Opportunity Information: Apply for RFA HD 16 007

  • The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Tools for Assessment and Improvement of Neurologic Outcomes (R43/R44)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865 Child Health and Human Development Extramural Research.
  • This funding opportunity was created on Aug 12, 2015 and posted on Aug 12, 2015.
  • Applicants must submit their applications by Dec 10, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • 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:

Tools for Assessment and Improvement of Neurologic Outcomes (R43/R44) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding opportunity focused on creating practical, scalable tools and technologies that can improve how neurologic problems are identified and managed around the time of pregnancy and early infancy. The aim is to support small businesses that want to develop new or improved approaches for diagnosing neurologic disease, guiding interventions, and ultimately improving outcomes for fetuses, newborns, and infants who either already have a known neurologic condition or are considered at high risk for neurologic complications. In plain terms, the government is looking for innovations that can help clinicians and families detect neurologic issues earlier, make better treatment decisions, and track whether interventions are actually helping during one of the most vulnerable periods of human development.

This opportunity was issued as a discretionary grant program under the NIH, with the activity category listed under Health, Income Security, and Social Services. It uses the SBIR mechanism with the R43/R44 format, which typically corresponds to a phased small business program designed to move a project from early feasibility and prototype development (Phase I, commonly associated with R43) toward more advanced research and development, validation, and preparation for commercialization (Phase II, commonly associated with R44). While the announcement text provided does not list specific budget caps or project durations, the R43/R44 structure generally signals that NIH expects applicants to propose a clear development plan that starts with early proof-of-concept work and progresses toward a product or clinically usable tool, with commercialization potential being an important part of the SBIR rationale.

The eligible applicants for this FOA are small business concerns. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, the notice indicates that "foreign components," as defined in the NIH Grants Policy Statement, may be allowed, which usually means a U.S.-based applicant may include certain discrete elements of work performed outside the U.S. if justified and compliant with NIH policy. There is no cost sharing or matching requirement, which is important for small businesses because it reduces the need to secure additional funds simply to qualify.

From an administrative standpoint, the opportunity is identified by Funding Opportunity Number RFA-HD-16-007 and is associated with CFDA (now commonly referred to under Assistance Listings) number 93.865, which corresponds to Child Health and Human Development Extramural Research. The FOA was posted and created on August 12, 2015, with an original and current closing date of December 10, 2015, and an archive date of January 10, 2016. That date history indicates the announcement is no longer open for applications, but it can still be useful as a reference point for the types of projects NIH has sought in this topic area and for locating successor opportunities with similar goals.

The core program focus is the development of tools and technology for diagnosis, intervention, and outcome improvement in neurologic disease affecting pregnancies and infants. That framing is broad and can encompass a wide range of product types, such as novel screening or diagnostic methods, monitoring technologies, decision-support tools, biomarkers, imaging or signal-processing approaches, digital health systems for longitudinal developmental tracking, and intervention-enabling devices or platforms. The emphasis on "tools" and "technology" and the SBIR mechanism together strongly imply an expectation that proposed research will translate into something usable beyond the research setting, such as a clinically deployable device, software, assay, or integrated care tool that can be validated and positioned for adoption in real-world maternal-fetal or neonatal care environments.

For applicants or stakeholders looking for the full official announcement, NIH provided an additional information link hosted on the NIH grants site: http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-16-007.html. For technical issues accessing the announcement, the contact point listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV, including help with electronic access problems or linking issues related to the funding announcement.

Frequently Asked Questions (FAQs)

What is the "Tools for Assessment and Improvement of Neurologic Outcomes (R43/R44)" opportunity?

It is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding opportunity focused on developing practical, scalable tools and technologies to improve how neurologic problems are identified and managed around the time of pregnancy and early infancy.

What is the main goal of this SBIR funding opportunity?

The goal is to support small businesses developing new or improved approaches for diagnosing neurologic disease, guiding interventions, and improving outcomes for fetuses, newborns, and infants who have a known neurologic condition or are at high risk for neurologic complications.

Who is this program intended to help?

The program targets innovations that can help clinicians and families detect neurologic issues earlier, make better treatment decisions, and track whether interventions are helping during pregnancy and early infancy.

What kinds of projects or technologies fit this funding opportunity?

The focus is broad and includes tools and technologies for diagnosis, intervention, and outcome improvement in neurologic disease affecting pregnancies and infants. Examples mentioned or implied include screening or diagnostic methods, monitoring technologies, decision-support tools, biomarkers, imaging or signal-processing approaches, digital health systems for longitudinal developmental tracking, and intervention-enabling devices or platforms.

What does the R43/R44 format mean?

R43/R44 refers to the phased SBIR structure typically used by NIH. It generally supports a progression from early feasibility and prototype development (Phase I, commonly associated with R43) to more advanced research and development, validation, and preparation for commercialization (Phase II, commonly associated with R44).

Is commercialization important for this opportunity?

Yes. Because this is an SBIR opportunity and the description emphasizes practical tools and technology, the expectation is that the work will translate into something usable beyond the research setting, with commercialization potential being an important part of the SBIR rationale.

Who is eligible to apply?

Eligible applicants are small business concerns.

Are foreign institutions eligible to apply?

No. Foreign institutions are not eligible to apply.

Can a U.S. organization include work performed outside the United States?

The notice indicates that "foreign components," as defined in the NIH Grants Policy Statement, may be allowed. This typically means a U.S.-based applicant may include discrete elements of work performed outside the U.S. if justified and compliant with NIH policy.

Are non-U.S. components of U.S. organizations eligible?

No. Non-U.S. components of U.S. organizations are not eligible.

Is cost sharing or matching required?

No. The opportunity states there is no cost sharing or matching requirement.

What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number is RFA-HD-16-007.

What is the CFDA/Assistance Listing number associated with this opportunity?

The associated CFDA (now commonly referred to as Assistance Listings) number is 93.865, which corresponds to Child Health and Human Development Extramural Research.

Which agency and program mechanism does this opportunity use?

This is an NIH discretionary grant program using the SBIR mechanism in the R43/R44 format.

What activity category is this opportunity listed under?

The activity category is listed as Health, Income Security, and Social Services.

When was this funding opportunity posted?

The FOA was posted (and created) on August 12, 2015.

What was the application closing date?

The original and current closing date listed is December 10, 2015.

Is this funding opportunity still open?

No. Based on the listed closing date (December 10, 2015) and archive date (January 10, 2016), this announcement is no longer open for applications.

What is the archive date and what does it imply?

The archive date is January 10, 2016. This indicates the announcement has been archived and is generally not accepting applications, though it may still be useful as a reference for similar or successor opportunities.

Does the announcement list specific budget caps or project durations?

No. The text provided does not list specific budget caps or project durations. However, the R43/R44 structure generally signals NIH expects a clear development plan that moves from proof-of-concept toward a clinically usable tool and commercialization readiness.

Where can I find the official NIH announcement text?

The official announcement is available on the NIH grants site at: http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-16-007.html

Who do I contact if I have technical issues accessing the announcement link?

For technical issues such as electronic access problems or linking issues related to the funding announcement, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.

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