partnering again, this time to advance their rapid antigen test for SARS-CoV-2 to U.S. FDA 510(k) clearanceFull Announcement
The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) coordinates Federal efforts to enhance chemical, biological, radiological and nuclear threats (CBRN) and emerging infectious diseases (EID) preparedness from a medical countermeasure (MCM) perspective
The HHS Assistant Secretary for Preparedness and Response (ASPR) is a leader in preparing the nation to respond to and recover from public health and medical disastersLearn More
The National Institute of Health's research provides the foundation for developing medical products and strategies to treat and prevent a wide range of infectious diseasesLearn More
The Food and Drug Administration plays a pivotal role in protecting our nation from chemical, biological, radiological, and nuclear threats, and from emerging infectious diseasesLearn More
The Centers for Disease Control and Prevention, a part of HHS, is the primary Federal agency for conducting and supporting public health activities in the United StatesLearn More
The mission of the Department of Defense is to provide the powerful military forces needed to deter war and to protect the security of our country.Learn More
The Department of Homeland Security secures the nation from the many threats we face. These threats include biological, chemical, radiological, and nuclear threatsLearn More
Biomedical Advanced Research and Development Authority (BARDA)
BARDA supports the transition of medical countermeasures such as vaccines, drugs, and diagnostics from research through advanced development towards consideration for approval by the FDA and inclusion into the Strategic National Stockpile.
BARDA also provides links to resources on grants and procurement opportunities available to those involved in the research, development and acquisition of medical countermeasures products, including Grants.gov, and grants available through the National Institutes of Health. Links to information on federal acquisition regulations are also available on this page.Learn More
Medical countermeasure policy and implementation development with the PHEMCE is coordinated by the Enterprise Senior Council, a body comprised of senior leadership from the PHEMCE agencies which serves as the decision forum for MCM development policy and implementation.
Together, the PHEMCE organizations and agencies work to optimize the Nation's preparedness for public health emergencies in regards to the development, manufacturing, stockpiling, and administration of medical countermeasures.
The PHEMCE mission components include:
- Requirements Setting
- Early Stage Research
- Advanced Development and Manufacturing
- Regulatory Science Management
- Procurement/Inventory Management/Stockpiling
- Response Planning, Policy, Guidance, and Communications
- Deployment/Distribution/ Dispensing/ Administration
- Monitoring/Evaluation/ Assessment
In 2012, HHS released the Public Health Emergency Medical Countermeasures Enterprise Strategy outlining the PHEMCE goals and objectives that will guide the policies and decisions of the partner agencies in regards to medical countermeasure capabilities that will enable our nation to have a nimble, flexible capacity to produce medical countermeasures rapidly in the face of any attack or threat.
The 2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy establishes the goals and objectives that HHS will use to ensure that medical countermeasures are available for effective use against the highest priority CBRN threats facing the Nation. The accompanying 2012 PHEMCE Implementation Plan details those programs and initiatives throughout the Department that will be prioritized in pursuit of the goals and objectives presented in the strategy document. Both documents together constitute the blueprints the PHEMCE will follow in the near-, mid-, and long-terms to make the best use of available resources to contribute to national health security.
The requirements we set for medical countermeasure development and acquisition are critical to establishing programs to meet our preparedness goals.
Medical countermeasure requirements in BARDA provide a solid foundation for establishing advanced development and acquisition programs that support the overarching ASPR mission and PHEMCE goals of reducing the adverse health effects of public health emergencies, including those caused by pandemic influenza, CBRN threat agents and emerging diseases.
National, PHEMCE, BARDA, and countermeasure specific strategies, implementation plans, and reports
The United States faces an array of natural, technological, and human-caused threats and hazards. These threats continually evolve and have potential to cause significant harm or disruption to the general public, critical infrastructure systems, the environment, and the delivery of healthcare and emergency public health and medical services.
Our nation faces diverse and evolving health security threats that have the potential to disrupt our public health and health care systems and inflict injury and loss...
It is a vital interest of the United States to manage the risk of biological incidents. In today’s interconnected world, biological incidents have the potential to cost...
The U.S. continues to face a range of serious threats to its health security from the unintentional release or deliberate use of chemical, biological, radiological...
Considering the progress achieved and the remaining strategic gaps in MCM preparedness, the PHEMCE annually examines the SIP goals and objectives...
The goal of the 2016 PHEMCE Stakeholders Workshop was to provide a forum within which a broad spectrum of stakeholders in the PHEMCE mission...
The United States (U.S.) continues to face a range of serious threats to its national health security from the deliberate use or accidental release of chemical...
Significant progress was made in 2014 in the regulatory review and approval of MCMs procured under Project BioShield.
The United States continues to face a range of serious threats to its national health security from the deliberate use or accidental release of chemical, biological...
The Project BioShield Act of 2004 [Project BioShield (PBS); Public Law [P.L.] 108-276] amended the Public Health Service (PHS) Act and the Federal Food...
The Medical Countermeasures (MCM) Enterprise had a significant year in 2012. The U.S. Department of Health and Human Services' (HHS) continued to leverage...
The 2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan describes the priorities that HHS, in collaboration with its...
The U.S. Government has a responsibility to protect the health and safety of its citizens. The American people continue to face a host of national health...
The nation has endeavored over the past ten years to become better prepared for the medical consequences of catastrophic events such as bioterrorist events...
The medical countermeasures pipeline has never held more promise than it does today. Innovation, enhanced partnerships and collaboration, and sustained...
Emerging infectious diseases, pandemics, and bioterrorism carry the potential for catastrophic impact, and the U.S. government has faced chronic challenges in...
Latest announcements related to medical countermeasures
OPPORTUNITIES TO PARTNER WITH BARDA
BARDA's DRIVe and NCATS, are partnering with three non-government organizations to advance the development of microphysiological systems (MPS)Full Announcement
BARDA is collaborating with PTx to advance a new diagnostic approach to stratify sepsis patients who are most likely to benefit from PTx’s FDA-approved therapeutic, Leukine (sargramostim)...Full Announcement