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Appendix A Acronyms ADE adverse drug event APUA Alliance for Prudent Use of Antibiotics ASPR Assistant Secretary for Preparedness and Response (Department of Health and Human Services) AVA anthrax vaccine adsorbed (a licensed anthrax vaccine) BAR BioWatch Actionable Result BARDA Biomedical Advanced Research and Development Authority BENS Business Executives for National Security BERM Bioterrorism and Epidemic Outbreak Response Model CDC Centers for Disease Control and Prevention CERT Community Emergency Response Team cGMP current good manufacturing practice CHC community health center CI confidence interval CRI Cities Readiness Initiative DHS Department of Homeland Security DOD Department of Defense DTD decision to dispense EPA Environmental Protection Agency EUA Emergency Use Authorization 217
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218 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX FDA Food and Drug Administration FFDCA Federal Food, Drug, and Cosmetic Act HHS Department of Health and Human Services HIPAA Health Insurance Portability and Accountability Act HoH head of household HPP Hospital Preparedness Program HRSA Health Resources and Services Administration IND Investigational New Drug IOM Institute of Medicine IV intravenous KI potassium iodide MCM medical countermeasures MCMDD Medical Countermeasures Distribution and Dispensing MDR multi-drug-resistant MERC Medical Emergency Response Cache (New York State) MOA memorandum of agreement MOU memorandum of understanding MSA metropolitan statistical area MTD Material Threat Determination NBSB National Biodefense Science Board NRC U.S. Nuclear Regulatory Commission OMB Office of Management and Budget PCR polymerase chain reaction PEP postexposure prophylaxis PHEP Public Health Emergency Preparedness PhRMA Pharmaceutical Research and Manufacturers of America POD point of dispensing PREP Act Public Readiness and Emergency Preparedness Act QA/QC quality assurance/quality control REMS risk evaluation and mitigation strategies RSS receiving, staging, and storage SHSP State Homeland Security Program SLEP Shelf Life Extension Program
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219 APPENDIX A SNS Strategic National Stockpile TAR Technical Assistance Review THIRA Threat and Hazard Identification and Risk Assessment UASI Urban Area Security Initiative USPS U.S. Postal Service VA Department of Veterans Affairs VMI vendor-managed inventory
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