Dec 31 -- The Commerce Department extends the deadline for comments to January 15, 2021. https://www.federalregister.gov/documents/2020/12/31/2020-29036/change-in-deadline-for-public-comments-on-condition-of-the-public-health-industrial-base-and
Dec 2 -- Under Executive Order 13944, the Commerce Department is directed to prepare an analysis and recommendations regarding the U.S. Public Health Industrial Base (PHIB) -- defined as the facilities and associated workforces within the United States, including research and development facilities, which help produce Essential Medicines, Medical Countermeasures, and Critical Inputs for the Healthcare and Public Health Sector. The PHIB includes all entities domestically manufacturing or producing medical products, including medical devices, medical equipment, medical countermeasures, and medications, pharmaceutical products, and other products designed to improve patient outcomes. This includes the manufacturing of components and materials that are essential to create end-item medical products, as well as ancillary supplies and disposable consumable products. The PHIB also includes the labor force necessary to conduct the manufacturing and supply chain operations described above. The report is due by February 2, 2021.
E.O. 13944 directs that domestic supply chains must be capable of meeting national security requirements for responding to threats arising from chemical, biological, radiological, and nuclear (CBRN) threats and public health emergencies, including emerging infectious diseases such as COVID-19. The E.O. further states that it is critical that the United States reduce its dependence on foreign manufacturers for Essential Medicines, Medical Countermeasures, and Critical Inputs to ensure sufficient and reliable long-term domestic production of these products, minimize potential shortages, and mobilize our Nation's PHIB to respond to these threats. The E.O. directed that the policy of the United States is to accelerate the development of cost-effective and efficient domestic production of Essential Medicines and Medical Countermeasures and to have adequate redundancy built into the domestic supply chain; ensure long-term demand for these items, and critical inputs that are produced in the United States; create, maintain, and maximize domestic production capabilities for these items that are essential to protect public safety and human health and to provide for the national defense; and combat the trafficking of these items, and critical inputs over e-commerce platforms and from third party online sellers involved in the government procurement process.
This notice requests comments from the public by December 23, 2020 to assist Commerce in preparing this report on the condition of the PHIB (“change in the status”) and recommending policies and actions (“initiatives”) to strengthen the PHIB. The request poses 27 primary questions. See https://www.federalregister.gov/documents/2020/12/02/2020-26609/notice-of-request-for-public-comments-on-condition-of-the-public-health-industrial-base-and