May 18 -- The Department of Health and Human Services (HHS), Assistant Secretary for Preparedness and Response, within Office of Strategy, Policy, Planning, and Requirements invites public comments by July 18, 2022 on identification and coordination of measurable activities -- by the U.S. government, SLTT (State, Local, Tribal, and Territorial) jurisdictions, and private sector partners -- implementing the National Strategy for a Resilient Public Health Supply Chain.
In July 2021, the White House published the National Strategy for a Resilient Public Health Supply Chain. The strategy calls out strategic goals and recommendations for building immediate and long-term resilience through increased visibility, agility, and robustness in the public health supply chain to prepare for and mitigate future public health emergencies.
As directed by Section 4 of Executive Order 14001 “On a Sustainable Public Health Supply Chain,” this National Strategy for a Resilient Public Health Supply Chain provides a strategic approach to design, build, and sustain a long-term capability in the United States to manufacture supplies for future pandemics and biological threats. This strategy outlines the U.S. Government’s vision to protect the health and security of Americans by ensuring a supply chain for PPE, medical devices, medicines, and other public health supplies that is consistent with our values and resilient against disruptions from pandemics and other biological threats.
This vision is supported by three strategic goals:
Goal 1: Build a diverse, agile public health supply chain and sustain long-term U.S. manufacturing capability for future pandemics;
Goal 2: Transform the U.S. Government’s ability to monitor and manage the public health supply chain through stockpiles, visibility, and engagement; and,
Goal 3: Establish standards, systems, and governance to manage the supply chain and ensure fair, equitable, and effective allocation of scarce resources.
Realizing these goals—through mechanisms that increase the resilience of the public health supply chain—will enable a more ethical, equitable, environmentally sustainable, innovative, and constructive U.S. public health supply chain. Such a supply chain would support the U.S.’s preparedness and response for future pandemics and biological threats. It would entail stronger products, people, and systems that we rely on in a public health
emergency. This strategy rests on a tailored definition of resilience, focusing on three key elements of public health supply chain resilience: robustness, visibility, and agility. Together, capability in these areas results in a supply chain in which the U.S. can have confidence during and in-between crises.
Achieving the above goals and qualities requires unprecedented investment in the public health industrial base as a national security asset—so that Americans have the supplies they need when they need them. The U.S. Government must make sustained investments in domestic manufacturing, as well as incentivize pandemic preparedness in the U.S. health care system. The U.S. Government must also continue to grow capabilities in supply chain intelligence, engagement, and management. Only through these collective actions can the U.S. public health supply chain be better situated to respond to future pandemics.
This strategy lays out recommendations to actualize these requirements, among them:
-- Make bold investments in the American public health industrial base: The U.S. should sustain investments over the long term in a durable, resilient American industry and workforce—able to scale quickly—to ensure PPE, diagnostics, and other medical countermeasures remain at the ready when we need them. The U.S. Government faces an opportunity to build on the past year’s reinvigoration of the U.S. public health industrial base, recognizing the public health industrial base as a specific sector requiring dedicated U.S. Government management, oversight, and sustainment as a national strategic imperative. Over the next ten years, the U.S. needs to make significant investments in industrial base expansion and sustainment. This funding would support extended long-term contracts, on-hand inventory, vendor-managed inventory, and other actions, many of which would be managed through an expanded Strategic National Stockpile.
-- Build a more capable and robust Strategic National Stockpile: The U.S. Government should build a larger, broader, and smarter Strategic National Stockpile (SNS) that is linked with State, local, Tribal, and territorial (SLTT) capabilities—continuing current momentum—so that the U.S. is prepared for intentional, natural, and emerging pandemic threats. This capability means focusing on not only the SNS’s mission, but also all aspects of domestic
preparedness including industrial base and supply chain solutions. Constituting a more capable medical countermeasures enterprise will require increased and sustainable funding, authorities, and coordination. It requires leveraging all available solutions, required resources, and tools—including solutions outside the SNS. Examples include centralized, SLTT, and vendor-managed-inventory stockpiling needed to ensure that the U.S. Government is ready to respond to future pandemics as well as intentional threats. To identify critical areas to meet future public health demands, the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) should lead an assessment of COVID-19 SNS-specific lessons learned. The PHEMCE can use insights and broader assessments of public health supply chain gaps to identify priorities for capability development.
-- Maintain end-to-end public health supply chain visibility: Supply chain visibility is critical to the U.S. Government’s ability to anticipate, prepare for, and respond to potential disruptions, particularly during a public health emergency. The U.S. Government is prepared to implement new supply chain situational awareness capabilities and authorities as well as establish a rhythm of regular supply chain illumination, analysis, and mapping. Expanding current supply chain visibility into critical public health and other all-hazard-scenario supplies requires 1) identifying and prioritizing the list of critical medical supplies/products for a pandemic response, and 2) prioritizing mapping and analysis of those products’ supply chains, to include raw materials, components, manufacturers, distributors, and end users. Visibility should also extend to stockpiles, including federal, SLTT, and private-sector stores. These capabilities will allow the U.S. Government to identify vulnerabilities, predict and prevent supply chain disruptions, and mitigate risks.
HHS is working with the White House and across the federal interagency to launch a multiyear implementation [of this strategy] involving the identification and coordination of measurable activities across the U.S. government, SLTT (State, Local, Tribal, and Territorial) jurisdictions, and private sector partners.
Cross-sectoral engagement is the underpinning of many of the interdependent implementation activities. For example, one such activity involves information collection from SLTT partners on facility, local, and state stockpiling plans to ensure coordinated plans are in place for a future public health emergency. Potential engagements include surveys, stakeholder meetings, RFI's, town hall meetings, and workshops. With each of these different mechanisms of engagement, there is a varied frequency ranging from single engagements to regularly recurring meetings.
HHS is requesting a 3-year PRA clearance [to collect data on implementation activities] and will engage with SLTT, trade groups, mixed cross-sector audiences, non-governmental organizations, manufacturers, academia, healthcare providers and facilities, and local communities.
E.O. 14001: A Sustainable Public Health Supply Chain https://www.federalregister.gov/d/2021-01865
National Strategy for a Resilient Public Health Supply Chain: https://www.phe.gov/Preparedness/legal/Documents/National-Strategy-for-Resilient-Public-Health-Supply-Chain.pdf
HHS/ASPR/ICC Office of Strategy, Policy, Planning, and Requirements https://aspr.hhs.gov/AboutASPR/ProgramOffices/ICC/Pages/OSPPR.aspx
Kristin DeBord, Director of ICC Division of Strategy firstname.lastname@example.org
FRN seeking comments: https://www.federalregister.gov/d/2022-10700