Chapter
HHS HAS BEGUN TO ADDRESS MOST OF ITS OWN RECOMMENDATIONS WITH INITIATIVES INTENDED TO IMPROVE MEDICAL COUNTERMEASURE ACTIVITIES, BUT DOES NOT HAVE AN ADEQUATE STRATEGY TO MONITOR IMPLEMENTATION
HHS Agencies and Offices Have Begun to Address Most of HHS’s Recommendations with Initiatives Intended to Improve PHEMCE and Its Medical Countermeasure Activities
HHS Has Gathered Information on Agencies’ and Offices’ Implementation of the Initiatives but Has Not Developed an Adequate Strategy to Monitor Overall Progress
HHS’S PHEMCE AND RELATED WRITTEN AGREEMENTS HAVE FACILITATED INTRADEPARTMENTAL COORDINATION, BUT CHALLENGES REMAIN THAT MAY BE ADDRESSED THROUGH HHS’S NEW INITIATIVES
HHS’s PHEMCE Structure and Related Written Agreements Have Facilitated Intradepartmental Coordination
Industry and Outside Experts Indicate That New Initiatives May Mitigate Some Coordination Challenges
RECOMMENDATIONS FOR EXECUTIVE ACTION
AGENCY COMMENTS AND OUR EVALUATION
APPENDIX I: HHS MEDICAL COUNTERMEASURE DEVELOPMENT AND ACQUISITION PRIORITIES AND INVESTMENTS
APPENDIX II: HHS INITIATIVES TO ADDRESS ITS RECOMMENDATIONS TO IMPROVE MEDICAL COUNTERMEASURE ACTIVITIES
End Notes for Appendix II
Chapter 2 NATIONAL PREPAREDNESS: DHS AND HHS CAN FURTHER STRENGTHEN COORDINATION FOR CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR RISK ASSESSMENTS
DHS AND HHS COORDINATE ON THE DEVELOPMENT OF CBRN RISK ASSESSMENTS BUT DO NOT HAVE WRITTEN PROCEDURES FOR THEIR DEVELOPMENT
DHS Coordination with HHS on the Development of Its CBRN Risk Assessments Has Varied, and DHS Has Not Yet Established Related Written Procedures
HHS Signed an Interagency Agreement and Coordinates with DHS to Develop Modeling Reports but Does Not Have Written Procedures for Their Development
RECOMMENDATIONS FOR EXECUTIVE ACTION
AGENCY COMMENTS AND OUR EVALUATION
APPENDIX I: DHS AND HHS CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR RISK ASSESSMENTS
DHS and HHS CBRN Risk Assessments
DHS Terrorism Risk Assessments
DHS Material Threat Assessments
HHS Public Health and Medical Consequence Modeling Reports
Chapter 3 STATEMENT OF GUS M. BILIRAKIS, CHAIRMAN OF SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE AND COMMUNICATIONS. HEARING ON “TAKING MEASURE OF COUNTERMEASURES(PART 1): A REVIEW OF GOVERNMENT AND INDUSTRY EFFORTS TO PROTECT THE HOMELAND THROUGH ACCELERATED RESEARCH, DEVELOPMENT, AND ACQUISITION OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES
Chapter 4 STATEMENT OF RICHARD J. HATCHETT, CHIEF MEDICAL OFFICER AND DEPUTY DIRECTOR FOR STRATEGIC SCIENCES AND MANAGEMENT, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. HEARING ON “TAKING MEASURE OF COUNTERMEASURES (PART 1): A REVIEW OF GOVERNMENT AND INDUSTRY EFFORTS TO PROTECT THE HOMELAND THROUGH ACCELERATED RESEARCH, DEVELOPMENT, AND ACQUISITION OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES”
INTRODUCTION - ASPR/BARDA MISSION
THE PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURE ENTERPRISE
PHEMCE MCM Requirement-Setting Process
Project BioShield MCM Procurements
Advanced Research and Development
Integrated Portfolio for CBRN Medical Countermeasures
MEDICAL COUNTERMEASURE ENTERPRISE REVIEW
MCM DISTRIBUTION - EXECUTIVE ORDER 13527
Chapter 5 STATEMENT OF DR. GERALD W. PARKER, JR., DEPUTY ASSISTANT TO THE SECRETARY OF DEFENSE FOR CHEMICAL AND BIOLOGICAL DEFENSE. HEARING ON “TAKING MEASURE OF COUNTERMEASURES (PART 1): A REVIEW OF GOVERNMENT AND INDUSTRY EFFORTS TO PROTECT THE HOMELAND THROUGH ACCELERATED RESEARCH, DEVELOPMENT, AND ACQUISITIONCHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES”
CHALLENGES TO PROGRESS ON MEDICAL COUNTERMEASURES
INTEGRATED BIODEFENSE APPROACH
Detection and Initial Response
Medical Countermeasures Discovery and Development
Advanced Development and Manufacturing
INTERAGENCY COLLABORATION
Chapter 6 TESTIMONY OF PHYLLIS ARTHUR, SENIOR DIRECTOR FOR VACCINES, IMMUNOTHERAPEUTICS AND DIAGNOSTICS POLICY AT THE BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO). HEARING ON “TAKING MEASURE OF COUNTERMEASURES(PART 1): A REVIEW OF GOVERNMENT AND INDUSTRY EFFORTS TO PROTECT THE HOMELAND THROUGH ACCELERATED RESEARCH, DEVELOPMENT, AND ACQUISITION OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES”
Chapter 7 TESTIMONY OF JOHN M. CLERICI, ESQ., PRINCIPAL, TIBER CREEK PARTNERS, LLC. HEARING ON “TAKING MEASURE OF COUNTERMEASURES(PART 1): A REVIEW OF GOVERNMENT AND INDUSTRY EFFORTS TO PROTECT THE HOMELAND THROUGH ACCELERATED RESEARCH, DEVELOPMENT, AND ACQUISITION OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES”
Chapter 8 TESTIMONY OF DANIEL B. FAGBUYI, MD, FAAP, AMERICAN ACADEMY OF PEDIATRICS. HEARING ON “TAKING MEASURE OF COUNTERMEASURES(PART 1): A REVIEW OF GOVERNMENT AND INDUSTRY EFFORTS TO PROTECT THE HOMELAND THROUGH ACCELERATED RESEARCH, DEVELOPMENT, AND ACQUISITION OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES”
CHILDREN ARE MORE VULNERABLE THAN ADULTS
CHILDREN HAVE UNIQUE TREATMENT NEEDS
CHILDREN NEED CARE FROM PROVIDERS TRAINED TO MEET THEIR UNIQUE NEEDS
EMERGENCY MEDICAL SERVICES FOR CHILDREN
NATIONAL COMMISSION ON CHILDREN AND DISASTERS
MEDICAL PRODUCTS FOR CHILDREN
MEDICAL COUNTERMEASURES FOR CHILDREN
OTHER POLICY RECOMMENDATIONS
Chapter 9 STATEMENT OF GUS M. BILIRAKIS, CHAIRMAN OF SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE AND COMMUNICATIONS. HEARING ON "TAKING MEASURE OF COUNTERMEASURES(PART 2): A REVIEW OF EFFORTS TO PROTECT THE HOMELAND THROUGH DISTRIBUTION AND DISPENSING OF CBRN MEDICAL COUNTERMEASURES"
Chapter 10 STATEMENT OF ALEXANDER G. GARZA, MD, MPH, ASSISTANT SECRETARY FOR HEALTH AFFAIRS AND CHIEF MEDICAL OFFICER, U.S. DEPARTMENT OF HOMELAND SECURITY. HEARING ON "TAKING MEASURE OF COUNTERMEASURES (PART 2): A REVIEW OF EFFORTS TO PROTECT THE HOMELAND THROUGH DISTRIBUTION AND DISPENSING OF CBRN MEDICAL COUNTERMEASURES"
OHA INITIATIVES THAT HELP MITIGATE BIOLOGICAL THREATS AND HELP PREPARE THE NATION TO QUICKLY DETECT AND RESPOND TO BIOLOGICAL EVENTS
DHS ASSISTS AND COORDINATES WITH STATE AND LOCAL GOVERNMENTS
EXECUTIVE ORDER 13527: ESTABLISHING FEDERAL CAPABILITY FOR THE TIMELY PROVISION OF MEDICAL COUNTERMEASURES FOLLOWING A BIOLOGICAL ATTACK
DHS WORKFORCE AND HEALTH PROTECTION
Chapter 11 TESTIMONY OF ALI S. KHAN, ASSISTANT SURGEON GENERAL, U.S. PUBLIC HEALTH SERVICE, AND DIRECTOR, OFFICE OF PUBLIC HEALTH PREPAREDNESS AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN SERVICES. HEARING ON "TAKING MEASURE OF COUNTERMEASURES (PART 2): A REVIEW OF EFFORTS TO PROTECT THE HOMELAND THROUGH DISTRIBUTION AND DISPENSING OF CBRN MEDICAL COUNTERMEASURES"
IMPORTANCE OF STATE AND LOCAL PARTNERSHIPS
FEDERAL PARTNER COLLABORATION
PHEMCE RECOMMENDATIONS GUIDE SNS PROCUREMENTS
CHALLENGES TO MAINTAINING A STRONG, FLEXIBLE SYSTEM
Chapter 12 TESTIMONY OF DAVID STARR, DIRECTOR OF COUNTERMEASURES RESPONSE, OFFICE OF EMERGENCY PREPAREDNESS AND RESPONSE, NEW YORK CITY DEPARTMENT OF HEALTH AND MENTAL HYGIENE. HEARING ON "TAKING MEASURE OF COUNTERMEASURES (PART 2): A REVIEW OF EFFORTS TO PROTECT THE HOMELAND THROUGH DISTRIBUTION AND DISPENSING OF CBRN MEDICAL COUNTERMEASURES"
Chapter 13 STATEMENT OF MIKE MCHARGUE, DIRECTOR, PUBLIC HEALTH & MEDICAL PLANNING & RESPONSE, FLORIDA DEPARTMENT OF HEALTH. HEARING ON "TAKING MEASURE OF COUNTERMEASURES (PART 2): A REVIEW OF EFFORTS TO PROTECT THE HOMELAND THROUGH DISTRIBUTION AND DISPENSING OF CBRN MEDICAL COUNTERMEASURES"
EMERGENCY MANAGEMENT STRUCTURE
DOMESTIC SECURITY STRUCTURE
MONITORING AND DETECTION OF THE THREAT
EVALUATIONS AND RECOMMENDATIONS FOR COUNTERMEASURES
INFORMATION MANAGEMENT BRANCH
POINTS OF DISPENSING (POD) STRATEGY
STRATEGIC NATIONAL STOCKPILE (SNS)
CITIES READINESS INITIATIVE (CRI)
Chapter 14 STATEMENT OF LAWRENCE E. TAN, CHIEF OF EMERGENCY MEDICAL SERVICES, NEW CASTLE COUNTY, DELAWARE. HEARING ON "TAKING MEASURE OF COUNTERMEASURES (PART 2): A REVIEW OF EFFORTS TO PROTECT THE HOMELAND THROUGH DISTRIBUTION AND DISPENSING OF CBRN MEDICAL COUNTERMEASURES"
Chapter 15 TESTIMONY OF JEFFREY LEVI, PHD, EXECUTIVE DIRECTOR, TRUST FOR AMERICA'S HEALTH. HEARING ON "TAKING MEASURE OF COUNTERMEASURES (PART 2): A REVIEW OF EFFORTS TO PROTECT THE HOMELAND THROUGH DISTRIBUTION AND DISPENSING OF CBRN MEDICAL COUNTERMEASURES"*
WORKFORCE AND INFRASTRUCTURE GAP
COMMUNITY RESILIENCY SUPPORT GAP
GAPS IN MEDICAL COUNTERMEASURE ENTERPRISE
SUCCESS AT RISK: THE URBAN-RURAL EXPERIENCE
Chemical, Biological, Radiological, and Nuclear Threats: Countermeasure Preparation
( Terrorism, Hot Spots and Conflict-Related Issues )
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