Opportunity Information: Apply for PAR 10 286
Apply for PAR 10 286
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Cancer Diagnostic and Therapeutic Agents Enabled by Nanotechnology (SBIR U43/U44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393 Cancer Cause and Prevention Research 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research 93.396 Cancer Biology Research.
- This funding opportunity was created on Sep 21, 2010 and posted on Sep 21, 2010.
- Applicants must submit their applications by Jul 8, 2013. (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 $150,000.00 in funding.
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The Cancer Diagnostic and Therapeutic Agents Enabled by Nanotechnology (SBIR U43/U44) opportunity (Funding Opportunity Number PAR-10-286) is a National Cancer Institute (NCI), National Institutes of Health (NIH) funding announcement aimed specifically at small business concerns that are developing nanotechnology-based products for cancer care. The central goal is to move promising nanotech-enabled cancer therapeutics and in vivo diagnostic agents beyond early discovery and into rigorous preclinical optimization and testing for a specific intended cancer type, with a clear line of sight to commercialization. In other words, the government is looking for projects that are building toward a real product that can be manufactured, characterized, tested, and ultimately positioned for regulatory submission and market entry, rather than exploratory science.
A defining feature of this FOA is that it targets the preclinical development window where many technologies stall: formulation refinement, reproducible manufacturing approaches, characterization, stability, performance optimization, and nonclinical testing that supports regulatory readiness. Projects are expected to be milestone-driven, meaning applicants should lay out measurable technical and development milestones that demonstrate progress toward a viable commercial diagnostic or therapeutic. The expected end point is not clinical testing, but rather the kind of preclinical package that would enable an FDA submission, specifically an Investigational New Drug (IND) application for therapeutics or an Investigational Device Exemption (IDE) for devices. The FOA states that a strong outcome would be being able to submit an IND or IDE by the end of Phase II or shortly after the Phase II project period concludes.
This program uses the SBIR cooperative agreement mechanisms U43 (Phase I) and U44 (Phase II). A cooperative agreement differs from a standard grant in that the funding agency typically expects to have more substantial involvement in the project, often through scientific or programmatic collaboration, guidance, or access to enabling resources. In this case, NCI indicates it will help awardees in multiple ways, including providing support through the NCI-sponsored Nanotechnology Characterization Laboratory. That detail signals that applicants working with complex nanomaterials can potentially access specialized characterization capabilities and standardized assessment approaches that may strengthen the quality and credibility of the preclinical development work.
The announcement is explicit about what it will not fund. It is not intended for basic research, studies focused on fundamental disease mechanisms, or clinical trials. Instead, it is tailored to development-oriented activities that reduce technical and translational risk and make a nanotechnology-based cancer agent more ready for regulatory review and eventual commercialization. This focus makes it particularly relevant for small companies that already have a lead nanotech formulation, platform, imaging agent, or delivery system and need support to optimize performance, scale and control critical quality attributes, and build the preclinical evidence needed to approach the FDA.
Eligibility is limited to small businesses, and there is no cost sharing or matching requirement listed. The funding instrument type is a cooperative agreement, and the opportunity is categorized as discretionary. The related CFDA program areas span multiple cancer R&D domains, including cancer cause and prevention research (93.393), detection and diagnosis research (93.394), treatment research (93.395), and cancer biology research (93.396), reflecting the broad applicability of nanotechnology across diagnostics and therapeutics as long as the proposed work is product-driven and preclinical in nature.
In terms of funding and awards, the FOA notes that awards depend on the availability of funds and the number of meritorious applications received. The total dollars and number of awards are not fixed and will vary based on application quality, project duration, and proposed costs. The source information lists an award ceiling of $150,000, which is a useful planning reference, though applicants typically need to verify how that ceiling applies across Phase I versus Phase II budgets and how NIH SBIR budget guidelines interact with the specific terms of this FOA.
Key administrative details in the record show the FOA was posted on September 21, 2010, with an original and current closing date of July 8, 2013, and an archive date of August 8, 2013, indicating it is no longer open. The full announcement was hosted on the NIH grants site (PAR-10-286), and the contact listed for access or linking issues is the NIH Office of Extramural Research (OER) webmaster.
Frequently Asked Questions (FAQs)
What is the Cancer Diagnostic and Therapeutic Agents Enabled by Nanotechnology (SBIR U43/U44) opportunity?
This opportunity (Funding Opportunity Number PAR-10-286) is a National Cancer Institute (NCI), National Institutes of Health (NIH) funding announcement focused on small business concerns developing nanotechnology-based products for cancer care. It targets product-oriented, preclinical development of nanotechnology-enabled cancer therapeutics and in vivo diagnostic agents.
Which agency is offering this funding opportunity?
The opportunity is offered by the National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH).
Who is eligible to apply?
Eligibility is limited to small businesses (small business concerns). The announcement is specifically framed as an SBIR opportunity using cooperative agreement mechanisms.
What funding mechanisms are used in this FOA?
The program uses SBIR cooperative agreement mechanisms U43 (Phase I) and U44 (Phase II).
What does it mean that this is a cooperative agreement rather than a standard grant?
A cooperative agreement generally means the funding agency expects to have more substantial involvement in the project compared with a standard grant. In this FOA, NCI indicates it will help awardees in multiple ways, including support through the NCI-sponsored Nanotechnology Characterization Laboratory.
What is the main goal of this FOA?
The central goal is to move promising nanotech-enabled cancer therapeutics and in vivo diagnostic agents beyond early discovery into rigorous preclinical optimization and testing for a specific intended cancer type, with a clear line of sight to commercialization.
What stage of development is this program designed to support?
This FOA targets the preclinical development window where technologies often stall. It emphasizes development work such as formulation refinement, reproducible manufacturing approaches, characterization, stability, performance optimization, and nonclinical testing that supports regulatory readiness.
What types of products or technologies does this FOA focus on?
It focuses on nanotechnology-based products for cancer care, specifically nanotechnology-enabled cancer therapeutics and in vivo diagnostic agents. The emphasis is on building toward a real product that can be manufactured, characterized, tested, and positioned for regulatory submission and market entry.
Does the FOA require a specific cancer indication?
Yes. The work is expected to be aimed at a specific intended cancer type rather than remaining broad or purely exploratory.
What activities are expected to be included in a proposed project?
Projects are expected to include development-oriented, preclinical activities such as formulation refinement, reproducible manufacturing approaches, characterization, stability work, performance optimization, and nonclinical testing that supports regulatory readiness.
Are projects required to be milestone-driven?
Yes. The FOA states that projects are expected to be milestone-driven, meaning applicants should define measurable technical and development milestones that show progress toward a viable commercial diagnostic or therapeutic product.
Is basic research supported under this FOA?
No. The announcement is explicit that it is not intended for basic research or studies focused on fundamental disease mechanisms. It is tailored to development-oriented work intended to reduce technical and translational risk.
Does this FOA fund clinical trials?
No. The FOA explicitly states it is not intended for clinical trials.
What is the expected endpoint of a project funded under this FOA?
The expected endpoint is not clinical testing. Instead, the goal is a preclinical package that would enable an FDA submission: an Investigational New Drug (IND) application for therapeutics or an Investigational Device Exemption (IDE) for devices. The FOA notes that a strong outcome would be the ability to submit an IND or IDE by the end of Phase II or shortly after the Phase II period concludes.
How does the FOA connect to FDA regulatory submissions?
The FOA is oriented toward generating the kind of nonclinical data and development readiness that supports regulatory review. It specifically references IND submissions for therapeutics and IDE submissions for devices as key targets enabled by the preclinical work.
What support does NCI mention for awardees working with nanomaterials?
NCI indicates it will support awardees in multiple ways, including providing support through the NCI-sponsored Nanotechnology Characterization Laboratory, which may help with specialized characterization capabilities and standardized assessment approaches.
Is cost sharing or matching required?
No cost sharing or matching requirement is listed in the provided information.
What is the funding instrument type and how is the opportunity categorized?
The funding instrument type is a cooperative agreement, and the opportunity is categorized as discretionary.
How are award amounts and the number of awards determined?
The FOA notes that awards depend on the availability of funds and the number of meritorious applications received. The total dollars and number of awards are not fixed and can vary based on application quality, project duration, and proposed costs.
Is there an award ceiling mentioned?
Yes. The source information lists an award ceiling of $150,000 as a planning reference, with a note that applicants typically need to verify how that ceiling applies across Phase I versus Phase II budgets and how NIH SBIR budget guidelines interact with the FOA terms.
Which CFDA program areas are related to this FOA?
The related CFDA program areas span multiple cancer R&D domains: cancer cause and prevention research (93.393), detection and diagnosis research (93.394), treatment research (93.395), and cancer biology research (93.396). This reflects broad applicability across diagnostics and therapeutics as long as the work is product-driven and preclinical.
When was this FOA posted and when did it close?
The FOA was posted on September 21, 2010. The original and current closing date listed is July 8, 2013, and the archive date is August 8, 2013.
Is this funding opportunity still open?
No. Based on the closing date (July 8, 2013) and archive date (August 8, 2013), it is no longer open.
Where was the full announcement hosted?
The full announcement was hosted on the NIH grants site under PAR-10-286.
Who is the listed contact for access or linking issues?
The contact listed for access or linking issues is the NIH Office of Extramural Research (OER) webmaster.
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