Opportunity Information: Apply for PA 15 132
Apply for PA 15 132
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NEI Administrative Supplements to Small Business Innovative Research (SBIR) Grants for the Procurement of Expertise in the Federal Regulatory Approval Process for New Drugs and/or Devices (Admin Supp)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.867 Vision Research.
- This funding opportunity was created on Mar 5, 2015 and posted on Mar 5, 2015.
- Applicants must submit their applications by Jul 1, 2017. (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 $25,000.00 in funding.
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The National Eye Institute (NEI), part of the National Institutes of Health (NIH), offered an administrative supplement funding opportunity to help small businesses that already hold active NEI SBIR Phase I or Phase II awards strengthen their path toward FDA and other federal regulatory approval. The core idea of the program is straightforward: many promising vision and eye care technologies stall or slow down because companies lack specialized regulatory expertise early enough in development, so NEI made small, targeted add-on funds available to let SBIR awardees hire outside consultants who understand the federal approval process for drugs and/or medical devices. By paying for this kind of regulatory guidance, the supplement is meant to help grantees move innovative products toward the marketplace more efficiently and with fewer missteps.
This opportunity was a discretionary grant mechanism categorized under health research, aligned with CFDA 93.867 (Vision Research). It did not require cost sharing or matching. The maximum award amount (award ceiling) was $25,000, reflecting its purpose as a focused supplement rather than a full standalone research project. Eligible applicants were small businesses, but only those that were already NEI awardees with an active SBIR Phase I or Phase II grant; in other words, it was not open to new applicants seeking initial SBIR funding, and it was not designed to fund new R and D aims. Instead, it supported added activities that complemented the active SBIR project by bringing in regulatory consulting services.
In practical terms, the supplement funds could be used to procure consultant support related to the federal regulatory approval pathway for the companys innovation, whether that meant clarifying whether a product is regulated as a drug, device, biologic, or combination product; identifying the likely approval route (for example, 510(k), De Novo, PMA, IND/NDA, etc.); mapping preclinical and clinical evidence expectations; preparing for interactions with FDA (such as meeting planning and question framing); or developing regulatory strategies and documentation plans that align product development with regulatory requirements. The emphasis is on expertise in the process itself, helping the business make informed, compliant decisions that reduce delays and avoid costly redesigns or study changes later.
Key administrative details from the notice include the funding opportunity number PA 15 132 and a posted date of March 5, 2015. The original and final closing date listed was July 1, 2017, and the opportunity was archived on August 1, 2017. Additional details were provided through the NIH Grants Guide announcement page (http://grants.nih.gov/grants/guide/pa-files/PA-15-132.html). For access or technical issues with the announcement, the contact listed was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Overall, the opportunity functioned as a small but strategic boost for NEI-funded SBIR companies: it did not expand the science budget in a broad way, but instead aimed to remove a common commercialization bottleneck by paying for high-value regulatory consulting, with the goal of helping vision and eye care innovations reach patients and providers faster and more smoothly.
FAQs: NEI Administrative Supplement for SBIR Regulatory Consulting (PA 15-132)
What was this grant opportunity?
This was an administrative supplement funding opportunity from the National Eye Institute (NEI), part of the National Institutes of Health (NIH). It provided small, targeted add-on funding to help existing NEI SBIR Phase I or Phase II awardees obtain specialized regulatory consulting to strengthen their path toward FDA (and other federal) regulatory approval.
What problem was NEI trying to solve with this supplement?
The supplement was designed to address a common bottleneck for small businesses developing vision and eye care innovations: promising technologies can slow down or stall because companies do not bring in regulatory expertise early enough. NEI offered this supplement so awardees could hire outside consultants who understand federal approval processes for drugs and/or medical devices, helping companies make informed, compliant choices earlier and avoid costly missteps later.
Who offered the supplement?
The opportunity was offered by the National Eye Institute (NEI), which is part of the National Institutes of Health (NIH).
What type of funding mechanism was it?
It was a discretionary grant mechanism provided as an administrative supplement. It was not intended to function like a standalone research grant.
What program area did it fall under?
The opportunity was categorized under health research and aligned with CFDA 93.867 (Vision Research).
What was the funding opportunity number?
The funding opportunity number was PA 15-132.
When was it posted?
The posted date listed in the notice was March 5, 2015.
What were the application closing dates?
The notice listed July 1, 2017 as both the original and the final closing date.
Is this opportunity still open?
No. The opportunity was archived on August 1, 2017.
What was the maximum award amount?
The award ceiling was $25,000. This reflected the intent to provide a focused supplement rather than fund a full new project.
Was cost sharing or matching required?
No. The notice stated that cost sharing or matching was not required.
Who was eligible to apply?
Eligible applicants were small businesses that already held an active NEI SBIR Phase I or Phase II award. It was limited to current NEI SBIR awardees with active grants.
Could a company apply if it did not already have an NEI SBIR award?
No. The supplement was not open to new applicants seeking initial SBIR funding. It was only available to small businesses with an active NEI SBIR Phase I or Phase II award.
Was this funding intended to support new R and D aims?
No. The supplement was not designed to fund new research and development aims. It supported added activities that complemented the active SBIR project.
What kinds of activities could the supplement funds support?
The supplement funds could be used to procure outside consultant support related to the federal regulatory approval pathway for the companys innovation. The focus was on regulatory expertise and planning rather than expanding the core science budget.
What types of regulatory consulting were specifically mentioned as examples?
Examples included consultant support to clarify whether a product is regulated as a drug, device, biologic, or combination product; identify the likely approval route (such as 510(k), De Novo, PMA, IND/NDA, etc.); map preclinical and clinical evidence expectations; prepare for interactions with FDA (including meeting planning and question framing); and develop regulatory strategies and documentation plans that align development work with regulatory requirements.
Was the supplement limited to FDA-related issues only?
The primary emphasis described was on FDA and the federal regulatory approval process, and it also referenced "other federal regulatory approval." The central use case was regulatory consulting to help move products toward approval more efficiently.
Why did NEI focus on paying for consultants instead of more lab work?
Based on the notice description, the supplement was meant to remove a commercialization bottleneck by funding high-value regulatory guidance. The intent was to help companies avoid delays, redesigns, or late-stage study changes that can happen when regulatory expectations are not addressed early.
Where could applicants find the official announcement details?
Additional details were provided through the NIH Grants Guide announcement page at: http://grants.nih.gov/grants/guide/pa-files/PA-15-132.html
Who was the contact for access or technical issues with the announcement page?
The contact listed for access or technical issues was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
In simple terms, what was the overall goal of the supplement?
The overall goal was to give NEI-funded SBIR companies a small but strategic boost by paying for regulatory consulting that helps move vision and eye care innovations toward the marketplace faster and with fewer regulatory missteps.
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