Opportunity Information: Apply for EP IDS 13 002

  • The Assistant Secretary for Preparedness and Response in the other (see text field entitled explanation of other category of funding activity for clarification) sector is offering a public funding opportunity titled "Chemistry, Manufacturing, and Control (CMC) and Clinical Trial Technical Support for Influenza Vaccine Manufacturers in Under Resourced Nations" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.360 Biomedical Advanced Research and Development Authority (BARDA), Biodefense Medical Countermeasure Development.
  • This funding opportunity was created on Aug 9, 2013 and posted on Aug 9, 2013.
  • Applicants must submit their applications by Sep 9, 2013 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 $4,250,000.00 in funding.
  • The number of recipients for this funding is limited to 4 candidate(s).
  • Eligible applicants include: Native American tribal governments (Federally recognized) Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education City or township governments For profit organizations other than small businesses.
  • Non domestic (non U.S.) entity, Tribal epidemiology centers, Faith based organizations,Community based organizations, Hospitals, Research Instructions
Apply for EP IDS 13 002

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Opportunity Summary:

This grant opportunity, titled "Chemistry, Manufacturing, and Control (CMC) and Clinical Trial Technical Support for Influenza Vaccine Manufacturers in Under Resourced Nations" (Funding Opportunity Number EP IDS 13 002), was a discretionary funding announcement from the Office of the Assistant Secretary for Preparedness and Response (ASPR), specifically connected to BARDA's biodefense and medical countermeasure development mission area (CFDA 93.360). The overall purpose was to strengthen influenza vaccine manufacturing readiness in under resourced nations by offering hands-on technical support focused on two critical areas: CMC (the quality and manufacturing backbone needed to make a vaccine consistently and safely) and clinical trial activities (the planning and execution needed to generate credible clinical evidence). Rather than funding routine production, the intent was to help existing manufacturers solve technical and regulatory hurdles that commonly slow or block vaccine development, scale-up, and licensure, especially in settings with limited resources.

The program targeted influenza vaccine manufacturers in under resourced nations that were already being supported through the ASPR/BARDA International Influenza Vaccine Manufacturing Capacity Building Program. In practical terms, this meant the funding was designed to complement and accelerate progress for manufacturers already within BARDA's broader capacity-building portfolio. Support under this FOA would typically align with issues such as improving process development and validation, strengthening quality systems, upgrading documentation and control strategies, and preparing the technical packages that regulators expect for vaccine approval. On the clinical side, the support focus implied assistance with clinical development planning, protocol design and implementation, trial operations, data integrity practices, and the technical components needed to move a product through ethically and scientifically sound clinical evaluation.

Awards were planned as cooperative agreements, which generally indicates a more active partnership style of funding where the agency expects substantial involvement during the project period, such as collaboration on work planning, technical direction, and coordination with broader program goals. The announcement anticipated up to four awards. Funding ranged widely, with an award floor of $50,000 and an award ceiling of $4,250,000, signaling that proposals could span from narrower, targeted technical interventions to larger, more comprehensive support efforts depending on the needs of manufacturers and the scope proposed. There was no cost-sharing or matching requirement, reducing financial barriers for applicants and making it more feasible for organizations operating in lower-resource settings to participate.

The funding activity category was listed under "Preparedness and Response," reflecting the pandemic and outbreak preparedness rationale behind expanding global influenza vaccine manufacturing capability. Influenza remains a recurring public health threat with pandemic potential, and one of the persistent challenges in pandemic response is the ability to produce vaccines quickly and broadly across regions. By investing in CMC and clinical trial technical support, ASPR/BARDA aimed to help ensure that manufacturers in under resourced nations could reach higher levels of technical maturity, meet regulatory expectations, and contribute to regional and global supply during emergencies rather than relying solely on external sources.

Eligibility was broad and included state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) entities), and for-profit organizations other than small businesses. The eligibility notes also explicitly referenced non-domestic (non-U.S.) entities and other organization types such as tribal epidemiology centers, faith-based organizations, community-based organizations, hospitals, and research organizations, indicating the program was structured to allow international participation and a range of technical partners. This matters because the work envisioned often requires specialized expertise that might be provided by academic groups, contract research organizations, clinical trial networks, consultants with regulatory and CMC depth, or partnerships that combine manufacturing, clinical operations, and quality/regulatory capabilities.

In terms of timing, the FOA was posted on August 9, 2013, with an original and current closing date of September 9, 2013, and it was archived on October 9, 2013. Assistance for accessing the full announcement was routed through the Grants.gov Contact Center, which provided around-the-clock support. Overall, the opportunity was essentially a capacity-acceleration mechanism: it sought to remove technical bottlenecks in manufacturing and clinical development so that influenza vaccine producers in under resourced nations could more quickly reach reliable production, generate acceptable clinical evidence, and be better positioned to supply vaccines during seasonal outbreaks and potential pandemics.

FAQs: Chemistry, Manufacturing, and Control (CMC) and Clinical Trial Technical Support for Influenza Vaccine Manufacturers in Under Resourced Nations (EP IDS 13 002)

What is the title and funding opportunity number for this grant?

The opportunity is titled "Chemistry, Manufacturing, and Control (CMC) and Clinical Trial Technical Support for Influenza Vaccine Manufacturers in Under Resourced Nations." The Funding Opportunity Number is EP IDS 13 002.

Which federal office issued this funding announcement?

This was a discretionary funding announcement from the Office of the Assistant Secretary for Preparedness and Response (ASPR), connected to BARDA's biodefense and medical countermeasure development mission area.

What CFDA program is this associated with?

This opportunity was associated with CFDA 93.360.

What problem was this grant trying to solve?

The purpose was to strengthen influenza vaccine manufacturing readiness in under resourced nations by helping manufacturers overcome technical and regulatory hurdles that commonly delay or prevent vaccine development, scale-up, and licensure, especially in lower-resource settings.

What was the overall purpose of the program?

The overall purpose was to provide hands-on technical support in two critical areas: CMC (the quality and manufacturing foundation needed to reliably and safely produce vaccine) and clinical trial activities (the planning and execution needed to generate credible clinical evidence).

Does this opportunity fund routine influenza vaccine production?

No. The intent was not to fund routine production. The funding was positioned as technical support to address bottlenecks in manufacturing quality systems, process readiness, regulatory documentation, and clinical development execution.

Who was the program specifically targeting?

The program targeted influenza vaccine manufacturers in under resourced nations that were already being supported through the ASPR/BARDA International Influenza Vaccine Manufacturing Capacity Building Program.

How does this grant relate to BARDA's broader influenza capacity-building work?

This funding was designed to complement and accelerate progress for manufacturers already in BARDA's broader capacity-building portfolio, acting as a capacity-acceleration mechanism focused on removing technical bottlenecks.

What kinds of CMC activities were implied as a fit for support?

The announcement described support typically aligning with activities such as improving process development and validation, strengthening quality systems, upgrading documentation and control strategies, and preparing the technical packages that regulators expect for vaccine approval.

What kinds of clinical trial activities were implied as a fit for support?

The clinical focus implied assistance with clinical development planning, protocol design and implementation, trial operations, data integrity practices, and other technical components required to move a product through ethically and scientifically sound clinical evaluation.

What type of award mechanism was planned?

Awards were planned as cooperative agreements.

What does it mean that awards were cooperative agreements?

Cooperative agreements generally indicate a more active partnership model where the agency expects substantial involvement during the project period, such as collaboration on work planning, technical direction, and coordination with broader program goals.

How many awards were anticipated?

The announcement anticipated up to four awards.

What were the minimum and maximum award sizes?

Funding ranged from an award floor of $50,000 to an award ceiling of $4,250,000.

Why did the funding range vary so widely?

The stated range signaled that proposals could span from narrower, targeted technical interventions to larger, more comprehensive technical support efforts, depending on manufacturer needs and the scope proposed.

Was cost-sharing or matching required?

No. There was no cost-sharing or matching requirement.

What was the funding activity category for this opportunity?

The funding activity category was listed under "Preparedness and Response."

Why was this categorized under preparedness and response?

The program was framed around pandemic and outbreak preparedness: expanding global influenza vaccine manufacturing capability helps address the challenge of producing vaccines quickly and broadly across regions during emergencies.

How does CMC and clinical trial support help pandemic preparedness?

By investing in CMC and clinical trial technical support, ASPR/BARDA aimed to help manufacturers meet regulatory expectations, reach higher technical maturity, generate acceptable clinical evidence, and be better positioned to contribute to regional and global vaccine supply during seasonal outbreaks and potential pandemics.

Which organizations were eligible to apply?

Eligibility included state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) entities), and for-profit organizations other than small businesses.

Were non-U.S. (non-domestic) entities allowed?

Yes. The eligibility notes explicitly referenced non-domestic (non-U.S.) entities, indicating the opportunity was structured to allow international participation.

What other organization types were explicitly referenced as eligible in the notes?

The eligibility notes also referenced organization types such as tribal epidemiology centers, faith-based organizations, community-based organizations, hospitals, and research organizations.

Why would the FOA include such a broad range of eligible organizations?

The work envisioned often requires specialized expertise that may come from academic groups, contract research organizations, clinical trial networks, consultants with regulatory and CMC expertise, or partnerships combining manufacturing, clinical operations, and quality/regulatory capabilities.

When was the opportunity posted, and what were the closing dates?

The FOA was posted on August 9, 2013. The original and current closing date was September 9, 2013.

When was the opportunity archived?

The opportunity was archived on October 9, 2013.

Where were applicants directed to get help accessing the full announcement?

Assistance for accessing the full announcement was routed through the Grants.gov Contact Center, which provided around-the-clock support.

What was the practical end goal of funding under this FOA?

The end goal was to remove technical bottlenecks in manufacturing and clinical development so that influenza vaccine producers in under resourced nations could more quickly reach reliable production, generate acceptable clinical evidence, and be better positioned to supply vaccines during seasonal outbreaks and potential pandemics.

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