Bioprinted Tissue Constructs for Obstetric, Gynecologic, and Pediatric Applications (R01 Clinical Trial Optional) | Apply Online

Frequently Asked Questions (FAQs)

What is the NIH funding opportunity being described?

This opportunity is NIH RFA-HD-23-004, titled "Bioprinted Tissue Constructs for Obstetric, Gynecologic, and Pediatric Applications (R01 Clinical Trial Optional)." It supports work intended to move 3D bioprinted tissue constructs closer to real-world medical use in areas aligned with the NICHD mission: obstetrics, gynecology, and pediatrics.

What is the main goal of this FOA?

The main goal is to advance mature 3D bioprinted tissue constructs toward clinical readiness by focusing on practical, translation-oriented development. The program is aimed at producing credible preclinical evidence and development progress that could support regulatory pathways and eventual use in humans.

What kinds of applications does the FOA emphasize (obstetric, gynecologic, pediatric)?

The FOA prioritizes bioprinted tissue constructs intended for obstetric, gynecologic, and pediatric applications. A key emphasis is on constructs designed for long-term function, including constructs that can adapt over time to the changing anatomy and physiology of growing children.

Is this opportunity focused on basic research or translation?

It is focused on translation. The FOA is described as not emphasizing basic discovery, and instead targets the practical steps needed to move bioprinted tissues from mature lab constructs toward products that can realistically progress to regulatory review and eventual human use.

What stage of technology is this FOA intended to support?

This FOA is intended to support bioprinted tissue constructs that are already relatively mature and need translational preclinical development to move toward clinical readiness. It is not intended for brand-new constructs that are still at the concept, feasibility, or early hypothesis-testing stage.

What are the "bottlenecks" this FOA wants projects to address?

The FOA specifically calls for projects that address common preclinical development bottlenecks that keep bioprinted tissues from advancing beyond the lab. Examples referenced include generating evidence that a construct is reproducible, performs as intended, and can be assessed using credible validation and verification activities that align with what regulators and clinicians care about.

What types of preclinical activities are expected or encouraged?

Based on the description, projects are expected to include validation and verification work and other preclinical translational steps such as addressing manufacturing consistency, functional performance over time, durability, biocompatibility, and integration with host tissue, with the goal of creating a data package supportive of regulatory pathways and subsequent human testing.

What does "long-term function" mean in the context of this FOA?

The FOA emphasizes constructs intended for long-term function, meaning the tissue constructs are expected to maintain functional performance over time rather than only demonstrating short-term proof-of-concept results.

How does the FOA address pediatric needs specifically?

A distinctive focus is on constructs that can adapt over time to the changing anatomy and physiology of growing children. This points to a preference for approaches that consider growth, durability, and longer-term performance in pediatric contexts.

Is the FOA intended to fund early proof-of-concept studies?

No. The FOA states it is not meant to fund early-stage hypothesis testing for brand-new constructs that are still in the concept or feasibility stage, and it emphasizes moving mature constructs closer to clinical readiness.

Does this FOA support clinical trials?

Clinical trials are listed as optional under the R01 mechanism, but the emphasis is clearly on preclinical translational steps that bridge academic innovation and clinical readiness. The FOA is also not intended to support large-scale clinical trials using bioprinted tissue constructs.

What does "Clinical Trial Optional" imply here?

It indicates that clinical trials are not required for the R01 under this FOA. The description provided stresses that the central focus is preclinical translational work intended to enable later regulatory and human-testing steps, rather than large clinical studies.

What is the funding mechanism?

The mechanism is an NIH R01 (Clinical Trial Optional), described as a discretionary NIH grant.

What is the CFDA number associated with this opportunity?

The health-related CFDA number listed for this opportunity is 93.865.

What is the award ceiling?

The opportunity lists an award ceiling of $500,000.

When was the opportunity posted and what was the original closing date?

The opportunity was posted with an original closing date of July 27, 2022.

How many awards are expected?

The notice indicates that awards are expected, but the number of expected awards is not specified in the provided information.

Who is eligible to apply?

Eligibility is broad and includes many U.S.-based applicant types, including state, county, city, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; Native American tribal governments (federally recognized); tribal organizations (including those other than federally recognized tribal governments); public housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.

Are certain institution types explicitly highlighted as eligible?

Yes. The FOA explicitly highlights categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions. It also includes faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Are non-U.S. (foreign) organizations eligible to apply as the main applicant?

No. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as the primary applicant organization.

Are foreign components allowed in a project?

Yes. While foreign institutions cannot be the primary applicant, foreign components are allowed as defined by the NIH Grants Policy Statement. This means a U.S.-based applicant may include certain foreign elements when justified and compliant with NIH policy.

What is meant by a "foreign component" in this context?

The FOA notes that foreign components are allowed as defined by the NIH Grants Policy Statement. The specific definition is not included in the provided information, but the key point is that certain foreign elements can be included within an otherwise eligible U.S.-based application, consistent with NIH policy.

What kind of outcome is NIH looking for from funded projects?

The FOA is looking for projects that generate the sort of credible, regulator-relevant preclinical evidence package needed to support regulatory pathways and enable subsequent human testing. The emphasis is on reproducibility, intended performance, and verification/validation rather than exploratory demonstrations.

Is the program intended to help projects reach regulatory review readiness?

Yes. The FOA is described as aiming to help mature bioprinted constructs become realistic candidates for regulatory review by supporting the preclinical development work and evidence generation that regulators and clinicians care about.

What types of challenges commonly block advancement that applicants should consider?

The FOA references practical issues that often block advancement, including manufacturing consistency, functional performance over time, durability, biocompatibility, and integration with host tissue, along with validation and verification demonstrating reproducibility and intended performance.

Is this FOA geared toward eventual use in humans?

Yes. The FOA is framed as a targeted push to bridge the gap between promising prototypes and evidence standards needed for regulatory approval and eventual human use, while focusing primarily on preclinical translational steps.