Opportunity Information: Apply for RFA AR 14 004
Apply for RFA AR 14 004
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Biomarker Candidate Platforms for Inflammatory Diseases (U44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846 Arthritis, Musculoskeletal and Skin Diseases Research.
- This funding opportunity was created on Oct 18, 2013 and posted on Apr 29, 2013.
- Applicants must submit their applications by Nov 1, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $450,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $225,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
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Opportunity Summary:
The Biomarker Candidate Platforms for Inflammatory Diseases (U44) opportunity (Funding Opportunity Number RFA-AR-14-004) is a National Institutes of Health (NIH) funding announcement from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). It is designed to support small businesses that are developing advanced biomarker platform technologies aimed at inflammatory diseases within NIAMS priorities. The core intent is practical, translational biomarker work: moving beyond early discovery toward testing and validation of promising biomarker candidates that could help clinicians and researchers predict when inflammatory disease is likely to begin, track how it progresses over time, and measure how well therapies are working.
This program is offered through the SBIR Fast Track mechanism using a U44 cooperative agreement. In practical terms, SBIR Fast Track is structured to speed development by allowing a company to propose an integrated Phase I and Phase II effort in one combined application rather than stopping between phases. The U44 cooperative agreement aspect signals that NIAMS expects to have substantial involvement during the project, which typically means closer scientific and programmatic coordination than a standard grant. The scientific scope emphasizes "state of the art" biomarker candidate platforms, meaning the NIH is looking for contemporary technologies and approaches that can realistically be advanced toward clinical or research use, not just exploratory hypotheses. Platforms might include assays, multi-analyte signatures, omics-based readouts, imaging-linked biomarkers, digital biomarkers, or integrated systems that can generate reliable, reproducible measurements relevant to inflammatory disease biology and treatment response.
The announcement highlights several specific use cases for the biomarker platforms it wants to support. One is prediction: identifying biomarkers that can forecast disease onset before full clinical presentation, or identify which individuals are likely to develop more severe disease. Another is monitoring progression: tracking disease trajectory and activity over time in a way that is more informative or earlier than standard clinical measures. A third is support for therapeutic development and evaluation, including biomarkers that can measure pharmacodynamics (whether a drug is hitting its intended target and producing expected biological effects), as well as biomarkers that contribute to evaluating safety and efficacy. In short, the FOA aims to strengthen the toolset used to develop and assess therapies for inflammatory diseases by improving the biological readouts available to investigators and clinicians.
Funding details in the source information indicate an expected total of about $450,000, with an anticipated two awards and an award ceiling of $225,000 per award. There is no cost sharing or matching requirement, which is typical for many NIH SBIR opportunities and reduces the need for applicants to bring non-federal matching dollars. The activity category is listed as Health, and the CFDA number is 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research), aligning it with NIAMS mission areas.
Eligibility is limited to small businesses, consistent with SBIR requirements, and the announcement explicitly notes that non-U.S. (foreign) entities are not eligible to apply. Likewise, non-U.S. components of U.S. organizations are not eligible to apply, though foreign components as defined under NIH policy may be allowed in some circumstances. This generally means the applicant organization must be U.S.-based and meet SBIR small business eligibility standards, while certain collaborations or subcontracting arrangements may be possible if they satisfy NIH grants policy and are well-justified.
In terms of timing, the opportunity was posted on April 29, 2013, with an original closing date of October 11, 2013 and a current closing date of November 1, 2013. The archive date is December 1, 2013, indicating it is an older, time-limited solicitation rather than an always-open NIH parent announcement. For the full official requirements, application instructions, and scientific priorities, the FOA points applicants to the NIH guide page at http://grants.nih.gov/grants/guide/rfa-files/RFA-AR-14-004.html. Administrative contact guidance is provided through the NIH Office of Extramural Research (OER) webmaster for access or linking issues, reflecting that this is a standard NIH-hosted funding notice.
Overall, this FOA targets companies that can credibly demonstrate a path to rigorous biomarker platform validation in inflammatory diseases relevant to NIAMS, with an emphasis on tools that can be used to predict disease course and to evaluate therapeutic effects in a measurable, decision-relevant way.
Frequently Asked Questions (FAQs)
What is the funding opportunity called?
The opportunity is titled Biomarker Candidate Platforms for Inflammatory Diseases (U44).
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-AR-14-004.
Which agency and institute are offering this opportunity?
This is a National Institutes of Health (NIH) funding announcement offered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
What is the main purpose of this FOA?
The core intent is to support practical, translational biomarker work for inflammatory diseases within NIAMS priorities. The focus is on moving beyond early discovery toward testing and validation of promising biomarker candidates that can be used to predict disease onset, track progression, and measure therapy response.
Who is this program intended to support?
It is designed to support small businesses developing advanced biomarker platform technologies relevant to inflammatory diseases within NIAMS priorities.
What funding mechanism is used for this program?
The program is offered through the SBIR Fast Track mechanism using a U44 cooperative agreement.
What does SBIR Fast Track mean in this FOA?
SBIR Fast Track allows a company to propose an integrated Phase I and Phase II effort in one combined application, rather than applying for Phase II after completing Phase I.
What does the U44 cooperative agreement imply about NIH involvement?
A U44 cooperative agreement indicates NIAMS expects to have substantial involvement during the project, typically meaning closer scientific and programmatic coordination than a standard grant.
What kinds of biomarker technologies or platforms are within scope?
The FOA emphasizes "state of the art" biomarker candidate platforms that can realistically be advanced toward clinical or research use. Examples mentioned include:
- Assays
- Multi-analyte signatures
- Omics-based readouts
- Imaging-linked biomarkers
- Digital biomarkers
- Integrated systems that generate reliable, reproducible measurements
What does "state of the art" mean in the context of this announcement?
It signals the NIH is looking for contemporary technologies and approaches that can be advanced toward practical clinical or research use, rather than purely exploratory hypotheses.
What are the key intended use cases for the biomarker platforms?
The announcement highlights three main use cases:
- Prediction: forecasting disease onset before full clinical presentation, or identifying who may develop more severe disease
- Monitoring progression: tracking disease trajectory and activity over time, potentially earlier or more informatively than standard clinical measures
- Therapeutic development and evaluation: measuring pharmacodynamics and contributing to evaluation of safety and efficacy
How does this FOA relate to therapeutic development?
It aims to strengthen the toolset used to develop and assess therapies by improving biological readouts. This includes biomarkers that can measure pharmacodynamics (whether a drug is hitting its target and producing expected biological effects) and biomarkers supporting safety and efficacy evaluation.
What is the total expected funding amount and number of awards?
The source information indicates an expected total of about $450,000, with an anticipated two awards.
What is the maximum award amount (award ceiling)?
The award ceiling is $225,000 per award.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
What is the activity category and CFDA number?
The activity category is listed as Health. The CFDA number is 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research).
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with SBIR requirements.
Are non-U.S. (foreign) entities eligible to apply?
No. The announcement explicitly notes that non-U.S. (foreign) entities are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible?
No. The FOA notes that non-U.S. components of U.S. organizations are not eligible to apply.
Are foreign components allowed in any form?
The information provided indicates that foreign components (as defined under NIH policy) may be allowed in some circumstances. This generally suggests certain collaborations or subcontracting arrangements could be possible if consistent with NIH grants policy and well-justified.
When was the opportunity posted?
The opportunity was posted on April 29, 2013.
What are the closing dates for applications?
The original closing date was October 11, 2013, and the current closing date listed is November 1, 2013.
What is the archive date and what does it suggest?
The archive date is December 1, 2013, which indicates this is an older, time-limited solicitation rather than an always-open NIH parent announcement.
Where can applicants find the official FOA and full instructions?
The FOA points to the NIH guide page here: http://grants.nih.gov/grants/guide/rfa-files/RFA-AR-14-004.html.
Who is listed for administrative contact or help with access/linking issues?
Administrative contact guidance is provided through the NIH Office of Extramural Research (OER) webmaster for access or linking issues.
What types of outcomes is NIAMS looking for from applicants?
The FOA targets companies that can credibly demonstrate a path to rigorous biomarker platform validation in inflammatory diseases relevant to NIAMS, emphasizing tools that help predict disease course and evaluate therapeutic effects in measurable, decision-relevant ways.
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