Opportunity Information: Apply for RFA FD 16 014
Apply for RFA FD 16 014
- The HHS-FDA in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Research, Education, and Outreach on Botanical Natural 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 Feb 29, 2016 and posted on Feb 29, 2016.
- Applicants must submit their applications by Apr 29, 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 $3,500,000.00 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 Research, Education, and Outreach on Botanical Natural Products (U01) opportunity (RFA-FD-16-014) is a discretionary cooperative agreement funded by the U.S. Department of Health and Human Services, Food and Drug Administration (HHS-FDA), under CFDA 93.103. It was created and posted on February 29, 2016, with an application closing date of April 29, 2016. The FDA indicated it expected to make one award, with an award ceiling of $3,500,000. While the eligibility field is listed broadly as "Others" (with additional clarification referenced in the full notice), the announcement makes clear that FDA intended to receive and consider a cooperative agreement specifically with the University of Mississippi (UM) to support the National Center for Natural Products Research (NCNPR).
At a high level, the goal of the agreement is to strengthen the research, scientific infrastructure, and information-sharing needed for better oversight and public-health decision-making around botanical natural products in the U.S. marketplace. FDA frames the partnership as a way to make the development and dissemination of natural products research and science more efficient, and to complement ongoing work already happening across both public and private sectors. Because the mechanism is a cooperative agreement (U01), the intent is not just to provide funds and step back, but to support an active collaboration where FDA scientists and the UM-NCNPR team interact, coordinate, and jointly advance priorities that matter for regulatory science and consumer protection.
The work described centers on botanicals used in foods, dietary supplements, and cosmetics marketed in the United States, especially where safety questions, market trends, or knowledge gaps suggest a need for closer attention. One major deliverable is helping identify and develop a prioritized list of botanical ingredients, using factors such as safety concerns, trends in use, and existing scientific knowledge. In practice, this kind of prioritization supports FDA by focusing limited research and evaluation resources on ingredients most likely to pose risk, be widely consumed, be subject to adulteration or misidentification, or otherwise generate regulatory and public-health concern.
Another core component is building and strengthening the foundation of high-quality reference materials. UM-NCNPR is expected to acquire, validate, and characterize authenticated reference materials that FDA can use in its safety-related evaluations. These materials include raw plant materials, processed plant materials, and purified natural products. The emphasis on authentication and characterization matters because botanical products can vary widely due to species differences, geography, cultivation and harvesting practices, processing steps, and potential substitution or adulteration. Having well-characterized reference materials supports reliable testing, method development, and scientific comparisons across laboratories.
The opportunity also emphasizes ongoing technical exchange and collaboration. UM-NCNPR would share technical and scientific information, analytical methods, and reference materials with FDA scientists and other stakeholders, helping standardize approaches and speed up scientific progress across the broader community working on botanical safety and quality. In addition, the agreement calls for collaboration with FDA scientists in research areas of mutual interest, reflecting the cooperative nature of the award and the expectation that research efforts align with high-priority regulatory science needs.
Finally, the cooperative agreement includes a strong education and outreach dimension through the coordination of scientific workshops and conferences on botanical topics that are relevant to public health. These events are meant to bring together experts, regulators, researchers, and other stakeholders to address high-priority science and research needs, surface emerging issues, and disseminate findings and best practices. Taken together, the components of the award point to an integrated effort: setting priorities, creating trusted reference standards, sharing methods and data, conducting collaborative research, and convening the field to improve the evidence base FDA relies on when evaluating botanical ingredients used in consumer products.
Frequently Asked Questions (FAQ)
What is the name of this funding opportunity?
The opportunity is titled "Research, Education, and Outreach on Botanical Natural Products (U01)" and is identified as RFA-FD-16-014.
Which federal agency is offering this opportunity?
It is funded by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
What type of award mechanism is being used?
This is a discretionary cooperative agreement using the U01 mechanism.
What does a cooperative agreement (U01) imply about FDA's role?
A cooperative agreement indicates active collaboration rather than a hands-off grant. The description emphasizes ongoing interaction and coordination between FDA scientists and the awardee team to jointly advance regulatory-science and public-health priorities related to botanical natural products.
What is the CFDA number for this program?
The CFDA listing provided is 93.103.
When was the opportunity created and posted?
The announcement was created and posted on February 29, 2016.
What was the application closing date?
The application closing date listed is April 29, 2016.
How many awards did FDA expect to make?
FDA indicated it expected to make one award.
What was the maximum (ceiling) award amount?
The award ceiling was $3,500,000.
Who was intended to receive the cooperative agreement?
Although the eligibility field is broadly listed as "Others" (with more detail referenced in the full notice), the announcement states FDA intended to receive and consider a cooperative agreement specifically with the University of Mississippi (UM) to support the National Center for Natural Products Research (NCNPR).
What is the overall purpose of the cooperative agreement?
The goal is to strengthen research, scientific infrastructure, and information-sharing to support better oversight and public-health decision-making for botanical natural products in the U.S. marketplace. FDA frames the partnership as a way to make natural products research and dissemination more efficient and to complement ongoing work across public and private sectors.
What kinds of products are in scope for this work?
The scope includes botanicals used in foods, dietary supplements, and cosmetics marketed in the United States.
Why is FDA focusing on botanical natural products?
Based on the description, FDA is focused on strengthening the evidence base and tools needed to evaluate botanicals that may raise safety questions, reflect changing market trends, or have scientific knowledge gaps that warrant closer attention for consumer protection and regulatory science.
What is one of the major deliverables mentioned?
A major deliverable is helping identify and develop a prioritized list of botanical ingredients, using factors such as safety concerns, trends in use, and existing scientific knowledge.
How would a prioritized list of botanical ingredients be used?
The prioritization is described as a way to help FDA focus limited research and evaluation resources on ingredients most likely to pose risk, be widely consumed, be subject to adulteration or misidentification, or otherwise create regulatory and public-health concerns.
What role do reference materials play in this project?
Building and strengthening high-quality reference materials is a core component. UM-NCNPR is expected to acquire, validate, and characterize authenticated reference materials that FDA can use in safety-related evaluations.
What types of reference materials are included?
The reference materials described include raw plant materials, processed plant materials, and purified natural products.
Why does the opportunity emphasize authentication and characterization of botanicals?
The announcement notes that botanical products can vary widely due to species differences, geography, cultivation and harvesting practices, processing steps, and potential substitution or adulteration. Authentication and characterization support reliable testing, method development, and comparisons across laboratories.
What kind of information-sharing is expected under this cooperative agreement?
The work emphasizes ongoing technical exchange, including sharing technical and scientific information, analytical methods, and reference materials with FDA scientists and other stakeholders to help standardize approaches and speed scientific progress in botanical safety and quality.
Is collaborative research with FDA part of the scope?
Yes. The opportunity calls for collaboration with FDA scientists in research areas of mutual interest, reflecting that research efforts should align with high-priority regulatory science needs.
What education and outreach activities are included?
The agreement includes coordinating scientific workshops and conferences on botanical topics relevant to public health. These events are intended to bring together experts, regulators, researchers, and other stakeholders to address high-priority needs, identify emerging issues, and disseminate findings and best practices.
How do the different project components fit together?
The announcement describes an integrated effort that combines (1) setting priorities for botanicals, (2) creating trusted reference materials, (3) sharing methods and information, (4) conducting collaborative research aligned with FDA priorities, and (5) convening the field through workshops and conferences to improve the evidence base used in FDA evaluations.
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