Blood 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, editor.

Format:

Book

Contributor:

Dauer, Edward A.

Forum on Blood Safety and Blood Availability.

Language:

English

Subjects (All):

Blood banks--Safety regulations--United States.

Blood--Transfusion--Safety regulations--United States.

Physical Description:

1 online resource (137 p.)

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, c1996.

Language Note:

English

Summary:

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.

Contents:

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

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.

Notes:

"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.

ISBN:

9786610191970

9780309175326

0309175321

9781280191978

128019197X

9780309589505

0309589509

9780585155494

0585155496

OCLC:

614658933