Opportunity Information: Apply for PA 16 335
Apply for PA 16 335
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "NHLBI Pilot Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical Devices (Diagnostics and Therapeutics) (Admin Supp)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840,.
- This funding opportunity was created on Jun 15, 2016 and posted on Jun 15, 2016.
- Applicants must submit their applications by Aug 15, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $5,000.00 in funding.
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The grant opportunity titled "NHLBI Pilot Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical Devices (Diagnostics and Therapeutics) (Admin Supp)" (Funding Opportunity Number PA 16 335) is an NIH/NHLBI administrative supplement designed specifically for small businesses that already hold active SBIR or STTR awards and are developing medical devices. Its central aim is to help these existing awardees strengthen their regulatory planning and execution by engaging directly and collaboratively with the US Food and Drug Administration (FDA), specifically the Center for Devices and Radiological Health (CDRH). The underlying idea is that earlier, clearer regulatory strategy work can reduce delays, prevent avoidable missteps, and accelerate the path from early development to market entry for promising diagnostic and therapeutic device technologies.
This opportunity falls under the US Department of Health and Human Services, National Institutes of Health (listed as HHS-NIH11), and is categorized as discretionary funding using the grant mechanism. Because it is an administrative supplement, it is not a stand-alone new SBIR/STTR award; instead, it provides additional targeted support layered onto an existing SBIR or STTR project. In practical terms, it is meant for companies that are already progressing through development and need structured regulatory input to make their work more aligned with FDA expectations as they move toward activities such as design controls, verification and validation, clinical planning where relevant, and eventual submission planning (for example, considerations tied to pathways such as 510(k), De Novo, or PMA, depending on device type and risk classification).
The program emphasizes collaboration with FDA CDRH to develop early-stage development strategies, which typically includes clarifying what evidence will be needed to support safety and effectiveness (or performance, depending on the device), identifying key regulatory risks, mapping appropriate testing and study plans, and improving the quality of regulatory communications. The larger value proposition is efficiency: by building a sound regulatory roadmap earlier, companies can often avoid rework, reduce uncertainty about requirements, and shorten timelines to key milestones that matter to both commercialization and later-stage investment.
Eligibility is limited to small businesses, reflecting its SBIR/STTR focus, and it is tied to specific NIH program and funding streams reflected by the CFDA numbers provided (93.233, 93.837, 93.838, 93.839, 93.840), which correspond to NIH and NHLBI-associated assistance listings. The award ceiling listed for this supplement is $5,000, indicating a modest, targeted funding level intended to support regulatory engagement activities rather than major new R&D work. The opportunity was created and posted on June 15, 2016, with an original and current closing date of August 15, 2016. Expected awards are not specified in the source data, suggesting that the number of supplements could depend on the availability of funds, the pool of eligible active SBIR/STTR projects, and the merit and fit of submitted supplement requests.
Overall, this administrative supplement opportunity is best understood as a focused regulatory support boost for existing NIH-funded SBIR/STTR device developers, intended to connect them with FDA CDRH collaboration early enough to make development decisions smarter and faster, ultimately improving the chances that innovative diagnostics and therapeutics reach the marketplace more efficiently.
FAQs: NHLBI Pilot Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical Devices (Diagnostics and Therapeutics) (Admin Supp) - PA 16 335
What is this grant opportunity?
This opportunity is an NIH/NHLBI administrative supplement called the "NHLBI Pilot Program to Provide Regulatory Support to SBIR/STTR Awardees Developing Medical Devices (Diagnostics and Therapeutics) (Admin Supp)" under Funding Opportunity Number PA 16 335. It is designed to add targeted regulatory support on top of an already-active SBIR or STTR award focused on medical device development.
Is this a stand-alone SBIR/STTR grant?
No. It is an administrative supplement, not a new, stand-alone SBIR or STTR award. It is meant to provide additional support layered onto an existing, active SBIR/STTR project.
Who is this supplement intended for?
It is intended for small businesses that already hold active SBIR or STTR awards and are developing medical devices, including diagnostics and therapeutics.
What is the main purpose of the supplement?
The central purpose is to strengthen regulatory planning and execution for existing SBIR/STTR device projects by supporting direct, collaborative engagement with the FDA, specifically the Center for Devices and Radiological Health (CDRH). The goal is to improve regulatory strategy earlier in development to reduce delays, prevent avoidable mistakes, and accelerate progress toward market entry.
Which federal agencies and offices are involved?
The opportunity sits under the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), specifically the National Heart, Lung, and Blood Institute (NHLBI). The regulatory collaboration emphasized in the description is with the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH).
What kinds of technologies does it focus on?
The focus is on medical devices, including diagnostics and therapeutic devices, being developed under active SBIR/STTR awards.
What types of activities is this supplement trying to support?
Based on the description, the supplement is meant to support regulatory engagement and planning activities, such as developing early-stage regulatory strategies, clarifying evidence expectations for safety/effectiveness or performance, identifying key regulatory risks, mapping testing and study plans, improving regulatory communications, and supporting planning toward eventual submission pathways (for example, 510(k), De Novo, or PMA depending on device type and risk classification).
What is the role of FDA CDRH in this program?
The program emphasizes direct collaboration with FDA CDRH to help companies develop clearer early-stage development and regulatory strategies, including what evidence will be needed and how to plan testing or studies to align development work with FDA expectations.
Why does the program emphasize early regulatory strategy?
The description highlights that earlier and clearer regulatory strategy work can reduce delays, prevent rework and missteps, reduce uncertainty about requirements, and shorten timelines to key development and commercialization milestones.
Does the opportunity specify which FDA regulatory pathway a device must use?
No. It references that submission planning may involve pathways such as 510(k), De Novo, or PMA depending on the device type and risk classification, but it does not require a single pathway for all applicants.
What is the maximum award amount for this administrative supplement?
The listed award ceiling for this supplement is $5,000. The description frames this as modest, targeted funding intended to support regulatory engagement activities rather than major new R&D work.
What type of funding mechanism is this?
It is discretionary funding using the grant mechanism, provided as an NIH/NHLBI administrative supplement to an existing award.
Is eligibility limited to small businesses?
Yes. Eligibility is limited to small businesses, consistent with its SBIR/STTR focus, and it is specifically tied to having an active SBIR or STTR award.
Does the opportunity indicate how many awards will be made?
No. The expected number of awards is not specified in the provided information. The description suggests it could depend on available funds, how many eligible active SBIR/STTR projects apply, and the merit and fit of supplement requests.
When was this opportunity posted?
The opportunity was created and posted on June 15, 2016.
What is the application closing date?
The original and current closing date listed is August 15, 2016.
What CFDA numbers are associated with this opportunity?
The information provided lists CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840 as the associated assistance listings tied to NIH and NHLBI-related funding streams.
What practical development areas are mentioned as being aligned with this regulatory support?
The description points to areas such as design controls, verification and validation, clinical planning where relevant, and eventual submission planning as examples of development decisions that can be strengthened by earlier regulatory input.
What is the overall value proposition for awardees?
The program is positioned as an efficiency and risk-reduction tool: building a sound regulatory roadmap earlier can help avoid rework, reduce uncertainty, speed progress to milestones that matter for commercialization and later-stage investment, and improve the chances that promising diagnostic and therapeutic devices reach the marketplace more efficiently.
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