Opportunity Information: Apply for RFA FD 21 031
This funding opportunity, titled "Collaboration in Regulatory Systems Strengthening and Standardization Activities to Increase Global Access to Safe and Effective Biological Products (U01) Clinical Trials Not Allowed" (Funding Opportunity Number RFA-FD-21-031), is a discretionary cooperative agreement offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). It sits within the funding activity area of agriculture/consumer protection/food and nutrition and is listed under CFDA number 93.103. The core purpose is to support work that strengthens regulatory systems, advances the development and adoption of norms and standards, and promotes innovative research aimed at improving global access to biological products that are safe, effective, and aligned with international standards.
A central feature of this announcement is that it is intended as a single-source award to the World Health Organization (WHO). In practical terms, that means the FDA is not running an open competition among many different applicants; instead, it is signaling its intent to fund WHO specifically because of WHO's unique role and global mandate in setting health-related norms and standards and supporting regulatory capacity-building across countries. While the eligibility field is described broadly as "Others (see text field entitled Additional Information on Eligibility for clarification)," the description makes clear that the contemplated recipient is WHO, and the agency expects to make only one award.
The planned mechanism is a cooperative agreement (U01), which generally indicates substantial involvement by the FDA during the project period compared with a standard grant. The project emphasis is collaborative work between FDA and WHO around regulatory systems strengthening and standardization activities. This can include efforts that help national and regional regulatory authorities improve their ability to evaluate, authorize, oversee, and monitor biological products, as well as work that supports the creation, refinement, or dissemination of internationally recognized regulatory norms and technical standards. The underlying public health goal is to reduce barriers to access by helping ensure that biological products reaching patients worldwide meet consistent benchmarks for quality, safety, and effectiveness.
The opportunity explicitly states that clinical trials are not allowed, meaning the scope is focused on regulatory science, standards development, capacity building, and related research or analytical activities rather than interventional studies in human participants. The emphasis is on systems-level impact and harmonization: improving how biological products are regulated and standardized across settings so that more people can reliably access products that meet internationally accepted expectations.
In terms of funding and timing, the FDA listed an award ceiling of $2,000,000 and indicated it expects to make one award. The opportunity was created on April 12, 2021, with an original closing date of July 13, 2021. Overall, the announcement reflects FDA's intent to partner with WHO to strengthen global regulatory ecosystems and standard-setting work, with the broader objective of expanding worldwide availability of safe and effective biological products that conform to international standards.Apply for RFA FD 21 031
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Collaboration in Regulatory Systems Strengthening and Standardization Activities to Increase Global Access to Safe and Effective Biological Products (U01) Clinical Trials Not Allowed" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Apr 12, 2021.
- Applicants must submit their applications by Jul 13, 2021. (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 $2,000,000.00 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).
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