Opportunity Information: Apply for RFA HD 17 002
Apply for RFA HD 17 002
- The HHS-NIH11 in the health, income security and social services sector is offering a public funding opportunity titled "Use of 3D Printing for Creation of Implantable Devices (R21/R33)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865,.
- This funding opportunity was created on Jan 13, 2016 and posted on Jan 13, 2016.
- Applicants must submit their applications by Mar 17, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: State governments, County governments, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education.
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Opportunity Summary:
The grant opportunity titled "Use of 3D Printing for Creation of Implantable Devices (R21/R33)" (Funding Opportunity Number RFA HD 17 002) is a discretionary NIH funding announcement aimed at accelerating the development of pediatric-focused implantable medical devices and biodegradable scaffolds using 3D printing. The core idea is to support projects that leverage additive manufacturing to create implants intended for long-term use in children, with a specific emphasis on designs that can accommodate growth over time. This reflects a major clinical gap in pediatrics, where many implants are built for adults and often require multiple replacement surgeries as a child grows. By encouraging 3D-printed solutions, the program highlights the potential for customization, rapid iteration, and novel material and structural designs that may be difficult to achieve through conventional manufacturing.
The award uses the NIH Phased Innovation mechanism (R21/R33). The first phase, the R21, can provide up to two years of support and is meant for early-stage work such as research planning, proof-of-concept development, and feasibility testing. This phase is where teams typically refine device concepts, demonstrate basic functionality, explore candidate biomaterials, establish preliminary manufacturing workflows, and generate data that justify moving into a more intensive development and validation stage. The second phase, the R33, represents an expansion of support intended for projects that successfully meet the milestones established during the R21 period. The transition is not automatic; it depends on the completion of applicant-defined milestones and also on NIH program priorities and available funds at the time of transition. In practice, this means applicants must propose clear, measurable go/no-go criteria from the outset, so progress can be evaluated objectively before the project is allowed to scale.
The scientific and technical focus is on 3D printing technologies applied to implantable devices and biodegradable scaffolds. "Implantable devices" can encompass a wide range of medical technologies placed inside the body, while "biodegradable scaffolds" generally refer to structures that provide temporary support for tissue regeneration and then safely break down over time. The pediatric requirement adds a design constraint: the implant or scaffold should be suitable for long-term use and should adapt to the needs of growing children. That adaptation might involve materials that remodel with tissue, structures that can expand, modular designs, or bioresorbable constructs that enable natural growth and regeneration rather than forcing static geometry on a developing body.
Eligible applicants are broad and include state and county governments; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations; and nonprofit organizations both with and without 501(c)(3) status (as long as they are not institutions of higher education in the nonprofit category listings). The sponsoring agency is the U.S. Department of Health and Human Services, National Institutes of Health (listed as HHS-NIH11). The activity category is Health, Income Security and Social Services, and the CFDA numbers associated with the opportunity are 93.865 (and an additional listing of 93., as provided in the source data). The funding instrument is a grant.
Key administrative details from the posting indicate it was created and posted on January 13, 2016, with an original and current closing date of March 17, 2016. The announcement anticipated approximately five awards. The award ceiling field is not specified in the provided data, so the maximum per-award amount is not stated here, but the two-phase structure implies an initial smaller feasibility period followed by a potentially larger expansion if milestones are met and funds remain available.
Overall, this FOA is designed to move promising 3D-printed pediatric implant concepts from early feasibility and planning into more robust development through a structured, milestone-driven pathway. It is especially relevant to multidisciplinary teams that can combine pediatric clinical insight, biomaterials science, mechanical and biomedical engineering, and additive manufacturing expertise, since success depends not only on printing a device but on creating something safe, functional, durable (or intentionally bioresorbable), and compatible with the unique demands of the growing human body.
Frequently Asked Questions (FAQs): Use of 3D Printing for Creation of Implantable Devices (R21/R33) (RFA HD 17 002)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Use of 3D Printing for Creation of Implantable Devices (R21/R33)" and the Funding Opportunity Number is RFA HD 17 002.
Which agency is sponsoring this funding opportunity?
The sponsoring agency is the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), listed as HHS-NIH11.
What is the main purpose of this grant opportunity?
This funding announcement is intended to accelerate development of pediatric-focused implantable medical devices and biodegradable scaffolds using 3D printing (additive manufacturing). A central goal is to encourage implant designs suitable for long-term use in children, including designs that can accommodate growth over time.
Why does the program emphasize pediatrics and growth-accommodating implants?
The program highlights a clinical gap in pediatrics: many implants are designed for adults and can require multiple replacement surgeries as a child grows. The FOA encourages solutions that better fit the needs of growing children, potentially reducing repeated surgeries and improving long-term outcomes.
What types of projects are in scope?
Projects should leverage 3D printing to create (1) implantable devices intended to be placed inside the body, and/or (2) biodegradable scaffolds that provide temporary support for tissue regeneration and then safely break down over time. The pediatric requirement adds the expectation that the resulting implant or scaffold is suitable for long-term pediatric use and responsive to growth-related needs.
What is meant by "3D printing" in this FOA?
The FOA focuses on additive manufacturing approaches that can enable customization, rapid iteration, and new material and structural designs that may be difficult to achieve using conventional manufacturing.
What is meant by an "implantable device" under this opportunity?
"Implantable devices" broadly refers to medical technologies placed inside the body. The FOA does not limit the definition to a single clinical area in the information provided, but it emphasizes pediatric suitability and long-term use.
What is meant by a "biodegradable scaffold" under this opportunity?
A biodegradable scaffold generally refers to a structure that temporarily supports tissue regeneration and then safely degrades over time. In the pediatric context, scaffolds may be especially relevant for enabling natural growth and regeneration rather than forcing a static implant geometry on a developing body.
How should projects address the needs of growing children?
The FOA emphasizes designs that can accommodate growth over time. Examples of adaptation approaches described include materials that remodel with tissue, structures that can expand, modular designs, or bioresorbable constructs that enable natural growth and regeneration.
What funding mechanism is used (R21/R33), and what does it mean?
This FOA uses the NIH Phased Innovation mechanism (R21/R33). It is a two-stage, milestone-driven pathway designed to move a project from early feasibility work (R21) into a more intensive development and validation stage (R33), if R21 milestones are successfully achieved.
What is the R21 phase intended to support?
The R21 phase can provide up to two years of support and is intended for early-stage activities such as research planning, proof-of-concept development, and feasibility testing. As described, teams may refine device concepts, demonstrate basic functionality, explore candidate biomaterials, establish preliminary manufacturing workflows, and generate data supporting transition to the R33 phase.
How does transition from R21 to R33 work?
Transition to the R33 phase is not automatic. It depends on completion of applicant-defined milestones and also on NIH program priorities and the availability of funds at the time of transition.
What kind of milestones are expected for the R21 to R33 transition?
Applicants are expected to propose clear, measurable go/no-go criteria from the outset so progress can be evaluated objectively before the project is allowed to scale into the R33 phase.
How long can the R21 phase last?
Based on the provided information, the R21 phase can provide up to two years of support.
Is the maximum award amount (award ceiling) provided?
No. The award ceiling field is not specified in the provided posting details, so the maximum per-award amount is not stated in the information provided.
How many awards were anticipated?
The announcement anticipated approximately five awards.
What is the funding instrument?
The funding instrument is a grant.
What is the activity category listed for this opportunity?
The activity category is listed as Health, Income Security and Social Services.
What CFDA numbers are associated with this opportunity?
The CFDA numbers associated with the opportunity are 93.865 (and an additional listing of 93. as provided in the source data).
Who is eligible to apply?
Eligible applicants include: state governments; county governments; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations; and nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education in the nonprofit category listings).
Are institutions of higher education eligible?
Yes. Both public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible applicant types.
Are nonprofit organizations eligible?
Yes. Nonprofits with or without 501(c)(3) status are listed as eligible, with the noted condition that the nonprofit category listings exclude institutions of higher education.
Are tribal governments or tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and Native American tribal organizations are listed as eligible applicants.
What are the key dates for this funding opportunity?
The posting was created and posted on January 13, 2016. The original closing date and the current closing date are both March 17, 2016.
What makes this FOA particularly relevant for multidisciplinary teams?
The FOA emphasizes that success depends on more than printing a device. Projects may require pediatric clinical insight along with biomaterials science, mechanical and biomedical engineering, and additive manufacturing expertise to develop implants that are safe, functional, and appropriate for pediatric long-term use (or intentionally bioresorbable, depending on the concept).
Does the FOA prioritize customization and rapid iteration?
Yes. The program highlights that 3D printing can support customization, rapid iteration, and novel material and structural designs that may be difficult to achieve through conventional manufacturing.
Is the R33 phase guaranteed if an applicant receives an R21 award?
No. The transition depends on meeting applicant-defined milestones and also on NIH program priorities and available funds at the time of transition.
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