Medical countermeasure (used interchangeably with security countermeasure (SC) ) as defined in Section (3) of the Project BioShield Act of 2004, Section 319F-2 of the Public Health Service Act (PHS Act): a drug (as that term is defined by section 201(g) (1) of the Federal Food, Drug, and Cosmetic Act [FDCA] (21 U.S.C. 321 (g) (1) ) ), biological product (as that term is defined by section 351(i) of PHS (42 U.S.C. 262(i) ) ), or device (as that term is defined by section 201 (h) of the Federal FDCA (21 U.S.C. 321 (h) ) ) that the Secretary of HHS determines to be a priority (consistent with sections 302(2) and 304(a) of the Homeland Security Act of 2002) to treat, identify, or prevent harm from any biological, chemical, radiological or nuclear agent identified as a material threat under paragraph (2) (A) (ii), or to treat, identify, or prevent harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; the Secretary determines under Section 319F-2(c) (2) (B) (ii) of the PHS Act to be a necessary countermeasure, and is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical experience or research data (including data, if available, from pre-clinical and clinical trials) support a reasonable conclusion that the countermeasure will qualify for approval or licensing within eight years after the date of a determination under paragraph (5) of Section 319F-2(c) or is approved or cleared under chapter V of the FDCA or licensed under section 351 of the PHS Act; or is authorized for emergency use under section 564 of the FDCA. (HHS, Pandemic and All-Hazards Preparedness Act Progress Report, November 2007, Appendix 1, Abbreviations and Glossary)