Opportunity Information: Apply for RFA HD 16 028

  • The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Non or Minimally Invasive Methods to Measure Biochemical Substances for Neonatal and Perinatal Clinical Care and Research (R41)" 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 Jul 2, 2015 and posted on Jun 22, 2015.
  • Applicants must submit their applications by Aug 24, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $1,000,000.00 to eligible and selected applicants.
  • Eligible applicants include: Small businesses.
  • Other Eligible Applicants include the followingNon 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 grant opportunity "Non or Minimally Invasive Methods to Measure Biochemical Substances for Neonatal and Perinatal Clinical Care and Research (R41)" (Funding Opportunity Number RFA-HD-16-028) is a National Institutes of Health (NIH) small business program solicitation focused on creating better ways to measure important biochemical substances in mothers and babies around the time of pregnancy, delivery, and early newborn care. The central idea is to support small businesses that can bring bioengineering and biomedical know-how to real clinical needs in perinatal and neonatal settings, where patients are especially vulnerable and where traditional testing often requires blood draws or other procedures that are difficult, risky, or impractical. By emphasizing non-invasive or minimally invasive measurement approaches, the FOA is aiming to reduce the amount of blood needed, lower procedural burden, and make monitoring more continuous, safer, and more feasible at the bedside, in the NICU, or in related clinical environments.

This is an R41 award mechanism, which indicates it is part of the Small Business Innovation Research (SBIR) program and corresponds to a Phase I project. In practical terms, that typically means the opportunity is meant to fund early-stage feasibility and proof-of-concept work: demonstrating that a proposed technology can accurately detect or quantify a biochemical analyte, that it can function in relevant samples and use conditions, and that it shows credible potential for eventual clinical utility. The FOA explicitly encourages "lab-on-a-chip" and similar rapid diagnostic or prognostic platforms, signaling interest in miniaturized devices and microfluidic or point-of-care systems that could deliver fast, actionable results where and when clinicians need them, rather than relying on central laboratory turnaround times.

The target populations are perinatal patient groups, which generally includes pregnant individuals, people in labor and delivery, postpartum patients, fetuses, and newborns (especially premature or medically fragile infants). The biochemical substances of interest are not limited in the provided excerpt, but the framing points to clinically meaningful analytes that guide care decisions, risk stratification, diagnosis, prognosis, or monitoring. The emphasis on care and research suggests that proposed technologies can be designed both for direct clinical management (for example, rapid bedside assessment) and for supporting studies where frequent or longitudinal sampling is valuable but conventional methods are too invasive or resource-intensive.

Administratively, the opportunity is a discretionary grant in the health domain and is listed under CFDA 93.865 (Child Health and Human Development Extramural Research), indicating the relevant NIH institute alignment with child health and human development priorities. The estimated total funding amount shown is $1,000,000 across the FOA. There is no cost-sharing or matching requirement, so applicants are not required to contribute matching funds as a condition of award, which is typical for many NIH SBIR opportunities.

Eligibility is limited to small businesses, consistent with SBIR Phase I requirements. The FOA also makes clear that non-U.S. (foreign) institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, "foreign components" as defined by NIH policy may be allowable, meaning certain project elements could potentially be conducted abroad if they meet NIH rules and are appropriately justified, even though the applicant organization itself must be U.S.-based and eligible as a small business.

Key dates included in the source data show the FOA was posted June 22, 2015, with an original closing date of July 15, 2015, later updated to a current closing date of August 24, 2015, and an archive date of September 24, 2015. The presence of an archive date indicates this specific solicitation is no longer active, but it is still useful as a reference point for the types of technologies NIH was seeking in this area and the programmatic interests around neonatal and perinatal biochemical monitoring.

For applicants or readers seeking the full official requirements, technical scope details, and submission instructions, the FOA is linked through NIH at http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-16-028.html. If there are access or linking problems, the contact provided is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV, which is the general support channel listed in the excerpt for difficulties reaching the announcement online.

Frequently Asked Questions (FAQs)

What is the name of this grant opportunity?

The opportunity is titled "Non or Minimally Invasive Methods to Measure Biochemical Substances for Neonatal and Perinatal Clinical Care and Research (R41)."

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is RFA-HD-16-028.

Which agency is offering this opportunity?

This is a National Institutes of Health (NIH) funding opportunity.

What type of award mechanism is this?

This is an R41 award mechanism, which corresponds to an SBIR (Small Business Innovation Research) Phase I project.

What is the main purpose of the FOA?

The FOA is focused on supporting small businesses developing non-invasive or minimally invasive ways to measure important biochemical substances relevant to care and research in perinatal and neonatal settings.

What problem is this FOA trying to address in clinical care?

It aims to reduce reliance on traditional testing that often requires blood draws or other difficult, risky, or impractical procedures for mothers and newborns, especially in vulnerable populations like premature or medically fragile infants.

What kinds of technologies does NIH appear to be interested in?

The FOA explicitly encourages "lab-on-a-chip" and similar rapid diagnostic or prognostic platforms, suggesting interest in miniaturized devices, microfluidic systems, and point-of-care approaches that can deliver timely, actionable results in clinical environments.

Does the FOA require the measurement method to be completely non-invasive?

No. The FOA supports both non-invasive and minimally invasive methods, with an emphasis on reducing blood volume needs and procedural burden while improving feasibility and safety.

What does SBIR Phase I (R41) generally fund in practical terms?

Based on the description provided, it is intended to fund early-stage feasibility and proof-of-concept work, such as demonstrating that a proposed technology can accurately detect or quantify an analyte and function in relevant samples and use conditions, with credible potential for clinical utility.

Who are the target patient populations for this FOA?

The target populations are perinatal groups, which include pregnant individuals, people in labor and delivery, postpartum patients, fetuses, and newborns (especially premature or medically fragile infants).

What kinds of biochemical substances (analytes) are included?

The excerpt does not list specific analytes. It frames the scope broadly as clinically meaningful biochemical substances that can guide care decisions, risk stratification, diagnosis, prognosis, or monitoring in perinatal and neonatal contexts.

Is the technology expected to be used for clinical care, research, or both?

Both. The FOA emphasizes neonatal and perinatal clinical care and research, including potential use for rapid bedside assessment and for studies requiring frequent or longitudinal sampling where conventional methods are too invasive or resource-intensive.

Where is the technology expected to be usable (care settings)?

The FOA highlights bedside use and clinical environments such as the NICU, as well as related perinatal and neonatal care settings where continuous or safer monitoring would be valuable.

What is the CFDA number associated with this opportunity?

The opportunity is listed under CFDA 93.865 (Child Health and Human Development Extramural Research).

What is the estimated total funding amount for the FOA?

The estimated total funding amount shown is $1,000,000 across the FOA.

Is cost-sharing or matching required?

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

Who is eligible to apply?

Eligibility is limited to small businesses, consistent with SBIR Phase I requirements.

Are non-U.S. (foreign) organizations eligible to apply?

No. The FOA states that non-U.S. (foreign) institutions are not eligible to apply.

Can a U.S. organization include non-U.S. components?

Non-U.S. components of U.S. organizations are not eligible. However, the excerpt notes that "foreign components" (as defined by NIH policy) may be allowable if they meet NIH rules and are appropriately justified, even though the applicant organization must be U.S.-based and eligible as a small business.

What are the key dates for this FOA?

The FOA was posted on June 22, 2015. The original closing date was July 15, 2015, later updated to a current closing date of August 24, 2015. The archive date is September 24, 2015.

Is this funding opportunity still open?

No. The presence of an archive date (September 24, 2015) indicates this specific solicitation is no longer active.

Where can applicants find the official FOA details?

The FOA is available through NIH at: http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-16-028.html

Who should be contacted if there are problems accessing the FOA link?

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

How should this FOA be used today if it is archived?

Based on the excerpt, it can still serve as a useful reference for understanding the types of technologies NIH sought in this area and the programmatic interests around neonatal and perinatal biochemical monitoring, even though the solicitation itself is no longer active.

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