Biodefense Indicators

A. Empower the Vice President with jurisdiction and authority.

The White House did not institutionalize bio­defense in the Office of the Vice President. Vice President Biden met with the Panel in December 2015, expressed concern regarding the biological threat, and agreed that the White House could better manage federal efforts to address the threat. More recently, the White House consolidated responsibilities for global health security, counter­ing biological threats, medical preparedness, and biosurveillance under a new National Security Council (NSC) staff position – Senior Director for Global Health Security and Biodefense – and reorganized the NSC staff structure to improve its response to biological events. This new position, while welcome, does not meet our recommendation to establish leadership in an official who can act on behalf of the President with the Executive Branch and the Congress. Further, despite the new NSC position, other NSC staff continue to retain responsibility for other aspects of biodefense (e.g., crisis response and nonproliferation), maintaining portfolio fragmentation.

Coordination

A. Require broad federal participation.

The White House did not establish a Biodefense Coordination Council. The NSC did continue its pre-existing engagement with the departments and agencies through its Interagency Policy, Deputies, and Principals Committees. The White House requires department and agency participation in these committees, some of which addressed specific biodefense issues over the past year. However, this piecemeal approach does not meet the need for a formalized council established at the Deputy Secretary level. S. 2967, the National Biodefense Strategy Act of 2016, would establish the Council. At the time of writing, this bill was before the full Senate for consideration.

B. Invite broad non-federal stakeholder participation.

The White House did not establish the Council and thus did not populate it with non-federal stakeholders. The White House Office of Science and Technology Policy (OSTP), per its normal process, continued to solicit feedback from the private sector; state, local, territorial, and tribal (SLTT) governments; science and higher education communities; and other nations to develop and implement science and technology policies and budgets. The OSTP President’s Council of Advisors on Science and Technology (PCAST) depended on academia to inform several reports addressing biodefense, systems engineering in healthcare, agricultural preparedness, drug innovation, influenza vaccine, and H1N1 influenza. These activities, however, continued to take place outside of the needed Biodefense Coordination Council structure. S. 2967 would establish the Council with non-federal stakeholder participation.

C. Structure the Council for consensus and accountability.

The White House did not establish the Council and, therefore, did not establish measures of consensus and accountability.

A. Collate the whole of biodefense policy.

In its May 2016 Statement of Administration Policy on H.R. 4909, the National Defense Authorization Act for Fiscal Year 2017, the White House acknow­ledged that the Executive Branch works under several existing biodefense-related Presidential Policy Directives and stated that the development of a comprehensive biodefense strategy was, therefore, unnecessary. It also stated that NSC staff have been working with departments and agencies to develop, coordinate, implement, and review biodefense efforts. The Commission is aware that the NSC had initiated a thorough review of biodefense policy, but it is not clear whether or how this important work will be further used, since the White House has rejected the need for a comprehensive strategy. S. 2967 would call for the President to develop a National Biodefense Strategy that aligns all federal efforts to establish an effective, unified biodefense enterprise. H.R. 4909 would require the Secretary of Agriculture, Secretary of Defense, Secretary of Health and Human Services, and Secretary of Homeland Security to develop a joint biodefense strategy, calling for an inventory of existing policies and plans as the first step of that process. At the time of writing, Congress had not passed either Act.

B. Identify requirements within all extant policies.

As a component of their efforts to identify existing policies and strategies, the NSC and OSTP identified requirements described within applicable biodefense legal and policy instruments. S. 2967 and H.R. 4909 would capture this recommendation.

A. Develop and execute a mandatory annual biodefense call for data.

OMB collects some biodefense data in accordance with Presidential Policy Directive 2, but these data do not address the full spectrum of activities undertaken by the entire biodefense enterprise. S. 2967 would require such data collection.

B. Conduct a cross-cutting biodefense budget analysis.

The White House did not complete the data call and, therefore, did not conduct a cross-cutting biodefense budget analysis.

A. Develop joint congressional oversight agendas.

Congressional leadership did not develop joint congressional oversight agendas at the start of the second session of the 114th Congress. Congress also did not hold joint-committee and joint-chamber hearings in accordance with our recommendation. While eight House and seven Senate Committees did hold 34 biodefense-related oversight hearings – demonstrating significant interest – these hearings were not components of established, comprehensive, and strategic oversight agendas.

A. Create a National Intelligence Manager for Biological Threats.

The DNI did not create this position. Within the Office of the Deputy Director of National Intelligence, National Intelligence Managers (NIMs) develop Unifying Intelligence Strategies for geographic and topic areas that help members of the Intelligence Community (IC) collaborate on high-priority intelligence issues. While several existing NIMs address various aspects of the biological threat as part of their portfolios, no single person addresses the entire issue, ensures adherence to a unifying intelligence strategy, arbitrates conflicts between the NIMs, or coordinates IC efforts to address the biological threat. S. 3017, the Senate Intelligence Authorization Act for FY 2017, would direct the DNI to analyze organizational requirements and responsibilities, including potentially creating new positions, one of which could be a NIM for Bio­logical Threats. At the time of writing, Congress  had not signed the Act into law.

B. Make biological weapons programs and related activities a discrete intelligence topic.

The IC continues to determine whether and how it should assign priorities to the biological weapons programs and activities of countries and non-state actors, and to classes of biological agents. Through its Biological Sciences Advisory Group, the IC interacts with private sector experts, but the Group does not foster analytical outreach or collaboration. The IC recognizes the need for scientific and other rele­vant knowledge within the Community, but made no significant attempts to increase expertise over the past year.

C. Require a biodefense spend plan from the National Institute of Allergy and Infectious Diseases.

The National Institute of Allergy and Infectious Diseases (NIAID) did not produce a biodefense spend plan. NIAID receives the majority share of biodefense funding for MCM, but a lack of transparency means it remains unclear whether and how its expenditures match the threats prioritized by the Biomedical Advanced Research and Development Authority (BARDA). The Public Health Emergency Medical Countermeasures Enterprise now provides a multiyear budget to Congress, but the budget does not demonstrate how technology will transition from NIAID to BARDA.

B. Place the Federal Bureau of Investigation in charge of the National Bioforensics Analysis Center.

The National Bioforensics Analysis Center (NBFAC), administered by the DHS Science and Technology Directorate (S&T), provides nearly all its services to the Federal Bureau of Investigation (FBI). This inefficient arrangement creates an unnecessary layer of bureaucracy for the primary end-user – the FBI – which should have housed the NBFAC from its inception. OMB, DHS S&T, and the FBI have begun discussing requirements for hand-off. Congress has not yet acted to enable this transfer.

A. Include the Federal Emergency Management Agency in efforts to address remediation.

OSTP considered and worked on biological response and recovery policy (including environmental decontamination and remediation) issues in prior years, but did not include a representative from the Federal Emergency Management Agency (FEMA) in those meetings. While the OSTP National Security and International Affairs Division did include FEMA in efforts to leverage science and technology to improve disaster preparedness this past year, these efforts did not address remediation.

B. Assign responsibility to the Environmental Protection Agency for environmental decontamination and remediation.

Six Senate Committees and six House Committees exercise jurisdiction over the Environmental Protection Agency (EPA). None amended statute to place the EPA Administrator in charge of environmental decontamination and remediation after biological accidents or attacks. Congress also did not provide funding for bioremediation to the EPA or any other federal agency.

A.  Implement the National Strategy for Biosurveillance.

The White House released the National Strategy for Biosurveillance in July 2012 and committed to producing an accompanying implementation plan by December 2012. The White House sub-Interagency Policy Committee that coordinated the development of the Strategy drafted an implementation plan, but did not publish or implement it.

A. Create an interagency biosurveillance planning committee.

The Secretary of Homeland Security did not establish this committee or make it the nexus for active collaboration among federal, non-federal, and non-governmental partners. In support of national biosurveillance, the DHS Office of Health Affairs collaborates with interagency partners, but while documents such as the National Biosurveillance Integration Center Concept of Operations describe various working groups, none exists for biosurveillance planning.

A. Assess the viability of the National Biosurveillance Integration System as the prime integrator of biosurveillance information.

The NSC did not examine the National Bio­surveillance Integration System (NBIS) to determine whether it yields useful information. DHS recognizes that it cannot fulfill congressional intent for NBIS if it cannot fully access needed federal and non-federal biosurveillance data and information, but the Department continues to try to make the System work while interagency issues confound its utility.

B. Fund the National Animal Health Laboratory Network at a level that allows it to achieve success.

Congress funded the National Animal Health Laboratory Network at its authorized level in H.R. 2029, the Consolidated Appropriations Act of 2016. This positive action is primarily U.S.-centric, and further U.S. government activity will need to address gaps in international biosurveillance capabilities.

C. Establish reasonable personal protective equipment guidelines and requirements in advance of a biological event.

The Secretary of Health and Human Services did not commission the Institute of Medicine to examine current personal protective equipment (PPE) research and requirements in consideration of potential biological threats. While the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) established and coordinated interagency working groups to address supply disruptions concerning PPE during public health emergencies, the ASPR did not establish guidelines and other requirements for PPE. The Centers for Disease Control and Prevention (CDC) provides general guidance for ongoing use of PPE in health care settings and by emergency medical services, but it only makes specific recommendations to tailor this guidance after an outbreak occurs in or affects the United States.

A. Strengthen the Joint Counterterrorism Assessment Team.

The Office of the DNI did not improve upon partnerships that form the basis of the Joint Counterterrorism Assessment Team (JCAT) because it believes the Team already functions well. The DNI did not solicit feedback from state and local members of the Team on how JCAT can function in a way that allows these stakeholders to participate more fully and provides more value to them. Thus, these personnel continue to struggle to advocate for the intelligence needs of SLTT partners.

B. Strengthen the ability of local police intelligence units to address the biological threat.

The Attorney General and the DNI did not share analytic methods relevant to local police intelligence units to assist in the development of more robust and effective biological threat analysis.

C. Enable fusion centers to address the biological threat.

The FEMA Administrator and the DHS Under Secretary for Intelligence and Analysis provide technical assistance to fusion centers. Activities in 2016 did not build upon previous efforts to enable fusion centers to work with members of the public health and other relevant communities to address the bio­logical threat.

A. Appropriate Public Health Emergency Preparedness funding to authorized levels or the President’s request, whichever is higher.

H.R. 2029, the Consolidated Appropriations Act, 2016, exceeded both the President’s request and the authorized level for Public Health Emergency Preparedness funding. Note that neither the President nor the Congress returned funding to levels they provided in the years following the anthrax events of 2001.

A. Standardize the development of clinical infection control guidelines before biological events occur.

Congress did not direct HHS and the Department of Labor (DOL) to implement a process to develop clinical guidelines for treatment, infection control, use of PPE, waste management, and other activities needed in the hospital setting to address biological events, in advance. HHS and DOL continue instead to address individual outbreaks (e.g., Zika) as they occur. The Administration, which could have taken the initiative without explicit congressional authorization, did not direct the CDC and Occupational Safety and Health Administration (OSHA) to identify and publicly communicate specific steps for this process. The CDC (specifically the National Institute for Occupational Safety and Health, NIOSH) and OSHA did work together to develop guidance to protect health care and outdoor personnel from occupational exposure to Zika virus.

B. Institute a process for obtaining and incorporating feedback regarding clinical infection control guidelines during biological events.

The White House did not direct the Secretary of Health and Human Services and the Secretary of Labor to create a standing group of experts to review feedback from federal, SLTT, and private health care facilities and meet weekly to evaluate, update, and reissue clinical guidelines during bio­logical events. However, OSHA and NIOSH did solicit input from private sector experts as they developed Zika guidelines.

A. Cap Hospital Preparedness Program management and administration costs at three percent.

A provision in the introduced version of H.R. 3299, the Strengthening Public Health Emergency Response Act of 2016, would have addressed this recommendation, but the House Committee on Energy and Commerce voted to remove it because some Members did not believe this approach would mitigate the financial inefficiencies within the grant program. HHS reported to the Commission that it regularly withholds about 5.6% of the program’s funds, while states withhold about 21%. HHS, therefore, believes that it would be better to reduce state withholding. Neither Congress nor HHS ensured in the last year that the greatest amount of funding reached intended recipients for a grant program that is already too small to achieve its purpose.

A. Stratify hospitals.

HHS did not establish a biodefense hospital system. They did not stratify hospitals to incorporate recognition, identification, and mitigation at lower level institutions, and rapid assured referral with surge capacity. However, the ASPR did issue grants to increase the capacity of some hospitals to respond to Ebola, an approach that the ASPR and stakeholders hope will lend itself to other infectious diseases. The Secretary of Health and Human Services did not add biodefense responsibilities to Accountable Care Organizations, trauma centers, and hospital coalitions to expand their capabilities. The Secretary did approve and allow the Administrator for the Centers for Medicare and Medicaid Services (CMS) to finalize a rule regarding minimal emergency preparedness requirements for Medicare and Medicaid providers and suppliers to address biological events and other emergencies.

A. Determine logistics and funding needs.

The CDC worked with the top ten Urban Area Security Initiative cities to assess their MCM dispen­sing capabilities, capacity, and timeliness. The CDC also addressed forward deployments, warehouse redistribution, and process improvements. One city has partially justified advance receipt of Strategic National Stockpile (SNS) assets and is continuing to work with the CDC toward receipt of forward deploy­ments. CDC experience with this process will inform its determination of assessment, logistical, and other requirements to forward deploy assets to other jurisdictions.

A. Continue to strengthen implementation of the Biological and Toxin Weapons Convention where U.S. support is unequivocal.

Although the Secretary of State did not lead efforts to revitalize the Biological and Toxin Weapons Convention (BWC), the United States did continue to support the BWC financially. The United States also participated in discussions during the April and August 2016 BWC preparatory meetings, as well as the Eighth BWC Review Conference in November 2016, to identify and establish substantive national implementation measures that reduce the threat of biological weapons. The United States co-convened meetings and submitted several working papers in advance of the August 2016 BWC preparatory meeting, recommending that parties to the BWC routinely determine the impact of cutting-edge science and technology (e.g., gene drives) and invite more subject matter experts to assist with these determinations.

B. Set U.S. goals for the Biological and Toxin Weapons Convention and determine the conditions necessary to achieve them.

NSC staff, with the Department of State (DOS) and other involved federal agencies, used the intervals leading up to BWC review conferences to determine some desired outcomes. However, the Secretary of State did not employ a high-level emissary to press these issues with other parties to the treaty in advance of these conferences. The Administration set several goals for the BWC and began exploring conditions necessary to achieve them, particularly regarding the need to evaluate the impact of relevant advances in science and technology

A. Conduct a review of military-civilian collaborative efforts.

The Department of Defense (DOD) did not undertake a formal review of previous and current efforts to collaborate with civilian counterparts and partners. However, the Department did participate in meetings to discuss collaboration regarding a wide variety of issues (e.g., conflict prevention, crisis response, disaster preparedness, humanitarian assistance, surgery, trauma care, and vaccine development). Some military and civilian efforts continued to operate in parallel, with no discernible improvement in communication between the two sectors on biodefense.

A. Prioritize innovation in medical countermeasures at agencies with biodefense responsibilities.

BARDA did not devote at least ten percent of its FY2016 budget request to fund innovative technologies to address a broad spectrum of biological threats. The struggle to field an MCM for Zika virus underscores urgent deficiencies in MCM innovation.

B. Exploit existing innovation.

The Director of NIAID, the Director of BARDA, and the Deputy Assistant Secretary of Defense for Chemical and Biological Defense (DASD Chem/Bio) did not coordinate to identify at least five promising novel technologies applicable to MCM development for material threats. Individually, these agencies have sought or evaluated some platform capabilities for improved response to emerging threats, but they did not work together in this regard.

A. Fund the medical countermeasure enterprise to no less than authorized levels.

Congress doubled the annual appropriation to the BioShield Special Reserve Fund in H.R. 2029, the Consolidated Appropriations Act, 2016. They also substantially increased advanced development funding. Yet the FY 2017 President’s Budget Request fell short by at least $160 million for Project BioShield. We are perplexed by this decreased request in light of Ebola, Zika, and the continued threat of bioterrorism. It is now up to the House and Senate to make up the difference and appropriate the full level of required funding.

B. Re-establish multi-year biodefense funding for medical countermeasure procurement.

Neither the President nor Congress re-established multi-year funding for Project BioShield. Thus, the marketplace for MCM remains at significant risk. Without a multi-year appropriation (like the 10-year advanced appropriation for the Special Reserve Fund that expired in 2013), government commitment to industry for developing biothreat vaccines, therapeutics, and diagnostics appears weak and short-term.

C. Address prioritization and funding for influenza preparedness.

The ASPR continues to work on influenza preparedness, and informed the Commission that it recently launched a new seasonal influenza vaccine initiative by leveraging investments in pandemic influenza preparedness funding. However, the ASPR did not confirm that it would review – or has reviewed, at least once every five years – existing pandemic influenza assets or assess their ability to fulfill pandemic preparedness goals. While seasonal influenza is an important public health problem, pandemic influenza is a national security problem. Many federal pandemic influenza vaccine assets were purchased about a decade ago and budgets have fallen dramatically since then. The CDC recently showed that the licensed H5N1 vaccine would not have protected humans from the highly pathogenic strain that caused a massive poultry epidemic in the Midwest in 2015. The absence of a regular and transparent assessment of capabilities for and gaps in pandemic influenza preparedness must be addressed, as should more effective engagement with industry. Additional congressional oversight is needed.

D. Improve the plan for incentivizing the private sector and academia.

The ASPR and DASD Chem/Bio did not convene stakeholders to mutually identify the set of incentives that are needed for industry and feasible for government. Industry – the only provider of MCM – thus continues to operate in an incentives vacuum and with uncertain federal commitment to the MCM enterprise.

A. Return contracting authority to the Biomedical Advanced Research and Development Authority.

The Office of the ASPR continued to defend its decision to retain the contracting authority it previously removed from BARDA. H.R. 3299 and S. 2055, the Medical Countermeasure Innovation Act of 2016, would require transition of this authority back to BARDA. As of the time of this writing, Congress had not voted on either bill.

B. Leverage previously provided authorities.

BARDA used its Other Transaction Authority (OTA) once since October 2015. This raises to two the number of OTA-based awards BARDA has issued since its inception. The Commission encourages further use of flexible funding authorities where appropriate.

C. Eliminate Office of Management and Budget review of BioShield procurements.

H.R. 3299 and S. 2055 both amend the Public Health Service Act to eliminate the artifactual and bureaucratic burden of OMB contract review.

A. Fund the development of advanced environmental detection systems to replace BioWatch.

In S. 3001, the Department of Homeland Security Appropriations Act of 2017, Congress expresses frustration with the prolonged review by DHS of DOD environ­mental biodetection systems, and provides an additional $12 million to accelerate research and development underway at DHS S&T for auto­nomous, real-time field screening technologies and related purposes. DHS S&T began partnering in October 2016 with the U.S. Army Edgewood Chemical Biological Center to test and evaluate DOD biodetection technology for civilian use and to advance SenseNet, an indoor biodetection program that seeks to improve performance while cost-sharing via commercial application. The White House did not require departments to engage in a formal process for the sharing of biodetection information and technology. The White House must take responsibility for determining a federal vision for environmental biodetection.

A. Undertake a major reassessment of the Select Agent Program.

Congressional committees continued oversight of the Federal Select Agent Program. However, Congress has yet to require a thorough re-examination of the Program. Several Executive Branch advisory bodies provided after-action reports and recommendations to improve the existing program, but none comprehensively reassessed it.

A. Convene human and animal health leaders.

The Secretary of State did not convene human and animal health leaders to evaluate current public health response mechanisms or develop a strategy or implementation plan for this purpose. However, the United States participated in multilateral meetings held by the U.N. and supported the preexisting Global Health Security Agenda (GHSA) assessment process that measures individual country capacity to prevent, detect, and respond to infectious disease threats. The DOS also worked to increase non-governmental engagement in the GHSA, including some non-governmental human and animal health leaders. U.S. leadership on animal health is especially important given that the GHSA process is becoming very focused on human health and not according sufficient priority to the animal-based zoonotic disease threat to human populations.