Opportunity Information: Apply for RFA FD 16 044
Apply for RFA FD 16 044
- The HHS-FDA 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 Access to Safe and Effective Biological Products - (U01)" 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 May 05, 2016 and posted on May 05, 2016.
- Applicants must submit their applications by Jul 05, 2016. (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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Opportunity Summary:
The grant opportunity titled "Collaboration in Regulatory Systems Strengthening and Standardization Activities to Increase Access to Safe and Effective Biological Products (U01)" is a U.S. Food and Drug Administration (FDA) cooperative agreement intended to support work that improves how biological products are regulated globally. The overall focus is on strengthening regulatory systems, advancing the development and use of international norms and standards, and supporting innovative, practical research that helps increase worldwide access to biological products that are safe, effective, and aligned with internationally recognized quality expectations.
This is a discretionary funding opportunity from HHS-FDA, listed under CFDA 93.103, and it uses the cooperative agreement mechanism (U01). That mechanism typically indicates substantial involvement by the FDA in the project beyond what would be expected in a standard grant, often through collaboration on technical approaches, alignment with public health priorities, and coordinated planning around deliverables. In practical terms, the work is meant to be collaborative rather than purely investigator-driven, with FDA and the recipient working closely to achieve shared regulatory and public health outcomes.
A defining feature of this announcement is that it is single-source and specifically intended for the World Health Organization (WHO). The FDA states its intention to accept and consider one application from WHO, meaning the eligibility is effectively limited and the program is designed as a targeted partnership rather than an open competition among many applicants. The aim is to leverage WHO's global convening role and its longstanding work on regulatory system strengthening, standard-setting, and international guidance that can be adopted or adapted by national regulatory authorities.
Programmatically, the opportunity centers on improving regulatory capacity and harmonization so that biological products can be developed, assessed, manufactured, and monitored in ways that meet international standards. Biological products can include vaccines, blood and blood components, allergens, somatic cells, gene therapy products, tissues, and recombinant therapeutic proteins. By emphasizing regulatory systems strengthening and standardization, the project area implies activities such as improving regulatory science capabilities, supporting consistent approaches to product evaluation, facilitating reliance or convergence models among regulators where appropriate, and promoting quality systems and post-market oversight practices that protect patients while enabling timely access.
The award’s maximum funding level is listed as an award ceiling of $2,000,000, and the FDA anticipates making a single award (ExpectedAwards: 1). The funding opportunity was created and posted on May 5, 2016, and the application closing date is July 5, 2016. The activity category is labeled under Agriculture, Consumer Protection, Food and Nutrition, reflecting FDA’s broad public health mission and the consumer protection aspects of ensuring that biological products available to populations meet safety and effectiveness standards.
In short, this opportunity is a focused FDA-WHO collaboration intended to improve global regulatory ecosystems for biological products through standards development, regulatory capacity building, and applied research. The intended outcome is a stronger, more consistent international regulatory environment that helps countries and regions expand access to high-quality biological products while maintaining public trust and safeguarding health.
FAQs: Collaboration in Regulatory Systems Strengthening and Standardization Activities to Increase Access to Safe and Effective Biological Products (U01)
What is the title of this grant opportunity?
The opportunity is titled "Collaboration in Regulatory Systems Strengthening and Standardization Activities to Increase Access to Safe and Effective Biological Products (U01)."
Which federal agency is offering this opportunity?
This is a U.S. Department of Health and Human Services (HHS) opportunity through the U.S. Food and Drug Administration (FDA).
What type of funding mechanism is used?
The funding mechanism is a cooperative agreement (U01). This generally means FDA expects substantial involvement in the project, such as collaboration on technical approaches, coordinated planning, and alignment on deliverables and public health priorities, rather than a fully independent, investigator-driven project.
Is this a competitive grant open to multiple applicants?
No. The announcement is described as single-source and specifically intended for the World Health Organization (WHO). FDA states it intends to accept and consider one application from WHO, so eligibility is effectively limited to that organization.
Who is the intended applicant/recipient?
The intended applicant is the World Health Organization (WHO). The program is designed as a targeted partnership that leverages WHO's global convening role and its work on regulatory system strengthening and international standards and guidance.
What is the main purpose of the award?
The purpose is to improve how biological products are regulated globally by strengthening regulatory systems, advancing the development and use of international norms and standards, and supporting innovative and practical research that increases worldwide access to biological products that are safe, effective, and aligned with internationally recognized quality expectations.
What kinds of products are considered "biological products" under this opportunity?
Biological products may include vaccines, blood and blood components, allergens, somatic cells, gene therapy products, tissues, and recombinant therapeutic proteins.
What does "regulatory systems strengthening" mean in the context of this opportunity?
Based on the description provided, it refers to improving regulatory capacity and harmonization so biological products can be developed, assessed, manufactured, and monitored in ways that meet international standards. It implies strengthening regulatory science capabilities and improving the consistency and quality of regulatory functions across settings.
What does "standardization activities" refer to?
Standardization activities refer to advancing the development and use of international norms and standards and supporting international guidance that can be adopted or adapted by national regulatory authorities to promote consistent expectations for quality, safety, and effectiveness.
What kinds of activities might be supported under this cooperative agreement?
The description suggests activities such as improving regulatory science capabilities, supporting consistent approaches to product evaluation, facilitating reliance or convergence models among regulators where appropriate, promoting quality systems, and strengthening post-market oversight practices that protect patients while enabling timely access.
How does FDA typically participate in a U01 cooperative agreement?
For a U01, FDA involvement is typically more substantial than in a standard grant. The opportunity description indicates collaboration on technical approaches, alignment with public health priorities, and coordinated planning around deliverables, with FDA and the recipient working closely toward shared regulatory and public health outcomes.
What is the overall expected public health outcome?
The intended outcome is a stronger and more consistent international regulatory environment that helps countries and regions expand access to high-quality biological products while maintaining public trust and safeguarding health.
What is the maximum funding amount available?
The award ceiling is listed as $2,000,000.
How many awards does FDA expect to make?
FDA anticipates making a single award (ExpectedAwards: 1).
What is the CFDA number associated with this opportunity?
The opportunity is listed under CFDA 93.103.
When was the opportunity posted, and what is the application deadline?
The opportunity was created and posted on May 5, 2016. The application closing date is July 5, 2016.
How is this opportunity categorized?
The activity category is labeled under Agriculture, Consumer Protection, Food and Nutrition, reflecting FDA's broad public health mission and the consumer protection aspects of ensuring biological products meet safety and effectiveness standards.
Why is WHO specifically named for this single-source award?
The description indicates the goal is to leverage WHO's global convening role and its longstanding work on regulatory system strengthening, standard-setting, and developing international guidance that can be used by national regulatory authorities.
Is the focus limited to the United States?
No. The focus is global, aimed at improving regulatory ecosystems worldwide so biological products can be regulated in ways that align with internationally recognized expectations for quality, safety, and effectiveness.
What is meant by increasing "access" to biological products in this context?
In this context, access is tied to strengthening and harmonizing regulatory capacity and standards so safe, effective, high-quality biological products can be developed, evaluated, manufactured, and monitored efficiently and reliably across countries and regions.
Does the opportunity emphasize research, implementation, or both?
Both are reflected in the description. It mentions innovative, practical research as well as regulatory capacity building and standards development and use, all aimed at real-world improvements in regulatory systems and product oversight.
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