Opportunity Information: Apply for RFA FD 15 002
Apply for RFA FD 15 002
- The Food Drug Administration in the regional development sector is offering a public funding opportunity titled "Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas" 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 Jul 23, 2014 and posted on Jul 11, 2014.
- Applicants must submit their applications by Aug 9, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $10,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $10,000,000.00 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 Pan American Health Organization (PAHO) serves as the Regional Office for the Americas of the World Health Organization (WHO), and is uniquely qualified to undertake the research described in this Cooperative Agreement.
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Opportunity Summary:
The grant opportunity "Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas" (Funding Opportunity Number RFA FD 15 002) is a U.S. Food and Drug Administration (FDA) initiative to fund a single cooperative agreement with the Pan American Health Organization (PAHO), which serves as the World Health Organization (WHO) Regional Office for the Americas. The central purpose is to deepen and expand existing FDA-PAHO collaboration to strengthen medical product regulatory systems across the Americas in ways that also support FDA's public health mission, particularly around the safety, quality, and oversight of medicines, vaccines, and other medical products. The award mechanism is a Cooperative Agreement, meaning FDA expects to remain actively involved in the work rather than simply providing a hands-off grant.
The scope of work is organized around three connected themes. First, the agreement supports the development and practical application of regional and global norms and standards for medical product regulation in the Americas. This includes convening expert meetings and technical consultations to share scientific findings and regulatory data, helping countries adopt and evaluate internationally recognized standards such as WHO guidelines and standards and those emerging from international harmonization bodies like the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). PAHO is expected to use its convening role to bring together relevant stakeholders and to promote alignment and convergence between standards used in the Americas and those used in other regions or global regulatory bodies, with the goal of improving consistency and reliability of regulatory approaches.
Second, the agreement emphasizes research and evidence generation on how regulatory systems are performing, where the gaps are, and what emerging risks and trends could affect performance. Activities under this theme are meant to strengthen the global understanding of the current state of medical product regulation, including the challenges countries face and the risks that can undermine product quality and patient safety. This work also aims to help make the "business case" for investing in stronger regulatory systems by documenting impacts and needs. A key deliverable area is improving data and information systems that can feed into evidence-based regulatory decisions, along with broader knowledge management tools and networks that allow regulators to learn from each other and act on better information.
Third, the opportunity supports direct technical assistance to strengthen regulatory capacity and to raise awareness of why regulatory systems matter within the broader global health and development agenda. The description highlights a wide range of regulatory domains where strengthening may be needed, including regulatory frameworks and governance; marketing authorization processes; import and export controls; postmarket surveillance; inspections; laboratory capacity; pharmacovigilance; clinical trial oversight; vaccine lot release; and workforce development and training, including professionalizing the regulatory workforce. It also includes strengthening monitoring and evaluation of product quality, inspection and surveillance across supply chains, and improved risk assessment, analysis, and risk management. In addition to hands-on capacity building, the work is intended to produce strategies that communicate the essential role of regulatory systems in public health, and to identify ways to leverage existing initiatives and partnerships or catalyze new investments.
In terms of funding and administrative details, FDA anticipated making one award under CFDA (now Assistance Listing) 93.103. The estimated total funding and award ceiling are both $10,000,000, with an award floor of $2,000,000, and there is no cost sharing or matching requirement. The opportunity was posted July 11, 2014, with an original and final closing date of August 9, 2014, and an archive date of September 8, 2014. Eligibility is effectively limited to PAHO as a single-source applicant because FDA identifies PAHO as uniquely qualified to carry out the regional research, convening, and technical cooperation described. The listed grants management contact is Oluyemisi Akinneye at the FDA (240-402-7560; oluyemisi.akinneye@fda.gov).
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA FD 15 002.
Which U.S. agency is offering this funding?
The opportunity is a U.S. Food and Drug Administration (FDA) initiative.
What is the purpose of the award?
The central purpose is to deepen and expand existing FDA-PAHO collaboration to strengthen medical product regulatory systems across the Americas, in ways that also support FDA's public health mission. The focus includes improving the safety, quality, and oversight of medicines, vaccines, and other medical products.
What type of award is being offered?
The award mechanism is a Cooperative Agreement. This means FDA expects to remain actively involved in the work rather than providing a hands-off grant.
How many awards does FDA anticipate making?
FDA anticipated making one award.
Who is eligible to apply?
Eligibility is effectively limited to the Pan American Health Organization (PAHO) as a single-source applicant, because FDA identifies PAHO as uniquely qualified to carry out the regional research, convening, and technical cooperation described.
What is PAHO's role in this project?
PAHO is expected to use its convening role to bring together relevant stakeholders across the Americas, support technical cooperation, and promote alignment and convergence of regulatory approaches with internationally recognized norms and standards.
Is PAHO connected to the World Health Organization (WHO)?
Yes. PAHO serves as the World Health Organization (WHO) Regional Office for the Americas.
What are the main themes or focus areas of the scope of work?
The scope of work is organized around three connected themes: (1) developing and applying regional and global norms and standards for medical product regulation; (2) research and evidence generation on regulatory system performance, gaps, risks, and trends; and (3) direct technical assistance to strengthen regulatory capacity and raise awareness of the importance of regulatory systems.
What activities are included under the norms and standards theme?
This theme includes convening expert meetings and technical consultations to share scientific findings and regulatory data; helping countries adopt and evaluate internationally recognized standards (including WHO guidelines and standards); and supporting alignment with standards emerging from international harmonization bodies such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Does the opportunity mention international harmonization?
Yes. The opportunity highlights harmonization and convergence between standards used in the Americas and those used in other regions or global regulatory bodies, including alignment with ICH-related approaches and WHO standards.
What is meant by improving consistency and reliability of regulatory approaches?
Within this opportunity, it refers to promoting alignment and convergence of regulatory norms and practices across countries, using internationally recognized standards so regulatory decisions and oversight are more consistent and dependable across the region.
What is included under the research and evidence generation theme?
Activities under this theme focus on understanding how regulatory systems are performing, identifying gaps, and tracking emerging risks and trends that could affect performance. It also includes documenting impacts and needs to help build a "business case" for investing in stronger regulatory systems.
Does the opportunity support improvements to data and information systems?
Yes. A key deliverable area includes improving data and information systems that feed into evidence-based regulatory decisions, along with knowledge management tools and networks that enable regulators to learn from each other and act on better information.
What is included under the technical assistance and capacity-building theme?
This theme supports direct technical assistance to strengthen regulatory capacity and raise awareness of the role of regulatory systems in public health and development. It spans multiple regulatory domains and includes hands-on capacity-building as well as strategies to communicate the importance of regulatory systems and leverage partnerships and investments.
Which regulatory domains are specifically mentioned as areas for strengthening?
The description highlights regulatory frameworks and governance; marketing authorization processes; import and export controls; postmarket surveillance; inspections; laboratory capacity; pharmacovigilance; clinical trial oversight; vaccine lot release; and workforce development and training (including professionalizing the regulatory workforce).
Does the scope mention supply chain monitoring and risk management?
Yes. It includes strengthening monitoring and evaluation of product quality, inspection and surveillance across supply chains, and improved risk assessment, analysis, and risk management.
Does the opportunity include communication and advocacy components?
Yes. In addition to technical work, the opportunity calls for strategies that communicate the essential role of regulatory systems in public health and to identify ways to leverage existing initiatives and partnerships or catalyze new investments.
What is the Assistance Listing (formerly CFDA) number?
The listing is CFDA (now Assistance Listing) 93.103.
What is the estimated total funding available?
The estimated total funding is $10,000,000.
What is the maximum award amount (award ceiling)?
The award ceiling is $10,000,000.
What is the minimum award amount (award floor)?
The award floor is $2,000,000.
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement stated for this opportunity.
When was the opportunity posted?
The opportunity was posted on July 11, 2014.
What was the application closing date?
The original and final closing date was August 9, 2014.
Is this funding opportunity still active?
No. The opportunity lists an archive date of September 8, 2014, indicating it has been archived.
Who is the listed grants management contact?
The listed grants management contact is Oluyemisi Akinneye at FDA.
How can the grants management contact be reached?
Phone: 240-402-7560. Email: oluyemisi.akinneye@fda.gov.
What geographic region does the work focus on?
The work focuses on strengthening medical product regulatory systems across the Americas.
What kinds of medical products are emphasized?
The description specifically mentions medicines, vaccines, and other medical products, with an emphasis on their safety, quality, and oversight.
Why does FDA describe PAHO as uniquely qualified for this award?
Based on the description, FDA identifies PAHO as uniquely qualified to conduct the regional research, convening, and technical cooperation needed to advance regulatory system strengthening across the Americas.
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