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Dec 16 -- The Office of Strategy, Policy, Planning, and Requirements, within the Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), invites comment to OMB by January 17, 2023 regarding collection of information to inform 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 (National Strategy), which 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. HHS is working with the White House and across the federal interagency to launch a multiyear implementation of the National Strategy involving the identification and coordination of measurable activities across the U.S. government, State, Local, Tribal, and Territorial (SLTT) jurisdictions, and the private sector.

HHS is requesting a 3-year PRA generic clearance for purposes of implementation to engage with SLTTs, trade groups, mixed cross-sector audiences, non-governmental organizations, manufacturers, academia, healthcare providers and facilities, local communities, and other partners to: gain a better understanding of the public health supply chain; develop future 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; and to ensure ASPR, HHS, and the broader U.S. government have current data and information to inform program and policy decision-making.

Cross-sectoral engagement underpins 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. Other potential engagements include, but are not limited to questionnaires, stakeholder meetings, requests for information, town hall meetings, and workshops. Stakeholder engagement frequency will vary depending on the type of stakeholder and the information collection needs. Therefore, some engagements may only occur once, while others may require a series of recurring meetings.
 
As directed by Executive Order 14001, The National Strategy for a Resilient Public Health Supply Chain (The National Strategy) 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. The Administration for Strategic Preparedness and Response (ASPR) at the Department of Health and Human Services (HHS) is leading an interagency team in implementing the National Strategy and is requesting a generic clearance for purposes of implementation to: gain a better understanding of the public health supply chain; develop future 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; and to ensure ASPR, HHS, and the broader U.S. government have current data and information to inform program and policy decision-making. We seek to obtain Office of Management and Budget (OMB) approval of a generic clearance to collect feedback on public health supply chain program and strategic issues. By feedback, we mean information that provides useful insights on perceptions and opinions but are not statistical surveys that yield results that can be generalized beyond the population of the study.  

The following federal Departments and Agencies compose the National Strategy interagency implementation team. Additional Departments and Agencies may be added to the team as needed as implementation activities continue:

HHS -- ASPR, Centers for Disease Control and Prevention, Food and Drug Administration, Office of the General Council, Office of Global Affairs
Department of Homeland Security
Department of Commerce
Department of Defense
Department of Energy
Department of Labor
Department of State
Department of Veterans Affairs
Office of Management and Budget
U.S. Environmental Protection Agency
U.S. Trade Representative
 
ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. ASPR collaborates with hospitals, healthcare coalitions, biotech firms, community members, state, local, tribal, and territorial (SLTT) governments, and other partners across the country to improve readiness and response capabilities. HHS/ASPR is working with the White House and with HHS and interagency partners to launch a multiyear implementation of over 20 efforts involving the identification and coordination of measurable activities across the U.S. government, SLTT jurisdictions, and private sector partners. Each of these action items must engage with SLTTs, the private sector, and other stakeholders to obtain information to create further plans, policies, and guidance to enhance the nation’s public health supply chain.  

This collection of information is necessary to enable ASPR and the National Strategy interagency implementation team to receive feedback in an efficient, timely manner, in accordance with ASPR’s mission and the National Strategy’s goals to build 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.

Formative research and assessment are the main objectives of the activities included in this clearance. The participants will include, but not be limited to, SLTTs, trade groups and associations, mixed cross-sector audiences, non-governmental organizations, manufacturers, academia, healthcare providers and facilities, and local communities, labor unions, workforce training providers, organizations, and state and local workforce boards.

ASPR and the National Strategy interagency implementation team will collect, analyze, and interpret information gathered through this generic clearance to support efforts to strengthen public health supply chains and improve understanding of current programs, policies, and services under the public health supply chain. The purpose is to obtain and better understand broad and diverse perspectives on the public health supply chain, engagement, health care and other emerging issues, and promising practices by innovative programs or organizations funded by HHS. ASPR and the National Strategy interagency implementation team will use the information to develop further plans, policies, strategies, and guidance to enhance the nation’s public health supply chain.

Under this clearance a variety of instruments will be used. Though the exact nature of the questions and samples is currently undetermined, ASPR and the National Strategy interagency implementation team expects that they will include but not be limited to issues related to:  

Global partnerships  
External stakeholder engagement and coordination  
Governance  
Innovation  
Manufacturing and Industrial Base Expansion investments  
Regulations, policy, and standards  
Workforce development  
Stockpiling, allocation, and coordination  
Trade policy & Buy American  

The data collection methods employed will vary based on the issue being examined, but examples include stakeholder meetings, surveys, town hall meetings, workshops, and working groups. The information collected will provide insights into stakeholder perceptions, experiences, and expectations. These collections will allow for ongoing, collaborative, and actionable communications between HHS/ASPR and the National Strategy interagency implementation team and their stakeholders.

ASPR Strengthening the Supply Chain & Industrial Base https://aspr.hhs.gov/MCM/IBx/2022Report/Pages/Strengthening-the-Supply-Chain-and-Industrial-Base.aspx
ASPR submission to OMB: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202211-0990-001 Click View Supporting Statement for technical documentation. Submit comments through this site.
FR notice inviting public comment: https://www.federalregister.gov/d/2022-27262
 
For AEA members wishing to submit comments, "A Primer on How to Respond to Calls for Comment on Federal Data Collections" is available at https://www.aeaweb.org/content/file?id=5806

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