eISBN Epub: 9780309175326
  • Place of publication:  United States
  • Year of digital publication: 1996
  • Month: June
  • Pages: 138
  • DDC: 615
  • Language: English

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 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

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