In the spring of 2022, researchers at the Federation of American Scientists began reading newly released U.S. Defense Department budget documents to look for updates concerning the Pentagon’s priorities for the next fiscal year. As the researchers poured over hundreds of pages, two words suddenly captured their attention: the Biden administration’s Fiscal Year (FY) 2023 budget request had added “the UK” to a list of countries receiving upgrades to their “special weapons” storage sites under a 13-year NATO investment program. The term “special weapons” is often used by the U.S. government when referring to nuclear weapons. However, the United States has not deployed nuclear weapons in the United Kingdom for nearly two decades. Those two words sparked dozens of questions, years of continued research, and a new local movement of protests against the return of a potential nuclear mission to RAF Lakenheath.

This new report provides an account of the nuclear history of RAF Lakenheath and the role it played in the US nuclear mission until nuclear weapons were withdrawn in 2008. The report then explains the mounting evidence from three years of collection of documentation and observations that show the United States Air Force is re-establishing its nuclear mission on UK soil for the first time in nearly two decades.

As of February 2025, there are no known public indications that nuclear weapons have been deployed to RAF Lakenheath – we assess that the return of the nuclear mission is intended primarily as a backup rather than to deploy weapons now. However, if this were to happen, it would break with decades of policy and planning and reverse the southern focus of the European nuclear deployment that emerged after the end of the Cold War. Even without weapons present, the addition of a large nuclear air base in northern Europe is a significant new development that would have been inconceivable just a decade-and-a-half ago.

Read the full report here

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The authors would like to thank Matt Korda and Kate Kohn for their invaluable contributions to this report, as well as the Joseph Rowntree Charitable Trust for their support.

The United States faces urgent challenges related to aging infrastructure, vulnerable energy systems, and economic competitiveness. Improving American competitiveness, security, and prosperity depends on private and public stakeholders’ ability to responsibly site, build, and deploy critical energy and infrastructure. Unfortunately, these projects face one common bottleneck: permitting. 

Permits and authorizations are required for the use of land and other resources under a series of laws, such as the National Environmental Policy Act (NEPA), the Endangered Species Act (ESA), and National Historic Preservation Act of 1966. However, recent court rulings and the Trump Administration’s executive actions have brought uncertainty and promise major disruption to the status quo. The Executive Order (EO) on Unleashing American Energy mandates guidance to agencies on permitting processes be expedited and simplified within 30 days, requires agencies prioritize efficiency and certainty over any other objectives, and revokes the Council of Environmental Quality’s (CEQ) authority to issue binding NEPA regulations. While these changes aim to advance the speed, efficiency, and certainty of permitting, the impact will ultimately depend on implementation by the permitting workforce.

Unfortunately, the permitting workforce is unprepared to swiftly implement changes following shifts in environmental policy and regulations. Teams responsible for permitting have historically been understaffed, overworked, and unable to complete their project backlogs, while demands for permits have increased significantly in recent years. Building workforce capacity is critical for efficient and effective federal permitting. 

Project Overview

Our team at the Federation of American Scientists (FAS) has spent 18 months studying and working to build government capacity for permitting talent. The Inflation Reduction Act (IRA) provided resources to expand the federal permitting workforce, and we partnered with the Permitting Council, which serves as a central body to improve the transparency, predictability, and accountability of the federal environmental review and authorization process, to gain a cross-agency understanding of the hiring challenges experienced in permitting agencies and prioritize key challenges to address. Through two co-hosted webinars for hiring managers, HR specialists, HR leaders, and program leaders within permitting agencies, we shared tactical solutions to improve the hiring process.

We complemented this understanding with voices from agencies (i.e., hiring managers, HR specialists, HR teams, and leaders) by conducting interviews to identify new issues, best practices, and successful strategies for building talent capacity. With this understanding, we developed long-term solutions to build a sustainable, federal permitting workforce for the future. While many of our recommendations are focused on permitting talent specifically, our work naturally uncovered challenges within the broader federal talent ecosystem. As such, we’ve included recommendations to advance federal talent systems and improve federal hiring.

Problem

Building permitting talent capacity across the federal government is not an easy endeavor. There are many stakeholders involved across different agencies with varying levels of influence who need to play a role: the Permitting Council staff, the Permitting Council members-represented by Deputy Secretaries (Deputy Secretaries) of permitting agencies, the Chief Environmental Review and Permitting Officers (CERPOs) in each agency, the Office of Personnel and Management (OPM), the Chief Human Capital Officer (CHCO) in each permitting agency, agency HR teams, agency permitting teams, hiring managers, and HR specialists. Permitting teams and roles are widely dispersed across agencies, regions, states, and programs. The role each agency plays in permitting varies based on their mission and responsibilities, and there are many silos within the broader ecosystem. Few have a holistic view of permitting activities and the permitting workforce across the federal government.

With this complex network of actors, one challenge that arises is a lack of standardization and consistency in both roles and teams across agencies. If agencies are looking to fill specialized roles unique to one permitting need, it means that there will be less opportunity for collaboration and for building efficiencies across the ecosystem. The federal hiring process is challenging, and there are many known bottlenecks that cause delays. If agencies don’t leverage opportunities to work together, these bottlenecks will multiply, impacting staff who need to hire and especially permitting and/or HR teams who are understaffed, which is not uncommon. Additionally, building applicant pools to have access to highly qualified candidates is time consuming and not scalable without more consistency.

Tracking workforce metrics and hiring progress is critical to informing these talent decisions. Yet, the tools available today are insufficient for understanding and identifying gaps in the federal permitting workforce. The uncertainty of long-term, sustainable funding for permitting talent only adds more complexity into these talent decisions. While there are many challenges, we have identified solutions that stakeholders within this ecosystem can take to build the permitting workforce for the future.

There are six key recommendations for addressing permitting workforce capacity outlined in the table below. Each is described in detail with corresponding actions in the Solutions section that follows. Our recommendations are for the Permitting Council staff, Deputy Secretaries, CERPOs, OPM, CHCOs, OMB, and Congress.

High-level Recommendations

Enhance the Permitting Council’s Authority to Improve Processes and Workforce Collaboration	Congress needs to give the Permitting Council staff greater authority to standardize permitting practices, direct better permitting outcomes, and serve as a central authority for mandating permitting performance.
Build Efficient Permitting Teams and Standardize Roles	The Permitting Council staff, Deputy Secretaries, CERPOs, OMB, and the CHCO Council should improve the performance and consistency of permitting processes by establishing standards in permitting team roles and configurations to support cross-agency collaboration and drive continuous improvements.
Improve Workforce Strategy, Planning, and Decisions through Quality Workforce Metrics	OPM, OMB, the CHCO Council, and Permitting Council staff need to accurately gather and report on hiring metrics for talent surges and workforce metrics by domain.
Invest in Professional Development and Early Career Pathways	The Permitting Council staff, Deputy Secretaries, and CERPOs should create more development opportunities and early career pathways for civil servants.
Improve and Invest in Pooled Hiring for Common Positions	OPM, CHCOs, OMB, Permitting Council staff, Deputy Secretaries, and CERPOs should improve and make joint announcements, shared position descriptions, assessments, and certificates of eligibles for common positions a standard practice.
Improve Human Resources Support for Hiring Managers	The CHCO Council, OPM, CERPOs, and the Permitting Council staff need to test new HR resourcing models to implement hiring best practices and offer additional support to hiring managers.

Solutions

The six solutions described below include an explanation of the problem and key actions our signal stakeholders (Permitting Council staff, Deputy Secretaries, CERPOs, OPM, CHCOs, OMB, and Congress) can take to build permitting workforce capacity. The table in the appendix specifies the stakeholders responsible for each recommendation.

Enhance the Permitting Council’s Authority to Improve Permitting Processes and Workforce Collaboration 

Permitting process, performance, and talent management cut across agencies and their bureaus—but their work is often disaggregated by agency and sub-agency, leading to inefficient and unnecessarily discrete practices. While the Permitting Council plays a critical coordinating role, it lacks the authority and accountability to direct and guide better permitting outcomes and staffing. There is no central authority for influencing and mandating permitting performance. Agency-level CERPOs vary widely in their authority, whereas the Permitting Council is uniquely positioned for this role. Choosing to overlook this entity will lead to another interagency workaround. Congress needs to give the Permitting Council staff greater authority to improve permitting processes and workforce collaboration. 

1. Enhance Permitting Council Authority for Improved Performance: Enhance provisions in FAST-41 and IRA by passing legislation that empowers the Permitting Council staff to create and enforce consistent performance criteria for permitting outcomes, permitting process metrics, permitting talent acquisition, talent management, and permitting teams KPIs.
2. Enhance Permitting Council Authority for Interagency Coordination: Empower the Permitting Council staff to manage interagency coordination and collaboration for defining permitting best practices, establishing frameworks for permitting, and reinforcing those frameworks across agencies. Clarify the roles and responsibilities between Permitting Council staff, Deputy Secretaries, CERPOs, and the Council on Environmental Quality (CEQ).
3. Assign Responsibility for Tracking Changes and Providing Guidance for Permitting Practices: Assign the Permitting Council staff in coordination with OMB responsibility for tracking changes and providing guidance on permitting practices in response to recent and ongoing court rulings that change how permitting outcomes are determined (e.g., Loper Bright/Chevron Deference, CEQ policies, etc.).
4. Provide Permitting Council staff with Consistent Funding: Either renew components of IRA and/or IIJA funding that enables the Council to invest in agency technologies, hiring, and workforce development, or provide consistent appropriations for this.
5. Enhance CERPO Authority and Position CERPOs for Agency-Wide and Cross-Agency Permitting Actions: Expand CERPO authority beyond the FAST-41 Act to include all permitting work within their agency. Through legislation, policy, and agency-level reporting relationships (e.g., CERPO roles assigned to the Secretary’s office), provide CERPOs with clear authority and accountability for permitting performance. 

Build Efficient Permitting Teams and Standardize Roles

In our research, we interviewed one program manager who restructured their team to drive efficiency and support continuous improvement. However, this is not common. Rather, there is a lack of standardization in roles engaged in permitting teams within and across agencies, which hinders collaboration and prevents efficiencies. This is likely driven by the different roles played by agencies in permitting processes. These variances are in opposition to shared certifications and standardized job descriptions, complicate workforce planning, hinder staff training and development, and impact report consistency. The Permitting Council staff, Deputy Secretaries, CERPOs, OMB, and the CHCO Council should improve the performance and consistency of permitting processes by establishing standards in permitting team roles and configurations to support cross-agency collaboration and drive continuous improvements.

1. Characterize Types of Permitting Processes: Permitting Council staff should work with Deputy Secretaries, CERPOs, and Permitting Program Team leaders to categorize types of permitting processes based on project “footprint”, complexity, regulatory reach (i.e., regulations activated), populations affected and other criteria. Identify the range of team configurations in use for the categories of processes.  
2. Map Agency Permitting Roles: Permitting Council staff should map and clarify the roles played by each agency in permitting processes (e.g., sponsoring agency, contributing agency) to provide a foundation for understanding the types of teams employed to execute permitting processes.
3. Research and Analyze Agency Permitting Staffing: Permitting Council staff should collaborate with OMB to conduct or refine a data call on permitting staffing. Analyze the data to compare the roles and team structures that exist between and across agencies. Conduct focus groups with cross agency teams to identify consistent talent needs, team functions, and opportunities for standardization.
4. Develop Permitting Team Case Studies: Permitting Council staff should conduct research to develop a series of case studies that highlight efficient and high performing permitting team structures and processes.
5. Develop Permitting Team Models: In collaboration with Deputy Secretaries and CERPOs, Permitting Council staff should develop team models for different agency roles (i.e., sponsor, lead agency, coordinating agency) that focus on driving efficiencies through process improvements and technology, and develop guidelines for forming new permitting teams.
6. Create Permitting Job Personas: In collaboration with Deputy Secretaries and CERPOs, Permitting Council staff should develop personas to showcase the roles needed on each type of permitting team and roles, recognizing that some variance will always remain, and the type of hiring authority that should be used to acquire those roles (e.g., IPA for highly specialized needs). This should also include new roles focused on process improvements; technology and data acquisition, use, and development; and product management for efficiency, improved customer experience, and effectiveness.
7. Define Standardized Permitting Roles and Job Analyses: With the support of Deputy Secretaries and CERPOs, Permitting Council staff should identify roles that can be standardized across agencies based on the personas, and collaborate with permitting agencies to develop standard job descriptions and job analyses.
8. Develop Permitting Practice Guide: In collaboration with Deputy Secretaries and CERPOs, Permitting Council staff should develop a primer on federal permitting practices that explains how to efficiently and effectively complete permitting activities.
9. Place Organizational Strategy Fellows: Permitting Council staff should hire at least one fellow to their staff to lead this effort and coordinate/liaise between permitting teams at different agencies.
10. Mandate Permitting Hiring Forecasts: Permitting Council staff should collaborate with the CHCO Council to mandate permitting hiring forecasts annually with quarterly updates.
11. Revise Permitting Funding Requirements: Permitting Council staff should include requirements for the adoption of new team models and roles in the resources and coordination provided to permitting agencies to drive process efficiencies.

Improve Workforce Strategy, Planning, and Decisions through Quality Workforce Metrics

Agency permitting leaders and those working across agencies do not have the information to make informed workforce decisions on hiring, deployment, or workload sharing. Attempts to access accurate permitting workforce data highlighted inefficient methods for collecting, tracking, and reporting on workforce metrics across agencies. This results in a lack of transparency into the permitting workforce, data quality issues, and an opaque hiring progress. With these unknowns, it becomes difficult to prioritize agency needs and support. Permitting provided a purview into this challenge, but it is not unique to the permitting domain. OPM, OMB, the CHCO Council, and Permitting Council staff need to accurately gather and report on hiring metrics for talent surges and workforce metrics by domain.

1. Establish Permitting Workforce Data Standards: OPM should create minimum data standards for hiring and expand existing data standards to include permitting roles in employee records, starting with the Request for Personnel Action that initiates hiring (SF52). Permitting Council staff should be consulted in defining standards for the permitting workforce.
2. Mandate Agency Data Sharing: OPM and OMB should require agencies share personnel action data; this should be done automatically through APIs or a weekly data pull between existing HR systems. To enable this sharing, agencies must centralize and standardize their personnel action data from their components.
3. Create Workforce Dashboards: OPM should create domain-specific workforce dashboards based on most recent agency data and make it accessible to the relevant agencies. This should be done for the permitting workforce.
4. Mandate Permitting Hiring Forecasts: The CHCO Council should mandate permitting hiring forecasts annually with quarterly updates. This data should feed into existing agency talent management/acquisition systems to track workforce needs and support adaptive decision making.

Invest in Professional Development and Early Career Pathways

There are few early career pathways and development opportunities for personnel who engage in permitting activities. This limits agencies’ workforce capacity and extends learning curves for new staff. This results in limited applicant pools for hiring, understaffed permitting teams, and limited access to expertise. More recently, many of the roles permitting teams hired for were higher level GS positions. With a greater focus on early career pathways and development, future openings could be filled with more internal personnel. In our research, one hiring manager shared how they established an apprenticeship program for early career staff, which has led 12 interns to continue into permanent federal service positions. The Permitting Council staff, Deputy Secretaries, and CERPOs should create more development opportunities and early career pathways for civil servants.

1. Invest in Training to Upskill and Reskill Staff: The Permitting Council staff should continue investing in training and development programs (i.e., Permitting University) to upskill and reskill federal employees in critical permitting skills and knowledge. Leveraging the knowledge gained through creating standard permitting team roles and collaborating with permitting leaders, the Permitting Council staff should define critical knowledge and skills needed for permitting and offer additional training to support existing staff in building their expertise and new employees in shortening their learning curve.
2. Allocate Permitting Staff Across Offices and Regions: CERPOs and Deputy Secretaries should implement a flexible staffing model to reallocate staff to projects in different offices and regions to build their experience and skill set in key areas, where permitting work is anticipated to grow. This can also help alleviate capacity constraints on projects or in specific locations.
3. Invest in Flexible Hiring Opportunities: CERPOs and Deputy Secretaries should invest in a range of flexible hiring options, including 10-year STEM term appointments and other temporary positions, to provide staffing flexibility depending on budget and program needs. Additionally, OPM needs to redefine STEM to include technology positions that do not require a degree (e.g., Environmental Protection Specialists).
4. Establish a Permitting Apprenticeship: The Permitting Council staff should establish a 1-year apprenticeship program for early career professionals to gain on-the-job experience and learn about permitting activities. The apprenticeship should focus on common roles shared across agencies and place talent into agency positions. A rotational component could benefit participants in experiencing different types of work.

Improve and Invest in Pooled Hiring for Common Positions

Outdated and inaccurate job descriptions slow down and delay the hiring process. Further delays are often caused by the use of non-skills-based assessments, often self-assessments, which reduce the quality of the certificate list, or the list of eligible candidates given to the hiring manager. HR leaders confront barriers in the authority they have to share job announcements, position descriptions (PDs), classification determinations, and certificate lists of eligible candidates (Certs). Coupled with the above ideas on creating consistency in permitting teams and roles and better workforce data, OPM, CHCOs, OMB, Permitting Council staff, Deputy Secretaries, and CERPOs should improve and make joint announcements, shared position descriptions, assessments, and certificates of eligibles for common positions a standard practice.

1. Provide CHCOs the Delegated Authority to Share Announcements, PDs, Assessments, and Certs: OPM and OMB should lower the barriers for agencies to share key hiring elements and jointly act on common permitting positions by delegating the authority for CHCOs to work together within and across their agencies, including with the Permitting Council staff.
2. Revise Shared Certificate Policies: OPM and OMB should revise shared certificate policies to allow agencies to share certificates regardless of locations designated in the original announcement and the type of hire (temporary or permanent). They should require skills-based assessments in all pooled hiring. Additionally, OPM should streamline and clarify the process for sharing certificates across agencies. Agencies need to understand and agree to the process for selecting candidates off the certificate list.
3. Create a Government-wide Platform for Permitting Hiring Collaboration: OPM should create a platform to gather and disseminate permitting job announcements, PDs, classification determinations, job/competency evaluations, and cert. lists to support the development of consistent permitting teams and roles.
4. Pilot Sharing of Announcements, PDs, Assessments, and Certs for Common Permitting Positions: OPM and the CHCO Council should collaborate with the Permitting Council staff to select most common and consistent permitting team roles (e.g., Environmental Protection Specialist) to pilot sharing within and across agencies.
5. Track Permitting Hiring and Workforce Performance through Data Sharing and Dashboards: Permitting Council staff, Deputy Secretaries, and CERPOs should leverage the metrics (see Improve Workforce Decisions Through Quality Workforce Metrics) and data actions above to track progress and make adjustments for sharing permitting hiring actions.
6. Incorporate Shared Certificates into Performance: OPM and the CHCO Council should incorporate the use of shared certificates into the performance evaluations of HR teams within agencies.

Improve Human Resources Support for Hiring Managers

Hiring managers lack sufficient support in navigating the hiring and recruiting process due to capacity constraints. This causes delays in the hiring process, restricts the agency’s recruiting capabilities, limits the size of the applicant pools, produces low quality candidate assessments, and leads to offer declinations. The CHCO Council, OPM, CERPOs, and the Permitting Council staff need to test new HR resourcing models to implement hiring best practices and offer additional support to hiring managers.

1. Develop HR Best Practice Case Studies: OPM should conduct research to develop a series of case studies that highlight HR best practices for recruitment, performance management, hiring, and training to share with CHCOs and provide guidance for implementation.
2. Document Surge Hiring Capabilities: In collaboration, the Permitting Council staff and CERPOs should document successful surge hiring structures (e.g., strike teams), including how they are formed, how they operate, what funding is required, and where they sit within an organization, and plan to replicate them for future surge hiring.
3. Create Hiring Manager Community of Practice: In collaboration, the Permitting Council staff and Permitting Agency HR Teams with support from the CHCO Council should convene a permitting hiring manager community of practice  to share best practices, lessons learned, and opportunities for collaboration across agencies. Participants should include those who engage in hiring, specifically permitting hiring managers, HR specialists, and HR leaders.
4. Develop Permitting Talent Training for HR: OPM should collaborate with CERPOs to create a centralized training for HR professionals to learn how to hire permitting staff. This training could be embedded in the Federal HR Institute.
5. Contract HR Support for Permitting: The Permitting Council staff should create an omnibus contract for HR support across permitting agencies and coordinate with OPM to ensure the resources are allocated based on capacity needs.
6. Establish HR Strike Teams: OPM should create a strike team of HR personnel that can be detailed to agencies to support surge hiring and provide supplemental support to hiring managers.
7. Place a Permitting Council HR Fellow: The Permitting Council should place an HR professional fellow on their staff to assist permitting agencies in shared certifications and build out talent pipelines for the key roles needed in permitting teams.
8. Establish Talent Centers of Excellence: The CHCO Council should mandate the formation of a Talent Center of Excellence in each agency, which is responsible for providing training, support, and tools to hiring managers across the agency. This could include training on hiring, hiring authorities, and hiring incentives; recruitment network development; career fair support; and the development of a system to track potential candidates.

Next Steps

These recommendations aim to address talent challenges within the federal permitting ecosystem. As you can see, these issues cannot be addressed by one stakeholder, or even one agency, rather it requires effort from stakeholders across government. Collaboration between these stakeholder groups will be key to realizing sustainable permitting workforce capacity.

Improving American competitiveness, security, and prosperity depends on private and public stakeholders’ ability to responsibly site, build, and deploy proposed critical energy, infrastructure, and environmental restoration projects. Some of these projects must undergo some level of National Environmental Policy Act (NEPA) review, a process that requires federal agencies to consider the environmental impacts of their decisions. 

Technology and data play an important role in and ultimately dictate how agencies, project developers, practitioners and the public engage with NEPA processes. Unfortunately, the status quo of permitting technology falls far short of what is possible in light of existing technology. Through a workstream focused on technology and NEPA, the Federation of American Scientists (FAS) and the Environmental Policy Innovation Center (EPIC) have described how technology is currently used in permitting processes, highlighted pockets of innovation, and made recommendations for improvement. 

Key findings, described in more detail below, include: 

• Systems and digital tools play an important role at every stage of the permitting process and ultimately dictate how federal employees, permit applicants, and constituents engage with NEPA processes and related requirements.
• Developing data standards and a data fabric should be a high priority to support agency innovation and collaboration. 
• Case management systems and a cohesive NEPA database are essential for supporting policy decisions and ensuring that data generated through NEPA is reusable. 
• Product management practices can and should be applied broadly across the permitting ecosystem to identify where technology investments can yield the highest gains in productivity. 
• User research methods and investments can ensure that NEPA technology are easier for agencies, applicants, and constituents to use.

Introduction

The Federation of American Scientists (FAS) is a nonprofit, nonpartisan organization that works to embed science, technology, innovation, and experience into government and public discourse. The Environmental Policy Innovation Center (EPIC) is a nonprofit, nonpartisan organization focused on building policies that deliver spectacular improvement in the speed of environmental progress. 

FAS and EPIC have partnered to evaluate how agencies use technology in permitting processes required by NEPA. We’ve highlighted pockets of innovation, talked to stakeholders working to streamline NEPA processes, and made evidence-based recommendations for improved technology practices in government. This work has substantiated our hypothesis that technology has untapped potential to improve the efficiency and utility of NEPA processes and data. 

Here, we share challenges that surfaced through our work and actionable solutions that stakeholders can take to achieve a more effective permitting process.

Background

NEPA was designed in the 1970s to address widespread industrial contamination and habitat loss. Today, it often creates obstacles to achieving the very problems it was designed to address. This is in part because of an emphasis on adhering to an expanding list of requirements that adds to administrative burdens and encourages risk aversion. 

Digital systems and tools play an important role at every stage of the permitting process and ultimately dictate how federal employees, permit applicants, and constituents engage with NEPA processes and related requirements. From project siting and design to permit application steps and post-permit activities, agencies use digital tools for an array of tasks throughout the permitting “life-cycle”—including for things like permit data collection and application development; analysis, surveys, and impact assessments; and public comment processes and post-permit monitoring. 

Unfortunately, the current technology landscape of NEPA comprises fragmented and outdated data, sub-par tools, and insufficient accessibility.  Agencies, project developers, practitioners and the public alike should have easy access to information about proposed projects, similar previous projects, public input, and up-to-date environmental and programmatic data to design better projects. 

Our work has largely been focused on center-of-government agencies and actions agencies can take that have benefits across government. 

Key actors include: 

• The Permitting Council. Established in 2015 through the Fixing America’s Surface Transportation Act (known as FAST-41), the Permitting Council is charged with facilitating coordination of qualified infrastructure projects subject to NEPA as well as serving as a center of excellence for permitting across the federal government. Administrative functions and salaries are supported primarily by annual appropriations. Infrastructure Investment and Jobs Act (IIJA) funding enables “ongoing operation of, maintenance of, and improvements to the Federal permitting dashboard” while Inflation Reduction Act (IRA) funding supports the center of excellence and coordination functions. 
• The Council on Environmental Quality (CEQ). CEQ is an office within the Executive Office of the President established in 1969 through the National Environmental Policy Act. Executive Order 11991, issued in 1977, gave CEQ the authority to issue regulations under NEPA. However, President Trump rescinded that EO in January 2025 and issued a new Executive Order on Unleashing American Energy. This new Executive Order directs the Chair of CEQ to provide “guidance on implementing the National Environmental Policy Act…and propose rescinding CEQ’s NEPA regulations found at 40 CFR 1500 et seq.” CEQ has received annual appropriations to support staff as well as supplemental funding. The IRA provided CEQ with $32.5 million to “support environmental and climate data collection efforts and $30 million more to “support efficient and effective environmental reviews.“ 

Below, we outline key challenges identified through our work and propose actionable solutions to achieve a more efficient, effective, and transparent NEPA process.

Challenges and Solutions

Product management practices are not being applied broadly to the development of technology tools used in NEPA processes. 

Applying product management practices and frameworks has potential to drastically improve the return on investment in permitting technology and process reform.  Product managers help shepherd the concept for what a project is trying to achieve and get it to the finish line, while project managers ensure that activities are completed on time and on budget.  In a recent blog post, Jennifer Pahlka (Senior Fellow at the Federation of American Scientists and the Niskanen Center) contrasts the project and product funding models in government. Product models, executed by a team with product management skills, facilitate iterative development of software and other tools that are responsive to the needs of users. 

Throughout our work, the importance of product management as a tool for improving permitting technology has become abundantly clear; however there is substantial work to be done to institutionalize product management practices in policy, technology, procurement, and programmatic settings.

Solutions: 

• Create process maps for the permitting process – in detail – within and across agencies. Once processes are mapped, agencies can develop tailored technology solutions to alleviate identified administrative burdens by either removing, streamlining, or automating steps where possible and appropriate. As part of this process, agencies should evaluate existing software assets, use these insights to streamline approval processes, and expand access to the most critical applications.  Agencies can work independently or in collaboration to inventory their software assets. Mapping should be a collaborative, iterative effort between project leads and practitioners. Mapping leads should consider whether the co-development of user journeys with practitioners who play different roles in the permitting process, such as applicants, environmental specialists (federal employees), and public commenters, would be a useful first step to help scope the effort.
• Hire product management and customer experience specialists in strategic roles. Agencies and center of government leaders should carefully consider where product management and customer experience expertise could support innovation. For example, the Permitting Council could hire a product management specialist or customer experience expert to consult with agencies on their technology development projects. Fellowship programs like the Presidential Innovation Fellows (PIF) or U.S. Digital Corps can be leveraged to provide agencies with expertise for specific projects. 
• Strategically leverage existing product management guidance and resources. Agencies should use existing resources to support product management in government. The 18F unit, part of the General Services Administration (GSA)’s Technology Transformation Services (TTS), helps federal agencies build, share, and buy technology products. 18F offers a number of tools to support agencies with product management. GSA’s IT Modernization Centers of Excellence can support agency staff in using a product-focused approach. The Centers focused on Contact Center, Customer Experience, and Data and Analytics may be most relevant for agencies building permitting technology. In addition, the U.S. Digital Service (USDS) “collaborates with public servants throughout the government”; their staff can assist with product, strategy, and operations as well as procurement and user experience. 18F and USDS could work together to provide product management training for relevant staff at agencies with a NEPA focus. 18F or USDS could create product management guidance specifically for agencies working on permitting, expanding on the 18F Product Guide. These resources could also explore how agencies can make decisions about building or buying when developing permitting technology. Agencies can also look to the private sector and NGOs for compelling examples of product development. 
• Learn from successes at other agencies. We have written about how agencies have successfully applied product management approaches inside and outside of the NEPA space. 

Siloed, fragmented data and systems cost money and time for governments and industry

As one partner said, “NEPA is where environmental data goes to die.” Data is needed to inform both risk analysis and decisions; data can and should be reused for these purposes. However, data used and generated through the NEPA process is often siloed and can’t be meaningfully used across agencies or across similar projects. Consequently, applicants and federal employees spend time and money collecting environmental data that is not meaningfully reused in subsequent decisions.   

Solutions: 

• Develop a data fabric and taxonomy for NEPA-related data. CEQ’s Report to Congress on the Potential for Online and Digital Technologies to Address Delays in Reviews and Improve Public Accessibility and Transparency, delivered in July 2024, recommends standards that would give agencies and the public the ability to track a project from start to finish, know specifically what type of project is being proposed, and understand the complexity of that project. The federal government should pilot interagency programs to coordinate permitting data for existing and future needs. Chief Environmental Review and Permitting Officers (CERPOs) should invest in this process and engage their staff where applicable and appropriate. 
• Establish a Digital Service for the Planet to work with agencies specifically on how environmental data is collected and shared across agencies.  The Administration should create a Digital Service for the Planet (DSP) that is staffed with specialists who have prior experience working on environmental projects. The DSP should support cross-agency technology development and improve digital infrastructure to better foster collaboration and reduce duplication of federal environmental efforts to achieve a more integrated approach to technology—one that makes it easier for all stakeholders to meet environmental, health, justice, and other goals for the American people. 
• Centralize access to NEPA documents and ensure that a user-friendly platform is available to facilitate public engagement. The federal government should ensure public access to a centralized repository of NEPA documents, and a searchable, user-friendly platform to explore and analyze those documents. Efforts to develop a user friendly platform should include dedicated digital infrastructure to continually update centralized datasets and an associated dashboard. Centralizing searchable historical NEPA documents and related agency actions would make it easier for interested parties to understand the environmental assessments, analyses, and decisions that shape projects. Congress can require  and provide resources to support this, agencies can invest staff time in participation, and agency leaders can set an expectation for participation in the effort. 

Technology tools used in NEPA processes fall far short of their potential

The status quo of permitting technology falls far short of what is possible in light of existing technology. Permitting tools we identified in our inventory range widely in intended use cases and maturity levels. Opportunities exist to reduce feature fragmentation across these tools and improve the reliability of their content. Additionally, many software tools are built and used by a single agency, instead of being efficiently shared across agencies. Consequently, technology is not realizing its potential to improve environmental decision-making and mitigation through the NEPA process. 

Solutions: 

• Set more ambitious modernization goals. We have the technological capabilities to go above and beyond data fabric and taxonomy. CEQ and the Permitting Council can focus on helping agencies scale successful permitting technology projects and develop decision support tools. This could include supporting agency tools to bring e-permitting into the modern era, which speeds processing time and saves staff time. Agency tools to enhance could include USACE’s Regulatory Request System and tool for tracking wetland mitigation credits (RIBITS), USFWS’s tool for Endangered Species Act consultation (IPaC), the Permitting Council’s FAST-41 dashboard, and CEQ’s eNEPA tool. Policymakers and staff working to improve permitting technology should consider replicating the functionality of successful existing tools, and automating the determination of  “application completeness”, which has frequently been cited as a source of delays.

• Institutionalize human centered design (HCD) principles and processes. Agencies should encourage and incentivize deployment of HCD processes. The Permitting Council, GSA, and agency leadership can play a key role in institutionalizing these principles through agency guidance and staff training. Applying human-centered design can ensure thoughtful, well-designed automation of tasks that free up staff members to focus their limited time and attention on matters that need their focus and, crucially, increase the number of NEPA decisions the federal government is able to reach in a designated period of time.  
• Prioritize development of digital applications with easy-to-use forms. Application systems may look different from agency to agency depending on their specific needs, but all should prioritize easy-to-use forms, working collaboratively where applicable. Relevant HCD principles include entering data once, user-friendly templates or visual aids, and auto-populating information. Eventually, more advanced features could be incorporated into such forms—including features like AI-generated suggestions for application improvements, fast-tracking reviews for submissions that use templates, and highlighting deviations from templates for review by counsel. 
• Create better pre-design tools to give applicants more information about where they can site projects. Improved pre-design tools can help applicants anticipate components of a site that may come up in environmental reviews, such as endangered species. Examples include Vibrant Planet’s landscape resilience tool and the USFWS iPAC platform. These platforms can be developed by agencies or by private-sector and nonprofit organizations. Agencies should seek opportunities to invest in tools that meet multiple needs or provide shared services. The Permitting Council and/or CEQ could lead an interagency task force on modernizing permitting and establish a cross-agency workflow to prevent the siloing of these tools and support agencies in pursuing shared services approaches where applicable. 
• Invest in decision-support tools to better equip federal employees. Many regulators lack either the technical skillset to review projects and/or lack the confidence to efficiently and effectively review permit applications to the extent needed. Decision-support tools are needed to lay out all options that the reviewer needs to be aware of to make an informed and timely decision that isn’t based on institutional knowledge (e.g., existing categorical exclusions or nationwide permits that fit the project). These types of decision-support tools can also help create more consistency across reviews. CEQ and/or the Permitting Council could establish a cross-agency workflow to prevent siloing of these tools and support agencies in pursuing shared services approaches where applicable. 

Existing NEPA technology tools are difficult for agencies, applicants, and constituents to use 

Agencies generally do not conduct sufficient user research in the development of permitting technology. This can be because agencies do not have the resources to hire product management expertise or train staff in product management approaches. Consequently, agencies may only engage users at the very end (if at all), or not think expansively about the range of users in the development of technology for NEPA applications. Advocacy groups and permit applicants aren’t well considered as tools are being developed. As a consequence, permitting forms and other tools are insufficiently customized for their sectors and audiences.

Solutions: 

• Incorporate user research into existing projects. Agencies can build user experience activities and funding into project plans and staffing for bespoke permitting tool development. There are resources available to agencies to incorporate user research if they don’t have the talent in-house (as many don’t). These include the 18F unit, GSA’s IT Modernization Centers of Excellence, USDS, and the Presidential Innovation Fellows program. 
• Elevate case studies of agencies using user research to improve product delivery. As a center of excellence, the Permitting Council can support elevating agencies using user research. CEQ can also support sharing both challenges and opportunities across agencies. CERPOs can exchange ideas and elevate case studies to explore what is working. 
• Launch a regulatory sandbox for permitting. A sandbox would allow testing of different forms and other small interventions. The sandbox would provide an environment for intentional AB testing (e.g., test a new permitting form with ten applicants). The sandbox could be managed by the Permitting Council or another agency, but responsibility to oversee the sandbox should be contained within one single agency. This office should be empowered to offer waivers or exemptions. Ideally, a customer experience specialist would lead the activities of the sandbox. Improving forms that project proponents or public commenters might encounter during the NEPA process is  low-hanging fruit that could be a first focus area for the sandbox. Better forms would make processes simpler for applicants, but would also make it possible for agencies to receive and manage associated geospatial and environmental data with applications.

Poor understanding of the costs and benefits of NEPA processes

Costs and benefits of the federal permitting sector have to date been poorly quantified, which makes it difficult to decide where to invest in technology, process reform, talent, or a combination. Applying technology solutions in the wrong place or at the wrong time could make processes more complicated and expensive, not less. For instance, automating a process that simply should not exist would be a waste of resources. At the same time, eliminating processes that provide critical certainty and consistency for developers while delivering substantial environmental benefits would work against goals of achieving greater efficiency and effectiveness.

A more reliable, comprehensive accounting of NEPA costs and benefits will help us design solutions that cost less for taxpayers, better account for public input, and enable rapid yet responsible deployment of energy infrastructure and other critical projects. 

Solutions: 

• Equip agencies with case management systems that automatically collect  data needed for process evaluation. Case management software systems support coordination across multiple stakeholders working on a shared task (e.g., an Environmental Impact Statement). Equipping agencies with these systems would enable automatic capture of data needed to conduct rigorous cost-benefit assessments, providing researchers with rich data to study the impacts of policy interventions on staff time and document quality. Automatic data collection would  also drastically reduce the need for expensive and time-consuming retrospective data gathering and analysis efforts. and 
• Rapidly execute on a permitting research agenda to support innovation. Establishing a robust case management system may take time. In the interim, agencies, philanthropy, nonprofits, and others can undertake research projects that inform  nearer-term decisions about NEPA. Collaborations with user researchers, designers, and product managers will make this research agenda successful. Key gaps a research agenda could address include:
  •  Money and Time Federal Agencies Spend on NEPA Tasks
    • How many staff whose primary job is spent on permitting-related tasks does each agency employ at the national, region, and field levels? The study scope could start with the agencies on the Permitting Council, as they are agencies with relatively large roles in the permitting process. 
    • How do staffing levels correspond with the number and kind of permitting actions by region and field office? Sources for agency staffing data could include General Services Administration employment classifications and agency NEPA offices.
    • What is each agency’s total budget allocated for NEPA review? Do budget codes accurately reflect permitting work?
  • Research Gap 2: Private Sector Cost and Scale. The NEPA sector is larger than just the federal government. For example, private-sector consulting firms sometimes help project sponsors prepare their applications and navigate federal processes. A number of private sector entities support the permitting process through government contracts. Questions include:
    • What is the total market size of the permitting private sector (dollar amount and employees)? 
    • What percent is spent on federally mandated permits? How does this break down by task? What are the most expensive labor components and why?
  • Research Gap 3: Technology-related Costs 
    • Building on FAS and EPIC’s permitting inventory, what is the annual technology budget for each agency’s major permit tracking system? Answers to this question should include both internal and external staff costs. 
    • How many years has each system been in operation? How did the application receive initial funding (e.g., appropriation, general fund, permitting-specific budget)? This helps us know 1) which systems are likely in the most need of an upgrade and 2) how likely it is that funding will be available in the future to modernize.

Conclusion

Policymakers, agencies, and permitting stakeholders should recognize the important role that systems and digital tools play in every stage of the permitting process and take steps to ensure that these technologies meet user needs. Developing data standards and a data fabric should be a high priority to support agency innovation and collaboration, while case management systems and a cohesive NEPA database are essential for supporting policy decisions and ensuring that data generated through NEPA is reusable. Leveraging technology in the right place at the right time can support permitting innovation that improves American competitiveness, security, and prosperity.

The United States is in the midst of a once in a generation effort to rebuild its transportation and mobility systems. Through the Infrastructure Investment and Jobs Act (IIJA) of 2021, hundreds of billions of dollars of new investments are flowing into American highway, rail, transit, aviation, port, pipeline, and active transportation projects.

This transportation infrastructure will be tested by new and emerging threats ranging from increased risk of flooding and heatwaves to supply chain disruptions and cyberattacks. Citizens are also rightly demanding more from the transportation sector—enhanced safety, faster project delivery, lower costs, increased sustainability, efficiency, resiliency, and a more equitable system for all users.

Meeting this moment will require bold investments in new and emerging transportation technologies—new materials, construction techniques, operations systems, planning tools, advanced sensing, computation, and beyond. Authorized in the IIJA, the Advanced Research Projects Agency – Infrastructure (ARPA-I), a new agency within the U.S. Department of Transportation (DOT), is poised to catalyze the transportation innovation ecosystem and accelerate and commercialize essential technologies that solve persistent infrastructure problems.

To inform its research agenda, ARPA-I embarked on a National Listening Tour from September 2023 through June 2024 to gather insights from a wide range of stakeholders from across the transportation ecosystem. With convenings held in the Pacific Northwest, Southeast, Midwest, and Mid-Atlantic, the tour provided several opportunities for ARPA-I to engage with 280 leading transportation experts. The goal was to ensure that ARPA-I heard both the priorities and capabilities of a broad range of transportation and infrastructure stakeholders from across the ecosystem. Of the 280 participants, 99 (35%) were from academia; 58 (21%) were from private corporations; 42 (15%) were from policy and nonprofit organizations; 38 (14%) were from federal, state, and local transportation agencies; 37 (13%) were from startups; and 6 (2%) were financial investors. The ideas shared by these participants will help shape ARPA-I’s future research agenda and will provide a framework for the Agency’s ambitions that will be achieved in part with the participation of and input from this broad ecosystem of stakeholders.

Purpose and Organization of this Report

This report summarizes the insights collected over the course of the ARPA-I National Listening Tour in 2023 and 2024 and the inaugural ARPA-I expert community convening in Washington, DC in December 2022. Insights were gathered from 280 participants in the form of written worksheets and transcribed notes from discussions during the Workshops. The insights summarized in sections 4-7 of this report are intended to inform potential areas for future innovative advanced research and development (R&D) programs to be funded and managed by ARPA–I.

This report is organized into the following sections:

2. Laying the Groundwork for ARPA-I
3. ARPA-I National Listening Tour Overview
4. Promising Ideas for Future ARPA-I R&D Programs
5. Challenges Facing U.S. Transportation Infrastructure
6. Opportunities to Solve U.S. Transportation Infrastructure Challenges
7. Predictions for U.S. Transportation Infrastructure in 10-20 Years
8. Conclusion
9. Acknowledgements

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Laying the Groundwork for ARPA-I

In November 2021, Congress passed the Infrastructure Investment and Jobs Act (IIJA), allocating $550 billion in new funding for various programs within the U.S. Department of Transportation (DOT), including the establishment of the Advanced Research Projects Agency-Infrastructure (ARPA-I). Modeled after highly successful agencies like the Defense Advanced Research Projects Agency (DARPA) and the Advanced Research Projects Agency-Energy (ARPA-E), ARPA-I aims to address significant transportation infrastructure challenges through innovative technology solutions.

ARPA-I’s mission involves funding high-risk, high-reward next-generation innovative technologies with the potential to revolutionize U.S. transportation infrastructure. The agency aims to develop innovative solutions that reduce long-term infrastructure costs, minimize environmental impacts, enhance the safe and efficient movement of goods and people, and improve infrastructure resilience against physical and cyber threats.

To achieve its goals, ARPA-I will support projects that advance early-stage novel research with practical applications, translate conceptual technologies to prototype and testing stages, develop advanced manufacturing processes, and accelerate technological advancements in areas where industry may not invest due to technical and financial uncertainties.

ARPA-I continues a legacy of ARPAs that have delivered breakthrough innovations in a number of sectors. DARPA, established in 1958 in response to the Soviet Sputnik launch, has led to significant technological advances, including the internet, GPS, and mRNA vaccines. Inspired by DARPA’s success, the government created similar agencies for other critical sectors, including the Intelligence Advanced Research Projects Activity (IARPA), ARPA-E, and the Advanced Research Projects Agency-Health (ARPA-H). ARPA-I will adopt many of the core cultural traits and rigorous ideation processes honed by prior ARPAs to seek similar breakthroughs for the transportation infrastructure sector.

To lay the groundwork for ARPA-I’s future, the White House Office of Science and Technology Policy (OSTP) and DOT hosted an inaugural ARPA-I Summit in June 2023 during which a series of announcements were made on future ARPA-I activities. These announcements included:

• Supercharging Infrastructure R&D Made Possible by the Bipartisan Infrastructure Law Programs: ARPA-I announced plans to work with DOT program offices to develop an innovative research agenda that complements flagship investment areas in the Bipartisan Infrastructure Law, including the $5 billion Safe Streets and Roads for All program, the $8.7 billion PROTECT resilient infrastructure program, and the $7.5 billion National Electric Vehicle Infrastructure program. This research agenda will identify technical chokepoints in each domain that could be overcome through a focused R&D initiative. 

• Partnering with Communities Across the Nation: ARPA-I is launching a national listening tour with leading researchers, entrepreneurs, companies, and transportation advocates to ensure that ARPA-I reflects the priorities and capabilities of transportation and infrastructure R&D stakeholders across the ecosystem. The listening tour will begin in the Pacific Northwest and will feature locations across the country.

• Request for Information (RFI): ARPA-I invites the public and experts across a variety of modes, sectors and disciplines to provide their ideas and input on high-potential areas for ARPA-I to explore.

• Advancing the Intersection Safety Challenge: ARPA-I is highlighting the USDOT Intersection Safety Challenge, a multi-phased challenge that began with a $6 million prize competition that leveraged machine vision, sensor fusion, and real-time decision making to create safer conditions for pedestrians, cyclists, and drivers at intersections. The first phase of the Intersection Safety Challenge was initiated in 2023. It featured a number of characteristics that have been successful aspects of other ARPA program, including performance-based procurement, stage-gated programs, cross-disciplinary teams and expertise, high-impact domains and open innovation ecosystems.

Building upon the initiatives announced in June 2023, DOT has since undertaken additional efforts related to key transportation infrastructure areas. In January 2024, DOT announced the winners of the first phase of the U.S. DOT Intersection Safety Challenge, a call for opportunities “to transform roadway intersection safety by incentivizing new and emerging technologies that identify and address unsafe conditions involving vehicles, and vulnerable road users at intersections.” In February 2024, DOT announced an RFI about opportunities and challenges of artificial intelligence (AI) in transportation, along with the $15 million Complete Streets AI Initiative–a new opportunity for American small businesses to leverage advancements in AI to improve transportation. 

Since its authorization, ARPA-I has made steady progress to gather insights from across our country’s transportation infrastructure experts and is prepared for future ARPA-I projects that will be both appropriately ambitious and focused on our largest transportation problems.

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ARPA-I National Listening Tour Overview

The ARPA-I National Listening Tour was the continuation and expansion of an inaugural ARPA-I expert community convening held at DOT headquarters in Washington, DC in December 2022 titled Transportation, Mobility, and the Future of Infrastructure. The National Listening Tour stops included:

• Pacific Northwest (hosted by the University of Washington in Seattle, WA) – September 2023
• Southeast (hosted by the Georgia Institute of Technology in Atlanta, GA) – February 2024
• Midwest (hosted by Newlab in Detroit, MI) – March 2024
• Mid-Atlantic (hosted by Cornell Tech in New York, NY) – June 2024

The purpose of the ARPA-I National Listening Tour was to convene leading researchers, entrepreneurs, companies, and other transportation innovators and initiate a dialogue to ensure that ARPA-I reflects the priorities and capabilities of transportation and infrastructure R&D stakeholders across the ecosystem. 

Each Workshop followed a consistent format of plenary presentations from DOT leadership highlighting the opportunity and imperative of this community’s involvement, along with providing background on the unique cultural and structural components that set ARPA agencies up to seed breakthrough innovations, how ARPAs ideate advanced research program designs, and crucial roles that partners outside of government can participate in ARPA-I programs. 

Beyond the plenary presentations, the bulk of each Workshop consisted of breakout activities and discussions that focused on some combination of ideal future visions for what U.S. transportation infrastructure could look like in 10-20 years, the biggest problems facing U.S. transportation infrastructure, and novel technological breakthroughs and opportunities that have the potential to solve those fundamental problems.

In total, 280 transportation infrastructure experts participated in the four Workshops and the inaugural convening in Washington, DC. These experts included representatives from academia; corporations; policy and nonprofit organizations; federal, state, and local departments of transportation; venture capital (VC) and other investment firms; and startups.

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Promising Ideas for Future ARPA-I R&D Programs

While the DOT continues to engage in strategy development and seek expert inputs to help shape ARPA-I’s initial set of research priorities once fully resourced, several promising ideas were uncovered during the ARPA-I National Listening Tour. Those ideas are described below in no particular order, along with the potential impact they could have on U.S. transportation infrastructure systems at scale. These ideas are not meant to serve as a current representation of priorities or research agendas of ARPA-I, but instead as a showcase of the creative and transformative solutions that the U.S. transportation infrastructure expert community is capable of envisioning.

AI-enabled efficiency throughout the infrastructure lifecycle

One of the most pervasive challenges in U.S. transportation infrastructure is the inefficiency of current project planning, design, and construction processes. Traditional methods often involve lengthy timelines, costly overruns, and frequent delays due to a lack of coordination and integration between stakeholders, planners, and contractors. These inefficiencies contribute to significant cost burdens on public funds and delay the delivery of much-needed transportation maintenance and improvements.

To address this challenge, one concept raised during the Workshops was that of a fully integrated, AI-enhanced project planning, design, scheduling, and construction schema. This idea leverages advancements in AI and “digital twin” technologies to streamline the entire lifecycle of transportation infrastructure projects—from conception to completion. By incorporating digital twins at all scales (geographic, structural, and temporal), the solution provides a powerful opportunity.

Implementing this AI-enhanced system would significantly accelerate the delivery of transportation infrastructure projects across the U.S., reducing both project completion times and overall costs. By enabling predictive analysis and continuous optimization, it would also lead to better resource allocation, reducing material waste and minimizing environmental impact. The result would be more efficient, resilient infrastructure systems that can adapt to future demands more effectively.

Priming physical road infrastructure for a digital future 

The rigidity of traditional road infrastructure design remains a key issue contributing to inefficient traffic management, safety concerns, and costly, timely physical infrastructure adaptations. Physical road infrastructure like bike lanes, vehicle lanes, and curbs are static and not reflective of the fluid nature of transportation needs, particularly in urban environments. A suite of technologies such as AI, drones, automated systems, and sensor-equipped barriers could be used to create smart lanes and barriers that adjust according to live traffic data, weather conditions, or sudden hazards, by rerouting traffic or narrowing lanes to optimize for current conditions.

If the U.S. could develop systems like this that have been piloted in other countries (e.g., Spain), the impact on transportation infrastructure would be transformative. City planners would have the ability to program infrastructure dynamically, creating safer, more adaptive environments for cyclists and other road users. The result would be fewer accidents, better traffic management, and more efficient use of space, with the additional benefit of reducing emissions by promoting cycling over car travel. The flexible nature of this infrastructure could also support emerging technologies such as connected vehicles and autonomous driving systems and allow the U.S. to design more sustainable, future-proof cities that prioritize adaptability, safety, and user-centric design.

Automated maintenance and on-site manufacturing

ARPA-I National Listening Tour Workshop participants repeatedly raised concerns around transportation construction and repair challenges, including labor shortages, inconsistent funding, slow project timelines, inefficiencies in traditional construction methods, and high carbon emissions to these methods.

Technologies including AI, robotics, and large-scale additive manufacturing, were noted for their potential to solve these challenges when applied at scale. AI-powered systems can monitor roads and bridges in real-time, predicting failures and enabling proactive repairs. Once detected, autonomous drones and robots can perform immediate repairs, reducing downtime and keeping workers safe by eliminating the need for human intervention in unsafe environments. Simultaneously, on-site manufacturing, using 3D printing and generative design, can produce infrastructure components directly at construction sites, reducing the need for long-distance transportation and reducing carbon emissions.

These solutions, especially if applied in tandem with one another, have the potential to make infrastructure maintenance autonomous, continuous, safer, and more cost-effective. On-site manufacturing would speed up construction projects and minimize logistical challenges while reducing the substantial impact the transportation sector currently has on carbon emissions.

New and emerging alternative PNT technologies

Positioning, Navigation, and Timing (PNT) services are essential to the nation’s critical infrastructure, enabling the safe, secure, and efficient operation of transportation systems for federal, state, commercial, and private entities across the U.S., including tribal lands and territories. These services provide crucial data that supports air and maritime supply chains, freight logistics, efficient roadway operations, crash prevention, and shared road use among vehicles and pedestrians. PNT services also ensure the safety and efficiency of aviation operations. For decades, the Global Positioning System (GPS) has been the backbone of PNT, continually evolving to improve accuracy, integrity, and security while expanding its applications.

However, despite the emergence of technologies like inertial navigation systems and Light Detection and Ranging (LiDAR) to improve the reliability of PNT data, these tools still have limitations. GPS, for example, relies on satellites, making it vulnerable to space weather disturbances and adversarial actions. Additionally, GPS systems can be compromised by threats such as jamming and spoofing.

Quantum sensors offer a promising solution, providing navigation capabilities in areas where GPS signals are weak or unavailable. These sensors use the principles of quantum mechanics to measure physical properties like time, acceleration, and magnetic fields with unprecedented accuracy. Quantum clocks, for instance, provide exceptional timekeeping precision, critical for synchronizing networks and systems. Quantum inertial sensors deliver highly accurate position and velocity measurements, making them invaluable during extended periods where GPS is unavailable. Meanwhile, quantum gravimeters and quantum magnetometers, which are passive systems, can operate under all weather conditions, at any time, and in featureless terrains such as oceans. These sensors enable gravitational anomaly-aided navigation (GravNav) and magnetic anomaly-aided navigation (MagNav). They collectively offer pathways to make our PNT systems more precise, more reliable and resilient.

Repurposing transportation rights-of-way for infrastructure of the future

Another critical challenge raised throughout the Workshops was that of meeting the growing demand for electric vehicles (EVs) and the integration of modern, sustainable technologies at scale. The current network, designed for traditional internal combustion engines, lacks the infrastructure to support widespread EV adoption and smart technologies like connected and autonomous vehicles. 

One solution posed during Workshops (and as part of the White House’s Net-Zero Game Changers Initiative) is to repurpose existing transportation rights-of-way (ROWs) along highways and railroads for dual use, enabling the development of EV charging infrastructure and clean energy transmission without the need for costly land acquisition or major structural changes. With 48,000 miles of interstate highways and 140,000 miles of freight railroads, the U.S. has a vast network of ROWs that can be leveraged for new infrastructure. These ROWs can host charging stations, and in some cases, technologies like inductive charging embedded within roadways, allowing vehicles to recharge as they drive. This would make long-distance EV travel more feasible, eliminating range anxiety and encouraging broader adoption of electric vehicles. 

Technological innovations like high-voltage underground cables and modular interconnection power electronics would help ensure grid stability while integrating energy and transportation infrastructure. These tools would allow the grid to balance the energy demands of electric vehicles in real time, creating a smarter, more resilient transportation network.

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Challenges Facing U.S. Transportation Infrastructure

A portion of each Workshop breakout discussion focused on identifying the fundamental problems and challenges facing U.S. transportation infrastructure. Throughout these discussions, 353 individual responses were gathered. Themes that emerged consisted of problems related to safety, aging infrastructure and maintenance, data access and other data issues, environmental sustainability and resilience, financial constraints, operational inefficiencies related to existing structures and processes, equity and accessibility, technology adoption and scaling, energy and electrification, and community and planning challenges. Each of these broad themes that arose is broken down in further detail below.

Categories of Transportation Infrastructure Challenges 

Safety (66 mentions): Safety remains a paramount issue with transportation-related fatalities once again topping 40,000 in the U.S. during 2023. Factors raised by participants as contributing to safety risks include impaired driving, driver distractions, excessive speeds, and inadequate infrastructure accommodations for vulnerable road users like pedestrians and cyclists. Unsafe street and intersection designs were also a critical concern, described as “the majority of intersections outside of urban centers are not designed to accommodate pedestrians safely.” The rise in the size and weight of vehicles, along with the general car-centric nature of much of U.S. transportation infrastructure, were frequently noted as an impediment to pedestrian safety. Multiple participants noted that current infrastructure prioritizes vehicle speed and efficiency over driver, pedestrian, and cyclist safety.

Aging Infrastructure (56 mentions): Aging physical infrastructure continues to be a top concern for many experts. Challenges participants pointed to included failing bridges, deteriorating road conditions, and corrosion of materials, resulting in considerable maintenance backlogs. Participants also frequently pointed to outdated designs that do not accommodate modern transportation needs and struggle to adapt to contemporary demands, including electrification needs and the ability to withstand climate-related events.

Data Inadequacies (42 mentions): Many participants made reference to a significant lack of real-time and comprehensive data for the transportation planning the U.S. needs. For instance, data on pedestrian and bike activities to analyze crash risks effectively is often historic, segmented, inaccurate, and inaccessible. Data collection on vehicle collisions takes up to a year, delaying critical safety decisions. Digital infrastructure gaps were a frequent concern, noting “many areas lack the necessary digital infrastructure for modern transportation systems.” The need for better people-oriented data was also emphasized, referring specifically to data on pedestrian and cyclist movements to improve safety. 

Environmental Sustainability and Resilience (37 mentions): The transportation sector is the largest contributor (28%) to U.S. greenhouse gas emissions. Accordingly, participants called out these emissions rates, the environmental impact of larger vehicles, the carbon intensive materials and processes currently used in infrastructure construction, and the need for influencing travel behavior towards low carbon trips. Alongside sustainability concerns, infrastructure resilience was another common challenge raised.

Financial Constraints (34 mentions): According to participants, high costs associated with constructing, repairing, and maintaining transportation infrastructure limit the scope and speed of improvements. Public agencies face difficulties in efficient procurement and funding allocation, exacerbated by a backlog in maintenance and capital improvements. There were also mentions of profit-driven interests in car infrastructure, limited revenue from fares, and the need for funding catalysts and public-private collaborations.

Operational Inefficiencies (34 mentions): Operational inefficiencies were a recurring theme among discussions, specifically fragmented management with comments like “the lack of coordination between agencies results in redundant efforts.” Inefficiencies in resource utilization were highlighted along with a lack of coordination across transportation modes.

Equity and Accessibility (25 mentions): Disparities in access to transportation infrastructure affect low-income and rural communities, as well as vulnerable populations. Car-centric infrastructure impacts and social inequities are major concerns. There are also challenges related to accessibility for people with disabilities, rural area connectivity, and access to reliable wireless connectivity for digital infrastructure advancements.

Technological Integration (21 mentions): Slow adoption of new technologies and integration with legacy systems are major hurdles, with participants asserting that there is resistance to adopting new technologies in the transportation sector. Challenges with autonomous vehicle integration, maritime and port digital integration, and procurement of new technologies are significant. There is also a need for improved cybersecurity alongside digital infrastructure buildout. 

Energy and Electrification (20 mentions): Grid limitations in rural areas and the need for improved electric vehicle (EV) charging infrastructure were common among discussions around our largest transportation infrastructure challenges. Specifically, there pointing to a mismatch between the transportation sector and the electric grid, as the current grid is not designed to handle the demands of electric transportation. 

Community and Planning Issues (18 mentions): Slow community engagement processes and the need for adaptable project designs were frequently cited issues. Encouraging transit ridership and the need for inclusive transportation planning are also mentioned.

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Opportunities to Solve U.S. Transportation Infrastructure Challenges

Building upon ARPA-I National Listening Tour breakout discussion on U.S. transportation infrastructure’s biggest challenges, Workshop participants shifted their attention to solving these problems. In order to do so, they brainstormed and discussed current and coming opportunities upon which we must capitalize in order to solve our most pressing challenges highlighted in the section above. 

Throughout these discussions, 415 individual responses were gathered. Participant insights included policy suggestions, stakeholder engagement strategies, and infrastructure improvements, but the primary focus of these discussions–given ARPA-I’s scope–was on technological opportunities (accounting for 334 of the 415 responses). Key themes raised include the integration of cutting-edge technologies such as artificial intelligence (AI) and machine learning (ML) AI, sensor technology, internet of things (IoT), digital twins, and edge computing to enhance data collection, processing, and real-time decision-making. Participants also emphasized the need for interoperable systems, standardization of data, and the creation of national repositories to streamline information sharing and improve infrastructure planning.

Technology Opportunities

Given ARPA-I’s focus on technology solutions, the primary opportunity types identified throughout National Listening Tour Workshops were cross-cutting technologies, described in detail below.

Sensors and Sensor-related Technologies (71 mentions): Sensors were the most frequently cited technology opportunity to address transportation infrastructure problems including real-time detection of hazards, infrastructure wear and tear, and the need for accurate, continuous data collection. Examples of specific sensor technologies or applications included:

• Multiple sensors on new vehicles to increase accessible and real-time data
• High tech cameras to detect pedestrians and reduce the risk of accidents in urban areas
• Low-cost sensors for infrastructure condition assessment to identify early signs of infrastructure failure and reduce the risk of catastrophic failures
• Sensor systems on bridges and within technology like geosynthetics

AI and Machine Learning (AI/ML) (50 mentions): AI and ML were mentioned throughout the National Listening Tour Workshops as necessary pieces to solve complex problems related to traffic management, predictive maintenance, and autonomous vehicle operations. AI and ML can improve the accuracy of predictions, optimize system performance, and automate decision-making processes. Examples of specific types and applications include:

• AI that can model and predict behavior
• Generative AI to address the issue of unforeseen scenarios in autonomous vehicle operations by generating solutions in real-time
• AI/ML to accelerate new materials and structures
• Physics-informed AI to accurately model infrastructure impacts

Data Standardization and Management (32 mentions): One opportunity that may not have one specific technology tool to point to, but is inherently a technological opportunity, is data standardization and management. This would tackle the issue of fragmented data systems, ensuring consistency and interoperability across various modes, networks, and stakeholders. This would facilitate better decision-making and more efficient infrastructure management. Examples of specific standardizations and management tools include:

• Standardized data formats
• National data repositories to create centralized databases
• Federated data change management
• Data version control

Autonomous Vehicles (AVs) (28 mentions): Participants pointed to advancement and widespread rollout of AV technology as perhaps the biggest transformation to come in U.S. transportation systems. Achieving this maturation and scale could address the problem of human error in driving, which is a leading cause of crashes. AVs could optimize traffic flow and reduce congestion, making transportation systems both safer and more efficient. Examples of AV applications and associated technologies include:

• Dedicated AV lanes between major transportation centers
• AV-ready road network
• Fully capable and scalable AV technology

Internet of Things (IoT) (27 mentions): IoT technology can help solve the problem of disconnected systems by enabling communication between various elements of the transportation network. Participants assert it as a way to achieve real-time monitoring, improve safety, and increase efficiency. Examples of IoT applications include:

• IoT and AI integration reducing the need for hardware devices
• Leveraging IoT to reduce urban congestion by creating connected spaces that optimize mobility

Digital Twins (23 mentions): Digital twins have the potential to address inefficient planning and maintenance by providing accurate virtual representations of physical infrastructure. This would allow for better simulation, monitoring, and optimization, leading to more informed decision-making. Examples of applications from Workshop participants include:

• Digital twin immersive testing to identify potential unexpected failures before physical implementation
• Digital twins of infrastructure and traffic models to improve traffic management by simulating real-world conditions and enabling proactive responses to potential issues

Edge Computing (19 mentions): According to many participants, edge computing could completely fix the issue of latency in data processing, which is critical for applications requiring immediate responses, such as AVs and real-time traffic management systems. Examples of edge computing applications include:

• Real-time processing and decision-making
• Onboard and edge computing capabilities to enable vehicle and infrastructure to operate autonomously

Electric Vehicles (EVs) (19 mentions): Participants pointed to the readily apparent opportunity that EVs represent if the technology, costs, and infrastructure can be achieved at scale. To get to scale, it was widely acknowledged that we need more efficient EV charging experience, with infrastructure that allows for rapid charging along service areas. Another challenge for EV adoption is the need to build a widespread, reliable charging network that can meet the demands of all users, including long-haul trucks.

Modeling-related Technologies(17 mentions): Modeling technologies are essential for predicting infrastructure performance, traffic patterns, and the impact of various interventions. Examples of modeling-related technologies raised by participants were:

• Predictive modeling to optimize safety planning and real-time traffic management
• Behavioral modeling to improve AV prediction and safety

5G/6G Communication (15 mentions): Advanced communication technologies like 5G and 6G were mentioned as crucial for enabling real-time data exchange between vehicles, infrastructure, and central systems. An example is the deployment of 6G to support point-to-point communications in vehicle-to-everything (V2X) systems. Examples  of applications include:

• 6G integrated sensing and communication to provide ultra-low latency necessary for AV operations and other critical applications
• 6G support for point-to-point communications in vehicle-to-everything (V2X) systems
• Pervasive broadband and level of service

Carbon Capture Technologies (10 mentions): Carbon capture technologies are critical for reducing greenhouse gas emissions across the transportation sector. Example mentioned by participants include: 

• Carbon capture methods such as amine-based technology, solid pellets, portable units, and direct air capture
• Use renewable hydrogen to decarbonize steel production
• Apply carbon capture, utilization and storage to cement

Drones and Related Technologies (10 mentions): Workshop discussions around drones noted that they offer innovative solutions for infrastructure monitoring, logistics, and transportation management. 

• 3D mobility enhancement through drones for last-mile delivery
• Swarms of drones used for large-scale infrastructure inspection

Low Carbon-related Innovations (9 mentions): Similar to carbon capture technologies, low carbon-related innovations will be important in reducing carbon emissions. Example of technologies raised during breakout discussions include:

• Low carbon materials to reduce the carbon footprint of physical infrastructure like roads and bridges
• Energy-storing materials (multifunctional concrete)

Quantum Computing (4 mentions): Quantum computing was raised a few times throughout discussions as a means for quantum material sensor development and also quantum sensing for unprecedented precision in infrastructure monitoring.

Non-technology Opportunities

Policy suggestions: Policy-related opportunities focused on creating a supportive regulatory framework, aligning financial investments with long-term infrastructure goals, and ensuring that policies are inclusive and equitable. These policies were intended to address challenges in planning, funding, and implementing large-scale infrastructure projects. Specifically, participants discussed opportunities to craft policies to ensure that transportation investments prioritize underserved communities, addressing the problem of unequal access to transportation resources. 

Stakeholder engagement strategies: Participants emphasized the opportunity presented by involving diverse groups, particularly those traditionally underserved or impacted by infrastructure projects to raise the voices of all community members so that infrastructure development is responsive to their needs. 

Physical infrastructure improvements: Non-technology-specific infrastructure improvements highlighted throughout the Workshops included enhancing the physical aspects of transportation systems, such as road design and public transit accessibility. 

For instance, increasing the use of roundabouts can help solve the problem of high accident rates at traditional intersections. Additionally, developing complete streets infrastructure that supports all users, including pedestrians and cyclists, addresses the problem of limited accessibility and safety on roads designed primarily for vehicles.

Financial and economic strategies: Opportunities raised  centered on creating sustainable funding mechanisms for transportation infrastructure projects. These strategies address the challenges of securing adequate, long-term financing for both new projects and the maintenance of existing infrastructure. Ideas included alternative funding mechanisms such as value capture or tolling.

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Predictions for U.S. Transportation Infrastructure in 10-20 Years

One of the key criteria for any good ARPA project is that it is appropriately ambitious. To set that level of ambition, ARPA-I National Listening Tour participants were asked to make a prediction for U.S. transportation infrastructure 10-20 years from now, taking an ambitious perspective and focusing on what could be. Throughout these discussions, 291 individual predictions were gathered. Despite the wide ranging and sometimes narrowly focused predictions, continuous themes emerged to help reveal a shared vision for what participants want to see in the transportation systems of tomorrow. 

Participants frequently emphasized the importance of widespread adoption and integration of advanced technologies such as autonomous vehicles, AI-driven traffic management, and real-time data communication to create a connected and efficient transportation network. Sustainability also emerged as a central theme, with many predicting a shift toward carbon-neutral transportation systems powered by renewable energy sources. Ideas included dynamic wireless charging for electric vehicles, infrastructure embedded with carbon sequestration capabilities, and the widespread adoption of alternative fuels like hydrogen. The focus on sustainability also extended to construction practices, with participants envisioning the use of self-healing and recyclable materials to build resilient infrastructure that can adapt to climate challenges.

Equity and accessibility were also frequently mentioned, with a strong emphasis on creating a transportation system that serves everyone, regardless of location or socioeconomic status. Visions included universal Americans with Disabilities Act (ADA) compliance, free public transportation, and the development of equity-based planning tools to ensure that investments benefit all communities. The overarching ambition is to build a transportation network that is not only technologically advanced and environmentally sustainable but also inclusive and equitable, providing reliable access to mobility for all.

Categories of Predictions for U.S. Transportation Infrastructure in 10-20 years

Automation and Autonomy (36 mentions): Participants imagined a future dominated by autonomous systems, including self-driving cars, autonomous shuttles, and urban air mobility. These systems would be interconnected, allowing for seamless operation and enhanced efficiency. Ideas included autonomous vehicle fleets, virtual “rails” for guiding autonomous vehicles, and the deployment of autonomous drones for transport. The overarching vision was a transportation ecosystem where human error is minimized, and transportation becomes more efficient and safer.

Connectivity (31 mentions): Connectivity was seen as the backbone of transportation infrastructure in the future, with participants envisioning a fully interconnected system where vehicles, infrastructure, and personal devices communicate seamlessly. Advanced technologies such as quantum sensing, AI-driven traffic management, and universal communication standards were proposed to create a hyperconnected network. This would enable real-time traffic management, reduce congestion, and optimize the flow of goods and people.

Sustainability and Environmental Impact (29 mentions): Participants proposed a wide range of ideas aimed at reducing the environmental impact of transportation in the future. These included self-healing materials that extend infrastructure life and reduced emissions associated with frequent maintenance and construction, carbon sequestration integrated into construction materials, and the development of energy-generating infrastructure such as smart trails to generate energy for electric bikes. Participants also discussed the potential of dynamic wireless charging for electric vehicles and the large-scale adoption of alternative fuels, ensuring that the transportation system is not only sustainable but actively contributes to environmental restoration.

Safety (28 mentions): Safety innovations were a frequent theme, with participants proposing strategies to achieve a near-zero fatality transportation system. Ideas included expanding Vision Zero strategies, integrating AI for real-time risk detection, and deploying automated enforcement systems to prevent unsafe driving behaviors. The reimagining of urban spaces to prioritize pedestrian and cyclist safety was also highlighted, with infrastructure designed to protect the most vulnerable road users.

Climate Resilience (25 mentions): Participants emphasized the importance of building infrastructure that can withstand and adapt to the impacts of climate change. Ideas included the use of self-healing and self-sensing materials, modular designs for easier repairs and upgrades, and infrastructure that is resilient to extreme weather events. The vision was for transportation infrastructure that is not only durable but also adaptable to future climate challenges, contributing to overall climate resilience.

Equity and Accessibility (24 mentions): Ensuring equity and accessibility was a priority for participants when thinking about the future, with ideas like universal ADA compliance, free public transportation, and the development of equity-based asset management tools. The goal was to create a transportation system that serves all communities, including those that are traditionally underserved, such as rural areas and marginalized populations. 

Public Transit (22 mentions): Public transit was envisioned as a fully integrated, multimodal system that is easy to use and highly efficient. Participants proposed the elimination of car-centric roadways in urban areas, replacing them with dedicated lanes for public transit, cycling, and walking. High-speed rail development, particularly in key regions, and the expansion of micro-mobility options were also highlighted as ways to enhance last-mile connectivity and reduce reliance on personal vehicles.

Innovation and Technology Adoption (18 mentions): Participants predicted a future where technologies like AI, quantum computing, and digital twins have been adopted at scale to optimize infrastructure performance and maintenance. These technologies at scale would allow for real-time monitoring, predictive maintenance, and dynamic system adjustments, and contribute to transportation systems being more efficient, resilient, and future-proofed.

Data-driven Planning (17 mentions): Participants envisioned the use of AI for real-time data analysis, along with the establishment of national data standards to ensure seamless integration across different modes, organizations, and stakeholders. 

Policies and Partnerships (13 mentions): Despite not being the focus of ARPA-I policy and governance were mentioned as enablers for many of the ambitious future visions. Participants proposed establishing public-private partnerships to fund and manage infrastructure projects and allow for more flexible and innovative financing models. They also envisioned equity-based asset management tools and policies, increased cross-jurisdictional collaboration, and policies to set national guidelines for climate adaptation in infrastructure design and construction. 

Multimodal Mobility (11 mentions): The collective vision for mobility included creating a seamless multimodal transportation system that allows users to easily switch between different modes such as bikes, trains, and buses. Participants hope for the development of unified payment systems to enhance the user experience and reduce reliance on personal vehicles. 

Energy (10 mentions): Energy integration predictions centered on using renewable energy sources, bidirectional EV charging for grid stability, and dynamic load management systems. Overall, participants want a future where transportation systems are tightly integrated with energy networks, ensuring reliability while reducing the carbon footprint of the transportation sector.

Urban Planning (10 mentions): Urban planning-related visions included the removal of highways in cities, replacing them with green spaces, light rail, and pedestrian-friendly streets. Participants also predicted the development of high-speed rail corridors connecting major cities, reducing the need for air travel and long car journeys, and integrating land use with transportation planning for more sustainable urban growth.

Materials and Construction (10 mentions): Participants want to see increased use of self-healing and self-sensing materials to extend infrastructure lifespans by centuries. Modular construction techniques and adopting low-carbon materials were also noted as ways to reduce construction times, costs, and environmental impact.

Community and Health Impacts (7 mentions): Transportation infrastructure was envisioned by some as a tool for improving community health and well-being in the future. Ideas included designing infrastructure that supports physical and mental health, reducing the “pink tax” on transportation for women and families, and creating transportation systems that enhance social cohesion and community safety.

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Conclusion

As ARPA-I continues its mission to revolutionize transportation infrastructure, it is essential to sustain and expand the support of the transportation expert community and stakeholders across the country. ARPA-I’s success will depend on the collective effort of researchers, innovators, policymakers, and industry leaders who recognize the agency’s potential to drive breakthrough solutions. To truly tackle our biggest transportation infrastructure challenges, we must deepen our commitment to collaboration, align resources strategically, and remain focused on innovative, high-impact outcomes. The expert community should continue to engage with DOT and ARPA-I, push the boundaries of what is possible in their own work, and seek to build the support necessary to turn ARPA-I’s ambitions into reality.

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For a full list of organizers, facilitators, and participant organizations, please see the full PDF-version of the report here.

From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

The FDA holds one of the most important roles as a federal agency which is to ensure public safety when approving vaccines, medical devices, and medicines. The approval of these products usually require extensive trials with data that supports their safety and efficacy. Considering that most of these decisions are complex and multifaceted, the FDA enlists the support of Advisory Committees to assist with their decision-making process. The primary role of FDA Advisory Committee members is to provide the FDA with informed advice and recommendations on issues spanning science, regulatory policy, and the evaluation of products under the FDA’s jurisdiction. Although AdComm members serve the FDA in an advisory capacity, their recommendations are non-binding. Therefore, they do not have the final say in the regulatory approval process. 

However, over the years, it has been made evident that the public is unaware of the role of Advisory Committees and ways in which they can engage with the FDA. In this case study, FAS hopes to share the current problem and actionable recommendations to combat public misconceptions regarding FDA AdComm roles and provide guidance on increasing FDA engagement with the public and other relevant stakeholders throughout the regulatory process.

Public Awareness Problems

While AdComm members are experts in their respective fields and volunteer their time to provide advice to the FDA, there are multiple factors that must be considered before making official decisions. The recommendations provided during Advisory Committee meetings are just one aspect that is considered for regulatory decision-making and do not guarantee an official approval or denial of a product by the FDA. During AdComm meetings, the FDA allows the general public to make public comments to the Agency and the AdComm regarding the topic that is being addressed. Despite this, members of the general public have expressed that, on many occasions, they are unaware AdComm meetings are occurring. This, in effect, deprives them of the opportunity to communicate directly with the FDA and the AdComm. Additionally, they feel the FDA fails to engage them in an adequate manner, thereby limiting opportunities for participatory engagement. It has also been noted that most members of the general public are unaware FDA Advisory Committees exist; and, for those who are aware, they are unclear about the capacity of their role within the regulatory process. 

For these reasons, the FDA must take measures to enhance public understanding in an effort to combat misinformation, educate, and raise awareness on the existence of Committees and their purpose.  

Communicating AdComms to the Public

Improving Public Awareness of Advisory Committees and their Role

Improving public awareness on the existence of FDA Advisory Committees and their purpose would assist the FDA with improving public trust and debunking myths and misinformation related to the approval of medical products. Advisory committees operate as an independent party and their recommendations assist with guiding regulatory decision-making. However, their recommendations are non-binding, and FDA leadership must consider additional factors before granting approvals or denials of medical products. 

To increase public awareness on Advisory Committees, it should be made clear that AdComm recommendations are not conclusive, as the FDA considers multiple factors in its official decisions. The FDA can leverage social media platforms to increase awareness and understanding of AdComms through the use of disseminating information via the use of ads and active social media engagement. A survey conducted by Pew Research Center states that eight in ten Americans believe social media platforms are an effective way to bring awareness. In addition, disclaimers should be included on all public facing materials referencing AdComms to indicate their purpose. Clearly communicating this to the public will dispel myths that AdComms make the final call on the approvals of medical products. 

Improving Communication about Advisory Committee Meetings

Encouraging public participation for Advisory Committee meetings will help foster a collaborative and engaged general public who can contribute valuable life experience to the regulatory process. FAS has identified ways in which the FDA can better communicate with the public to inform them of Advisory Committee meetings. First, the FDA can develop a webpage that allows people to receive notifications of upcoming AdComm meetings. The FDA can also establish relationships with state and local public health agencies, as well as advocacy organizations to spread awareness. Through these relationships, the various agencies and organizations can use their networks to disseminate widespread information on AdComm meetings. Public health agencies and advocacy organizations can gauge the best ways in which these communities would like the FDA to engage with them. This understanding of the communities they serve makes them an ideal partner for fostering continuous engagement.  

Policy Recommendations

In an effort to improve public awareness and understanding of AdComms, the potential policy recommendations are as follows: 

• FDA can leverage social media platforms to increase awareness and understanding of AdComms through the use of disseminating information (e.g., engagement, ads, etc.)
• FDA should include a disclaimer on all communications and marketing materials regarding AdComms
  • These disclaimers should be made at all public meetings
  • Disclaimers should emphasize the purpose of AdComm votes. Disclaimers should state that votes allow AdComm members to provide an official stance to the FDA as experts, but votes are non-binding.
• Develop a webpage that allows people to be placed on a listserv regarding upcoming meetings
• Partner with state and local public health agencies and advocacy organizations to spread awareness

Conclusion

Advisory Committees are essential to the FDA regulatory decision-making process. It’s imperative that their role is understood by them and the general public to best move the needle forward. While the FDA currently allows the public to provide public comment at Committee meetings, that alone cannot be considered engaging the community. The FDA must create new opportunities for interpersonal communication which will create an environment of mutual trust and understanding between both parties.

From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

The regulation of medical products is the responsibility of the Food and Drug Administration (FDA). To ensure effective decision-making regarding these products, the FDA recognizes the importance of patient advocacy and the perspectives of patients. In 1988, the FDA initiated the patient engagement process through the Office of Aids Coordination, and within five years, the first patient representative was appointed to an FDA Advisory Committee. Since then, the FDA has significantly enhanced its methods of engaging patients, caregivers, and patient advocates. This includes the establishment of various offices, programs, collaboratives, listening sessions, public guidance, and more.

The Evolution of Patient Engagement at the FDA

The FDA employs several avenues to engage patients in the regulatory process. Some avenues include the Patient Engagement Advisory Committee (PEAC), public comment, the Patient Focused Drug Development Initiative (PFDD), the Patient Listening Session Program, Patient Engagement Collaborative (PEC), and the Patient Representative Program (PRP). This list does not cover all the ways in which the FDA engages patients and advocates but provides an overview of the key operations involved in patient engagement efforts. 

The Patient Engagement Advisory Committee is the only Committee that is completely composed of caregivers, patients, and patient representatives from various organizations, as a way to ensure that the lived experiences of these populations and their opinions are included in the deliberations and regulatory decision-making of medical products. Public comment is a requirement by law for federal agencies, allowing the public to provide feedback on proposed actions or new rules and regulations. Public comment is also sought during Advisory Committee meetings to gather information and perspectives from the public. PFDD meetings provide a platform for the FDA to obtain insights from patients on specific diseases and their treatments. To identify the issues most important to patients, the FDA has a series of guidance documents that are used specifically for PFDD meetings. 

The Patient Listening Session Program facilitates informal meetings between patients, their representatives, and FDA staff. These sessions cover a range of topics, including treatment preferences, quality of life, unmet medical needs, and the impact of diseases and their symptoms. The PEC offers a forum for patients, caregivers, and advocates to discuss patient engagement operations. Lastly, the PRP allows patients, caregivers, and advocates who serve as special government employees the opportunity to provide advice to the FDA’s Commissioner or a designated representative on matters related to medical devices and their regulation.

Although there are various avenues for patient engagement and advocacy participation in the medical product regulation process, there are also ways in which these avenues can be expanded or improved.   

Patient Advocacy Problems

For many years, patients and their caregivers have not seen significant or sustainable treatments that have been developed to treat many illnesses and diseases. Some treatments have proven to be ineffective yet still made it to market approval. On the other hand, there are treatments that met safety and efficacy standards but were not approved. There are also those treatments that are simply not affordable to the populations that need them most. In many of these scenarios, the patient representative voice was lost as they did not have the option to express their concerns or perspectives on certain treatments with decision makers. This further confirms that the role of patient advocacy and allowing space for the patient representative voice is crucial to the regulation process of medical products. 

At the moment, the patient voice is not always heard because there are some FDA Advisory Committees that do not have a patient representative.

While the role of patient advocacy is crucial, it is important to note there should be boundaries in which patient perspective is considered for decision-making. Although patients and their advocates seek treatments that better address their needs, this desire can sometimes obscure their judgment concerning long-term treatment effectiveness. Frequently, patients and their supporters present powerful arguments to Advisory Committees and the FDA for approval of particular medical products which can lead to expedited medical product approval in the absence of supportive evidence. 

The endorsement of eteplirsen, which was intended for the treatment of Duchenne muscular dystrophy (DMD), illustrates this point. Despite a 7 to 3 vote by the FDA’s Advisory Committee against approval due to insufficient evidence of its benefits, opposition from the FDA’s Center for Drug Evaluation and Research’s former leader resulted in the drug’s authorization. This sparked substantial internal and public criticism and led Dr. Ellis Unger from the FDA’s Office of Drug Evaluation to challenge the approval decision. Dr. Unger emphasized that “patient-focused drug development is about listening to patient perspectives about what matters to them; it is not about basing drug approvals on anecdotal testimony that is not corroborated by data.”

This approval was perceived by many as having been heavily influenced by patient advocacy and raised concerns about potential long-term implications for patient health. It also signaled a need to further examine both patient education and the appropriate limits of patient involvement in the regulatory process. This could have been mitigated had there been a list of criteria in place to be followed for public comment. 

Incorporating Patient Perspectives

The Food and Drug Administration (FDA) is committed to understanding the balance of benefits and risks acceptable to patients as they relate to medical products. The FDA defines the role of patient representatives that serve on Advisory Committees as “Special Government Employees” who provide direct input to agency staff and share valuable insight on their experiences with various diseases, conditions, and devices while gaining access to confidential information. These representatives are selected by the FDA to serve on Advisory Committees using a specific set of criteria including, but not limited to: 

• “Personal experience with the disease either as a patient or primary caregiver”
• “Knowledge about most treatment options and research for their areas of experience they are representing”
• “Impartiality and compliance with Federal ethics requirements (for example, financial interest, such as stock, in companies that may be affected by FDA decisions)”

This criteria ensures the FDA will understand the patient perspective as it relates to various medical products and ensures those selected to serve on Advisory Committees are knowledgeable about the areas in which they are aiming to provide guidance. Currently, there are some FDA Advisory Committees that do not have a patient representative. Further, the patient representatives serving on committees do not always have voting privileges. The absence of consistent voting privileges for some patient representatives on Advisory Committees and not having a standing patient representative on all committees hinders these individuals from providing an official stance on behalf of the community they represent. Additionally, public comment plays a significant role at Advisory Committee meetings by permitting individuals—including patients, caregivers, and advocacy organizations—to highlight concerns and propose solutions that may not have been previously considered by decision-makers. This process also helps the committee and agency gauge patient acceptance or opposition related to medical products, thereby enhancing their ability to make decisions that more accurately reflect public needs. 

When Sarepta was seeking approval of eteplirsen for the treatment of DMD, a patient advocacy organization brought hundreds of patients, caregivers, and other advocates to the Advisory Committee convening so they could make a public comment to the Committee and the agency. Shortly after, the drug received a swift approval. Although it presented much controversy within the agency and the public, it showed how influential patient advocacy can be. Personal lived experiences, compelling stories of debilitating illnesses, and experiences with current treatment have the ability to impact regulatory decision-making. 

The role of patient advocacy continues to be important in the Advisory Committee process and FDA regulatory decision-making process because it is crucial to assisting with decisions that affect the American public. Patient advocacy can be presented in the form of patient representatives that serve on Advisory Committees, those who make public comments during Advisory Committee convenings, and various outreach programs by advocacy organizations. The role of advocacy gives patients and caregivers support, promotes and protects their rights, and allows broader visibility for the issues that are most important to them. All of these avenues for patient perspective are important to understand how treatments perform, the current needs of the patient population, and how to tailor care for these populations by truly understanding their condition, diagnosis, and current management. Therefore, their voice is critical to truly understanding how various medical products will benefit their population, how they will access and afford these products, and how they will fill an unmet medical need.

Policy Recommendations

In an effort to better leverage Advisory Committee membership, the potential policy recommendations are as follows: 

• Dedicate staff to identifying crucial public comments from patient advocates that should be considered for regulatory decision-making
• Include a patient representative on all committees that are reviewing medical products
  • If possible, ensure that patient representatives selected have basic knowledge of the federal regulation process 
• Establish criteria for which all public comments must abide by
  • This can be done by creating a checklist for the public to review and consider before forming their comment and that clearly delineates the mandatory criteria that a medical product must meet to be considered for approval
  • A disclaimer can also be added to state that there is a specific threshold or sample size of a population who must benefit from the medical product
• Promote patient focused medical product development through the use of incorporating patient perspectives into the life cycle of the regulatory process
  • This can be done through hosting patient town hall discussions for areas such as rare diseases and expanding initiatives such as the Patient Focused Drug Development (PFDD) public meetings
  • Make patient engagement ongoing, rather than only allowing patient engagement quarterly or annually as done with most FDA-led programs and initiatives

Conclusion

The landscape of disease burden and associated symptoms is ever-evolving. To ensure the FDA is best prepared for this changing landscape, patient advocacy and amplifying the patient voice should be considered vital to the development and regulation of medical products. Involving those who are the most impacted by these products is essential. The FDA can further promote the patient perspective and advance patient-centered health through incorporating patient representatives on all Committees that are reviewing medical products, making patient engagement an ongoing process, hosting town halls for patients to allow a broader audience the opportunity to voice opinions, and having dedicated staff to sort through public comments from patients.

From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

The FDA relies on its scientific staff and Advisory Committees to provide conclusions from trial and study data, which aid in the process of regulating and approving medical products. However, there are instances when disagreements arise between the agency’s scientists, statisticians, Advisory Committees, and leadership on the accelerated or full approval of medical products. The resolution of these disagreements present a growing concern about FDA leadership overruling the expert opinions of scientific staff and proceeding with official approvals, thus undermining staff expertise, decreasing agency morale, and potentially diminishing public trust.

When Disagreements Between FDA and AdComms Arise 

The Federal Advisory Committee Act governs the FDA’s Advisory Committees and establishes a process in which the FDA can seek expert advice on various issues related to science, regulatory policy, and the evaluation of products under the FDA’s jurisdiction. When the FDA has differing opinions on safety and efficacy requirements of medical products, certain products may be referred to an Advisory Committee for further data review by an impartial entity. To aid in this matter, the FDA has developed guidance detailing the process for assembling Advisory Committees. Since the resources required for convening these committees are significant, the FDA ensures there is substantial uncertainty or disagreement regarding the data. Advisory Committees will discuss the evidence and provide feedback with the goal of producing the most optimal evidence-based resolution. This part of the regulatory process is crucial to the agency’s regulatory decision-making as it involves unbiased parties and leads to transparency, upholding public safety, and maintaining public trust. However, there are times that FDA leadership disagrees with the votes of their Committees and proceeds with controversial approvals. One example of this scenario was approval of the drug Aduhelm. Aduhelm, which was marketed as a treatment for Alzheimer’s, received an overwhelmingly negative vote from the Advisory Committee to move forward with its approval for market distribution. Ten of eleven Committee members stated the data did not support adequate efficacy for approval. Nonetheless, the FDA granted accelerated approval, sparking resignations from a third of their Committee and outrage amongst the public. This disregard for expert opinion was viewed as the FDA exhibiting an approval bias, a perspective the public currently maintains of the FDA. 

In 2023, various organizations and coalitions, such as Doctors for America, Jacob’s Institute of Women’s Health, National Center for Health Research, TMJ Association and more publicly expressed concerns regarding the FDA’s leadership and their approach to drug approvals through a letter addressed to the FDA’s Chief Scientist, Dr. Namandje N. Bumpus. They highlighted FDA leadership had ignored claims by scientific staff that safety and efficacy standards were not being met for the drug Elevidys. Manufactured by Sarepta Therapeutics, Elevidys was granted accelerated approval by FDA leadership. Dr. Bumpus responded to this letter defending the FDA’s approval of Elevidys by referring to the agency’s comprehensive review of the data and consideration of the potential risks of the approved treatment, nature of the disease and its impact on patients, and the limited amount of therapies available. However, the response did little to quell public scrutiny of the controversial approval. Critics were apt to point out that the FDA had a record of approving products in this manner. Years prior, the FDA had approved the drug Eteplirsen for the treatment of duchenne muscular dystrophy (DMD), despite the objections of their scientific staff which disclosed a lack of evidence for the efficacy of this treatment. Criticism was also directed at FDA leadership suggesting the approval of some medical products were potentially due to favoritism toward companies seeking approval.

Resolving Internal FDA Disagreements

While it is acknowledged that the FDA must consider technological and political implications alongside scientific evidence in decision-making, it is essential to address the concerns of these organizations and coalitions. As part of an ongoing project to reform the FDA’s Advisory Committee system and assist the FDA with getting the advice needed to make the best evidence-based decisions, FAS engaged in discussions with current and former Advisory Committee members to seek their input on resolving disagreements between FDA staff and leadership. These conversations highlighted the breach of trust between the FDA, its staff, and the public.

Quotes from Experts

“FDA leadership needs to make is clear what data was used and why they’re moving forward when there is opposition”

“Disagreements should be addressed by a non-biased source because it affects the public safety.”

“There will be times where there are disagreements between staff and leadership. However, there’s a critical need for transparency within the FDA about why decisions are made. These are not decisions about evidence only. Ever.”

“Disagreements should be a matter of public scrutiny. There should be transparency that doesn’t jeopardize confidentiality.”

The FDA’s Commissioner has acknowledged the lack of trust within the institution and expressed a commitment to address the issue. There are many reasons for the lack of trust. However, one reason stems from the FDA’s approval of medical products despite clear opposition from its scientists and sometimes Advisory Committee members.

This raises the question of how the FDA intends to address these internal disagreements, which have the potential to impact the health and safety of the American public. Currently, the FDA has implemented a program called Scientific Dispute Resolution (SDR) to handle such conflicts. This document was initially developed in 2009 and recently updated in 2021 with the purpose of outlining the process for communication regarding internal scientific disputes within FDA Centers. It defines scientific disputes as disagreements that arise from the interpretation of science and the resulting decisions. This definition clearly distinguishes the circumstances in which the guidance should be utilized to resolve discrepancies between FDA scientists, statisticians, and their respective Center leadership. The guidance offers valuable examples of best practices for resolving formal and informal scientific disputes within the agency. Some of those best practices include, but are not limited to: 

• Centers employing various mechanisms to disseminate dispute resolution Standard Operating Procedures (SOPs) to employees.
• Requiring Center SOPs for dispute resolution to clearly state that written documentation is the only avenue in which a formal dispute can be triggered (this step ensures appropriate historical documentation).
• Developing several avenues to address scientific issues through the use of regulatory briefings, advisory committees, internal discussions with Center Directors, standing subject matter committees, and multi-disciplinary teams. 

However, it should be noted these best practice recommendations are not obligatory and their adoption is left to the discretion of the individual Centers. Furthermore, the document provides a process by which any of the internal parties involved can appeal the resolution of their dispute if they find it unsatisfactory through the Office of Research  Integrity at Health & Human Services (HHS).

Policy Recommendations

To increase morale and improve the approach and resolution of internal disagreements within the agency, the policy recommendations are as follows:

1. Ensure that all FDA staff and leadership are fully cognizant of the existence and details of the Scientific Dispute Resolution at FDA guidance and the process for submitting disputes for review.
2. Incorporate the Scientific Dispute Resolution at FDA guidance into FDA regulations
   1. Note: To incorporate this guidance into FDA regulations, the FDA will propose the regulation for OMB review. OMB will review and open the regulation up for public comment through the Federal Register. Responses to comments will be developed, and a final draft submitted to OMB for review. If approved, the final regulation will be published in the Code of Federal Regulations (Congressional Research Service, 2013). The involvement of Congress will not be necessary.
3. Amend the Scientific Dispute Resolution at FDA guidance to dictate the mandatory execution of best practices within the dispute resolution process.
   1. This guidance should identify additional non-biased parties (that may not be government-affiliated) to provide impartial guidance on complex scientific matters affecting public safety. 
4. Develop guidance that clearly explains a transparent process to communicate effectively with AdComm members regarding decision making when parties have opposing viewpoints
   1. Implementing a transparent process to communicate with AdComm members regarding differences between the agency and the AdComm will assist in improving morale between both parties, but also encourage continued support of the AdComm.
   2. This recommendation is also supported by a survey conducted by 3D Communications with 400+ AdComm members where 94% of members concurred that the FDA should develop a process to communicate their reasoning for decisions in opposition to Committee recommendations (3D Communications, 2024).

Conclusion

While FDA leadership ultimately holds the authority to grant approvals, it is crucial that the perspectives of all experts are duly considered. This includes the valuable input from the agency’s scientists, statisticians, and advisory committees. To regain public trust and restore integrity, it is imperative to first rebuild trust internally among the dedicated public servants within the FDA. Adoption of the aforementioned recommendations would start the trust-rebuilding process and lead to increased safety and precaution measures when approving drugs and medical devices.

From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

The FDA relies on its scientific staff and Advisory Committees to provide conclusions from trial and study data, which aid in the process of regulating and approving medical products. Discussions have been centered around how to appropriately leverage the membership of Advisory Committee experts to assist with areas of difficulty surrounding the safety and efficacy of medical products. Nonetheless, the methods by which these systems currently generate the evidence the Government needs can be improved. This case study focuses on five key areas we believe can assist in fully utilizing the capacity in which AdComms serve and improve overall engagement with AdComms membership.

AdComm Membership Problems

Advisory Committees serve as the core for expert engagement in the Food and Drug Administration’s (FDA) decision-making processes and are composed of medical professionals, industry representatives, patient advocates, and scientific experts. Their primary role is to provide the FDA with informed advice and recommendations on issues spanning science, regulatory policy, and the evaluation of products under the FDA’s jurisdiction.

The intricacies of being an effective AdComm member, however, have been somewhat overlooked. Conversations with current and ex-members have highlighted areas for enhancement that would strengthen the function of AdComms and enrich the advice provided. Feedback indicated a lack of transparency in the FDA’s recruitment methods for committee positions, insufficient orientation or training for new members, limited understanding of regulatory procedures among members, and an onerous conflict of interest protocol that served as a deterrent for some members who were asked to return or renew their membership. 

Pathways to Improving AdComms Membership

Committee Composition

The composition of Advisory Committees vary depending on the charter that has been set in place. In some cases, committee composition has been set by law. However, where there is flexibility in determining the composition of a committee, consideration should be given to all categories of expertise that should be included and diversity of voices that are selected to participate in these meetings. Committee composition should reflect the diversity of the world and populations of whom their recommendations could potentially affect. For this reason, discussions with current and former Advisory Committee members indicated the need for three additional areas of expertise that should be included on all Committees. Insights discovered that all Committees should include a patient representative who has the knowledge from lived experience and understanding of how treatments affect day-to-day life. This recommendation was further corroborated by a 3D Communications survey conducted with 400+ FDA AdComm members where results indicated that 48% agreed there should be a patient and consumer representative on all Committees. Members also stated that pharmacists should be included because drugs and devices eventually pass through their hands to give to patients. Pharmacologists should serve on the Committee due to their clinical application knowledge of drugs and devices. Finally, a roster of temporary members should be created for varying categories to use when additional expertise is needed on a Committee because of a conflict of interest or when a certain skillset or knowledge base is lacking on the current Committee. 

Role of the Advisory Committee Chair

The FDA describes the purpose of an Advisory Committee chair as one who will “preside at committee meetings and ensure that all rules of order and conduct are maintained during each session”. The chair also has the responsibility of ensuring all recommendations and advice from AdComm members are clear and evidence-based. Moreover, the role of the chair should be used to enhance the overall committee experience as well as be of service to the FDA. Despite these requirements, there’s an underutilization of the chair’s role in terms of communication and stakeholder coordination, as evidenced by the chair not being listed as a primary point of contact for the Advisory Committee and a lack of coordination amongst stakeholders.

Chairpersons are usually selected due to their critical domain knowledge, understanding of best practices, ability to identify risks and keep members engaged, and expansive relationships within their industry. Maximizing the chairperson’s role requires discussion on how to utilize their valuable domain knowledge and professional networks. Chairs possess extensive networks that could support the identification of permanent or temporary expert participants for AdComms, aiding the FDA’s mission to recruit top talent for guidance. This would ensure the FDA’s continued success in recruiting the brightest minds in the industry to assist with providing advice. Additionally, chairs should have oversight in identifying relevant issues or products for their respective committees to appraise, which can provide another layer for the FDA to keep abreast of critical public concerns via appropriate committee evaluation. 

Training

Training is a significant part of many Federal Government service positions. However, besides ethics and conflict of interest trainings, there is no set training program in place for most new Advisory Committee members. Considering Advisory Committee members come from different professional backgrounds with varying levels of expertise, the FDA should develop an onboarding training program to assist with acclimating all new AdComm members into their roles. Many former and current AdComm members mentioned that no formal training was provided as part of the onboarding process. Some members who were new to the FDA AdComm process or who were not physicians or scientists stated they had no knowledge of statistical analyses, clinical trial design, or how the FDA views the role of the AdComm in the regulatory process. 

A foundational training, covering these aspects, would greatly benefit those members such as consumer and patient representatives who may lack this shared base of expertise. An investment in such an onboarding experience would promote stronger rapport among members and guarantee their preparedness in analyzing scientific and technical submissions.

Quotes from the Committee

“There should be basic training for all laypeople on the committee. This would help to prepare them for fulfilling their duties.”

“There should be an orientation that explains the relationship between the advisory committee and the FDA, and how the FDA thinks about this process.”

Learning about the FDA Regulatory Process

The Food & Drug Administration (FDA) was established with the purpose of regulating drugs and medical devices to ensure their safety and effectiveness for all citizens in the United States. Many Advisory Committee members join these committees without basic knowledge of the FDA’s regulatory process. During FAS’ discussions with current and former AdComm members, approximately 71% of members stated that basic knowledge of the regulatory process and how the FDA makes their decisions was unknown to them.

Providing AdComm members with an introductory course on the FDA’s regulatory process could enhance their comprehension, potentially allowing them to make more effective contributions and informed clinical decisions (based on their occupation). Although the FDA provides some online resources about its processes, like FAQs and guidelines, an expansion of this material should be considered for inclusion in AdComm orientation activities.  

Conflict of Interest (COI) Process

18 U.S.C. 208(a) prohibits Advisory Committee members who are designated as special government employees (SGE) from serving on federal advisory committees or any other Federal Government form of service that will have a “direct or predictable effect” on their financial interests. Similarly, the FDA describes a conflict of interest as an occurrence “when an individual selected to serve on an advisory committee has financial interests that may be impacted by the individual’s work on the advisory committee”. The auditing process for conflicts of interest is designed to confirm that the members of the advisory committee maintain impartiality and ensure the integrity of public health safety. Prior to any committee gathering, the FDA mandates that each participant, classified as either an AdComm member or SGE, complete an FDA 3410 form that reveals all financial connections that could be seen as potential COIs.

However, the process of what happens after the 3410 form has been completed is ambiguous. In 2007, the FDA submitted draft guidance to the federal register for comment entitled, Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees in an effort to determine if there is an inappropriate COI that should exclude members from participating in a committee meeting. Moreover, the official guidance is not easily accessible. Another draft guidance was developed with a detailed listing of considerations to be given when examining conflict of interests can be found in the FDA’s draft guidance on Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees.

Discussions with current and former AdComm members about the COI auditing process sparked varying views regarding whether flexibility should be exercised for COIs. 82% of members concurred that while they recognize the necessity for such a system, it tends to be overly demanding due to repetitive paperwork, especially when their circumstances remain unchanged. The strenuous nature of this routine has even deterred some from continuing their membership each year and remains a key aspect as to why members choose to end their service.

Despite having a COI process in place, there are loopholes that allow members with conflicts of interest to remain as voting members for specific AdComm meetings. A certain incident involved an Advisory Committee where 10 members who had financial ties to the sponsor were allowed to participate in an AdComm meeting. These individuals ultimately took part in endorsing the TriClip G4 System by Abbott and unanimously agreed that its benefits outweighed the potential risks. To further complicate matters, this information was not disclosed to the public at the time of approval.

While the COI process has resulted in members being rightfully disqualified from meetings due to actual or apparent conflicts, there is room to refine how these conflicts are identified and the standards employed to judge permissible COIs.

Policy Recommendations

In an effort to better leverage Advisory Committee membership, the potential policy recommendations are as follows:

Committee Composition

• If there is flexibility and committee composition is not bound by law, include a patient representative and pharmacist and/or pharmacologist on each Committee
  • Patient representatives provide a needed perspective due to lived experiences and understanding of how specific drugs and devices affect their day-to-day life
  • Drugs and devices will usually pass through the hands of pharmacists and pharmacologists. Therefore, they should have the opportunity to serve on these Committees and provide feedback. Pharmacologists also understand the clinical application of drugs. 
  • Develop a register of temporary members that can be utilized when additional expertise is needed for Committee meetings or when there is a conflict of interest (COI)

Role of the Chair

• Expand the role of the Committee chair that will encompass the task of recruiting both standing and ad hoc members, as well as identifying prominent issues and products for Committee consideration, thereby allowing for specialized input from their Committee  

Training and Regulatory Process

• Institute a basic 101 training for all newly appointed Advisory Committee members that covers statistical analysis, clinical trial design, and elucidates the partnership between the FDA and AdComm 
• Include an overview of the regulatory process and how the FDA’s decision-making process is performed

COI Auditing Process

• Develop a process that can quickly replace individuals who have a known conflict of interest
• Clearly delineate criteria for committee service acceptance regarding individuals with potential or actual conflicts of interest
• Streamline the COI process to prevent duplicative work that may act as a deterrent to experts volunteering to serve on the AdComm (work with GSA on this matter if necessary)

Conclusion

Advisory Committees are pivotal to maintaining trust with the public. It is essential for public safety to ensure that the most qualified experts are selected to serve on these Committees and that they have the tools to provide the FDA with informed and evidence-based recommendations. In an effort to increase public health safety, the FDA should enhance the AdComm structure by expanding the chair’s role, creating training programs for all new Advisory Committee members, and revising the conflict of interest procedures.

From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former Advisory Committee (AdComm) members. Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case study format detailing the recurring themes that emerged and policy recommendations for improvement.

Advisory Committees (AdComms) serve as the core for expert engagement in the Food and Drug Administration’s (FDA) decision-making processes. These committees are composed of medical professionals, industry representatives, patient advocates, and scientific experts. Their primary role is to provide the FDA with informed advice and recommendations on issues spanning science, regulatory policy, and the evaluation of products under the FDA’s jurisdiction. Public meetings led by the FDA with these committees are instrumental in facilitating transparent deliberation between the FDA, the advisory body, and the American public. This practice helps to cultivate a collaborative environment between the FDA, the AdComms, and the public. AdComm recommendations are integral to strengthening public trust and reinforcing the FDA’s credibility. This relationship is corroborated by aligning the counsel of these independent entities with the FDA’s regulatory actions.

Key Problems Facing Advisory Committees

A critical component of the AdComm structure is its voting mechanism, a method by which hand-selected experts offer expert advice or recommendations on questions that have been proposed by the FDA to assist with informing its formal, regulatory decision-making. These questions include a broad range of topics, from evaluating post-market safety data to assessing pre-market product risks and benefits, and gauging whether a product should be approved or withdrawn from the market. The outcomes of the votes serve as barometers for the AdComms official stance on products and provide the FDA with a comprehensive and collective viewpoint. However, the recommendations proposed by AdComms are suggestive rather than prescriptive; ultimately, leaving the final decision to FDA leadership. 

Recent patterns indicate a reduction in the convening of AdComm meetings. In 2010, 55% of FDA-approved drugs were referred to an advisory committee. By 2021, the percentage of FDA-approved drugs with an advisory committee referral had dropped to 6%. The decline of meetings eliminates opportunities for evidence-based evaluation and deliberation that could potentially affect the health and well-being of Americans. Furthermore, the diminishing of these crucial interactions between the FDA, AdComms and the public exacerbates the lack of trust and erodes transparency. Interestingly, while most committees present definitive votes that are supported by explicit justifications for either approving or rejecting items under review, FDA Commissioner Robert Califf has suggested in multiple interviews that AC votes can be useful but are not mandatory for every meeting. This viewpoint raises concerns about the potential removal of voting from the reform agenda, which could undermine AdComms capacity to evaluate intricate topics that affect the American public consumer base. In addition, a survey conducted by 3D Communications with 400+ current and former AdComm members asked about the importance of voting. Results showed that 95% of AdComm members believe that voting should be retained when reviewing the benefits and risks of medical products. Reform discussions have materialized due to these factors, in addition to the FDA’s accelerated approval of Adulhelm (aducanumab) despite clear AdComm opposition. Demand for reform is inevitable and many are urging for there to be an increased number of AC meetings and a thorough reorganization of advisory committee operations and voting protocols. Such reform is not only administrative but also symbolic. This type of reform confirms that decisions affecting public health should be informed and shaped by multidisciplinary expertise. Additionally, it re-establishes the pivotal role of public input in regulatory affairs, which is an indispensable component to maintaining the American public’s trust.

Significance of AdComm Voting

In response to this call for AdComm reform, a project spearheaded by FAS has sought feedback from AdComm members regarding their views on the significance of voting. The intention of engagement is to understand members’ experiences as experts and their perspectives on voting by asking the following questions:

• Describe your Advisory Committee’s voting process.
• On a 1-5 scale, how crucial is it for you to vote on products?

These questions aimed to measure the variability in voting mechanisms across committees and the value members place on voting. Results from 30 participants demonstrate a consensus on the critical role of voting in formulating committee recommendations, with 87% of committee members indicating a five (very important) as their stance on the importance of voting.

Policy Recommendations

To uphold the FDA’s integrity and regain public confidence, retaining voting at AdComm meetings is essential in addition to other recommendations to enhance the advisory committee process. The recommendations are as follows: 

• Maintain voting as an integral function, allowing FDA Advisory Committee members to convey their collective expertise and advice, aiding the FDA in informed decision-making on scientific and regulatory matters. 
• Revise the guidance for FDA Advisory Committee Members and FDA Staff to explicitly define circumstances for which voting should occur, eliminate sequential voting

Conclusion

The recommendations of FDA Advisory Committee members are a pivotal component to the FDA’s regulatory decision-making process. Maintaining the voting protocol for Advisory Committee meetings is essential as members strive toward the continued provision of precise, impartial, and evidence-based counsel to the FDA. This voting mechanism guarantees the inclusion of each member’s perspective and ensures that an official committee stance is taken, offering the FDA definitive and straightforward guidance.

Policy entrepreneurs inside and outside of government, as well as other stakeholders and advocates, are often interested in expanding the use of effective methods across many or all federal agencies, because how the government accomplishes its mission is integral to what the government is able to produce in terms of outcomes for the public it serves. Adoption and use of promising new methods by federal agencies can be slowed by a number of factors that discourage risk-taking and experimentation, and instead encourage compliance and standardization, too often as a false proxy for accountability. As a result, many agency-specific and government-wide authorities for promising methods go under-considered and under-utilized. 

Policy entrepreneurs within center-of-government agencies (e.g., Executive Office of the President) are well-positioned to use a variety of policy levers and actions to encourage and accelerate federal agency adoption of promising and effective methods. Some interventions by center-of-government agencies are better suited to driving initial adoption, others to accelerating or maintaining momentum, and yet others to codifying and making adoption durable once widespread. Therefore, a policy entrepreneur interested in expanding adoption of a given method should first seek to understand the “adoption maturity” of that method and then undertake interventions appropriate for that stage of adoption. The arc of agency adoption of new methods can be long—measured in years and decades, not weeks and months. Policy entrepreneurs should be prepared to support adoption over similar timescales. In considering adoption maturity of a method of interest, policy entrepreneurs can also reference the ideas of Tom Kalil in a July 2024 Federation of American Scientists blog post on “Increasing the ‘Policy Readiness of Ideas,” which offers sample questions to ask about “the policy landscape surrounding a particular idea.”

As a case study for driving federal adoption of a new method, this paper looks back at actions that supported the widespread adoption of incentive prizes by most federal agencies over the course of fiscal years 2010 through 2020. Federal agency use of prizes increased from several incentive prize competitions being offered by a handful of agencies in the early 2000s to more than 2,000 prize competitions offered by over 100 federal agencies by the end of fiscal year 2022. These incentive prize competitions have helped federal agencies identify novel solutions and technologies, establish new industry benchmarks, pay only for results, and engage new talent and organizations. 

A summary framework below includes types of actions that can be taken by policy entrepreneurs within center-of-government agencies to support awareness, piloting, and ongoing use of new methods by federal agencies in the years ahead. (Federal agency program and project managers who seek to scale up innovative methods within their agencies are encouraged to reference related resources such as this article by Jenn Gustetic in the Winter 2018 Issues in Science and Technology: “Scaling Up Policy Innovations in the Federal Government: Lessons from the Trenches.”) 

Efforts to expand federal capacity through new and promising methods are worthwhile to ensure the federal government can use a full and robust toolbox of tactics to meet its varied goals and missions. 

OPPORTUNITIES AND CHALLENGES IN FEDERAL ADOPTION OF NEW METHODS

Opportunities for federal adoption and use of promising and effective methods

To address national priorities, solve tough challenges, or better meet federal missions to serve the public, a policy entrepreneur may aim to pilot, scale, and make lasting federal use of a specific method. 

A policy entrepreneur’s goals might include new ways for federal agencies to, for example:

• Catalyze the development, demonstration, and deployment of technology and novel solutions; 
• Acquire or commercialize products and services that meet government or national needs; 
• Engage and seek input from communities and the public;
• Deliver more effective, efficient, and equitable services and benefits; 
• Provide technical assistance to state, local, Tribal, and territorial governments;
• Retain and recruit talent for mission critical occupations or to fill federal skills gaps; 
• Assess and evaluate organizational health and performance or program-level outcomes; or
• Translate evidence to practice.

To support these and other goals, an array of promising methods exist and have been demonstrated, such as in other sectors like philanthropy, industry, and civil society, in state, local, Tribal, or territorial governments and communities, or in one or several federal agencies—with promise for beneficial impact if more federal agencies adopted these practices. Many methods are either specifically supported or generally allowable under existing government-wide or agency-specific authorities. 

Center-of-government agencies include components of the Executive Office of the President (EOP) like the Office of Management and Budget (OMB) and the Office of Science and Technology Policy (OSTP), as well as the Office of Personnel Management (OPM) and the General Services Administration (GSA). These agencies direct, guide, convene, support, and influence the implementation of law, regulation, and the President’s policies across all Federal agencies, especially the executive departments. An August 2016 report by the Partnership for Public Service and the IBM Center for the Business of Government noted that, “The Office of Management and Budget and other “center of government” agencies are often viewed as adding processes that inhibit positive change—however, they can also drive innovation forward across the government.”

A policy entrepreneur interested in expanding adoption of a given method through actions driven or coordinated by one or more center-of-government agencies should first seek to understand the “adoption maturity” of a given method of interest by assessing: (1) the extent that adoption of the method has already occurred across the federal interagency; (2) any real or perceived barriers to adoption and use; and (3) the robustness of existing policy frameworks and agency-specific and government-wide infrastructure and resources that support agency use of the method.

Challenges in federal adoption and use of new methods

Policy entrepreneurs are usually interested in expanding federal adoption of new methods for good reason: a focus on supporting and expanding beneficial outcomes. Effective leaders and managers across sectors understand the importance of matching appropriate and creative tactics with well-defined problems and opportunities. Ideally, leaders are picking which tactic or tool to use based on their expert understanding of the target problem or opportunity, not using a method solely because it is novel or because it is the way work has always been done in the past. Design of effective program strategies is supported by access to a robust and well-stocked toolbox of tactics. 

However, many currently authorized and allowable methods for achieving federal goals are generally underutilized in the implementation strategies and day-to-day tactics of federal agencies. Looking at the wide variety of existing authorities in law and the various flexibilities allowed for in regulation and guidance, one might expect agency tactics for common activities like acquisition or public comment to be varied, diverse, iterative, and even experimental in nature, where appropriate. In practice, however, agency methods are often remarkably homogeneous, repeated, and standardized.   

This underutilization of existing authorities and allowable flexibilities is due to factors such as:

• Comfort with existing methods among program and legal staff (“but that’s how we have always done it!”); 
• In turn, limited internal expertise on how to deploy specific new methods (“who in our agency knows how to do this well?”);
• Unclear legal authorities or lack of established agency policies or processes (“are we allowed to do that and, if so, where is that authority written?”)
• Unclear permission authorities and approval roles (“whose review and sign-off do I need to do that?”);
• Difficulties clearly defining the opportunity or problem to be addressed at an actionable level of specificity (“what does success look like?”);
• Concerns about perceived risks, such as the risk of funds going unawarded or effective solutions not being identified (“what if no one/nothing meets our target?”); 
• Oversight processes that seek out failure, flaws, and non-compliance and overreliance on strict procedures to ensure accountability (“who is responsible for this failure?” instead of “what can we learn from this for the future?”, and “have all the boxes been checked?” instead of “where might we start and how will we learn along the way?”); and
• Reluctance to define and implement meaningful performance indicators and assessment methods at the start of program design (“how will we know if this new method improves our outcomes compared to the status quo?”). 

Strategies for addressing challenges in federal adoption and use of new methods

Attention and action by center-of-government agencies often is needed to address the factors cited above that slow the adoption and use of new methods across federal agencies and to build momentum. The following strategies are further explored in the case study on federal use of incentive prizes that follows: 

• clarifying government-wide and agency-specific policies and processes;
• building awareness and fostering leadership and staff buy-in; 
• offering case studies, examples, and “how-to” playbooks; 
• creating connections among a federal community of practice 
• engaging external experts and practitioners; 
• removing identified barriers;
• increasing ambition through iterative experimentation; and 
• fostering an enterprise-wide learning culture that encourages experimentation, invests in evaluation, and manages risk.

Additional strategies can be deployed within federal agencies to address agency-level barriers and scale promising methods—see, for example, this article by Jenn Gustetic in the Winter 2018 Issues in Science and Technology: “Scaling Up Policy Innovations in the Federal Government: Lessons from the Trenches.” 

LOOKING BACK: A DECADE OF POLICY ACTIONS SUPPORTING EXPANDED FEDERAL USE OF INCENTIVE PRIZES

The use of incentive prizes is one method for open innovation that has been adopted broadly by most federal agencies, with extensive bipartisan support in Congress and with White House engagement across multiple administrations. In contrast to recognition prizes, such as the Nobel Prize or various presidential medals, which reward past accomplishments, incentive prizes specify a target, establish a judging process (ideally as objective as possible), and use a monetary prize purse and/or non-monetary incentives (such as media and online recognition, access to development and commercialization facilities, resources, or experts, or even qualification for certain regulatory flexibility) to induce new efforts by solvers competing for the prize. 

The use of incentive prizes by governments (and by high net worth individuals) to catalyze novel solutions certainly is not new. In 1795, Napoleon offered 12,000 francs to improve upon the prevailing food preservation methods of the time, with a goal of better feeding his army. Fifteen years later, confectioner Nicolas François Appert claimed the prize for his method involving heating, boiling and sealing food in airtight glass jars — the same basic technology still used to can foods. Dava Sobel’s book Longitude details how the rulers of Spain, the Netherlands, and Britain all offered separate prizes, starting in 1567, for methods of figuring out longitude at sea, and finally John Harrison was awarded Britain’s top longitude prize in 1773. In 1919, Raymond Orteig, a French-American hotelier, aviation enthusiast, and philanthropist, offered a $25,000 prize for the first person who could perform a nonstop flight between New York and Paris. The prize offer initially expired by 1924 without anyone claiming it. Given technological advances and a number of engaged pilots involved in trying to win the prize, Orteig extended the deadline by 5 years. By 1926, nine teams had come forward to formally compete, and the prize went to a little-known aviator named Charles Lindbergh, who attempted the flight in a custom-built plane known as the “Spirit of St. Louis.”

The U.S. Government did not begin to adopt the use of incentive prizes until the early 21st century, following a 1999 National Academy of Engineering workshop about the use of prizes as an innovation tool. In the first decade of the 2000s, the Defense Advanced Research Projects Agency (DARPA), the National Aeronautics and Space Administration (NASA), and the Department of Energy conducted a small number of pilot prize competitions. These early agency-led prizes focused on autonomous vehicles, space exploration, and energy efficiency, demonstrating a range of benefits to federal agency missions. 

Federal use of incentive prizes did not accelerate until, in the America COMPETES Reauthorization Act of 2010, Congress granted all federal agencies the authority to conduct prize competitions (15 USC § 3719). With that new authority in place, and with the support of a variety of other policy actions, federal use of incentive prizes reached scale, with over 2,000 prize competitions offered on Challenge.gov by over 100 federal agencies between the fiscal years 2010 and 2022. 

There certainly remains extensive opportunity to improve the design, rigor, ambition, and effectiveness of federal prize competitions. That said, there are informative lessons to be drawn from how incentive prizes evolved in the United States from a method used primarily outside of government, with limited pilots among a handful of early-adopter federal agencies, to a method being tried by many civil servants across an active interagency community of practice and lauded by administration leaders, bipartisan members of Congress, and external stakeholders alike. 

A summary follows of the strategies and tactics used by policy entrepreneurs within the EOP—with support and engagement from Congress as well as program managers and legal staff across federal agencies—that led to increased adoption and use of incentive prizes in the federal government.

Summary of strategies and policy levers supporting expanded use of incentive prizes

In considering how best to expand awareness, adoption, and use among federal agencies of promising methods, policy entrepreneurs might consider utilizing some or all of the strategies and policy levers described below in the incentive prizes example. Those strategies and levers are summarized generally in the table that follows. Some of the listed levers can advance multiple strategies and goals. This framework is intended to be flexible and to spark brainstorming among policy entrepreneurs, as they build momentum in the use of particular innovation methods. 

Policy entrepreneurs are advised to consider and monitor the maturity level of federal awareness, adoption, and use, and to adjust their strategies and tactics accordingly. They are encouraged to return to earlier strategies and policy levers as needed, should adoption and momentum lag, should agency ambition in design and implementation of initiatives be insufficient, or should concerns regarding risk management be raised by agencies, Congress, or stakeholders. 

Stage of Federal Adoption	Strategy	Types of Center-of-Government Policy Levers
Early – No or few Federal agencies using method	Understand federal opportunities to use method, and identify barriers and challenges	* Connect with early adopters across federal agencies to understand use of agency-specific authorities, identify pain points and lessons learned, and capture case studies (e.g., 2000-2009) * Engage stakeholder community of contractors, experts, researchers, and philanthropy * Look to and learn from use of method in other sectors (such as by philanthropy, industry, or academia) and document (or encourage third-party documentation of) that use and its known benefits and attributes (e.g., April 1999, July 2009) * Encourage research, analysis, reports, and evidence-building by National Academies, academia, think tanks, and other stakeholders (e.g., April 1999, July 2009, June 2014) * Discuss method with OMB Office of General Counsel and other relevant agency counsel * Discuss method with relevant Congressional authorizing committee staff * Host convenings that connect interested federal agency representatives with experts * Support and connect nascent federal “community of interest”
Early – No or few Federal agencies using method	Build interest among federal agencies	* Designate primary policy point of contact/dedicated staff member in the EOP (e.g., 2009-2017, 2017-2021) * Designate a primary implementation point of contact/dedicated staff at GSA and/or OPM * Identify leads in all or certain federal agencies * Connect topic to other administration policy agendas and strategies * Highlight early adopters within agencies in communications from center-of-government agencies to other federal agencies (and to external audiences) * Offer congressional briefings and foster bipartisan collaboration (e.g., 2015)
Early – No or few Federal agencies using method	Establish legal authorities and general administration policy	* Engage OMB Office of OMB General Counsel and OMB Legislative Review Division, as well as other relevant OMB offices and EOP policy councils * Identify existing general authorities and regulations that could support federal agency use of method (e.g., March 2010) * Establish general policy guidelines, including by leveraging Presidential authorities through executive orders or memoranda (e.g., January 2009) * Issue OMB directives on specific follow-on agency actions or guidance to support agency implementation (“M-Memos” or similar) (e.g., December 2009, March 2010, August 2011, March 2012) * Provide technical assistance to Congress regarding government-wide or agency-specific authority (or authorities) (e.g., June-July 2010, January 2011) * Delegate existing authorities within agencies (e.g., October 2011) * Encourage issuance of agency-specific guidance (e.g., October 2011, February 2014) * Include direction to agencies as part of broader Administration policy agendas (e.g., September 2009, 2011-2016)
Early – No or few Federal agencies using method	Remove barriers and “make it easier”	* Create a central government website with information for federal agency practitioners (such as toolkits, case studies, and trainings) and for the public (e.g., September 2010) * Create dedicated GSA schedule of vendors (e.g., July 2011) * Establish an interagency center of excellence (e.g., September 2011) * Encourage use of interagency agreements on design or implementation of pilot initiatives (e.g., September 2011) * Request agency budget submissions to OMB to support pilot use in President’s budget (e.g., December 2013)
Adoption well underway – Many federal agencies have begun to use method	Connect practitioners	* Launch a federal “community of practice” with support from GSA for meetings, listserv, and collaborative projects (e.g., April 2010, 2016, June 2019) * Host regular events, workshops, and conferences with federal agency and, where appropriate and allowable, seek philanthropic or nonprofit co-hosts (e.g., April 2010, June 2012, April 2015, March 2018, May 2022)
Adoption well underway – Many federal agencies have begun to use method	Strengthen agency infrastructure	* Foster leadership buy-in through briefings from White House/EOP to agency leadership, including members of the career senior executive service * Encourage agencies to dedicate agency staff and invest in prize design support within agencies * Encourage agencies to create contract vehicles as needed to support collaboration with vendors/ experts * Encourage agencies to develop intra-agency networks of practitioners and to provide external communications support and platforms for outreach * Request agency budget submissions to OMB for investments in agency infrastructure and expansion of use, to include in the President's budget where needed (e.g., 2012-2013), and request agencies otherwise accommodate lower-dollar support (such as allocation of FTEs) where possible within their budget toplines
Adoption well underway – Many federal agencies have begun to use method	Clarify existing policies and authorities	* Issue updated OMB, OSTP, or agency-specific policy guidance and memoranda as needed based on engagement with agencies and stakeholders (e.g.,: August 2011, March 2012) * Provide technical assistance to Congress on any needed updates to government-wide or agency-specific authorities (e.g., January 2017)
Adoption prevalent – Most if not all federal agencies have adopted, with a need to maintain use and momentum over time	Highlight progress and capture lessons learned	* Require regular reporting from agencies to EOP (OSTP, OMB, or similar) (e.g., April 2012, May 2022) * Require and take full advantage of regular reports to Congress (e.g., April 2012, December 2013, May 2014, May 2015, August 2016, June 2019, May 2022, April 2024) * Continue to capture and publish federal-use case studies in multiple formats online (e.g., June 2012) * Undertake research, evaluation, and evidence-building * Co-develop practitioner toolkit with federal agency experts (e.g., December 2016) * Continue to feature promising examples on White House/EOP blogs and communication channels (e.g., October 2015, August 2020) * Engage media and seek both general interest and targeted press coverage, including through external awards/honorifics (e.g., December 2013)
Adoption prevalent – Most if not all federal agencies have adopted, with a need to maintain use and momentum over time	Prepare for presidential transitions and document opportunities for future administrations	* Integrate go-forward proposals and lessons learned into presidential transition planning and transition briefings (e.g., June 2016-January 2017) * Brief external stakeholders and Congressional supporters on progress and future opportunities * Connect use of method to other, broader policy objectives and national priorities (e.g., August 2020, May 2022, April 2024)

Phases and timeline of policy actions advancing the adoption of incentive prizes by federal agencies

1. Growing number of incentive prizes offered outside government (early 2000s)

At the close of the 20th century, federal use of incentive prizes to induce activity toward targeted solutions was limited, though the federal government regularly utilized recognition prizes to reward past accomplishment. In October 2004, the $10 million Ansari XPRIZE—which was first announced in May 1996—was awarded by the XPRIZE Foundation for the successful flights of Spaceship One by Scaled Composites. Following the awarding of the Ansari XPRIZE and the extensive resulting news coverage, philanthropists and high net worth individuals began to offer prize purses to incentivize action on a wide variety of technology and social challenges. A variety of new online challenge platforms sprung up, and new vendors began offering consulting services for designing and hosting challenges, trends that lowered the cost of prize competition administration and broadened participation in prize competitions among thousands of diverse solvers around the world. This growth in the use of prizes by philanthropists and the private sector increased the interest of the federal government in trying out incentive prizes to help meet agency missions and solve national challenges. Actions during this period to support federal use of incentive prizes include:

• EXTERNAL REPORT/ANALYSIS (April 1999): In response to a request from the Clinton-Gore Administration’s National Economic Council, the National Academy of Engineering (NAE), with funding from the National Science Foundation, convened a workshop in April 1999 to “assess the potential value of federally sponsored prizes and contests in advancing science and technology in the public interest” and issued a brief summary report, which recommended “limited experiments” in the use of federally sponsored incentive prizes and encouraged both Congress and federal agencies “to take a flexible approach to the design and administration” of such prizes and that the use of incentive prizes be “evaluated at specified intervals by the agencies involved to determine their effectiveness and impact.”  

• AGENCY-SPECIFIC AUTHORITIES and PILOTS (early 2000s): During this period, though, only a few federal government agencies had (and still have) flexible agency-specific prize authorities that allowed them to pilot the use of incentive prizes to advance their missions, scan markets for new solutions, engage new solvers, and solve long-standing problems. Early examples include:

• Because of prizes authority provided to DARPA by Congress under 10 U.S.C. 2374a, enacted as part of the National Defense Authorization Act of 2000 in October 1999, DARPA was early in the federal prizes game, offering a series of challenges demonstrating the capabilities of autonomous vehicles in 2004 and 2005, called the DARPA Grand Challenges. 
• With authority from Congress, NASA began offering its ongoing series of Centennial Challenges starting in 2005, to directly engage the public in the process of advanced technology development related to problems of interest to NASA and the nation. 
• Congress also saw opportunity for the Department of Energy (DOE) to make progress on energy challenges through the use of incentive prizes, giving DOE authority through the Energy Independence and Security Act of 2007 to run a prize focused on efficient lighting call the “L-Prize” and also to run a series of “H-Prizes” to encourage research into the use of hydrogen as an energy carrier in a hydrogen economy.

2. Obama-Biden Administration Seeks to Expand Federal Prizes Through Administrative Action (2009-2010)

From the start of the Obama-Biden Administration, OSTP and OMB took a series of policy steps to expand the use of incentive prizes across federal agencies and build federal capacity to support those open-innovation efforts. Bipartisan support in Congress for these actions soon led to new legislation to further advance agency adoption of incentive prizes. Actions during this period to support federal use of incentive prizes include:

• PRESIDENTIAL DIRECTIVE (January 2009): On the first day of the Obama-Biden Administration on January 21, 2009, President Barack Obama signed a Memorandum on Transparency and Open Government, committing the Administration to creating a more transparent, participatory, and collaborative government. The memorandum directed that federal agencies “should offer Americans increased opportunities to participate in policymaking and to provide their Government with the benefits of their collective expertise and information.”

• EXTERNAL REPORT/ANALYSIS (July 2009): In July 2009, with funding from the Templeton Foundation, McKinsey issued a report called And the Winner Is… that documented the recent resurgence of incentive prizes and noted that over the past decade total prize purses across the large incentive prizes being offered had tripled to surpass $375 million. This report provided synthesis of learnings from recent prizes. For example, the report found that, “As Ken Davidian, formerly of the NASA Challenges, puts it, there are at least four core rewards that drive participants to compete for prizes: ‘goal, glory, guts, and gold—and gold is usually last.’ Or to be more precise (if less memorable), competitors are motivated by the intrinsic interest of a challenge, the recognition or prestige accompanying a winner, the challenge of the problem-solving process itself, and any material incentive. Which motives matter most, and in what mix, will vary depending on the problem—and the problem solver.”

• INCLUSION IN ADMINISTRATION POLICY AGENDA (September 2009): In addition, in September 2009, President Obama released his Strategy for American Innovation, developed by the National Economic Council (NEC) and OSTP. In that strategy, the President called for federal agencies to “take advantage of the expertise and insight of people both inside and outside the federal government, use high-risk, high-reward policy tools such as prizes and challenges to solve tough problems.” 

• OMB DIRECTIVE (December 2009): Responding to President Obama’s open government memorandum, on December 8, 2009, the OMB Director issued an Open Government Directive, which required executive departments and agencies to take specific actions to further the principles established by the open government memorandum. The directive charged the OMB Deputy Director for Management to “issue, through separate guidance or as part of any planned comprehensive management guidance, a framework for how agencies can use challenges, prizes, and other incentive-backed strategies to find innovative or cost-effective solutions to improving open government.” The directive also charged federal agencies to include in agency Open Government Plans “innovative methods, such as prizes and competitions, to obtain ideas from and to increase collaboration with those in the private sector, non-profit, and academic communities.”

• EOP LEADERSHIP ROLES (January 2009-January 2017): To support the development and implementation of these and other open-innovation policies, a member of the OSTP policy staff served as policy lead for open innovation, reporting to OSTP Deputy Director Tom Kalil, with additional leadership backing from OSTP Director John Holdren, the inaugural U.S. Chief Technology Officer (CTO) Aneesh Choprah, and then Deputy U.S. CTO Beth Noveck. During the Obama Administration, this OSTP open-innovation policy role was filled by Robynn Sturm Steffen from 2009-2011, the author (Cristin Dorgelo) from 2011-2014 until she became OSTP Chief of Staff, Jenn Gustetic on detail from NASA from 2014-2016, and Christofer Nelson from 2016 through the end of the Administration in January 2017. Sonal Shah as inaugural director of the White House Office of Social Innovation and Civic Participation in the Domestic Policy Council (DPC), and her successor Jonathan Greenblatt, also provided helpful leadership and led key stakeholder engagement efforts.

• OMB GUIDANCE (March 2010): Consistent with the Open Government Directive and the Strategy for American Innovation, OSTP worked closely with the OMB Office of the Deputy Director for Management and the OMB Office of General Counsel on developing guidance on incentive prizes for federal agencies. In March 2010, OMB issued OMB Memorandum M-10-11, Guidance on the Use of Challenges and Prizes to Promote Open Government. This memorandum included clarifications for federal agencies regarding what authorities they could use to offer prize purses, host and sponsor prize competitions, and engage third parties to operate such competitions. OMB Memorandum M-10-11 also established as Administration policy that agencies should:

• Utilize prizes and challenges as tools for advancing open government, innovation, and the agency’s mission;
• Identify and proactively address legal, regulatory, technical, and other barriers to the use of prizes and challenges;
• Select one or more individuals to identify and implement prizes and challenges, potentially in partnership with outside organizations, and to participate in a governmentwide “community of practice” led by OMB and OSTP; and
• Increase their capacity to support, design, and manage prizes, potentially in collaboration with external partners.

• CONVENING and COMMUNITY OF PRACTICE (April 2010): In April 2010, the White House (OSTP and the DPC Office of Social Innovation and Civic Participation) with the Case Foundation convened experts in incentive prize design and administration to share private-sector success stories with nearly 200 representatives from more than 35 federal agencies. This Summit on Promoting Innovation: Prizes, Challenges and Open Grantmaking served as a formal kickoff to a federal prizes and challenges community of practice, which GSA administered, and for which OSTP and OMB provided strategic direction, substantive agenda setting, and resourcing. With GSA’s support, this community of practice remains more than a decade later a valuable network for federal prize practitioners to connect and exchange promising practices and lessons learned. 

• TECHNICAL ASSISTANCE TO CONGRESS TO INFORM NEW LEGAL AUTHORITY (June-July 2010): Throughout this period, OSTP and OMB were collaborating with Congress to advance government-wide prize authority. On June 24, 2010, Senators Mark Pryor and Mark Warner introduced in the 111th Congress S.3530, the Reward Innovation in America Act of 2010. Drawing from this introduced bill, in July 2010, the Senate Commerce Committee approved the America COMPETES Reauthorization Act of 2010 with a provision providing government-wide prize authority. Specifically, P.L. 111-358 added Section 24 to the Stevenson-Wydler Technology Innovation Act of 1980 (15 USC § 3719). On July 27, 2010, the Director of OSTP thanked Senators Pryor and Warner for their leadership in a letter that OSTP also published on its blog, highlighting the steps the Administration was taking to set the stage for agencies to take full advantage of prizes authority should Congress move the authority forward.

• SHARED GOVERNMENT WEBSITE (September 2010 to Present): Responding to directives in M-10-11, with support from OSTP and OMB, and with leadership from internal champions, GSA in September 2010 launched a government-wide website called Challenge.gov to provide one place for citizen solvers to come and find the challenges being offered by federal agencies. Over time, Challenge.gov developed back-end capabilities to help federal program managers administer certain types of prize competition and expanded to serve as a knowledge repository for federal program managers looking for more information about designing and administering incentive prizes. Challenge.gov remains today the primary online hub for federally hosted prize competitions. 

3. Implementing New Government-Wide Prizes Authority Provided by the America COMPETES Act (2011-2016)

During this period of expansion in the federal use of incentive prizes supported by new government-wide prize authority provided by Congress, the Obama-Biden Administration continued to emphasize its commitment to the model, including as a key method for accomplishing administration priorities, including priorities related to open government and evidence-based decision making. Actions during this period to support federal use of incentive prizes include:

• NEW AUTHORITIES THROUGH LEGISLATION (January 2011): On January 4, 2011, President Obama signed into law the America COMPETES Reauthorization Act of 2010 (COMPETES Act), granting all agencies broad authority to conduct prize competitions to spur innovation, solve tough problems, and advance their core missions (Public Law 111-358). 

• GSA CONTRACT VEHICLE (July 2011 to Present): In July 2011, as called for by the new law, GSA established a contract vehicle—originally, Sub-Schedule 541 4G, now maintained as the Multiple Award Schedule, 541613, Professional Services – Marketing and Public Relations—to help federal agencies access private-sector technical assistance and consulting support for incentive prizes. Because prize competitions were still an emerging practice both inside and outside of the federal government, this contract vehicle allowed federal agencies to access experts and consultants who were building capacity for prizes across sectors and identifying what works in prize design and operations.

• OMB GUIDANCE (August 2011): In August 2011, OMB’s General Counsel and Chief Information Officer issued a memorandum on the new COMPETES prize authority to agency general counsels and CIOs, which OMB developed hand-in-hand with OSTP. The memorandum included a concise summary of the COMPETES Act’s new prizes authorities and requirements, and it provided guidance to agencies in their implementation of the prize authority found in this legislation. It also addressed an array of frequently asked questions raised by agencies, including agency questions about the new authority to conduct prizes up to $50 million with existing appropriations, as well as the new authorities to: accept private-sector funds for the design, administration, or prize purse of a competition; to partner with nonprofits and tap the expertise of for-profits for successful implementation; and to co-sponsor with another agency.

• AGENCY-SPECIFIC POLICIES and DELEGATION OF AUTHORITY (October 2011): Following issuance of this government-wide guidance, with the support of OSTP and OMB, agencies began to establish strategies and policies to further accelerate widespread use of the new prize authority granted to them under COMPETES. For example, the Department of Health and Human Services (HHS) was at the forefront of agency implementation efforts. On October 12, 2011, HHS Secretary Kathleen Sebelius issued a memorandum notifying the Department of the new prize authority provided under the America COMPETES Reauthorization Act, outlining the Department’s strategy to optimize the use of prize competitions, and calling on the heads of HHS operating and staff divisions to forecast their future use of prize competitions to stimulate innovation in advancing the agency’s mission. Secretary Sebelious also issued a formal delegation of the new prize authority in the Federal Register.

• CENTER OF EXCELLENCE and INTERAGENCY AGREEMENTS (November 2011): In November 2011, OSTP worked with NASA to launch a Center of Excellence for Collaborative Innovation (CoECI), which was co-founded by Jason Crusan and Jeff Davis. As NASA continued to mature the use of challenges and crowdsourcing methods as a new tool in its toolkit, OSTP encouraged NASA to assist other federal agencies in the use of crowdsourced challenges to solve tough, mission-critical problems. This included the new Center working with federal agencies on challenge design through interagency agreements, and supporting those agencies with accessing NASA’s contracts with prize platforms, including for algorithm and apps challenges and for ideation challenges. 

• OMB GUIDANCE (March 2012): Throughout 2011, OSTP met regularly with agencies, holding regular phone calls and in-person meetings—often at agency offices—with agency leadership, counsel, and program managers who were considering the use of prizes or undertaking prize design. In these interactions, OSTP listened to agencies, asked clarifying questions, and tracked common issues and challenges. For example, OSTP heard in these agency conversations a variety of agency questions regarding the Paperwork Reduction Act and its intersection with prize authorities. OSTP then collaborated with OMB to assess these issues and determine how clarifying guidance could support agency implementation of prizes. On March 1, 2012, OMB Office of Information and Regulatory Affairs (OIRA) issued a Frequently Asked Questions summary to address common agency questions. 

• AGENCY REPORTING TO EOP and REPORT TO CONGRESS (April 2012): In April 2012, the Obama-Biden Administration released a first report to Congress on federal use of incentive prizes in fiscal year 2011, as required by the America COMPETES Act. These reports to Congress and related reporting from federal agencies to OSTP—initially on an annual cycle and now biennial—have been an essential mechanism for tracking federal agency prize activity and capturing case studies and outcomes. The work led by OSTP with GSA to standardize how federal agencies tracked indicators and metrics regarding federal incentive prizes supported both progress tracking over time as well as storytelling by the Administration and prize supporters in Congress. The reports have also recorded steps taken by OSTP, GSA, and other agencies like NASA to build government-wide capacity and infrastructure related to prizes, and the steps taken within agencies to establish policies and processes to ease the use of prizes and remove barriers.

• CONVENING and ONLINE CASE STUDIES AND RESOURCES (June 2012): In June 2012, OSTP, the Case Foundation, and the Joyce Foundation hosted a day-long conference called Collaborative Innovation: Public Sector Prizes, which brought together hundreds of public- and private-sector practitioners to share case studies, research, and lessons learned. The event was partially live streamed, and resulted in a large amount of case studies and video resources that were available on the Case Foundation website, now archived.

• INCLUSION IN ADMINISTRATION POLICY AGENDA (2011-2016): The use of incentive prizes was included and encouraged throughout a variety of Administration policy agendas, year over year. For example, commitments related to prizes and challenges were included in each of the United States Open Government biennial National Action Plans issued during the Obama-Biden Administration, to maintain momentum and highlight this body of work to the international open government community. 

• GUIDANCE ON AGENCY BUDGET PROPOSALS (2012-2013): OSTP also collaborated with OMB to ensure that agencies considered and submitted to OMB budget proposals to expand their use of incentive prizes. On May 18, 2012, OMB issued Memorandum M-12-14 on the Use of Evidence and Evaluation in the 2014 Budget, which directed, “Agencies should also consider using the new authority under the America COMPETES legislation to support incentive prizes of up to $50 million. Like Pay for Success, well designed prizes and challenges can yield a very high return on the taxpayer dollar.” For agencies seeking to learn more about prizes, the memo noted, “The Office of Science and Technology Policy has created a ‘community of practice’ for agency personnel involved in designing and managing incentive prizes.” On July 26, 2013, OMB issued Memorandum M-13-17 on Next Steps in the Evidence and Innovation Agenda, OMB encouraged federal agencies to develop budget proposals “that focus Federal dollars on effective practices while also encouraging innovation in service delivery” and specifically mentioned incentive prizes as an encouraged pay-for-performance strategy. 

• REPORT TO CONGRESS (December 2013): On December 27, 2013, OSTP released a second report to Congress of federal use of incentive prizes under the COMPETES Act authority, and other authorities, in fiscal year 2012.

• LIFTING UP EFFORT FOR EXTERNAL RECOGNITION (December 2013): On January 24, 2014, Harvard University’s Ash Center for Democratic Governance and Innovation announced Challenge.gov as winner of the prestigious 2013 “Innovations in American Government Award” in honor of exemplary service and creativity in the public interest. The Obama Administration through GSA nominated Challenge.gov for this external honor to raise awareness and increase attention for federal prizes. 

• AGENCY-SPECIFIC POLICIES (February 2014): Agencies continued to state and clarify their internal policies and processes related to incentive prizes. For example, on February 12, 2014, the NASA Administrator issued an agency-wide policy directive—still in place today and last updated in June 2023—to encourage “the use of challenges, prize competitions, and crowdsourcing activities at all levels of the Agency to further its mission.”

• REPORT TO CONGRESS (May 2014): On May 7, 2014, OSTP released a third report to Congress on federal use of incentive prizes, focused on fiscal year 2013. This report found an 85 percent annual increase in prizes run under all legal authorities, an over 50 percent increase in the number of prizes conducted under the authority provided by COMPETES increased by over 50 percent compared to fiscal year 2012 (and nearly six-fold compared to 2011), and an increase in the size of agency-sponsored prize purses has grown as well—11 prizes had prize purses of $100,000 or greater in fiscal year 2013. 

• EXTERNAL REPORT/ANALYSIS (June 2014): On June 19, 2014, Deloitte University Press released a report—informed by research involving prize practitioners across government—covering in depth the lessons learned and best practices identified from over 350 prizes conducted by the Federal government and over 50 prizes conducted by state, local, and philanthropic leaders. The report, titled The craft of Prize Design: lessons from the public sector, was produced by Doblin (Deloitte’s innovation practice), in collaboration with Bloomberg Philanthropies, the Case Foundation, the Joyce Foundation, the Knight Foundation, the Kresge Foundation, and the Rockefeller Foundation.

• REPORT TO CONGRESS (May 2015): On May 8, 2015, OSTP released a fourth report to Congress on federal use of incentive prizes, focused on fiscal year 2014. This report highlighted steps agencies were taking to support the use of incentive prizes across their components and divisions, from streamlining access to vendors to support the design and implementation of prize competitions through contract vehicles, creating internal working groups, designating points of contact, and creating internal and external communications tools. 

• CONVENING and WHITE HOUSE MICROSITE (October 2015): On Oct 7, 2015, five years after the launch of Challenge.gov, the White House, in conjunction with the Case Foundation, the Joyce Foundation, and Georgetown University hosted a conference called  “All Hands on Deck: Solving Complex Problems through Prizes and Challenges” to convene federal prize practitioners and catalyze the next generation of ambitious federal prizes. The following day, GSA brought together the federal community to recognize progress with an awards ceremony. By that point, more than 440 federal prizes had been offered, engaging more than 200,000 citizen solvers. Also in October 2015, OSTP and DPC collaborated on the launch of a WhiteHouse.gov microsite with information on federal use of incentive prizes.

• FOSTER BIPARTISAN CONGRESSIONAL SUPPORT (2015): During this period, bipartisan support for the use of incentive prizes by federal agencies continued. In 2015, a Congressional Prize Caucus with bipartisan sponsorship was held to increase awareness and encourage the use of prize competitions. Numerous pieces of legislation supporting prize competitions to fuel medical research were also passed (e.g., the 21st Century Cures Act [Public Law 114-255] included a provision on EUREKA Prize Competitions [42 U.S.C. 284et seq] that authorized the National Institutes of Health in the Department of Health and Human Services to conduct prize competitions to fuel medical research).

• REPORT TO CONGRESS and TRAINING (August 2016): In August 2016, OSTP released a fifth report to Congress on the federal use of prizes in fiscal year 2015. OSTP noted that Challenge.gov had, by August 2016, “featured more than 700 prize competitions and challenges—conducted under the authority provided by COMPETES and other authorities—from more than 100 Federal agencies, departments, and bureaus.” OSTP and GSA together had engaged more than 1,500 federal professionals in training on prize design and operations. 

• PRACTITIONER TOOLKIT (December 2016): In December 2016, building on the robust body of federal knowledge on prizes, OSTP and GSA with the federal Community of Practice on Prizes and Challenges issued a robust practitioner’s toolkit on Challenge.gov with a lot of how-to information and practical case studies. The toolkit was developed by an interagency team using insights drawn from experts across federal agencies. 
  
  

4. Maintaining Momentum in New Presidential Administrations

Support for federal use of incentive prizes continued beyond the Obama-Biden Administration foundational efforts. Leadership by federal agency prize leads was particularly important to support this momentum from administration to administration. Actions during the Trump-Pence and Biden-Harris Administrations to support federal use of incentive prizes include:

• INTEGRATION INTO PRESIDENTIAL TRANSITION PLANNING (June 2016 – January 2017): As the end of the Obama-Biden Administration neared, OSTP worked with GSA and federal agency prize leads to prepare for the upcoming presidential transition and ensure the agency leads felt prepared, empowered, and supported with agency-level policies and processes so they could continue to design and launch prize competitions as part of their ongoing regular course of business. OSTP also integrated incentive prizes into its transition communications as a recommendation for the Trump-Pence Administration to continue. For example, in its list of 100 examples of the Obama-Biden Administration putting science it its rightful place, issued in June 2016, OSTP included the following: 

Harnessed American ingenuity through increased use of incentive prizes. Since 2010, more than 80 Federal agencies have engaged 250,000 Americans through more than 700 challenges on Challenge.gov to address tough problems ranging from fighting Ebola, to decreasing the cost of solar energy, to blocking illegal robocalls. These competitions have made more than $220 million available to entrepreneurs and innovators and have led to the formation of over 275 startup companies with over $70 million in follow-on funding, creating over 1,000 new jobs.

In addition, in January 2017, the Obama-Biden Administration OSTP mentioned the use of incentive prizes in its public “exit memo” as a key “pay-for-performance” method in agency science and technology strategies that “can deliver better results at lower cost for the American people,” and also noted:

Harnessing the ingenuity of citizen solvers and citizen scientists. The Obama Administration has harnessed American ingenuity, driven local innovation, and engaged citizen solvers in communities across the Nation by increasing the use of open-innovation approaches including crowdsourcing, citizen science, and incentive prizes. Following guidance and legislation in 2010, over 700 incentive prize competitions have been featured on Challenge.gov from over 100 Federal agencies, with steady growth every year.

• TECHNICAL ASSISTANCE TO CONGRESS ON UPDATES TO AUTHORITIES (January 2017): On January 6, 2017, the American Innovation and Competitiveness Act (AICA) was signed into law by President Obama [Public Law 114-329]. Reflecting extensive, multi-year staff-level engagement among Congressional staff and experts at the Obama-Biden Administration’s OSTP and OMB, the AICA updated the government-wide authority that previously had been granted to federal agencies by the COMPETES Act. The aim of the updates were to encourage more ambitious interagency and cross-sector partnerships (and co-funding, with explicit authority to solicit funds for federal prizes from beyond the federal government) in the design and administration of prize competitions, and to eliminate unnecessary administrative burden, among other changes. 

• EOP LEADERSHIP ROLES (2017-2021): During the Trump-Pence Administration, support for federal agency use of prizes and challenges continued. In the EOP, Matt Lira, then Special Assistant to the President for Innovation Policy in the White House Office of American Innovation, Michael Kratsios, then Deputy Assistant to the President and Deputy U.S. Chief Technology Officer, and others in OSTP engaged with agencies to maintain momentum and identify new opportunities for the effective application of the COMPETES Act prize authority. 

• CONVENING (March 2018): In March 2018, the White House hosted a “Fostering Innovation with Prizes and Challenges” roundtable with then Secretary of Energy Rick Perry and other leaders. The White House confirmed to participants that, “the Trump Administration strongly supports efforts by Federal agencies to host prizes and challenges, particularly those that leverage COMPETES Act authority, to address some of the Nation’s most pressing issues.”

• REPORT TO CONGRESS AND COMMUNITY OF PRACTICE (June 2019): During the Trump-Pence Administration, the federal prizes and challenges community of practice supported by GSA continued a network and active email list exchange of more than 730 current and prospective challenge managers in the Federal space. These agency prize practitioners were and continue to be essential to forward progress in the use of incentive prizes, in the federal government and beyond. OSTP’s fiscal year 2017-2018 biennial report to Congress on agency use of prizes, issued in June 2019 and the sixth such report, noted that, “monitoring the proliferation of State and local crowdsourcing initiatives, Challenge.gov expanded the email list to State and local government prize practitioners in 2018, inviting exchange and opening avenues for partnership.”

• CONNECTIONS TO NATIONAL PRIORITIES AND LEVERAGING WHITE HOUSE COMMUNICATION CHANNELS (August 2020): As the nation faced the COVID-19 pandemic, and as federal agencies responded to emerging challenges and sought to meet urgent needs during the ongoing public health crisis, they turned to incentive prizes as one tool for connecting with solvers across the country and identifying promising solutions. On August 12, 2020, then Director of OSTP Kelvin Droegemeier issued a memorandum to federal agencies highlighting nine prize competitions launched by agencies related to COVID-19 and calling on agencies to “double-down” on their deployment of prizes to meet the challenges of COVID-19. The memo also noted that OSTP was convening open innovation working groups to support these efforts and planning to host a series of webinars with Challenge.gov. The White House also issued a Fact Sheet communicating agency prize competition and open innovation activities related to COVID-19, with incentive prizes being used to catalyze advances in testing technologies, computational models, mental health services, ventilators, and needs of frontline health care workers.

• CONVENING (May 2022): OSTP and GSA collaborated on hosting an Open Innovation Forum to bring together practitioners of incentive prizes, citizen science, and crowdsourcing from across government and other sectors.

• AGENCY REPORTING TO EOP, REPORT TO CONGRESS, AND CONNECTIONS TO POLICY AGENDAS (May 2022 and April 2024): The Biden-Harris Administration has supported the continued use of incentive prizes by federal agencies as part of its commitment to expanding and improving public engagement in the work of the federal government. 

• On May 4, 2022, OSTP released its seventh report to Congress on federal incentive prize competitions (and the second that also included a focus on citizen science and crowdsourcing activities alongside incentive prizes). In releasing the report, OSTP noted in a blog post, “This new report details recent Federal efforts to stimulate innovation and partnership and expand the American public’s participation in science. These developments are aligned with the Biden-Harris Administration’s commitment to advancing equity in the science and technology ecosystem, including OSTP’s Time is Now Initiative, and recently released Equity Action Plan.” This report also reflected a new and more robust survey approach used by OSTP and GSA to collect information from agencies about federal incentive prizes, as well as continued efforts among federal agencies to streamline the use of incentive prizes and reduce or remove barriers. 
• On April 16, 2024, OSTP released its eighth report to Congress on Federal incentive prize competitions (and the third that also included a focus on citizen science and crowdsourcing). The report connected the continued growth in the use of incentive prizes by federal agencies to a broader Administration-wide “movement towards improving and expanding participation and engagement in not only government research and development, but also government processes more broadly.”

By the end of fiscal year 2022, federal agencies had hosted over 2,000 prize competitions on Challenge.gov, since its launch in 2010. OSTP, GSA, and NASA CoECI had provided training to well over 2,000 federal practitioners during that same period. 

Number of Federal Prize Competitions by Authority FY14-FY22

Source: Office of Science and Technology Policy. Biennial Report on “IMPLEMENTATION OF FEDERAL PRIZE AND CITIZEN SCIENCE AUTHORITY: FISCAL YEARS 2021-22.” April 2024.

Federal Agency Practices to Support the Use of Prize Competitions

Source: Office of Science and Technology Policy. Biennial Report on “IMPLEMENTATION OF FEDERAL PRIZE AND CITIZEN SCIENCE AUTHORITY: FISCAL YEARS 2019-20.” March 2022. 

CONCLUSION

Over the span of a decade, incentive prizes had moved from a tool used primarily outside of the federal government to one used commonly across federal agencies, due to a concerted, multi-pronged effort led by policy entrepreneurs and incentive prize practitioners in the EOP and across federal agencies, with bipartisan congressional support, crossing several presidential administrations. And yet, the work to support the use of prizes by federal agencies is not complete–there remains extensive opportunity to further improve the design, rigor, ambition, and effectiveness of federal prize competitions; to move beyond “ideas challenges” to increase the use of incentive prizes to demonstrate technologies and solutions in testbeds and real-world deployment scenarios; to train additional federal personnel on the use of incentive prizes; to learn from the results of federal incentive prizes competitions; and to apply this method to address pressing and emerging challenges facing the nation.

In applying these lessons to efforts to expand the use of other promising methods in federal agencies, policy entrepreneurs in center-of-government federal agencies should be strategic in the policy actions they take to encourage and scale method adoption, by first seeking to understand the adoption maturity of that method (as well as the relevant policy readiness) and then by undertaking interventions appropriate for that stage of adoption. With attention and action by policy entrepreneurs to address factors that discourage risk-taking, experimentation, and piloting of new methods by federal agencies, it will be possible for federal agencies to utilize a further-expanded strategic portfolio of methods to catalyze the development, demonstration, and deployment of technology and innovative solutions to meet agency missions, solve long-standing problems, and address grand challenges facing our nation. 

Photo by Nick Fewings

KEY TAKEAWAYS

• OSHA’s proposed heat safety standard is a critical step towards protecting millions of workers, but its success depends on substantial infrastructure investment.
• Effective implementation requires a multifaceted approach, improving workforce development, employer and industry resources, regulatory capacity, healthcare access and community support.
• Federal government plays a pivotal role through funding, grants, technical assistance, and interagency collaboration to protect workers from the effects of extreme heat.
• Investing in heat safety infrastructure offers multiple benefits: lives saved, injuries prevented, economic protection, and enhanced climate resilience.
• Challenges to implementation include regulatory delays, insufficient funding, financial constraints for small businesses, diverse settings, rural infrastructure limitations, and lack of awareness.
• Overcoming these challenges requires dedicated funding sources, financial incentives, tailored solutions, and comprehensive education campaigns.
• The success of the OSHA standard hinges on prioritizing these infrastructure investments to create a comprehensive, well-resourced system for heat safety.

This article is informed by extensive research and stakeholder engagement conducted by the Federation of American Scientists, including a comprehensive literature review and interviews with experts in the field. Much of this work informed our recent publication which can be found here. 

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The Imperative for Infrastructure Investment

As climate change intensifies, the need for robust heat safety measures for outdoor workers has never been more pressing. The Occupational Safety and Health Administration has taken a significant step forward in protecting workers from extreme heat by proposing a new safety standard. The proposed rule aims to protect approximately 36 million workers in indoor and outdoor settings from heat-related illnesses and fatalities. As we move forward, the rule’s success hinges on substantial investments to bridge the gap between policy and practice. It is crucial to examine how the federal government can create the necessary infrastructure to support and maximize the effectiveness of this potentially groundbreaking standard.

The need for these investments is underscored by the significant economic and human costs of heat-related illnesses and fatalities. A study by the Atlantic Council estimates that extreme heat costs the U.S. economy $100 billion annually, with agricultural workers being among the most affected. Proper implementation of safety measures could potentially prevent many of these fatalities and reduce substantial economic losses.

Key Areas for Infrastructure Development to Meet OSHA’s Heat Safety Rules

The outdoor occupational sector, employing tens of millions of workers across diverse landscapes and industries, faces unique challenges in properly implementing heat safety measures. From vast open fields to enclosed processing facilities, the infrastructure needs are as varied as the sector itself. Without targeted investments, the OSHA standard risks becoming an unfunded mandate, unable to fulfill its life-saving potential.

The effective implementation of OSHA’s proposed standard requires a multifaceted approach to infrastructure development. By focusing on these key areas, we can create a robust framework that supports the standard’s goals and protects outdoor workers across diverse settings and conditions. To maximize the impact of the proposed rule, investments must be strategically directed across several key areas. It is important to note that these areas represent a broad overview and are not exhaustive– comprehensive stakeholder engagement is essential to tailor solutions to specific needs across different states, regions, industries, and employers.

Workforce

Developing a resilient and well-prepared workforce is a cornerstone of effective safety measures. Key investments in training, access to facilities, and health monitoring ensure that workers are equipped to handle extreme heat conditions, safeguarding their health and productivity.

1. Training & Education. Developing multilingual, interactive training modules accessible to all workers is crucial. These programs must include ongoing education to ensure workers are continually updated on best practices for heat safety.
2. Access to Infrastructure. Installing hydration stations and shaded rest areas is essential to provide necessary relief from extreme heat. These facilities enable workers to stay hydrated and take breaks, significantly reducing the risk of heat exhaustion and heat stroke.
3. Personal Protective Equipment. Providing cooling vests, lightweight clothing, and sunscreen to protect workers from heat stress is another critical component. PPE must be tailored to the specific needs of workers, offering protection without hindering productivity.
4. Health Insurance. Ensuring workers have access to adequate health insurance is crucial, particularly for those in rural and underserved areas. This includes addressing the unique challenges faced by workers with complex immigration statuses, who may be hesitant to seek medical care or face barriers in obtaining insurance coverage.
5. Awareness. Implementing acclimatization programs and regular health screenings can help monitor workers’ health and identify early signs of heat stress. This includes educating workers about recognizing early signs of heat stress in themselves and colleagues, and understanding the importance of gradual adaptation to hot working conditions. 
6. Migrant Worker Vulnerabilities. Undocumented workers face unique challenges in accessing heat safety protections, such as fear of retaliation for reporting unsafe conditions, which can lead to underreporting of incidents. This vulnerability highlights the need for stronger protections and outreach strategies specifically tailored to this population.

Employer & Industry

Employers and industries play a critical role in implementing heat safety standards. By investing in infrastructure, regulatory compliance, and technological innovations, they can create safer working environments and ensure the sustainability of their operations.

1. Financial Assistance. Offering grants, subsidies, and tax incentives can support employers in implementing necessary safety measures. Financial support can alleviate the burden on small and medium-sized enterprises, ensuring that all employers can invest in heat safety infrastructure.
2. Physical Infrastructure. Employers must invest in the necessary infrastructure, including hydration stations, shaded rest areas, and cooling systems. These investments are essential for creating a safe working environment and ensuring compliance with the proposed standards.
3. Regulatory Compliance Support. Developing clear guidelines and compliance tools can help employers adhere to the new standards. Providing technical assistance and resources for compliance can simplify the process and encourage widespread adoption of safety measures .
4. Technology & Innovation. Utilizing weather monitoring systems, wearable heat sensors, and mobile health applications can enhance worker safety. These technologies enable real-time tracking of heat exposure and facilitate timely interventions, reducing the risk of heat-related illnesses.
5. Rural Infrastructure. Many agricultural operations are in rural areas with limited resources and infrastructure. This includes a lack of nearby healthcare facilities, making it difficult to quickly respond to heat-related illnesses in the workplace. Investments in rural infrastructure and targeted support can address these limitations.

Regulatory Agencies

Regulatory agencies are essential in enforcing heat safety standards. Increased resources, staffing, and technical expertise, along with robust data collection and public outreach, are necessary to support compliance and drive continuous improvement in safety measures.

1. Resources & Staffing. Adequate staffing is essential to enforce the new standards effectively. Increased financial resources would support hiring additional staff, enhance the technological capabilities for monitoring compliance, and ensure that there are adequate resources to investigate and address non-compliance.
2. Training & Expertise. Ensuring regulatory agencies possess the necessary technical and operational expertise through ongoing training for inspectors and regulatory staff to stay updated on the latest heat safety technologies, practices, and research.
3. Data Collection & Analysis. Developing incident reporting systems, syndromic surveillance, and integration of data with a centralized health and safety database can inform policy decisions and improve safety measures.
4. Public Outreach & Education. Implementing awareness campaigns, community engagement initiatives, and distributing educational materials can increase awareness of safety.
5. Research & Development. Funding for research collaborations with academic institutions and pilot programs to test new heat safety technologies and strategies is vital.
6. Whistleblower Protections. To ensure the effectiveness of heat safety measures, it’s crucial that all workers, including undocumented workers, can report dangerous conditions without fear of retaliation. Strengthening and enforcing whistleblower protections is essential to create a culture of safety and compliance.

Healthcare

A robust healthcare infrastructure is vital to support the prevention, early detection, and treatment of heat-related illnesses among outdoor workers. Investments in medical facilities, telemedicine, emergency response systems, and healthcare worker training are crucial to providing timely and effective care. 

1. Access to Healthcare. Strengthening access to healthcare is crucial, especially in rural and underserved areas. This involves expanding medical facilities and ensuring workers have access to qualified healthcare professionals and affordable treatment options tailored to heat-related conditions.
2. Telemedicine Infrastructure. Developing robust telemedicine platforms enables remote consultations for workers in remote areas. This provides timely healthcare interventions without the need for extensive travel.
3. Emergency Response Systems. Bolstering emergency response capabilities ensures that medical aid is swiftly available during critical heat-related incidents. This reduces potential health complications and improves outcomes for affected workers.
4. Healthcare Worker Training. Training healthcare professionals in the specifics of heat-related illnesses prepares them to offer effective treatment and preventative care. This enhances the overall response to heat stress conditions and improves patient outcomes.
5. Data Sharing & Coordination. Creating data-sharing frameworks between healthcare providers, emergency services, and public health agencies ensures a coordinated response to heat-related health issues. This enhances overall healthcare efficacy and enables better tracking and management of heat-related incidents.

Community & Advocacy Groups

Community and advocacy groups play a pivotal role in bridging the gap between policy and practice. By supporting local networks, grassroots education programs, and worker advocacy efforts, these groups can significantly enhance the effectiveness of heat safety initiatives. Their involvement ensures that programs are culturally appropriate, widely understood, and effectively implemented on the ground.

1. Worker Education. Implementing wide-reaching education and advocacy programs helps raise awareness about heat risks. These efforts promote community-wide preventive measures and empower workers to protect themselves.
2. Advocacy. Ensuring direct worker representation in policy discussions and implementation planning is crucial. Their firsthand experiences are invaluable in creating effective, practical safety measures that address real-world challenges.
3. Local Heat Safety Networks. Supporting the creation of community networks ensures the distribution of heat safety resources. These networks enhance preparedness and response to heat risks at the local level.
4. Worker Advocacy Support. Providing resources to advocacy groups enables effective representation of workers‘ safety interests. This ensures that policies are worker-centered and address the actual needs of those most affected by heat hazards.
5. Community Resilience Planning. Collaborating with community groups to develop localized resilience strategies strengthens community preparedness against heat impacts. This approach integrates workplace safety measures with broader community resilience efforts.

The Federal Government’s Role in Facilitating Investments

Successful implementation of OSHA’s heat safety standard requires substantial federal support and coordination. The government must actively facilitate and incentivize necessary investments to create a robust heat safety infrastructure. By leveraging its resources, the federal government can catalyze nationwide improvements. Key actions include:

1. Program Investment. Must significantly invest in funding agencies like OSHA and HHS to enhance their capacity to implement and enforce the safety program. This includes financial resources for hiring additional staff, improving technological capabilities, and offering comprehensive training and support to employers.
2. Providing Financial Incentives. Should provide targeted grants, subsidies, and tax incentives. These financial aids will alleviate the burden on small and medium-sized enterprises, fostering widespread adoption of advanced heat safety measures.).
3. Capacity Building. Must develop and support comprehensive educational programs and training workshops to enhance the capabilities of the workforce. This will ensure that workers are well-informed and equipped to effectively navigate and implement complex safety regulations.
4. Public-Private Partnerships. Must encourage collaboration between the public sector and private enterprises, leveraging private innovation alongside public resources to ensure that safety solutions are comprehensive and widely accessible.
5. Interagency Coordination. This involves pooling resources, expertise, and efforts from diverse federal agencies to support and enforce the heat safety regulations efficiently. Agencies should identify and allocate resources within their scope to contribute to a broad-based support network—ranging from funding and manpower to specific programmatic initiatives, as well as data-sharing and surveillance.
6. Overcoming Bureaucratic Inertia. Delays and resistance within government agencies can impede the timely adoption and enforcement of new regulations. Streamlining processes and clear mandates can help overcome this inertia.

The Benefits of Investing in Heat Safety Infrastructure

Investing in heat safety infrastructure yields numerous benefits, including:

1. Lives Saved, Improved Worker Health & Safety. Investing in proper heat safety infrastructure significantly reduces the incidence of heat-related illnesses, such as heat exhaustion and heat stroke, which can be fatal. This reduction cascades into numerous health and safety benefits:
   • The most immediate and crucial benefit is the preservation of human life and health
   • Enhances workplace safety culture
   • Reduces long-term health complications from chronic heat exposure
   • Enables better management of pre-existing health conditions exacerbated by heat
   • Improves public health outcomes in heat-vulnerable communities
   • Reduces inequality by protecting vulnerable worker populations
   • Example: a study reported a 91% decrease in heat-related illnesses following the implementation of safety measures.
2. Economic Benefits. Heat safety investments stimulate economic growth through multiple channels, creating a positive ripple effect across businesses and communities. Key economic advantages include:
   • Increased workforce productivity and efficiency
   • Reduced absenteeism and turnover rates
   • Stimulation of local economies through infrastructure investments
   • Reduced healthcare costs for both employers and the broader healthcare system
   • Improved job satisfaction and worker morale
   • Enhanced employer reputation and ability to attract/retain talent
   • Example: the same study saw heat-related illness claims drop from 30 per 1,000 workers to zero, eliminating workers’ compensation claims entirely.
3. Climate Resilience.  As global temperatures rise, building infrastructure to withstand extreme heat conditions becomes crucial for overall climate resilience. This proactive approach offers several strategic advantages:
   • Increases adaptability to rising global temperatures
   • Enables integration with broader climate adaptation strategies
   • Reduces energy consumption through efficient cooling methods
   • Enhances business continuity during extreme weather events
   • Reduces risk of legal liabilities and regulatory penalties
   • Enhances organizational preparedness for climate change impacts

Moving Forward

As we face the escalating challenges of climate change, the urgency to protect our workforce cannot be overstated. The proposed OSHA heat safety standard marks a crucial advancement in safeguarding our agricultural workers from the rise of extreme heat conditions. While some may express concerns about the costs and regulatory burden of these investments, it’s crucial to consider the long-term benefits. The initial expenses are outweighed by reduced healthcare costs, increased productivity, and avoided workers’ compensation claims. These measures protect businesses from potential legal liabilities and reputational damage associated with worker heat-related illnesses or fatalities. Moreover, investing in federal infrastructure to support this standard is a strategic imperative that will yield significant returns in public health, economic productivity, and climate resilience.

By thoughtfully allocating resources, the federal government can create a powerful framework for implementing and maximizing the impact of the proposed standard. The health and safety of millions of workers, particularly in high-risk sectors like agriculture, depend on our ability to create a comprehensive, well-resourced system. Every stakeholder from policymakers to industry leaders must now rise to the occasion. It is imperative that we channel collective efforts and resources before another heatwave claims more lives. The consequences of inaction are too severe to ignore.

For specific actions you can take to protect our outdoor workers, please refer to the strategies outlined in Appendix A: Call to Action Guide.

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Appendix A. Call to Action Guide

This guide offers strategies for various stakeholders to support and enhance the implementation of OSHA’s heat safety rule.

For Policymakers

• Prioritize Funding. Expedite allocation of funds for heat safety infrastructure development.
• Facilitate Collaboration. Promote interagency cooperation to streamline rule implementation.
• Supportive Legislation. Enact laws that reinforce and expand heat safety protections.
• Oversight. Conduct regular reviews of the rule’s implementation and effectiveness.

For Employers

• Proactive Adoption. Implement heat safety measures ahead of the OSHA rule finalization.
• Infrastructure Investment. Allocate resources for necessary heat safety equipment and facilities.
• Training Programs. Develop comprehensive heat safety education for all employees.
• Best Practices. Engage with industry associations to share effective strategies.

For Workers and Advocacy Groups

• Active Participation. Engage in public comment periods and local heat safety initiatives.
• Collaboration. Work with employers to identify and address workplace heat risks.
• Community Education. Raise awareness about heat safety rights and available resources.
• Reporting. Encourage the use of whistleblower protections to report unsafe conditions.

For Healthcare Providers

• Emergency Preparedness. Enhance readiness for heat-related illnesses, especially in underserved areas.
• Ongoing Training. Participate in regular updates on heat illness prevention and treatment.
• Community Outreach. Partner with employers and local organizations to promote heat safety awareness.
• Data Sharing. Contribute to heat-related illness surveillance efforts to inform policy and practice.

For Researchers and Academic Institutions

• Effectiveness Studies. Evaluate various heat safety measures and emerging technologies.
• Innovation. Develop new solutions for heat stress prevention and management.
• Industry Partnerships. Collaborate with businesses to apply research findings in real-world settings.
• Policy Guidance. Provide evidence-based recommendations to inform future regulations.

The U.S. bioeconomy—defined by the National Institute of Standards and Technology (NIST) as “economic activity derived from the life sciences, particularly in the areas of biotechnology and biomanufacturing, including industries, products, services, and the workforce” and valued by some at ~$1 trillion—has been a major focus of policy development over the past few years. These policy advances include the White House Executive Order on “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy” (Bioeconomy EO), the CHIPS & Science Act, and the Inflation Reduction Act (IRA). In March 2024, the Office of Science and Technology Policy (OSTP), announced the launch of the National Bioeconomy Board (NBB). The board will “partner across the public and private sectors to advance societal well-being, national security, sustainability, economic productivity, and competitiveness through biotechnology and biomanufacturing,” highlighting the Biden Administration’s commitment to future-proofing an economically sustainable U.S. bioeconomy. 

Despite these advances, the vast intersectionality inherent to the bioeconomy (e.g., with health, clean energy, national security, climate change, economic development) poses unique challenges for the U.S. government. This complexity makes it difficult for the various agencies to coordinate and even more difficult for the general public to understand the government’s approach to the bioeconomy. Nonetheless, to maintain the continued growth within the bioeconomy that has resulted from these policy advances, it will be imperative to clarify a strategic vision that coordinates and publicizes governmental efforts that support the burgeoning U.S. bioeconomy.

The NBB can play an important role in promoting this strategic vision. As directed by the Bioeconomy EO, the interagency through the Executive Office of the President set up the NBB to promote interagency coordination and collaboration on the bioeconomy. The NBB is co-chaired by OSTP, the Department of Commerce (DOC), and the Department of Defense (DOD), and nine other agencies make up the entirety of the board. Other agencies not represented on the NBB itself, including the Environmental Protection Agency (EPA), work with the NBB through various working groups and play an integral role. 

To understand the range of governmental priorities for the bioeconomy, the overarching strategy, the work underway, the various programs within the agencies, and the role of environmental sustainability, our team at the Federation of American Scientists (FAS) spoke with key agencies represented on the NBB to collect their perspectives.

The perspectives summarized below demonstrate that the agencies align bioeconomy-related initiatives to their varied mission areas and, through the NBB and other interagency activities, are working together to develop a shared vision. However, the summaries also show the diversity in focus that informs how agencies approach the bioeconomy. The agency views encompass the broader bioeconomy landscape, including biotechnologies from commodity fuels and agriculture to individualized therapeutics, and biomanufacturing solutions from biomass production to final product. This range highlights both the important role that each agency plays in supporting the U.S. bioeconomy as well as the challenge in coordinating their activities and programs across the federal government.

Approach

In order to collect perspectives from the agencies represented on the NBB around the U.S. bioeconomy, FAS conducted semi-structured interviews with key NBB officials from the OSTP, DOC, DOD, Department of Energy (DOE), Department of Health and Human Services (HHS), and the U.S. Department of Agriculture (USDA) from May 2024 through June 2024. With the exception of USDA, all agency interviews were conducted over Zoom and answers were documented by note-taking. All summaries have been reviewed by agency representatives to confirm consent and validity. The USDA perspective was summarized using publicly available reports and have also been confirmed for validity by an agency representative.

Perspectives from these agencies on the Bioeconomy EO deliverables, bioeconomy-related programs, coordination, goals, hurdles, and the role of environmental sustainability are summarized below. The full list of questions used in the semi-structured interviews can be found in Appendix A.

Agency Perspectives

Office of Science & Technology Policy

For OSTP’s perspective, FAS conducted a semi-structured interview with Dr. Sarah Glaven, principal assistant director for biotechnology and biomanufacturing.

The Office of Science & Technology Policy plays an important role in interagency coordination for topics, like the bioeconomy, that cut across many different agencies, and is one of the co-chairs for the NBB. In adherence with the Bioeconomy EO, OSTP has coordinated interagency efforts and published several reports on the bioeconomy: Bold Goals for U.S. Biotechnology and Biomanufacturing, Building the Bioworkforce of the Future, and Visions, Needs & Proposed Actions for Data for the Bioeconomy Initiative. They are currently working with interagency groups on several activities, including one that recently published a report, in conjunction with USDA and other agencies, that recommended revisions to the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS) to better capture economic activity related to the bioeconomy. The creation of the NBB itself fulfills directives from both the Bioeconomy EO as well as the CHIPS & Science Act, which called on OSTP to establish a coordination office on these topics. Currently, due to a lack of funding, OSTP is not an official coordinating office but will function to coordinate activities through the NBB. 

According to OSTP, the Bioeconomy EO reflects the whole-of-government approach that will be needed to support the bioeconomy. For the near term, OSTP plans to show the value and utility of the NBB, execute policy from the Bioeconomy EO, prioritize specific actions from the resulting Bioeconomy EO reports, highlight significant investments, and produce a report on the NAICS and NAPCS codes. In the long term, OSTP hopes that the NBB will become a sustainable government entity that drives a clear national strategy to move the bioeconomy forward and enables the United States to work collaboratively with global partners. 

A key challenge is measuring the bioeconomy. It is difficult to prioritize, strategize, or advocate for additional resources in the absence of baseline economic metrics to track impact or estimate the potential return on investment. Ultimately, OSTP believes it is important to clarify the definition of the bioeconomy in order to create measurements and classifications.

A challenge for OSTP is continuity as it experiences staff turnover and administration changes. However, the NBB and coordination of the bioeconomy portfolio will be well positioned to persist, in part by relying on the NBB’s co-chairs. Also, the Bioeconomy EO allowed OSTP to create principal and assistant director positions for the bioeconomy portfolio, which can help ensure that it remains a high priority. At OSTP, this portfolio sits within the Industrial Innovation Group, which also houses coordination efforts for semiconductors and clean energy. OSTP leadership understands the importance of the bioeconomy and is keen to see the intersections of biomanufacturing with other initiatives, like the DOE’s Earth Shot programs and other clean energy initiatives. 

On the issue of environmental sustainability and the bioeconomy, OSTP highlights efforts by DOE to push for sustainable aviation fuels and USDA’s sustainable biomass supply chain framework as initiatives that are setting the pace for sustainability. There is also an opportunity to consider how biomanufacturing and biosynthesis fit into the broader sustainable chemistry landscape.

Department of Commerce

For DOC’s perspective, FAS conducted a semi-structured interview with Dr. Christopher Szakal, acting director, program coordination office at the National Institute of Standards and Technology.

The Department of Commerce is one of the NBB co-chairs. DOC is sector-agnostic and is interested in the bioeconomy as a way to support the broader economy, remain competitive, and solve broader challenges, such as those related to supply chain resilience. In response to the Bioeconomy EO, the DOC has released the bioeconomy lexicon from NIST and the Feasibility Study for measuring the bioeconomy from the Bureau of Economic Analysis. It has also participated in several interagency activities, including development of OSTP’s Bold Goals report and USDA’s Biomass Supply Chain report, as well as ongoing working groups focusing on updating systems for measuring economic activities (e.g., the NAICS and NAPCS codes) and on biological data and cybersecurity. Separate from the executive order, the Inflation Reduction Act provided significant investments for the Economic Development Administration in biotechnology-related regional technology hubs. Other ongoing activities at DOC in support of the bioeconomy include efforts to support biotechnology and biomanufacturing standards development at NIST, supply chain analyses at the International Trade Administration, work at the Bureau of Industry and Security and at the Patent and Trademark Office to ensure a safe and fair market, and the Workforce Development Strategy.

By nature, DOC keeps a broad perspective and tries to understand how the bioeconomy intersects with other parts of the economy and how technological developments may impact progress. There are important intersections of the bioeconomy with artificial intelligence (AI) and with data security, and policy development in these other areas will have implications for the bioeconomy. For example, the October 2023 Executive Order on AI called for significant new requirements for providers of synthetic nucleic acids to conduct biosecurity screening, which will have implications for biotechnology and biomanufacturing. NIST is tasked with developing standards for this new policy. The intersectional nature of the bioeconomy requires coordination both within the DOC and across the U.S. government. A key challenge is the need for sustained funding because coordination requires time and effort. 

On environmental sustainability, the DOC prioritizes the market and what U.S. companies will find profitable in both the near term and the long term. Elevating sustainability has been challenging because there is uncertainty in how sustainability is measured. Additionally, market drivers have been inconsistent relative to the level needed to address the uncertainty. DOC is looking to utilize the NBB to help provide clarity on how to achieve more consistent market forces in support of sustainability to drive growth of the bioeconomy. 

Department of Defense

For DOD’s perspective, FAS conducted a semi-structured interview with Dr. Peter Emanuel, senior research scientist, bioengineering at U.S. Army Combat Capabilities Development Command.

The Department of Defense is one of the NBB co-chairs. In September 2022 (before the Bioeconomy EO was announced), DOD announced a $1.2 billion investment in biomanufacturing. In March 2023, DOD released a Biomanufacturing Strategy, which was informed by both the National Defense Authorization Act for Fiscal Year 2023 and the Bioeconomy EO. In support of this strategy and the investments made by DOD, the Department’s Defense Production Act Investments (DPAI) Office published an open Request for Information that sought input from industry on biomanufactured products and process capabilities that could help address defense needs. Significant additional investments in biomanufacturing are likely to be forthcoming.

The bioeconomy portfolio is a tiny portion of the overall programmatic budget for DOD. Previously, the DOD’s interest in biology and biotechnology was limited to military medicine and chemical and biological defense, but the department is increasingly focused on nonmedical biomanufacturing applications and believes that they will be key for ensuring national security. The department also acknowledges the importance of workforce development and the need for standardization and infrastructure for the bioeconomy and strongly supports these areas. This commitment can be seen with DOD’s large investments in 2020 in BioMADE, a Manufacturing Innovation Institute focused on creating a sustainable, domestic end-to-end bioindustrial manufacturing ecosystem. 

In the future, DOD hopes to take advantage of biomanufacturing’s potential to support defense objectives beyond just medical countermeasures and other human health-related advances, such as production of bio-based materials, chemicals, and foods. However, DOD faces challenges both internally and externally in communicating the full potential of the bioeconomy and biomanufacturing for DOD. 

On environmental sustainability, DOD believes that economic and environmental sustainability for the bioeconomy go hand-in-hand. For example, a company that could make chemicals without waste would have a significant economic advantage and would support environmental sustainability. Historically, DOD has seen significant costs due to polluted sites, and so understands the value of cleaner products and processes. In addition, DOD is investing in different technologies that would valorize waste streams.

Department of Energy

For DOE’s perspective, FAS conducted a semi-structured interview with Dr. Valerie Reed, director, Bioenergy Technologies Office.

The Department of Energy has many goals for advancing the bioeconomy, with the common denominator being to decarbonize America’s transportation and fuel sectors and to build resilient clean energy for generations to come. In response to the Bioeconomy EO, the DOE contributed to the OSTP Bold Goals report and was tasked to work with other agencies to write reports on National Security Recommendations for Federal Procurement (forthcoming) and best practices for cyber security documentation. Furthermore, DOE also played a large role in an upcoming biotechnology and biomanufacturing report mandated by the Bioeconomy EO. Outside of the direct requirements from the EO, the DOE plays a crucial role in supporting industrial biotechnology through additional reports and their involvement in ongoing interagency activities. For example, the Billion Ton Report provides a comprehensive assessment of biomass availability today and how to sustainably produce more than one billion tons of biomass per year to meet the demand for sustainable aviation fuel production. 

DOE’s bioeconomy efforts are concentrated within the Bioenergy Technologies Office (BETO) and the Office of Science. BETO aims to utilize biomass for sustainable and renewable fuel and chemical production, while the Office of Science supports fundamental research that enables the bioeconomy, including synthetic biology and thermochemical conversion. Under the Inflation Reduction Act and CHIPS & Science Act, significant support was given to bioenergy solutions and clean energy demonstrations, including DOE tax incentives aimed at carbon reduction in fuel production.

In the short term, DOE is focused on prioritizing the use of biomass for Sustainable Aviation Fuel (SAF) and marine fuel production, as well as supporting renewable diesel and ethanol for medium- and heavy-duty vehicles. Long-term goals include transitioning to electrification using biomass, achieving substantial SAF production by 2035 through the SAF Grand Challenge, and scaling up the production of specific chemicals by 2035 as part of the industrial decarbonization strategy. Additionally, in coordination with the USDA, there are focused efforts to increase cultivation of purpose-grown energy crops.

One of the major hurdles the DOE currently faces, and may continue to face in the future, is ensuring sustained funding levels that support ongoing development. Currently, biomass is seen as an expensive feedstock. While the IRA provided an initial policy bridge, it is essential to establish a longer-term incentive to meet market demand, like the 40B (SAF production) and 45Z (clean fuel production) tax credits. 

On environmental sustainability, the DOE is very focused on goals for decarbonization of transportation and fuels, including replacing petroleum-based products with sustainable biomass solutions and conducting life cycle assessments (LCAs) to measure sustainability impacts throughout the supply chain. DOE created the GREET Model for LCAs, which was updated recently, to reduce ambiguity and to help standardize the process for measuring carbon emissions. Additionally, DOE’s Clean Fuels and Products Earthshot is an important cross-agency collaboration that supports accelerating bio-based fuels and chemicals production and decarbonizing both the fuel and chemical industry.

Department of Health & Human Services

For HHS’s perspective, FAS conducted a semi-structured interview with Dr. Lyric Jorgenson, associate director for science policy and the director of the Office of Science Policy at the National Institutes of Health (NIH), and Dr. Julia Limage, director, Office of Strategy, Policy, and Requirements in the Administration for Strategic Preparedness and Response (ASPR).

The Department of Health & Human Services has two representatives on the NBB, one from NIH and one from ASPR. HHS has a broad mission in support of human health, and many of its programs could be considered part of the bioeconomy. However, the Bioeconomy EO outlined a set of priorities that called for additional focus at HHS on advances specific to biotechnology and biomanufacturing, many of which were included in the OSTP Bold Goals report. The EO also tasked HHS with leading the establishment of a Biosafety and Biosecurity Innovation Initiative; a strategic plan for this initiative will be available soon. Another area of intersection of HHS and the Bioeconomy EO is on the regulatory side: the Food and Drug Administration worked with USDA and EPA to provide updates on the regulatory system as deliverables for the EO. Many of the activities related to the EO draw on interagency working groups and other ongoing activities—for example, the work toward pandemic preparedness and biodefense, as well as collaborations between NIH and NSF on health-relevant research.

In the near future, HHS will focus on advancing biotechnologies such as multi-omic medicine, gene editing, and other therapeutics tailored to individual patients. Biomanufacturing and scale-up is another key focus to increase speed and availability of key medicines. In regards to public health, the COVID pandemic highlighted the need for fast and secure biomanufacturing for vaccine production. The Biomedical Advanced Research and Development Authority (BARDA) in ASPR has made significant investments in biomanufacturing for this reason. ASPR also has an Office of Industrial Base Management and Supply Chain to support domestic biomanufacturing in case of public health emergencies.

For HHS, activities related to the bioeconomy directly and unambiguously support the department’s mission and will continue to be prioritized. A key challenge for HHS is the need for sustained funding, especially for coordination, which requires time and effort above and beyond programmatic work. To be effective, activities initiated by the Bioeconomy EO will need to be funded. Some HHS activities, including some related to biomanufacturing of medical countermeasures, were funded with COVID supplemental funding that will soon run out.

On environmental sustainability, HHS has not had any significant focus. However, there have been efforts to decrease the use of single-use plastics and equipment in research and public health activities.

United States Department of Agriculture

For USDA’s perspective, FAS gathered information from publicly available reports and documents, with guidance and direction from Herrick Fox, USDA’s bioeconomy coordinator in the Office of the Chief Economist, and Greg Jaffe, senior advisor in the Office of the Secretary.

The Bioeconomy EO tasked USDA with a wide range of deliverables, and USDA has released many related reports and products that reflect its bioeconomy-related priorities. One set of deliverables focuses on biomass and feedstocks, and supports the strategic vision outlined for agriculture in OSTP’s Bold Goals report. This includes the report on Building a Resilient Biomass Supply—A Plan to Enable the Bioeconomy in America, along with an Implementation Framework. USDA also has a long-standing focus on bio-based products, including support of the BioPreferred Program, a program created by the 2002 Farm Bill to increase the purchase of bio-based products and reauthorized in the 2018 Farm Bill. Their recent Economic Impact Analysis of the U.S. Biobased Products Industry report summarizes the status of bio-based products, an important component of the bioeconomy.

USDA also plays a central role in regulating biotechnology products, and the Bioeconomy EO called for updates to the regulatory system. In response, USDA (along with the FDA and the EPA) conducted stakeholder outreach, which is summarized in a report on Ambiguities, Gaps, and Uncertainties in Regulation of Biotechnology Under the Coordinated Framework. USDA also released a Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology and produced an updated Coordinated Framework website. Activities to improve coordination across the three major regulatory agencies are ongoing.

Unlike most federal departments and agencies, most programs and activities at USDA have a link with the life sciences, including those that support food and fiber, forests and grasslands, and other natural resources, as well as the manufacturing of numerous bio-based products and biofuels from these resources and the R&D and infrastructure that supports it. From USDA’s perspective, the department has served the bioeconomy since its founding in 1862. This broad focus provides many opportunities for strategic partnerships with other parts of the U.S. government working on the bioeconomy, and there are many different ways that USDA can contribute to the NBB.

On environmental sustainability, USDA has demonstrated its commitment to developing a circular bioeconomy, which is reflected in its Biomass Plan, and in its support for bio-based products and sustainable agriculture initiatives.

Conclusion

The agencies that make up the NBB highlight the complex nature of the U.S. bioeconomy and the various sectors that fall under it. Nevertheless, despite this complexity, the NBB is providing a whole-of-government approach to enable agencies to better support the burgeoning U.S. bioeconomy. The work underway is underpinned by the agencies’ priorities and programmatic expertise, but comes together to build the foundational base needed to support and grow the U.S. bioeconomy. Each agency also has a focus on environmental sustainability, with some, like DOE, DOD, and USDA, having a stronger focus due to their direct connections with the environment. Finally, agencies also agree on the need for more data on the bioeconomy’s impact as the different sectors evolve and the need for sustained funding to promote coordination, which takes time and effort beyond just programmatic work.

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Appendix A. Interview Questions

1. In response to the September 2022 Bioeconomy EO, your agency has produced some reports and other deliverables on the bioeconomy.
   • Are we missing any deliverables? Are there any other reports or activities that are already completed or still to come in response to the EO?

2. Are there programs or other deliverables relevant to the bioeconomy that your agency has pursued under the Inflation Reduction Act or the CHIPS & Science Act?

3. Are there other activities within your agency that you believe support the bioeconomy? Is the bioeconomy broader than what was captured by the EO and these other efforts?

4. What does your agency hope to achieve in the foreseeable future and in the more distant future regarding the U.S. bioeconomy?
   • Are these goals related to the OSTP Bold Goals Report or other deliverables for the Bioeconomy EO?
   • To what extent will this progress be prioritized within your agency? How central to your agency is progress in the bioeconomy – now and into the future?

5. What are the major hurdles your agency currently faces or may face in the future in reaching these goals?

6. How does your agency tackle the issue of creating an environmentally sustainable bioeconomy and/or a circular bioeconomy?
   • Are there any initiatives in place currently or coming up in the near future that speak towards this?