Opportunity Information: Apply for RFA FD 14 003
Apply for RFA FD 14 003
- The Food Drug Administration in the education health science and technology and other research and development sector is offering a public funding opportunity titled "Convener of Discussions on Medical Policy Issues Impacting Drug Development" 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 Mar 30, 2014 and posted on Mar 31, 2014.
- Applicants must submit their applications by Jun 2, 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 $600,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $600,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
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Opportunity Summary:
This funding opportunity (RFA FD 14 003), titled "Convener of Discussions on Medical Policy Issues Impacting Drug Development," was offered by the U.S. Food and Drug Administration (FDA) under the Center for Drug Evaluation and Research (CDER), specifically through the Office of Medical Policy (OMP). The core purpose of the award is to support an organization that can convene and manage public discussions and working group style meetings on medical policy issues that affect the drug development lifecycle. OMP plays a leadership role in shaping medical policy and procedures tied to drug development and approval, bioresearch monitoring, protection of human research participants, and post market surveillance. Because policy initiatives in these areas often have broad implications, FDA is seeking a neutral convener that can bring together a wide range of stakeholders in an organized, transparent way so FDA can hear informed perspectives before, during, and after implementing new initiatives.
A central theme of the announcement is what these meetings are and are not meant to do. The meetings are not advisory committees intended to provide recommendations on specific regulatory actions, and they are not meant to produce decisions or formal consensus outcomes. Instead, the intent is to create structured forums where FDA can listen to the views of subject matter experts and affected stakeholders, surface key issues, and better understand practical concerns, emerging evidence, and policy tradeoffs. In other words, the value is in gathering high quality input and framing the problem space clearly, rather than voting on solutions or generating official agency direction.
Transparency and public accessibility are emphasized as essential requirements. The opportunity stresses that information produced through these discussions and any associated working groups must be described, managed, and made available to the public through an open and transparent approach. That implies responsibilities such as documenting proceedings, handling materials in an orderly way, and ensuring that outputs from meetings are shared publicly so the broader community can see what was discussed and how the dialogue was organized. At the same time, the announcement recognizes practical limits: participation should be as inclusive as possible, but still sized appropriately to support productive discussion and the specific objectives of each meeting.
From an administrative standpoint, the mechanism is a cooperative agreement, which generally indicates substantial involvement or collaboration with the FDA during performance rather than a hands off grant. The activity category spans education, health, science and technology, and other research and development, reflecting that the work is primarily about convening, information exchange, and policy oriented dialogue rather than bench research. The program is associated with CFDA number 93.103 (FDA Research). The announcement projected up to five awards, with an estimated total funding amount of $600,000. The listed award ceiling was $600,000 and the award floor was $550,000, and there was no cost sharing or matching requirement.
Eligibility was limited to nonprofit organizations, including both 501(c)(3) nonprofits (other than institutions of higher education) and nonprofits without 501(c)(3) status (also other than institutions of higher education). Key timeline details from the posting indicate it was posted March 31, 2014, with an original and current closing date of June 2, 2014, and an archive date of July 2, 2014. For access issues or grants management questions, the announcement referenced a grants management specialist contact at FDA (Gladys Melendez Bohler, phone 301 827 7175). Overall, the opportunity funds the infrastructure and coordination needed to run credible, well managed stakeholder discussions that help FDA identify and explore policy issues affecting drug development while maintaining strong public transparency.
Frequently Asked Questions (FAQs)
What is the title and reference number of this funding opportunity?
The opportunity is titled "Convener of Discussions on Medical Policy Issues Impacting Drug Development" and is identified as RFA FD 14 003.
Which agency and FDA offices are associated with this opportunity?
This opportunity was offered by the U.S. Food and Drug Administration (FDA) under the Center for Drug Evaluation and Research (CDER), through the Office of Medical Policy (OMP).
What is the primary purpose of the award?
The award is intended to support an organization that can convene and manage public discussions and working group style meetings on medical policy issues that affect the drug development lifecycle.
What types of medical policy areas does OMP focus on, as described in the announcement?
OMP is described as having a leadership role in shaping medical policy and procedures tied to drug development and approval, bioresearch monitoring, protection of human research participants, and post market surveillance.
Why does FDA want a "neutral convener" for these discussions?
Because policy initiatives in these areas can have broad implications, FDA is seeking a neutral convener that can bring together a wide range of stakeholders in an organized and transparent way so FDA can hear informed perspectives before, during, and after implementing new initiatives.
Are these meetings FDA advisory committee meetings?
No. The announcement states these meetings are not advisory committees intended to provide recommendations on specific regulatory actions.
Are the meetings expected to produce decisions, formal recommendations, or consensus outcomes?
No. The intent is not to produce decisions or formal consensus outcomes. The meetings are structured forums for FDA to listen, surface key issues, and better understand practical concerns, emerging evidence, and policy tradeoffs.
If the meetings do not produce formal decisions, what is the value or intended outcome?
The value is in gathering high quality input and clearly framing the problem space. The meetings help FDA hear informed perspectives and understand issues that may affect policy initiatives impacting drug development.
What kinds of meeting formats are contemplated by the opportunity?
The opportunity emphasizes public discussions and working group style meetings focused on medical policy issues impacting the drug development lifecycle.
What does the announcement say about transparency and public access?
Transparency and public accessibility are described as essential requirements. Information produced through the discussions and any associated working groups must be described, managed, and made available to the public through an open and transparent approach.
What kinds of public-facing responsibilities are implied for the awardee?
Based on the announcement, responsibilities imply documenting proceedings, handling materials in an orderly way, and ensuring that outputs from meetings are shared publicly so the broader community can see what was discussed and how the dialogue was organized.
Does the opportunity require inclusive participation, and are there limits?
Yes. Participation should be as inclusive as possible, but still sized appropriately to support productive discussion and the specific objectives of each meeting.
What is the funding mechanism for this opportunity?
The mechanism is a cooperative agreement.
What does a cooperative agreement imply for how FDA will be involved?
The announcement notes that a cooperative agreement generally indicates substantial involvement or collaboration with FDA during performance, rather than a hands off grant.
What activity categories are associated with the program?
The activity category spans education, health, science and technology, and other research and development, reflecting work centered on convening, information exchange, and policy oriented dialogue rather than bench research.
What is the CFDA number associated with this program?
The program is associated with CFDA number 93.103 (FDA Research).
How many awards were anticipated under this announcement?
The announcement projected up to five awards.
What was the estimated total funding amount?
The estimated total funding amount listed was $600,000.
What were the award ceiling and award floor?
The listed award ceiling was $600,000 and the award floor was $550,000.
Was cost sharing or matching required?
No. The announcement states there was no cost sharing or matching requirement.
Who was eligible to apply?
Eligibility was limited to nonprofit organizations, including 501(c)(3) nonprofits (other than institutions of higher education) and nonprofits without 501(c)(3) status (also other than institutions of higher education).
Are institutions of higher education eligible under this opportunity?
No. The eligibility description explicitly excludes institutions of higher education.
When was the opportunity posted?
The posting date listed was March 31, 2014.
What were the closing date and archive date?
The original and current closing date was June 2, 2014, and the archive date was July 2, 2014.
Who is the contact for access issues or grants management questions?
The announcement referenced an FDA grants management specialist: Gladys Melendez Bohler, phone 301 827 7175.
In one sentence, what does this opportunity fund?
It funds the infrastructure and coordination needed to run credible, well managed, publicly transparent stakeholder discussions that help FDA identify and explore medical policy issues affecting drug development.
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