Sec. 3. Essential medicines risk assessment
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The Secretary, in coordination with the Secretary of Defense and in consultation with the heads of other relevant departments and agencies, shall conduct a comprehensive risk assessment of the supply chains for active pharmaceutical ingredients and drugs included on the Essential Medicines List described in section 2. At a minimum, the risk assessment under subsection
(a)shall identify, to the extent available— key starting materials and excipients used in manufacturing the active pharmaceutical ingredients and drugs on the Essential Medicines List; the active pharmaceutical ingredients and drugs on the Essential Medicines List that rely on a high-risk foreign supplier or foreign entity of concern (as defined in section 9901(8) of the William M.
(Mac)Thornberry National Authorization Act for Fiscal Year 2021 ( 15 U.S.C. 4651(8) )) for more than 50 percent of production; the active pharmaceutical ingredients and drugs on the Essential Medicines List that are sourced exclusively or primarily from foreign establishments, including drugs manufactured domestically from active pharmaceutical ingredients sourced exclusively or primarily from foreign establishments; current domestic manufacturing capabilities for active pharmaceutical ingredients and drugs on the Essential Medicines List, including the key starting materials and excipients of such ingredients and drugs, and any cost-effective manufacturing technologies, including advanced manufacturing; public health and national security risks, including cybersecurity threats and critical infrastructure designations specific to the supply chains of active pharmaceutical ingredients and drugs included on the Essential Medicines List; any deficiencies, lack of authorities, or limitations in policy or process that reduce the ability of the Federal Government to address any identified public health or national security risks related to supply chains for active pharmaceutical ingredients and drugs included on the Essential Medicines List; and how the Federal Government will mitigate such national security risks, including through the use of authorities under the Defense Production Act of 1950 ( 50 U.S.C. 4501 et seq. ). Not later than 180 days after the date of enactment of this Act, and annually thereafter, the Secretary, in consultation with the heads of relevant Federal departments and agencies consulted under subsection (a), shall submit a report with the findings under subsection
(b)to— the Committee on Armed Services, the Committee on Health, Education, Labor, and Pensions, and the Committee on Homeland Security and Governmental Affairs of the Senate; the Committee on Armed Services, the Committee on Energy and Commerce, and the Committee on Homeland Security of the House of Representatives; and the Office of the Director of National Intelligence. Not later than 1 year after the date of enactment of this Act, the Secretary, in consultation with the heads of relevant Federal departments and agencies consulted under subsection (a), shall release a public version of the report submitted under paragraph (1).
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