Medical Planning and Countermeasures

• Building Domestic Cell-Based Influenza Vaccine Manufacturing Facilities

• Acquisition of Avian Influenza H5N1 Vaccine for Strategic National Stockpile

• Knowledge, Attitudes, and Practices Regarding Avian Influenza (H5N1), Afghanistan

• Highly Pathogenic Avian Influenza Virus (H5N1) Isolated from Whooper Swans

• Public Workshop: Animal Models for the Treatment of Acute Radiation Syndrome

• HHS and DHS Announce Guidnace on Pandemic Vaccination Allocation

• Bacterial Pneumonia and Pandemic Influenza Planning

• Deaths from Bacterial Pneumonia during 1918-1919 Pandemic

• Genotyping Rickettsia prowazekii Isolates

• Risk for Avian Influenza Virus Exposure at Human-Wildlife Interface

• Optimizing Use of Multistream Influenza Sentinel Surveillance Data

• RFP-HHS-BARDA-08-09-Draft: Request for Information on Building Domestic Cell-based Influenza Vaccine Manufacturing Facilities

• Guidance for Industry:  CGMP for Phase 1 Investigational Drugs

• Synopsis: Acquisition of Avian Influenza H5N1 Vaccine for Strategic National Stockpile

• HHS Awards Contracts for CRO Services for Safety and Immunogenicity Studies

• HHS Awards Contracts for CRO Services for Toxicology Studies

• NIAID Workshop:  Development of Animal Models for Dengue (September 18-19, 2008)

• HHS Awards Contracts for the Development of Faster Influenza Diagnostic Tests

• Recombinant Protective Antigen (rPA) Anthrax Vaccine for the Strategic National Stockpile

• Testimony by RADM Vanderwagen before the U.S. Senate Committee on Homeland Security and Governmental Affairs: Nuclear Terrorism: Providing Medical Care and Meeting Basic Needs in the Aftermath – the Federal Response

• Experimental Infection of Cattle with Highly Pathogenic Avian Influenza Virus (H5N1) D. Kalthoff et al.

• Physical and Biological Dosimetry Techniques and Devices Useful in Initial Triage after Radiologic and Nuclear Events

• Facilitating Development of and Access to New Vaccines: An FDA Perspective (PDF - 129 KB)

• Avian Influenza A Virus (H5N1) Outbreaks, Kuwait, 2007

• Levaquin Approved for Pediatric Anthrax Exposure

• Advanced Development of Next Generation Portable Ventilators

• Pandemic Planning – Update V

• “Virtual” Flu Outbreak Points to Options for Preventing Spread

• Pathogen Recognition and Signaling in Innate Immunity

• SS-HHS-BARDA-08-99:  Emergency Responder Anthrax Antimicrobial Kits

• RFP-BARDA-08-15 (Amendment 1): recombinant Protective Antigen (rPA) Anthrax Vaccine for the Strategic National Stockpile 

• RFP-BARDA-08-12 (Amendment 1): Medkits

• BAA-BARDA-08-08 (Solicitation 1): Therapies for Hematopoietic Syndrome, Bone Marrow Stromal Cell Loss and Vascular Injury Resulting From Acute Exposure to Ionizing Radiation.

• HHS-BARDA-08-10:  Advanced Therapeutics for Treating Neutropenia Resulting from Acute Exposure to Ionizing Radiation

• RFA-AI-08-014:  Cooperative Centers for Translational Research on Human Immunology and Biodefense

• RFA-AI-08-001:  Cooperative Research Partnerships for Biodefense and Emerging Infectious Diseases

• Levaquin Approved for Pediatric Anthrax Exposure

•  Notice to Readers: Newly Licensed Smallpox Vaccine to Replace Old Smallpox Vaccine

• Notice from CDC to Vaccine Holders to Destroy Dryvax Vaccine

• CDC Pandemic Influenza Funding Announcement for Competitive Proposals

• FAQ Pandemic Influenza Funding Announcement for Competitive Proposals:  1 of 2

• FAQ Pandemic Influenza Funding Announcement for Competitive Proposals:  2 of 2

• RFA-AI-08-001: Cooperative Research Partnerships for Biodefense and Emerging Infectious Diseases

• BAA-DMID-NIAID-BARDA-NIHAI20080022: Application of Platform Technologies for the Development of Therapeutics for Biodefense

• BAA-BARDA-08-08: Therapies for Hematopoietic Syndrome, Bone Marrow Stromal Cell Loss and Vascular Injury Resulting From Acute Exposure to Ionizing Radiation

• Draft Guidance for Industry and FDA Staff: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses

• New Vaccine Against H5N1 Bird Flu

• RFP-BARDA-08-15: recombinant Protective Antigen (rPA) Anthrax Vaccine for the Strategic National Stockpile

• Vaccines and Related Biological Products Advisory Committee (February 20-21, 2008)

• Notice from CDC to Vaccine Holders to Destroy Dryvax Vaccine

• Researchers Discover New Battleground for Viruses and Immune Cells

• Research Priorities in Emergency Preparedness and Response for Public Health Systems: A Letter Report (Institute of Medicine, January 22, 2008)

• Vaccine Safety and Risk Management Update (CBER, January 30, 2008)

• Notice from CDC to Vaccine Holders to Destroy Dryvax Vaccine

• HHS-BARDA-08-01-SB:  recombinant Protective Antigen (rPA) Anthrax Vaccine for the Strategic National Stockpile (Synopsis)

• SS-DHHS-BARDA-07-01:  Anthrax recombinant Protective Antigen (rPA) vaccine for the Strategic National Stockpile (SNS) (Amendment 01)

• RFP-BARDA-08-12: Medkits

• Upcoming Videocast: National Science Advisory Board for Biosecurity (Day 1)

• Upcoming Videocast: National Science Advisory Board for Biosecurity (Day 2)

• $24M of CDC funding for IT for pandemic flu preparedness

• RFA-AI-08-002 Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) Program

• “Medicine in the Media” Course (May 5-7)

• Upcoming Videocast: Emergency Preparedness and Biodefense (February 26, 2008)

• Upcoming Videocast: Burn Care (January 29, 2008: Videocast)

• FDA Clears for Marketing Real-Time Test for Respiratory Viruses (January 18, 2008)

• Vaccine Safety: An FDA Prespecitve (January 10, 2008)

• Influenza-Testing and Antiviral-Agent Prescribing Practices --- Connecticut, Minnesota, New Mexico, and New York, 2006--07 Influenza Season (January 25, 2008)

• Bioviolence: Preventing Biological Terror and Crime (January 18, 2008)

• Encyclopedia of Infectious Diseases: Modern Methodologies (January 18, 2008)

• Emerging Infectious Diseases: Trends and Issues. 2nd Edition. (January 18, 2008)

• This Time of Dying (January 18, 2008)

• Burkholderia pseudomallei Antibodies in Children, Cambodia (January 3, 2008)

• BARDA/NIAID Medical Countermeasures to Mitigate and/or Treat Ionizing Radiation-Induced Pulmonary Injury: Project Bioshield (RC1)

• Workshop: Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development – Webcast

• Change of Submission Schedule for RFA-AI-07-037, BARDA/NIAID Medical Countermeasures to Mitigate and/or Treat Ionizing Radiation-Induced Cutaneous Injury: Project Bioshield (RC1)

• Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile

• Institutional Clinical and Translational Science Award (U54)

• Upcoming Videocast: National Science Advisory Board for Biosecurity (Day 1)

• Upcoming Videocast: National Science Advisory Board for Biosecurity (Day 2)

• $24M of CDC funding for IT for pandemic flu preparedness

• RFA-AI-08-002 Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) Program

• “Medicine in the Media” Course (May 5-7)

• Upcoming Videocast: Emergency Preparedness and Biodefense (February 26, 2008)

• Upcoming Videocast: Burn Care (January 29, 2008: Videocast)

• FDA Clears for Marketing Real-Time Test for Respiratory Viruses (January 18, 2008)

• Vaccine Safety: An FDA Prespecitve (January 10, 2008)

• Influenza-Testing and Antiviral-Agent Prescribing Practices --- Connecticut, Minnesota, New Mexico, and New York, 2006--07 Influenza Season (January 25, 2008)

• Bioviolence: Preventing Biological Terror and Crime (January 18, 2008)

• Encyclopedia of Infectious Diseases: Modern Methodologies (January 18, 2008)

• Emerging Infectious Diseases: Trends and Issues. 2nd Edition. (January 18, 2008)

• This Time of Dying (January 18, 2008)

• Burkholderia pseudomallei Antibodies in Children, Cambodia (January 3, 2008)

• New Software To Aid Early Detection of Infectious Disease Outbreaks
  A newly released software program will let health authorities at the site of an infectious disease outbreak quickly analyze data, speeding the detection of new cases and the implementation of effective interventions.

• BARDA/NIAID Medical Countermeasures to Mitigate and/or Treat Ionizing Radiation-Induced Cutaneous Injury: Project Bioshield (RC1)
  Note: The Project BioShield Act of 2004, enacted on July 21, 2004, authorizes the Secretary, Department of Health and Human Services (DHHS), through the program carried out by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), to expedite peer review and award of grants, contracts, and cooperative agreements to perform, administer, or support research and development of countermeasures determined by the Secretary to be a priority to treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security, or adverse health consequences. Consistent with this authority, the NIAID is announcing a new grant initiative focused on the development of novel medical countermeasures to prevent or mitigate cutaneous injury, or restore morphology and function after exposure to ionizing radiation.

• IND Overview (Presentation by the FDA)

• Regulatory Considerations for the Manufacture of Investigational Vaccines for Clinical Trials (Presentation by the FDA)

• Regulatory Aspects of the Nonclinical Safety Assessment of Adjuvanted Preventive Vaccines (Presentation by the FDA)

• Regulatory Perspectives on Development of Preventative Vaccines for Global Infectious Diseases

• Vaccine Allocation: Join the Online Discussion
  Who gets vaccinated first in a flu pandemic? Doctors? Paramedics? Kids? The elderly? It’s the central question posed in a series of public forums seeking input on a draft plan that spells out how vaccines will be allocated in the early days of a flu pandemic.

• NIAID Strengthens and Expands Vaccine and Treatment Evaluation Units

• United States, Canada and Mexico Agree to Mutual Assistance
  The U.S. Department of Health and Human Services (HHS), the Public Health Agency of Canada, and the Ministry of Health of the United Mexican States today agreed to strengthen cross-border coordination and cooperation in the surveillance, prevention, and control of infectious diseases for the protection of the health, well-being, and quality of life of their peoples.

• BARDA Publishes Draft Strategic Plan for Medical Countermeasure Research, Development, and Procurement
  The Biomedical Advanced Research and Development Authority (BARDA), in concert with its partners throughout HHS, has created the Draft Biomedical Advanced Research and Development Authority Strategic Plan for Medical Countermeasure Research, Development, and Procurement as a comprehensive approach for how BARDA will guide and facilitate the research, development, innovation, and procurement of medical countermeasures in fulfillment of Section 401(b) of Pandemic and All Hazards Preparedness Act.

• FDA Releases New Software Tool to Help Keep Food Facilities Safe from Attack
  Latest Effort in Strengthening U.S. Food Defense
  The U.S. Food and Drug Administration (FDA) today released a new tool to help the U.S. food industry, its federal partners, state and local regulators, as well as the international community determine the vulnerability of individual food facilities to biological, chemical, or radiological attack.

• Preparedness for Chemical, Biological, Radiological, Nuclear, and Explosive Events
  Questionnaire for Health Care Facilities
  With the attacks of September 11, 2001, Hurricane Katrina, and more recently the potential for a flu pandemic, Federal, State, and local governments and public and private health care systems increasingly have focused on the ability of the health care system to prepare for and respond to mass casualty incidents. A critical component of a public health emergency preparedness strategy is the availability of tools to assist government agencies and healthcare facilities alike in emergency preparedness planning. This questionnaire will help both agencies and individual health care facilities assess preparedness. Such an assessment offers government officials and health care system administrators a point of departure for this aspect of preparedness planning.

• Health Threat from Wildfire Smoke
  Smoke from wildfires is a mixture of gases and fine particles from burning trees and other plant materials. Smoke can hurt your eyes, irritate your respiratory system, and worsen chronic heart and lung diseases.

• CDC Call for Emergency Medical Care and Public Health Model Communities
  The Centers for Disease Control and Prevention (CDC), through its Terrorism Injuries: Information Dissemination and Exchange (TIIDE) Project, is examining the relationship between the Emergency Care Community and Public Health in relation to preparedness for mass casualty incidents. The Emergency Care Community is composed of emergency medical services, emergency departments, trauma centers, and acute care hospitals The CDC TIIDE Project is seeking examples of “model communities” in which the relationship between the emergency care community and public health is well-established and operationally functional in terms of its capacity to respond to events that might produce large numbers of injuries.

• CDC assists FEMA with Formaldehyde-related Health Concerns
  In the aftermath of Hurricane Katrina, the Federal Emergency Management Agency (FEMA) provided either mobile homes or travel trailers to Gulf Coast victims who had lost their homes in the hurricane. Concerns have surfaced recently about air quality in the trailers and the occurrence of respiratory and other symptoms resulting from exposure to formaldehyde or other respiratory irritants among residents of the mobile homes. CDC is working with FEMA to investigate the health concerns of those living in the trailers and mobile homes.

• CDC Provides Bridge Collapse Resources
  In the aftermath of the Minneapolis bridge collapse, CDC has compiled links to online resources which provide important information for the public and health professionals about injuries, mass casualty events, and coping with a traumatic event.

• Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE)

• Clinical Trials Registration in ClinicalTrials.gov (Public Law 110-85): Competing Applications and Non-Competing Progress Reports

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