Opportunity Information: Apply for RFA FD 16 015
Apply for RFA FD 16 015
- The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Architectural review of the BRIDG model (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 Mar 17, 2016 and posted on Mar 17, 2016.
- Applicants must submit their applications by May 23, 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 $225,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), 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, Private institutions of higher education, For profit organizations other than small businesses, Small businesses.
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Opportunity Summary:
This funding opportunity, titled "Architectural review of the BRIDG model (U01)" (RFA-FD-16-015), is a cooperative agreement offered by the U.S. Department of Health and Human Services (HHS), through the Food and Drug Administration (FDA). It centers on the Biomedical Research Integrated Domain Group (BRIDG) model, a long-running, multi-stakeholder effort that brings together major standards and regulatory organizations including CDISC, FDA, the HL7 Regulated Clinical Research Information Management (RCRIM) Work Group, and the National Cancer Institute (NCI). BRIDG is intended to provide a shared, consistent representation of protocol-driven biomedical research, including the research processes and the regulatory artifacts that accompany them, while also aligning with aspects of basic life sciences research. In practical terms, BRIDG acts as a common reference model meant to help different parties describe, exchange, and interpret clinical research information in compatible ways.
The main purpose of the grant is to support an architectural review of the BRIDG model. FDA's Center for Drug Evaluation and Research (CDER) is specifically interested in examining how BRIDG has grown and changed over time as it has tried to meet the needs of multiple stakeholders, and whether its current structure still best supports the future goals of the program. The review is meant to assess and improve the model's overall architecture so that BRIDG remains sustainable over the long term and is better positioned for interoperability with the healthcare domain. That interoperability emphasis reflects the reality that clinical research does not exist in isolation: research workflows and data increasingly need to connect smoothly with healthcare standards, systems, and real-world clinical information, and an architectural evaluation can identify design choices that either enable or obstruct that kind of alignment.
The award mechanism is a U01 cooperative agreement, which generally indicates a funded partnership where the government expects to have substantial involvement in the work as it proceeds, rather than operating purely as a hands-off grant. The opportunity is categorized under discretionary funding and falls within activity areas described as consumer protection, food and nutrition, and health. The CFDA number associated with the opportunity is 93.103. The program anticipated making a single award, with an award ceiling of $225,000, signaling that this is a focused effort aimed at producing specific review findings and recommendations rather than supporting a large multi-project portfolio.
Eligibility is broad and includes many types of domestic entities: state, county, and city/township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The opportunity was created and posted on March 17, 2016, and the application closing date was May 23, 2016.
Overall, the grant is essentially a targeted investment by FDA/CDER to take a hard look at BRIDG as an evolving standards-based domain model, identify architectural strengths and weaknesses that have emerged as the model expanded to satisfy multiple communities, and propose changes that make it more maintainable, more coherent, and more compatible with the broader healthcare information ecosystem.
Frequently Asked Questions
What is the title of this funding opportunity?
The opportunity is titled "Architectural review of the BRIDG model (U01)" (RFA-FD-16-015).
Which federal agency is offering this grant?
It is offered by the U.S. Department of Health and Human Services (HHS) through the Food and Drug Administration (FDA).
Which part of FDA is specifically interested in this work?
FDA's Center for Drug Evaluation and Research (CDER) is specifically interested in examining the BRIDG model's evolution and architecture.
What is BRIDG?
BRIDG (Biomedical Research Integrated Domain Group) is a shared reference model intended to provide a consistent representation of protocol-driven biomedical research, including related research processes and regulatory artifacts, while also aligning with aspects of basic life sciences research.
Why does BRIDG matter in practical terms?
BRIDG is meant to help different parties describe, exchange, and interpret clinical research information in compatible ways, supporting more consistent communication across organizations and systems.
Who are the main stakeholder organizations involved with BRIDG?
The BRIDG effort brings together major standards and regulatory organizations including CDISC, FDA, the HL7 Regulated Clinical Research Information Management (RCRIM) Work Group, and the National Cancer Institute (NCI).
What is the main purpose of this grant?
The main purpose is to support an architectural review of the BRIDG model, focusing on how it has grown and changed over time and whether its current structure best supports future program goals.
What does the architectural review aim to assess and improve?
The review is intended to assess and improve the model's overall architecture so that BRIDG remains sustainable over the long term and is better positioned for interoperability with the healthcare domain.
Why is interoperability with the healthcare domain emphasized?
The opportunity notes that clinical research does not exist in isolation and that research workflows and data increasingly need to connect smoothly with healthcare standards, systems, and real-world clinical information. The architectural evaluation is meant to identify design choices that enable or obstruct that alignment.
What does the "U01" award mechanism mean for this project?
The award mechanism is a U01 cooperative agreement, which generally indicates a funded partnership where the government expects to have substantial involvement as the work proceeds, rather than operating purely as a hands-off grant.
What type of funding category is this opportunity?
It is categorized as discretionary funding.
What activity areas are associated with this opportunity?
The activity areas listed are consumer protection, food and nutrition, and health.
What is the CFDA number for this opportunity?
The CFDA number associated with the opportunity is 93.103.
How many awards were anticipated?
The program anticipated making a single award.
What is the maximum award amount (award ceiling)?
The award ceiling is $225,000.
What does the award ceiling suggest about the scope of work?
The stated ceiling and single-award plan indicate this is a focused effort aimed at producing specific review findings and recommendations rather than supporting a large multi-project portfolio.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic entities, including:
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Other tribal organizations
- Public housing authorities/Indian housing authorities
- Nonprofits with 501(c)(3) status (excluding institutions of higher education under the nonprofit categories)
- Nonprofits without 501(c)(3) status (excluding institutions of higher education under the nonprofit categories)
- For-profit organizations other than small businesses
- Small businesses
When was this opportunity posted?
The opportunity was created and posted on March 17, 2016.
What was the application closing date?
The application closing date was May 23, 2016.
What problem is FDA/CDER trying to address through this grant?
FDA/CDER is aiming to take a hard look at BRIDG as it has expanded to satisfy multiple communities, identify architectural strengths and weaknesses that emerged over time, and propose changes that make the model more maintainable, coherent, sustainable, and compatible with the broader healthcare information ecosystem.
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