Specifically, the Declaration notes that Covered Countermeasures must be "qualified pandemic or epidemic products,'' or "security countermeasures,'' or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act. Liability immunity under the provisions of the PREP Act and the conditions of the Declaration continue during these additional time periods. A great Secretary can manage the political demands of the U.S. Congress and President while satisfying the individual heads of each agency under their purview. U.S. Department of Health & Human Services 200 Independence Avenue, S.W. 247d-6d and 42 U.S.C. The PREP Act's liability immunity applies to “Covered Persons” with respect to administration or use of a Covered Countermeasure. These liability protections provide that, “[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.” In Section IV of the Declaration, the Secretary states that liability protections are in effect with respect to the Recommended Activities. In December 2019, the novel coronavirus was detected in Wuhan City, Hubei Province, China. 42 U.S.C. In Section II of the Declaration, the Secretary states that he has considered these factors.  Trump then named Don J. Wright, Deputy Assistant Secretary for Health and Director of the Office of Disease Prevention and Health Promotion, as acting secretary until Deputy Secretary Eric Hargan was sworn in on October 10, 2017. This compensation does not influence our school rankings, resource guides, or other editorially-independent information published on this site. In Section VIII of the Declaration, the Secretary states that the disease threat for which he recommends administration or use of the Covered Countermeasures is COVID -19 caused by SARS- CoV-2 or a virus mutating therefrom. The definition of “administration” extends only to physical provision of a countermeasure to a recipient, such as vaccination or handing drugs to patients, and to activities related to management and operation of programs and locations for providing countermeasures to recipients, such as decisions and actions involving security and queuing, but only insofar as those activities directly relate to the countermeasure activities. 2. A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer. Even if you never become the Secretary of Health and Human Services, you can still find a fulfilling career in the DHHS. DHHR provides services in all 55 counties through a dedicated staff of nearly 6,000 individuals. Covered Countermeasures are any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product. To be a Covered Countermeasure, qualified pandemic or epidemic products or security countermeasures also must be approved or cleared under the FD&C Act; licensed under the PHS Act; or authorized for emergency use under Sections 564, 564A, or 564B of the FD&C Act. This includes advising the president on matters of health, welfare, and income security programs.
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