Opportunity Information: Apply for RFA FD 11 011
Apply for RFA FD 11 011
- The Food Drug Administration in the agriculture business and commerce education employment, labor and training environment health information and statistics natural resources regional development science and technology and other research and development sector is offering a public funding opportunity titled "Collaboration in Regulatory Science and Capacity to Advance Global Access to Safe Vaccines and Biological (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Jun 13, 2011 and posted on Jun 13, 2011.
- Applicants must submit their applications by Jul 8, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $800,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $800,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for award to the World Health Organization (WHO) in support of collaboration in regulatory science and capacity to advance global access to safe vaccines and biologicals that are of good quality and meet international standards.
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Opportunity Summary:
This grant opportunity, titled "Collaboration in Regulatory Science and Capacity to Advance Global Access to Safe Vaccines and Biological (U01)," is a cooperative agreement offered by the U.S. Food and Drug Administration (FDA), specifically through its Center for Biologics Evaluation and Research (CBER). The core aim is to strengthen global public health by supporting international work that improves the quality, safety, and standardization of vaccines and other biological products. The announcement emphasizes a practical public health rationale: preventing and controlling infectious disease threats globally also helps protect the health of people in the United States, since outbreaks and supply chain risks do not stop at national borders. In that context, the FDA positions this funding as part of its long-running engagement with global partners to reinforce regulatory science and regulatory capacity.
A central feature of the opportunity is that it is a single-source award. FDA states its intention to accept and consider one application for funding, and the eligible applicant is the World Health Organization (WHO). In other words, this is not a broadly competed grant; it is structured to directly support FDA/CBER and WHO collaboration, building on established institutional relationships and mutually agreed priorities. The collaboration is framed by formal Terms of Reference (TOR) that define the purpose, scope, and activities for the relevant term, reflecting shared interests in vaccine and biologics quality, safety, and standards work.
The description highlights that FDA/CBER has been involved with WHO for many years, including serving as a Pan American Health Organization (PAHO)/WHO Collaborating Center for Biological Standardization since 1998. That role signals a sustained commitment to international biological standardization efforts, which often include work such as developing, evaluating, or promoting reference materials and harmonized approaches that help laboratories and regulators compare results and ensure products meet appropriate benchmarks. The grant is meant to support this general ecosystem of regulatory science cooperation, where scientific methods, standards, and regulatory decision-making reinforce one another.
A major programmatic focus described in the announcement is the WHO Vaccine Prequalification Program. WHO uses this program to advise UNICEF and other United Nations agencies on whether vaccines are acceptable, in principle, for procurement and use in vaccination programs those agencies support. Prequalification is especially important for global immunization because it helps buyers and countries have confidence that vaccines meet international expectations for quality, safety, and performance. The opportunity underscores that WHO relies heavily on the National Regulatory Authority (NRA) of the vaccine's country of manufacture, provided that the NRA meets WHO indicators showing it is "functional." This reliance model makes it essential that strong, credible regulators contribute to the global assurance system.
Within that prequalification framework, FDA notes that in 2009 it established an arrangement with WHO (referencing WHO/QSS) that enables FDA/CBER to serve as a reference NRA for the prequalification program. At the time of the announcement, FDA/CBER is described as a reference NRA for eight U.S.-licensed vaccines, including five influenza vaccines. The practical implication is that FDA scientific and regulatory assessments can be leveraged internationally to support confidence in certain vaccines considered for UN procurement, helping speed access while maintaining rigorous expectations for safety and quality.
From an administrative standpoint, the funding opportunity number is RFA-FD-11-011, and the instrument is a cooperative agreement (U01), which typically means FDA expects substantial involvement in the funded activities rather than a hands-off grant relationship. The total estimated funding is $800,000, with an award ceiling and floor both set at $800,000, indicating a single award in a fixed amount. There is no cost-sharing or matching requirement. The opportunity was posted on June 13, 2011, with an original and current closing date of July 8, 2011, and an archive date of August 7, 2011. It lists one expected award and is associated with CFDA number 93.103 (Food and Drug Administration Research).
Overall, the opportunity is best understood as targeted support for WHO-FDA collaboration aimed at strengthening the science and regulatory systems that underpin vaccine and biologics oversight worldwide. By investing in shared standards, regulatory capacity, and the mechanisms that allow trusted regulators to support WHO prequalification decisions, the award is designed to advance global access to vaccines and biologicals that meet international standards for quality and safety, while also reinforcing the broader goal of protecting public health in the United States through stronger global disease prevention and response infrastructure.
Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Collaboration in Regulatory Science and Capacity to Advance Global Access to Safe Vaccines and Biological (U01)."
Which U.S. agency is offering this opportunity?
The opportunity is offered by the U.S. Food and Drug Administration (FDA), through its Center for Biologics Evaluation and Research (CBER).
What type of funding instrument is this?
This is a cooperative agreement (U01). In general, a cooperative agreement indicates that FDA expects substantial involvement in the supported activities, rather than a fully hands-off relationship.
What is the main purpose of the award?
The core aim is to strengthen global public health by supporting international work that improves the quality, safety, and standardization of vaccines and other biological products. The rationale described is that stronger global prevention and control of infectious disease threats also protects people in the United States, since outbreaks and supply chain risks can cross borders.
Is this a competitive funding opportunity open to multiple applicants?
No. The announcement describes this as a single-source award. FDA states its intention to accept and consider one application for funding.
Who is eligible to apply?
The eligible applicant identified in the announcement is the World Health Organization (WHO).
How is the collaboration between FDA/CBER and WHO described?
The opportunity is structured to support FDA/CBER and WHO collaboration built on established institutional relationships and mutually agreed priorities. The collaboration is framed by formal Terms of Reference (TOR) that define purpose, scope, and activities for the relevant term.
What kinds of activities does the funding aim to support (at a high level)?
At a high level, the opportunity emphasizes international regulatory science cooperation and regulatory capacity building related to vaccines and other biological products, with a focus on quality, safety, and standardization, including work connected to WHO systems that support global confidence in vaccines and biologicals.
What is FDA/CBER's historical role with WHO mentioned in the announcement?
FDA/CBER is described as having been involved with WHO for many years and serving as a Pan American Health Organization (PAHO)/WHO Collaborating Center for Biological Standardization since 1998.
What does "biological standardization" refer to in this context?
In the announcement, biological standardization is discussed in terms of international efforts that can include developing, evaluating, or promoting reference materials and harmonized approaches that help laboratories and regulators compare results and ensure products meet appropriate benchmarks.
What major WHO program is specifically highlighted?
The announcement highlights the WHO Vaccine Prequalification Program as a major programmatic focus.
What is the WHO Vaccine Prequalification Program used for, according to the description?
WHO uses the Vaccine Prequalification Program to advise UNICEF and other United Nations agencies on whether vaccines are acceptable, in principle, for procurement and use in vaccination programs supported by those agencies.
Why is vaccine prequalification described as important?
Prequalification is described as especially important for global immunization because it helps buyers and countries have confidence that vaccines meet international expectations for quality, safety, and performance.
How does WHO rely on National Regulatory Authorities (NRAs) in the prequalification process?
The announcement states that WHO relies heavily on the National Regulatory Authority (NRA) of the vaccine's country of manufacture, provided that the NRA meets WHO indicators showing it is "functional."
What does it mean for an NRA to be "functional" in the announcement?
The announcement indicates that WHO uses indicators to determine whether an NRA is "functional." The specific indicators are not listed in the provided description.
What arrangement between FDA and WHO is mentioned, and when was it established?
The announcement notes that in 2009 FDA established an arrangement with WHO (referencing WHO/QSS) that enables FDA/CBER to serve as a reference NRA for the WHO Vaccine Prequalification Program.
What is FDA/CBER's role as a "reference NRA" described to include?
The practical implication described is that FDA scientific and regulatory assessments can be leveraged internationally to support confidence in certain vaccines considered for UN procurement, helping speed access while maintaining rigorous expectations for safety and quality.
How many U.S.-licensed vaccines are covered by FDA/CBER's reference NRA role in the announcement?
At the time of the announcement, FDA/CBER is described as a reference NRA for eight U.S.-licensed vaccines, including five influenza vaccines.
What is the funding opportunity number?
The funding opportunity number is RFA-FD-11-011.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.103 (Food and Drug Administration Research).
How much total funding is estimated for this award?
The total estimated funding is $800,000.
What are the award ceiling and award floor?
Both the award ceiling and the award floor are set at $800,000, indicating a single award in a fixed amount.
How many awards does FDA expect to make under this announcement?
The announcement lists one expected award.
Is cost-sharing or matching required?
No. The announcement states there is no cost-sharing or matching requirement.
When was the opportunity posted?
The opportunity was posted on June 13, 2011.
What are the closing date and archive date listed?
The original and current closing date is July 8, 2011, and the archive date is August 7, 2011.
What is the broader public health rationale given for this work?
The announcement emphasizes that preventing and controlling infectious disease threats globally also helps protect health in the United States, because outbreaks and supply chain risks do not stop at national borders.
How should this opportunity be understood overall?
Based on the description, it is targeted support for WHO-FDA collaboration aimed at strengthening the science and regulatory systems that underpin vaccine and biologics oversight worldwide, including shared standards, regulatory capacity, and mechanisms that allow trusted regulators to support WHO prequalification decisions.
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