Opportunity Information: Apply for RFA HL 14 010

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Developing a Point of Care Device for the Diagnosis of Sickle Cell Disease in Low Resource Settings SBIR (R43/ R44)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.839 Blood Diseases and Resources Research.
  • This funding opportunity was created on Jul 8, 2013 and posted on Jul 8, 2013.
  • Applicants must submit their applications by Oct 23, 2015. (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.
  • Eligible applicants include: Small businesses.
Apply for RFA HL 14 010

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Opportunity Summary:

The funding opportunity titled "Developing a Point of Care Device for the Diagnosis of Sickle Cell Disease in Low Resource Settings SBIR (R43/R44)" (Funding Opportunity Number RFA-HL-14-010) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant program focused on creating practical, field-ready diagnostic tools for sickle cell disease (SCD). The core purpose is to support small businesses in developing a point-of-care (POC) device that can rapidly diagnose SCD in infants and young children, especially in low-income and low-resource settings where traditional laboratory infrastructure, trained personnel, and reliable supply chains may be limited. The public health motivation behind the program is straightforward: if children can be diagnosed quickly and early in life, they can be linked to appropriate therapies and preventive care sooner, which can reduce severe complications and improve survival and long-term outcomes.

The FOA emphasizes early childhood diagnosis because sickle cell disease can lead to life-threatening complications in infancy and early childhood if it goes unrecognized and untreated. In many regions with a high burden of SCD, confirmatory testing may require centralized labs and advanced equipment, causing delays or loss to follow-up. A POC diagnostic device, used where the child is seen (for example, local clinics, community health posts, or mobile health settings), is meant to close that gap by enabling rapid results and immediate clinical decision-making. The program’s stated aim is not simply to create another test, but to enable timely diagnosis so that appropriate therapy can be given to reduce the risk of future complications.

From an administrative and eligibility standpoint, this is a discretionary grant mechanism under the SBIR program, using the R43 and R44 activity codes. R43 typically corresponds to SBIR Phase I feasibility and early proof-of-concept work, while R44 corresponds to SBIR Phase II research and development activities that further mature and validate the technology. The eligible applicants are small businesses, reflecting the SBIR program’s broader goal of encouraging commercialization-oriented innovation and translating promising technologies into products that can be deployed in real-world healthcare settings. There is no cost sharing or matching requirement listed, which generally reduces barriers for small companies that might otherwise struggle to commit additional funds.

In terms of scope and expected project direction, the opportunity is designed around the realities of low-resource settings. While the FOA description provided here is brief, the intent clearly points toward devices that can function reliably outside sophisticated hospital laboratories. In practical terms, that usually means design priorities like speed, ease of use, minimal training requirements, robustness to heat and humidity, limited dependence on continuous electricity, and simple workflows appropriate for frontline health workers. Since the target population is infants and young children, it also implies attention to pediatric sample types and constraints, such as the ability to work with small blood volumes and to produce results quickly enough to influence same-visit counseling and care planning. The opportunity is tied to the NIH’s health mission and is categorized under CFDA 93.839, Blood Diseases and Resources Research, which aligns with SCD as a hematologic disorder with significant global health impact.

Key dates and funding parameters are also clearly defined in the source information. The FOA was posted and created on July 8, 2013, with an original and current closing date of October 23, 2015, and an archive date of November 23, 2015, indicating that this particular announcement is no longer active. The listed award ceiling is $225,000, which typically aligns with early-stage SBIR budgets (often Phase I scale), though actual allowable budgets and phase-specific limits are usually detailed in the full FOA text. The funding instrument type is a grant, and the activity category is health, reflecting NIH’s role as the sponsoring agency.

For applicants or interested parties who want the complete requirements, evaluation criteria, and submission instructions, the FOA provides an additional information link to the NIH Grants Guide page (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-14-010.html). The contact information included is primarily technical support for accessing or linking to the funding announcement, directing users to the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV. Overall, the opportunity is best understood as a targeted SBIR initiative intended to catalyze the development of a practical, rapid, point-of-care diagnostic device for sickle cell disease that can be used where resources are limited, with the larger goal of enabling early intervention and reducing preventable complications in young children.

FAQs: Developing a Point of Care Device for the Diagnosis of Sickle Cell Disease in Low Resource Settings SBIR (R43/R44) (RFA-HL-14-010)

What is the title of this funding opportunity?

The funding opportunity is titled "Developing a Point of Care Device for the Diagnosis of Sickle Cell Disease in Low Resource Settings SBIR (R43/R44)."

What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number is RFA-HL-14-010.

Which agency is sponsoring this program?

This opportunity is sponsored by the National Institutes of Health (NIH) under its Small Business Innovation Research (SBIR) program.

What type of funding instrument is this?

The funding instrument type is a grant.

What is the main purpose of this SBIR opportunity?

The main purpose is to support small businesses in developing a practical, field-ready point-of-care (POC) device that can rapidly diagnose sickle cell disease (SCD) in infants and young children, particularly in low-income and low-resource settings.

Why does the opportunity focus on point-of-care (POC) diagnosis?

The opportunity emphasizes POC diagnosis because, in many high-burden regions, confirmatory testing often requires centralized labs and advanced equipment. That can cause delays or loss to follow-up. A POC device is intended to deliver rapid results where the child is seen (for example, local clinics or community health posts), enabling immediate clinical decision-making.

Why does the FOA emphasize infants and young children?

The FOA emphasizes early childhood diagnosis because sickle cell disease can cause life-threatening complications in infancy and early childhood if it is not recognized and treated. Earlier diagnosis supports earlier linkage to appropriate therapies and preventive care.

What health condition is the focus of the device being developed?

The device focus is sickle cell disease (SCD), a hematologic disorder with major public health impact.

What is the expected outcome or public health impact of projects under this FOA?

The intended impact is to enable timely diagnosis of SCD so appropriate therapy and preventive care can be provided sooner, reducing severe complications and improving survival and longer-term outcomes in young children.

Who is eligible to apply?

Eligible applicants are small businesses, consistent with the SBIR program's goal of encouraging commercialization-oriented innovation.

Which SBIR phases or activity codes are included?

The FOA uses NIH SBIR activity codes R43 and R44. R43 generally corresponds to SBIR Phase I feasibility/proof-of-concept work, and R44 generally corresponds to SBIR Phase II research and development to further mature and validate the technology.

Is cost sharing or matching required?

No cost sharing or matching requirement is listed in the provided information.

What kinds of settings is the device intended for?

The device is intended for low-resource settings where traditional laboratory infrastructure, trained personnel, and reliable supply chains may be limited. Examples mentioned include local clinics, community health posts, and mobile health settings.

What design priorities are implied for devices used in low-resource settings?

Based on the stated intent, the device is expected to be practical outside sophisticated laboratories. This typically implies priorities such as rapid results, ease of use, minimal training needs, robustness to heat and humidity, limited dependence on continuous electricity, and simple workflows for frontline health workers.

Are there any considerations mentioned for pediatric testing?

Yes. Because the target population is infants and young children, the description implies attention to pediatric sample constraints, such as working with small blood volumes and producing results quickly enough to influence same-visit counseling and care planning.

What is the award ceiling listed for this opportunity?

The listed award ceiling is $225,000.

Is this funding opportunity still active?

No. The opportunity is no longer active based on the dates provided. The closing date was October 23, 2015, and the archive date was November 23, 2015.

When was the FOA posted and created?

The FOA was posted and created on July 8, 2013.

What were the closing date and archive date?

The original and current closing date was October 23, 2015, and the archive date was November 23, 2015.

What is the CFDA number and program area associated with this opportunity?

The opportunity is categorized under CFDA 93.839, Blood Diseases and Resources Research.

Where can someone find the full funding announcement details?

The provided link for additional information is: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-14-010.html

Who is listed as a contact for technical support related to accessing or linking to the announcement?

The contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.

Does the description indicate the program is focused on commercialization?

Yes. The opportunity is part of the SBIR program and is described as supporting "commercialization-oriented innovation" and translating technologies into products deployable in real-world healthcare settings.

Is the goal only to create a new test?

No. The stated aim is not simply to create another test, but to enable timely diagnosis so appropriate therapy can be given to reduce the risk of future complications.

What broader NIH mission area does this opportunity fall under?

The activity category is health, aligning with NIH's role and mission in supporting health-related research and development.

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