Strengthening Processes and Building Capacity to Facilitate Regulatory Review and Approval of Medical Countermeasures During Public Health Emergencies with the World Health Organization | EP IDS 17 006

Opportunity Information: Apply for EP IDS 17 006

The grant opportunity titled "Strengthening Processes and Building Capacity to Facilitate Regulatory Review and Approval of Medical Countermeasures During Public Health Emergencies with the World Health Organization" is a U.S. Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) funding announcement designed to support a single, targeted cooperative agreement with the World Health Organization (WHO). It was issued as a discretionary funding opportunity (Funding Opportunity Number EP IDS 17 006; CFDA 93.019) and structured as a sole-source request, meaning the WHO is the intended and only applicant. The award is aimed at the FY 2017 to FY 2019 period, with an award ceiling of $500,000 and an expectation of one award. The FOA was created on July 19, 2017, with an original closing date of September 18, 2017.

At its core, the opportunity focuses on improving how countries and regions rapidly evaluate and authorize medical countermeasures during crises, including diagnostics, vaccines, and therapeutics. The central problem it addresses is that during fast-moving public health emergencies, regulatory systems can become a major bottleneck. Even when products are available, countries often have different legal and regulatory requirements for importing, approving, and distributing them. Past experiences have shown that these differences can cause delays that cost lives, especially when a response depends on quickly getting tools into affected communities. The cooperative agreement is intended to strengthen WHO-led processes that help national and regional regulators make timely, evidence-based decisions during emergencies, while also encouraging alignment and engagement among key stakeholders involved in regulatory activities.

The FOA is explicitly tied to global health security and the International Health Regulations (2005). It references IHR Article 44.1(a), which calls on States Parties to collaborate in technical cooperation, logistical support, and coordinated detection, assessment, and response. The announcement frames this collaboration as essential because health threats do not respect borders. It notes that international deployment of medical countermeasures may be critical not only for naturally occurring outbreaks (including emerging infectious diseases like pandemic influenza) but also for deliberate or accidental releases involving chemical, biological, radiological, or nuclear (CBRN) agents. In that context, having pre-established and trusted emergency regulatory pathways becomes part of preparedness, not an afterthought during response.

A major justification for the work is drawn from real-world lessons learned during prior emergencies. The FOA highlights the after-action review of the WHO 2009 H1N1 Vaccine Deployment Initiative, which found that each recipient country followed a different regulatory route to legally import and distribute vaccines. Some relied on one-time waivers, while others required more burdensome steps such as clinical trials as part of registration. This uneven landscape created friction and delays, showing the value of more harmonized emergency approaches. It also points to experiences from other Public Health Emergencies of International Concern (PHEIC), including Ebola virus disease and Zika virus, where timely deployment of diagnostics, vaccines, and medicines depended heavily on having workable global frameworks for emergency regulatory review.

To build practical capacity, the FOA aims to expand upon WHO’s Emergency Use Assessment and Listing (EUAL) procedures, originally developed to support emergency evaluation of in vitro diagnostics (IVDs), vaccines, and medicines during Ebola, and later applied to Zika IVDs and laboratory technologies. The EUAL concept is important because it provides a structured, WHO-led mechanism to assess products for emergency use when full regulatory approval pathways may be too slow for an unfolding crisis. By strengthening and refining these processes, the cooperative agreement is meant to help countries make quicker decisions about what can be used, under what conditions, and with what safeguards, while still grounding decisions in evidence and risk-benefit considerations.

The opportunity also builds on prior ASPR-WHO work conducted under a 2014-2016 cooperative agreement, including efforts to develop processes that facilitate regulatory review and recommendations related to smallpox vaccine use. In addition, it aligns with recommendations from a WHO informal consultation focused on improving regulatory preparedness for public health emergencies. In practical terms, the FOA is positioned as a continuation and scaling of established collaborative work rather than a brand-new initiative, with the expectation that the WHO is uniquely placed to convene partners, set normative guidance, and support national and regional capacity-building within diverse political and legal environments.

Finally, the FOA underscores that WHO has an irreplaceable role in setting global processes and supporting the development of emergency regulatory capacity worldwide. The cooperative agreement is intended to span a wide range of collaborative activities, reflecting shared strategic objectives across the U.S. Government, HHS, ASPR, and WHO. The desired outcome is a stronger, more coordinated global system where regulators are better prepared before a crisis hits, where emergency review pathways are clearer and more aligned, and where medical countermeasures can be reviewed, authorized, and made accessible fast enough to matter during public health emergencies.

• The Department of Health and Human Services, Assistant Secretary for Preparedness and Response in the health, science and technology and other research and development sector is offering a public funding opportunity titled "Strengthening Processes and Building Capacity to Facilitate Regulatory Review and Approval of Medical Countermeasures During Public Health Emergencies with the World Health Organization" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.019.
• This funding opportunity was created on Jul 19, 2017.
• Applicants must submit their applications by Sep 18, 2017 No Explanation. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: For profit organizations other than small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).

Apply for EP IDS 17 006

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