![]() PAHPRA clarifies and enhances FDA’s authority to support emergency preparedness and response and foster the development and availability of medical products for use in these emergencies. 3 The provisions in PAHPRA, described in section II of this guidance, include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats such as pandemic influenza. This guidance explains FDA's general recommendations and procedures applicable to the authorization of the emergency use of certain medical products under sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic Act 2 as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). IMPORTING AND EXPORTING MEDICAL PRODUCTS UNDER AN EUAĪppendix A: EUA Conditions of Authorization: Required vs Discretionary REFERENCE INFORMATIONįDA offices that issued this guidance I. EMERGENCY USE INSTRUCTIONS WITHOUT AN EUA Duration of an Emergency Dispensing OrderĮ. ![]() Scope and Conditions of Emergency Dispensing Ordersģ. Procedures for Issuing Emergency Dispensing OrdersĢ. WAIVER OF CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS WITHOUT AN EUAġ. EXPIRATION DATE EXTENSIONS WITHOUT AN EUAĬ. EMERGENCY USE OF ELIGIBLE FDA-APPROVED MCMs WITHOUT AN EUAī. OPTION TO CARRY OUT AUTHORIZED ACTIVITIES CATEGORIZATION OF LABORATORY TESTS UNDER AN EUA Waivers or Limitations of Compliance With Other Requirementsį. Monitoring and Reporting of Adverse EventsĤ. Information Relating to the EUA ProductĢ. Determinations to Support an EUA Declarationġ. EUA DECLARATION JUSTIFYING EMERGENCY USEġ. Queuing, bottle-necking, slow egress are all a results of improperly designed egress systems.Office of the Commissioner, Office of the Chief Scientist, Office of Counterterrorism and Emerging Threats Guidance for Industry and Other StakeholdersĬontents | Reference Information CONTENTSĪ. When the occupant load of a building or area exceeds what is was designed for, the egress capacity cannot accommodate the occupants safely and efficiently. The occupant load is the maximum of either the calculated value OR the maximum probably number of people expected in the space.Įgress capacity is calculated based upon the available width of egress components (doors, stairs, corridors, walkways, etc.) Further requirements in Chapter 14 of NFPA 1 provide the details for calculating egress capacity of the space. The occupant load is to reflect the maximum number of people anticipated to occupy the building rooms or spaces at any given time and under all probable situations. The number of people or occupant load for which the means of egress system must provide egress capacity is calculated per the requirements set forth in NFPA 1 or otherwise determined. Occupant Load = The total number of persons that might occupy a building or portion thereof at any one time.ġ4.8.1.1.1 The total capacity of the means of egress for any story, balcony, tier, or other occupied space shall be sufficient for the occupant load thereof. Sizing is accomplished by matching the occupant load of a floor with the calculated egress capacity of the egress components serving the floor.Ĭapacity = The number of people the egress system can accommodate safely during an emergency. It is a basic concept of the Code that the means of egress system be sized to accommodate all people occupying a building. So, how exactly does a building determine its "occupant load" and why is it so important that these requirements are adhered to? The direction provided by the fire Code helps prevent overcrowding and potential insufficient egress capacity. NFPA 1, Fire Code, is a valuable resource for fire marshals and AHJs when determining occupant load and the egress capacity of a space. Let's talk about the Code requirements behind this concept of occupant load. Yesterday, NFPA's Nicole Comeau wrote a fantastic post about assembly occupancies, the dangers of crowds and the importance of enforcing fire and life safety codes at these venues.
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