WHERE ARE THE COUNTERMEASURES?

PROTECTING AMERICA'S HEALTH FROM CBRN THREATS

A REPORT OF THE NATIONAL BIODEFENSE SCIENCE BOARD

1. The Secretary of HHS, in coordination with Secretaries of Defense and Homeland Security, confers and coordinates with the White House on how best to protect America from CBRN threats, including the merits of establishing a position on the National Security Council (NSC) to lead the relevant National Strategy.

2. The Secretary of HHS, in coordination with Secretaries of Defense and Homeland Security, coordinates with the White House on a unifying end-to-end National Strategy to address intentional, natural, and emerging CBRN threats.

3. The Secretary of HHS promptly identifies at least three high-priority new MCMs the Department will develop to counter CBRN threats, with target timelines. At least one of these MCMs should address radiation exposure.

4. The Secretary of HHS promptly coordinates with the Secretaries of Defense and Homeland Security to develop prioritized lists of CBRN threats of both natural and intentional origin, to guide further prioritization of MCM efforts.

5. The Secretary of HHS empowers the ASPR as the operational MCM leader, with authority to synchronize the efforts of HHS agencies and with end-to-end oversight.

6. The Secretary of HHS tasks the ASPR to refine the HHS acquisition structure and metrics, to provide accountability for the MCM program.

7. The Secretary of HHS designates the Director of the Biomedical Advanced Research and Development Authority (BARDA) as the MCM Portfolio Director, to coordinate technical aspects of balancing the HHS MCM portfolio.

8. The Secretary of HHS promptly tasks senior HHS leaders to develop a common set of prioritized research goals, prioritized product requirements, and prioritized dispensing goals for civilian populations; and coordinates these priorities with DoD.

9. The Secretary of HHS, in consultation with the Secretary of Homeland Security, develops a plan to overcome existing obstacles that preclude timely distribution and administration of MCMs to people in need (including children and those with limited functional ability).

Recommendations:

10. The Secretary of HHS promptly determines the coordinated budget requirements for Fiscal Year (FY) 2011 relevant to CBRN MCM budget lines within the National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID), BARDA, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and ASPR (and in conjunction with DoD), and communicates requests for revision of the President's Budget to the Office of Management and Budget. Secretary gives special attention to FDA resource needs.

11. For FY2012 and beyond, the Secretary of HHS develops a coordinated budget request relevant to CBRN MCM budget lines within NIH, NIAID, BARDA, CDC, FDA, and ASPR (and in conjunction with DoD).

12. The Secretary of HHS develops a legislative plan to seek multi-year funding authority for CBRN MCM efforts.

13. The Secretary of HHS develops a legislative plan to seek appropriate modification and reauthorization of the Project BioShield Special Reserve Fund, before its expiration in 2013.

14. The ASPR promptly provides a plan to the Secretary of HHS to provide for centralized advanced development and manufacturing of selected biological MCMs, based on one or more public-private partnerships (PPPs) or federally funded research-and-development centers (FFRDCs).

15. The FDA Commissioner promptly provides a plan to the Secretary of HHS for designating appropriate candidate MCMs for high-priority review, with the appropriate criteria of evidence for safety and efficacy.

16. The FDA Commissioner promptly advises the Secretary of HHS on a plan to revise the draft guidance on the "animal rule."

17. The CDC, BARDA, and NIAID Directors develop a plan for the ASPR for identifying and addressing the need for screening and diagnostic tests for CBRN agents that can be performed in clinical settings, prioritized among other MCM needs.

18. The ASPR, in coordination with leaders of other relevant agencies:

A. Identifies to the Secretary of HHS needs for additional pediatric products for the SNS.

B. Provides to the Secretary of HHS a plan to determine pediatric dosages for at least three MCMs.

C. Identifies to the Secretary of HHS a plan to create and maintain pre-Emergency Use Authorization (EUA) dossiers for the top 20 MCMs, in coordination with DoD.

D. Provides to the Secretary of HHS a plan to write integrated response plans for three high-priority threat scenarios, to describe response from alert to MCM dispensing.

E. Provides to the Secretary of HHS an evaluation of State-level MCM distribution plans to assess adequacy in caring for children and for individuals with functional limitations, and a plan to resolve common problems identified.

19. The NIH Director and NIAID Director provide the Secretary of HHS a plan on how to align NIH resources for MCMs to the national prioritized lists of research goals and product requirements.

20. The Secretary of HHS (working with NIH, NIAID, BARDA, and DoD) develops a plan to rationally allocate limited animal resources and facilities to CBRN animal-model development and testing in alignment with the national prioritized list of research goals.

21. The Secretary of HHS develops a plan to fund the Countermeasures Injury Compensation Program (CICP) for all covered countermeasures, and to extend the filing deadline to a consistent 3-year interval.

22. The ASPR provides to the Secretary of HHS a plan to release more information on CBRN consequences to the public, as part of a sustained multi-faceted education and communication plan.

23. The ASPR provides to the Secretary of HHS a plan to make information about MCMs available to the public before and during emergencies in appropriate, accessible and alternative formats.

Recommendations

A number of recommendations may be made to advance the national understanding of cyber threats in general and supply chain threats in particular. The U.S. must:

1. Ensure the nation is prepared to react to and preempt cyber attacks;

2. Make supply chain security part of the establishment of an overall cyber intelligence capability;

3. Develop the ability to build a limited number of computer and communication systems that are absolutely certain to be secure; and

4. Carry out a sustained strategic communications campaign to provide the public with a realistic appreciation of the cyber threat.

Reference

H.R. 5498, THE WMD PREVENTION AND

PREPAREDNESS ACT OF 2010

U.S.HOUSE OF REPRESENTATIVES COMMITTEE ON HOMELAND SECURITY, SUBCOMMITTEE

ON EMERGING THREATS, CYBERSECURITY, AND SCIENCE AND TECHNOLOGY

ONE HUNDRED ELEVENTH CONGRESS, SECOND SESSION