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U.S. Department of Health and Human Services

NBSB Recommendations

  • October 28, 2011 -  “Challenges in the Use of Anthrax Vaccine Adsorbed (AVA) in the Pediatric Population as a Component of Post-Exposure Prophylaxis (PEP).” 
    A Report from the National Biodefense Science Board (PDF)
    The NBSB’s Anthrax Vaccine (AV) Working Group (WG) presented, by teleconference, their report with recommendation, titled “Challenges in the Use of Anthrax Vaccine Adsorbed (AVA) in the Pediatric Population as a Component of Post-Exposure Prophylaxis (PEP),” to the Board for discussion and public comment. The report describes the challenges of administering AVA to children before versus after an attack with B. anthracis spores. The report also includes background information, responses to four questions posed by Dr. Lurie in her April 2011 letter to the NBSB, two options for HHS consideration, and a recommendation. The NBSB debated how best to obtain scientifically valid safety and immunogenicity data about AVA PEP for children. The NBSB concluded that it would be in the best interests of children, their parents, and the United States Government to attempt to gather the safety and immunogenicity data about AVA PEP in children prior to an anthrax event, rather than to wait for a future crisis to attempt to gather that information. This issue should be referred to an appropriate review board to formally address the ethical considerations. This board should include ethicists and public representation. If the ethical considerations are adequately addressed, HHS should develop a plan for and conduct a pre-event study of AVA in children to include a research Investigational New Drug application. HHS should submit the study protocol to one or more IRBs, and comply with the 21 CFR 50.54/45 CFR 46.407 federal review process.
  • April 28, 2011 – “Call to Action:  Include Scientific Investigations as an Integral Component of Disaster Planning and Response”
    A Report from the NBSB     [PDF]
    The NBSB’s All Hazards Science Response (AHSR) Working Group (WG) presented their report with recommendations to the NBSB entitled “Call to Action:  Include Scientific Investigations as an Integral Component of Disaster Planning and Response, A Report from the National Biodefense Science Board.”  The Board approved the recommendations.  In its report, the NBSB offers 10 recommendations to improve the Nation’s ability to mount a comprehensive and rapid mobilization of its scientific resources in the investigative response to disasters that threaten public health.  The NBSB recommended that the HHS:  Convene expert planning panels to identify research questions likely to arise during an array of incident types, including those that fall under Federal Emergency Management Agency (FEMA) planning scenarios;  Add a scientific response component to the National Response Framework and the National Oil and Hazardous Substances Pollution Contingency Plan, and Establish an ASPR center to plan and coordinate scientific investigations before, during, and after disasters.  According to the proposed recommendations, the ASPR center staff would carry out seven other recommended functions, which range from appointing a liaison to help streamline the Office of Management and Budget's Paperwork Reduction Act requirements as they pertain to scientific protocols, to establishing a funding mechanism to support the research, to identifying new information technology to collect field data. 
    • September 22, 2010 – “Integration of Behavioral Health in Federal Disaster Preparedness, Response, and Recovery: Assessment and Recommendations" [PDF]
      Disaster Mental Health Subcommittee Report Adopted by the NBSB
      The NBSB’s Disaster Mental Health Subcommittee presented their report with conclusions and recommendations to the NBSB entitled “Integration of Behavioral Health in Federal Disaster Preparedness, Response, and Recovery: Assessment and Recommendations.” The NBSB voted to adopt the five recommendations in the report focusing on developing policy and ensuring that organizational and structural elements are in place to translate policy into action. Successful integration requires meaningful metrics and accountability.

       

    • September 22, 2010 – Future of the NBSB [PDF]
      The NBSB’s Future of the NBSB Working Group presented their findings to the NBSB on several topics: short and long term priority areas; an analysis of the current NBSB Working Groups and the Disaster Mental Health Subcommittee; and NBSB membership appointments.

       

    • March 26, 2010 – “Where are the Countermeasures? Protecting America’s Health from CBRN Events" [PDF]
      The NBSB’s Medical Countermeasures Working Group (MCM-WG) presented their report with recommendations to the NBSB entitled “Where are the Countermeasures? Protecting America’s Health from CBRN Events”. The report identifies three important themes needed to develop MCMs. The first is prioritization: National strategy must proceed from a clear assessment of CBRN threats and subsequent identification of the most urgently needed and attainable MCMs. The second is synchronization: Efforts to produce those MCMs must be coordinated across many government agencies and entities, with budgets allocated to ensure smooth transitions from one development stage to the next. The third is anticipation: Plans to distribute and dispense MCMS must be devised and realistically tested, so that foreseeable logistical problems are minimized. Finally, the report issues 23 recommendations to encourage a unified National strategy, centralized leadership, and adequate and sustained funding to develop the full portfolio of MCMs needed to protect America’s health from CBRN events.

       

    • February 10, 2010 — Optimizing Industrial Involvement with Medical Countermeasure Development [PDF] The NBSB’s Medical Countermeasures (MCMs) Markets and Sustainability Working Group (M&S-WG) presented their report with recommendations to the NBSB entitled “Optimizing Industrial Involvement with Medical Countermeasure Development”. The report emphasizes the need to accelerate the development of MCMs to protect against biological threats—although the NBSB recognizes that more efficient MCM development against nuclear and radiological weapons, as well as chemical weapons, also is necessary. The report summarizes the findings of the Working Group, which includes real and perceived barriers that have prevented effective industry participation in the development of MCMs. Finally, the report issues eight recommendations to the U.S. Government encouraging more persistent and more innovative efforts to develop the full portfolio of MCMs needed to protect the country against CBRN events.

       

    • November 13, 2009 — Actions to consider taking to prevent and mitigate adverse behavioral health outcomes during the H1N1 public health emergency [PDF]
      The Members of the NBSB voted to send a letter to the Secretary approving recommendations developed by the Disaster Mental Health Subcommittee. The Subcommittee was asked to provide actions that public health officials should consider taking to prevent and mitigate adverse behavioral health outcomes during the H1N1 public health emergency. State and local public health officials should be encouraged to invite their behavioral health authorities to meet and discuss local efforts and plans; strategies should be developed to maintain calm at treatment sites; a list of specific resources that pertain to behavioral health was compiled in order to minimize stress for providers.

       

    • October 14, 2009—Support for the National 2009 H1N1 Immunization Program [PDF]
      The members of the NBSB voted to send a letter to the Secretary expressing their strong support for the national 2009 H1N1 immunization program based on overwhelming evidence that the benefits for vaccination far outweigh any potential risks. The Board strongly encourages the early voluntary immunization of all high-risk Americans followed by the vaccination of all others who would like to be progected from this infection as the vaccine supply grows over the coming months.

       

    • July 17, 2009—H1N1 Influenza Countermeasures [PDF]
      The Pandemic Influenza Working Group made recommendations to the NBSB on countermeasures for novel H1N1 influenza virus. The report and recommendations were a direct result of the NBSB Pandemic Influenza Working Group convening an urgent meeting on June 18-19, 2009, entitled the "H1N1 Countermeasures Strategy and Decision Making Forum”. Topics addressed during the Forum included H1N1 vaccines, antivirals, and diagnostics. Forum participants included influenza experts from the U.S. Government, State and Local governments, industry, academia, another federal advisory committees, and professional organizations. Following discussion and deliberation, the Board voted on and unanimously approved recommendations to be transmitted to Secretary Sebelius.

       

    • November 18-19, 2008—Protecting, Preserving, and Restoring Individual and Community Mental Health [PDF]
      Report of the Disaster Mental Health Subcommittee
      Established in April 2008 in accordance with HSPD-21, the Disaster Mental Health Subcommittee made recommendations to the NBSB for protecting, preserving, and restoring individual and community mental health in catastrophic health event settings, including pre-event, intra-event, and post-event education, messaging, and interventions. Following discussion and deliberation, the Board voted on and unanimously approved recommendations to be transmitted to Secretary Leavitt.

       

    • October 14, 2008—Personal Preparedness and Homestockpiling [PDF]
      The Personal Preparedness Working Group made recommendations to the NBSB that high-quality specific information can and should be obtained from an operational evaluation during the pre-positioning of antibiotic countermeasure programs; that operational and qualitative research be conducted in order to better understand what issues and triggers drive individual decisions to participate in personal preparedness activities and their adherence to instructions on proper storage and use of individual antibiotic caches; and that draft HHS documents providing guidance on the use of antibiotic drugs be considered for, modified, and used during pilot testing in pre-positioning of antibiotic countermeasure programs. Following discussion and deliberation, the Board voted on and unanimously approved recommendations to be transmitted to Secretary Leavitt.

       

    • National Disaster Medical System (NDMS) and National Medical Surge—September 23, 2008 [PDF]
      Report from the Disaster Medicine Working Group NDMS Assessment Panel
      The Disaster Medicine Working Group made recommendations to the NBSB on strategic improvements to the NDMS and national medical surge capacity. Following discussion and deliberation, the Board voted on and unanimously approved recommendations to be transmitted to Secretary Leavitt.

       

    • August 11, 2008—Homestockpiling of Antibiotics [PDF]
      The Personal Preparedness Working Group made recommendations to the NBSB on efforts to improve personal preparedness; more specifically whether or not individual stockpiling of antibiotics contributes to these efforts. Citing scientific data demonstrating risks of homestockpiling, including antibiotic misuse, inappropriate dosing, adverse events and selection of resistance through misuse before an event, the Working Group urged policy makers to cautiously move forward on the implementation of individual stockpiling programs. Following discussion and deliberation, the Board voted on and unanimously approved recommendations to be transmitted to Secretary Leavitt.

       

    • June 18, 2008—Individual Stockpiling of Antibiotics and Antivirals [PDF]
      NBSB Excerpt on Personal Preparedness, June 18, 2008
      Letter to the Secretary expressing concerns about personal stockpiling of antibiotics, particularly through ordinary prescriptions. Establishment of the Personal Preparedness Working Group of the NBSB. Following discussion and deliberation, the Board voted on and unanimously approved the letter with an attached summary detailing the opinions expressed during the meeting be transmitted to Secretary Leavitt.

       

    • March 26, 2008—Federal Education and Training Interagency Group (FETIG) Charter [PDF]
      The Disaster Medicine Working Group made recommendations to the NBSB that the FETIG Charter be revised to clarify the responsibilities of the FETIG and the role of the Joint Program. Following discussion and deliberation, the Board voted on and unanimously approved recommendations to be transmitted to Secretary Leavitt.

    National Biodefense Science Board

    • This page last reviewed: December 05, 2011