Opportunity Information: Apply for PA 14 205
Apply for PA 14 205
- 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 May 2, 2014 and posted on May 2, 2014.
- Applicants must submit their applications by Jul 11, 2014. (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 Only NEI funded R43/R44 SBIR grantees are eligible to apply. This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project. IMPORTANT The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH supported grant project.
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Opportunity Summary:
The National Eye Institute (NEI), part of the National Institutes of Health (NIH), offered an administrative supplement opportunity (Funding Opportunity Number PA-14-205) aimed at helping existing NEI-funded SBIR projects move more smoothly through the federal regulatory pathway for new drugs and/or medical devices. The core idea behind this supplement was practical: many small businesses developing vision and eye care technologies run into specialized regulatory questions as they get closer to commercialization, and the supplement funding was intended to let those companies bring in outside regulatory expertise. In particular, the funds could be used to procure consultants who understand the federal approval process (most commonly the U.S. Food and Drug Administration pathways), so that regulatory strategy, documentation, and planning could be handled more efficiently and with fewer missteps. The overall goal was to help innovative eye and vision products reach the marketplace faster and more effectively.
This was a discretionary grant supplement rather than a standalone grant program, meaning applicants could not apply unless they already held an eligible NEI SBIR award. Only small businesses with active NEI-funded SBIR Phase I or Phase II awards under the R43/R44 mechanisms were eligible. Because it was an administrative supplement to an existing project, the parent award had to be active, and the work proposed under the supplement had to be completed within the existing competitive segment of that award. Just as important, the supplement work had to remain within the original scope of the peer-reviewed and approved SBIR project. In other words, it was not meant to fund a new research direction; it was meant to cover additional costs tied to the current project when those costs arose due to unforeseen circumstances, and when the requested activities fit squarely inside what NIH had already agreed to support.
The funding focus fell under health, specifically vision research (CFDA 93.867), and there was no cost sharing or matching requirement. The opportunity was posted on May 2, 2014, with an application deadline of July 11, 2014, and it was later archived on August 11, 2014. The official announcement and details were provided through the NIH Grants Guide (linked in the notice), and NIH’s Office of Extramural Research webmaster contacts were listed for technical issues accessing or linking to the full announcement.
FAQs: NEI Administrative Supplement for SBIR Regulatory Support (PA-14-205)
What is this grant opportunity?
This opportunity was an administrative supplement offered by the National Eye Institute (NEI), part of the National Institutes of Health (NIH), under Funding Opportunity Number PA-14-205. It was designed to help certain existing NEI-funded SBIR projects move more smoothly through the federal regulatory pathway for new drugs and/or medical devices.
What problem was the supplement meant to solve?
As small businesses developing eye and vision technologies get closer to commercialization, they often run into specialized regulatory questions. The supplement funding was intended to help companies address regulatory strategy, documentation, and planning more efficiently and with fewer missteps, so that innovative products could reach the marketplace faster and more effectively.
Who offered the supplement?
The supplement was offered by the National Eye Institute (NEI), which is part of the National Institutes of Health (NIH).
Is this a standalone grant program?
No. This was a discretionary administrative supplement, not a standalone grant. You could not apply unless you already had an eligible, active NEI-funded SBIR award.
Who was eligible to apply?
Only small businesses with active NEI-funded SBIR Phase I or Phase II awards were eligible, specifically under the R43/R44 mechanisms.
What types of SBIR awards were eligible (Phase I or Phase II)?
Active NEI-funded SBIR Phase I and Phase II awards were eligible (R43/R44).
Does the parent SBIR award have to be active at the time of application?
Yes. Because it was an administrative supplement to an existing project, the parent NEI SBIR award had to be active.
What could the supplement funds be used for?
The funds could be used to procure outside regulatory expertise, such as consultants who understand federal approval processes (most commonly U.S. Food and Drug Administration pathways). The intent was to support regulatory strategy work, documentation, and planning tied to advancing the existing SBIR project through the regulatory pathway.
What is an example of the type of expertise this supplement was trying to fund?
A key example described in the opportunity was hiring consultants familiar with the federal approval process, most often FDA pathways, to help ensure regulatory planning and documentation were handled properly.
Was the supplement meant to fund a new research direction?
No. The supplement work had to remain within the original scope of the peer-reviewed and approved SBIR project. It was intended to cover additional costs tied to the current project rather than support a new research direction.
Does the proposed supplement work need to fit within the existing project period?
Yes. The work proposed under the supplement had to be completed within the existing competitive segment of the parent award.
Why did NIH characterize this as an administrative supplement?
Because it was added onto an existing award rather than issued as a separate award. The supplement was meant to address additional costs that arose due to unforeseen circumstances, as long as the requested activities fit within what NIH had already approved for the project.
What area of research or topic did this opportunity focus on?
The focus fell under health, specifically vision research, associated with CFDA 93.867.
Was cost sharing or matching required?
No. The opportunity stated there was no cost sharing or matching requirement.
When was this opportunity posted?
It was posted on May 2, 2014.
What was the application deadline?
The application deadline was July 11, 2014.
When was the opportunity archived?
It was archived on August 11, 2014.
Where were the official details published?
The official announcement and details were provided through the NIH Grants Guide (linked in the notice).
What if someone had technical issues accessing the official announcement link?
The notice listed NIH Office of Extramural Research webmaster contacts for technical issues related to accessing or linking to the full announcement.
What was the overall goal of the supplement?
The overall goal was to help innovative eye and vision products reach the marketplace faster and more effectively by supporting regulatory planning and expertise for existing NEI-funded SBIR projects approaching the federal regulatory pathway.
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