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Appendix B: PHEMCE High-Priority Threats

The PHEMCE continues to address MCM needs to protect against high-priority threats. In 2017-2018, the PHEMCE added one new category of chemical agents (pharmaceutical-based agents) to the list, and in 2019-2020, one new category of biological threat (severe acute respiratory syndrome-related coronavirus (SARS-CoV)) was added. The PHEMCE high-priority threats are (in alphabetical order by threat area):

* Indicates an identified material threat under section 319-2(c)(2)(A)(ii) of the Public Health Service Act, that, among other things, may make an MCM developer eligible to be awarded a material threat MCM priority review voucher pursuant to meeting the statutory criteria of 21 U.S.C. § 360bbb-4a.

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