Opportunity Information: Apply for RFA HD 14 005

  • The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "In vivo Methods for Assessing Placental Development and Function (SBIR) (R43/R44)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health 93.865 Child Health and Human Development Extramural Research.
  • This funding opportunity was created on Sep 9, 2013 and posted on May 22, 2013.
  • Applicants must submit their applications by Sep 10, 2013. (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.
Apply for RFA HD 14 005

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Opportunity Summary:

This funding opportunity, RFA-HD-14-005, is an NIH Small Business Innovation Research (SBIR) solicitation from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and participating NIH components. It supports small businesses that want to create and develop practical, in vivo tools that can evaluate how the human placenta is developing and functioning during pregnancy. The central goal is to push forward methods that are safe for use in pregnant people, can be used in real time, and are non-invasive or minimally invasive, with an emphasis on technologies that could realistically be used in clinical or near-clinical settings to monitor placental health.

The scientific focus is specifically on measuring placental development and function in living patients rather than relying on indirect markers or after-delivery analysis. Placental dysfunction is tied to major pregnancy complications and poor maternal and fetal outcomes, so the program is aimed at enabling better detection, monitoring, and possibly earlier intervention by improving the ability to assess the placenta directly during pregnancy. Projects responsive to this announcement would generally be expected to translate biomedical engineering, imaging, sensing, biomarker detection, or other diagnostic approaches into tools that can characterize placental structure and performance in a way that is actionable, repeatable, and safe.

Mechanistically, the opportunity uses the SBIR phased grant structure under the R43/R44 mechanisms. That means applicants can propose a Phase I (R43) project focused on feasibility and early proof-of-concept, and a Phase II (R44) project aimed at further development, validation, and steps toward commercialization. As an SBIR program, the expectation is that the work is not just basic research for its own sake, but research and development that leads toward a product or service that could ultimately reach the market and be adopted by clinicians, researchers, or health systems.

From an administrative standpoint, this is a discretionary grant opportunity categorized under Health, with CFDA numbers 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health) and 93.865 (Child Health and Human Development Extramural Research). There is no cost sharing or matching requirement, which is typical for NIH SBIR awards and lowers the barrier for small companies that may not have significant non-federal funds available.

Eligibility is limited to small businesses, consistent with SBIR rules. Foreign (non-U.S.) institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible as applicants. However, foreign components as defined by the NIH Grants Policy Statement may be allowed in some circumstances, which usually means a U.S.-based small business could potentially include certain foreign elements or collaborations if they are well justified and meet NIH policy requirements.

Key dates included a posted date of May 22, 2013, with the original closing date listed as August 21, 2013, and a current closing date of September 10, 2013. The archive date was October 10, 2013, indicating it is an older, time-limited solicitation rather than an always-open program announcement. For the full official details, applicants were directed to the NIH Guide for Grants and Contracts entry at http://grants.nih.gov/grants/guide/rfa_files/RFA-HD-14-005.html, and NIH Office of Extramural Research (OER) web support contacts were provided for access or linking issues.

In practical terms, a strong application under this announcement would typically describe a clear technical approach for real-time, in vivo placental assessment; explain how the method minimizes risk and burden for pregnant patients; define measurable performance targets; lay out a development and validation plan appropriate to Phase I and Phase II; and include a credible commercialization pathway showing how the technology could move from prototype to a usable product. The overall emphasis is on enabling better, safer monitoring of placental health through innovative, clinically relevant technology developed by small businesses.

Frequently Asked Questions (FAQs) - NIH SBIR RFA-HD-14-005 (Placental In Vivo Assessment Tools)

What is the funding opportunity RFA-HD-14-005?

RFA-HD-14-005 is an NIH Small Business Innovation Research (SBIR) solicitation led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), with other participating NIH components. It supports small businesses developing practical tools to evaluate how the human placenta is developing and functioning during pregnancy, directly in living patients (in vivo).

What is the main goal of this solicitation?

The central goal is to advance safe, real-time, non-invasive or minimally invasive methods that can assess placental development and function during pregnancy. The emphasis is on technologies that could realistically be used in clinical or near-clinical settings to monitor placental health.

What kinds of projects are considered responsive?

Projects are generally expected to translate approaches such as biomedical engineering, imaging, sensing, biomarker detection, or other diagnostic strategies into in vivo tools that characterize placental structure and performance in a way that is actionable, repeatable, and safe for use in pregnant people.

Does the program focus on the placenta during pregnancy or after delivery?

The scientific focus is specifically on measuring placental development and function in living patients during pregnancy, rather than relying primarily on indirect markers or analyses performed after delivery.

Why is NIH focusing on placental assessment tools?

Placental dysfunction is associated with major pregnancy complications and poor maternal and fetal outcomes. By enabling more direct assessment of the placenta during pregnancy, the program aims to support better detection and monitoring and potentially earlier intervention.

What does "in vivo" mean in the context of this RFA?

In this context, "in vivo" refers to evaluating the placenta within the pregnant patient during pregnancy, using tools that can measure placental development and function directly in the living system.

Are non-invasive approaches required?

The opportunity emphasizes approaches that are non-invasive or minimally invasive and safe for use in pregnant people. The intention is to move the field toward methods that minimize risk and patient burden while still producing clinically useful information.

Is real-time measurement important for this solicitation?

Yes. A key emphasis is on technologies that can be used in real time to monitor placental health, supporting more immediate and practical assessment during pregnancy.

What award mechanisms are used?

This solicitation uses the SBIR phased structure under the R43/R44 mechanisms. Applicants may propose Phase I (R43) for feasibility and early proof-of-concept, and Phase II (R44) for further development, validation, and steps toward commercialization.

What is the difference between Phase I (R43) and Phase II (R44) under SBIR?

Phase I (R43) is intended to establish feasibility and early proof-of-concept. Phase II (R44) supports continued development and validation and is oriented toward advancing the project toward commercialization and practical adoption.

Is this opportunity intended for basic research or product development?

As an SBIR program, it is intended for research and development that leads toward a product or service. The expectation is not basic research for its own sake, but work that supports eventual commercialization and real-world use.

Who is eligible to apply?

Eligibility is limited to small businesses, consistent with SBIR rules.

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

No. Foreign (non-U.S.) institutions are not eligible to apply under this solicitation.

Can a non-U.S. component of a U.S. organization apply as the applicant?

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

Are any foreign activities or collaborations allowed?

Potentially. The solicitation notes that foreign components (as defined by the NIH Grants Policy Statement) may be allowed in some circumstances. This generally means a U.S.-based small business applicant might be able to include certain foreign elements or collaborations if they are well justified and consistent with NIH policy.

Is cost sharing or matching required?

No. There is no cost sharing or matching requirement stated for this opportunity, which is typical for NIH SBIR awards.

How is this opportunity categorized administratively?

It is a discretionary grant opportunity categorized under Health.

What CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health) and 93.865 (Child Health and Human Development Extramural Research).

What are the key dates for this solicitation?

The posted date was May 22, 2013. The original closing date was August 21, 2013, and the current closing date was September 10, 2013. The archive date was October 10, 2013.

Is this an open, ongoing program announcement?

No. The archive date (October 10, 2013) indicates it is an older, time-limited solicitation rather than an always-open program.

Where can applicants find the official announcement?

The solicitation directs applicants to the NIH Guide for Grants and Contracts entry at: http://grants.nih.gov/grants/guide/rfa_files/RFA-HD-14-005.html

What kinds of technical characteristics would a strong application typically address?

Based on the program emphasis, a strong application would typically describe a clear technical approach for real-time, in vivo placental assessment; explain how the method minimizes risk and burden for pregnant patients; define measurable performance targets; outline a development and validation plan appropriate to Phase I and Phase II; and present a credible commercialization pathway from prototype to a usable product.

Does the solicitation emphasize clinical usability?

Yes. There is an explicit emphasis on technologies that could realistically be used in clinical or near-clinical settings, meaning practical deployment and repeatable, actionable results matter.

What does "actionable" mean in the context of placental assessment tools?

Within the context provided, "actionable" refers to characterizing placental structure and performance in a way that can support meaningful monitoring decisions during pregnancy (for example, producing information that can be interpreted and used consistently rather than being purely exploratory).

What does "repeatable" imply for proposed tools?

"Repeatable" implies the tool can be used multiple times and provide consistent assessment of placental development and function over time, which aligns with the goal of monitoring placental health during pregnancy.

Who are the likely end users of technologies developed under this SBIR?

The solicitation frames potential adoption by clinicians, researchers, or health systems, reflecting the goal of real-world use and commercialization.

What support contacts are mentioned for technical access issues?

NIH Office of Extramural Research (OER) web support contacts were provided for access or linking issues related to the official posting.

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