Opportunity Information: Apply for PA 15 065
Apply for PA 15 065
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Radiological/Nuclear Medical Countermeasure Product Development Program (R43/R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Dec 10, 2014 and posted on Dec 10, 2014.
- Applicants must submit their applications by Jan 7, 2018. (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 United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture SBIR and STTR. Be a concern which is more than 50 directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these OR SBIR only. Be a concern which is more than 50 owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 of the concern OR SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements. Has, including its affiliates, not more than 500 employees.
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Opportunity Summary:
The Radiological/Nuclear Medical Countermeasure Product Development Program (R43/R44) is an NIH Small Business Innovation Research (SBIR) funding opportunity designed to push practical, regulated product development work for medical countermeasures that could be used in radiological or nuclear incidents. Instead of supporting only early discovery science, the emphasis is on concrete development activities that move a candidate drug, biologic, or medical device toward a formal FDA submission, specifically an Investigational New Drug (IND) package for therapeutics/biologics or an Investigational Device Exemption (IDE) package for devices. In plain terms, the program is meant to help small companies do the kind of focused, documentation-heavy, milestone-driven work that turns a promising concept into something ready to enter clinical testing or device investigation under FDA oversight.
This opportunity (Funding Opportunity Number PA 15 065) falls under the discretionary grant category and uses the SBIR grant mechanisms R43 and R44, which correspond to SBIR Phase I and Phase II. That structure generally means Phase I supports feasibility and early proof of concept, while Phase II supports more advanced development and validation work, with both phases oriented here toward producing the data and supporting materials needed for IND/IDE submissions. The activity category is Health, and it is tied to CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research), reflecting NIH programmatic alignment even though the central theme is preparedness for radiation/nuclear public health threats. The announcement states there is no cost sharing or matching requirement, which is important for small businesses budgeting their R and D plans.
Eligibility is limited to United States small business concerns. Applicants must be for-profit entities with a place of business in the U.S. and must operate primarily in the U.S. or make a significant contribution to the U.S. economy through taxes or the use of American products, materials, or labor. The small business can take common legal forms such as an individual proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative, with specific limits on foreign participation when structured as a joint venture. The business, including affiliates, must have no more than 500 employees. Ownership and control rules follow SBIR requirements and include the standard majority ownership by U.S. citizens or permanent resident aliens, while also allowing (for SBIR) certain majority ownership structures involving multiple venture capital operating companies, hedge funds, or private equity firms, provided no single such entity owns more than 50 percent. Joint ventures are also permitted if each participating entity meets the applicable SBIR ownership and registration requirements.
From a timeline standpoint, the opportunity was posted and created on December 10, 2014, with an original and current closing date of January 7, 2018, and an archive date of February 7, 2018. That means the specific announcement as listed is no longer open, but the summary still captures what NIH was seeking under this FOA: SBIR projects that directly support regulated product development for radiological/nuclear medical countermeasures, with a clear line of sight to an IND or IDE submission package.
Administrative and applicant support details are also provided. The sponsoring agency is the National Institutes of Health. The full announcement was hosted through the NIH grants guide, and applicants having trouble accessing or linking to the FOA were directed to contact the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
FAQs: Radiological/Nuclear Medical Countermeasure Product Development Program (SBIR R43/R44) - PA 15 065
What is this funding opportunity?
The Radiological/Nuclear Medical Countermeasure Product Development Program (R43/R44) is an NIH Small Business Innovation Research (SBIR) funding opportunity focused on advancing practical, regulated product development for medical countermeasures that could be used in radiological or nuclear incidents.
What is the main goal of the program?
The emphasis is on concrete development activities that move a candidate drug, biologic, or medical device toward a formal FDA submission package. Specifically, the program targets development work that supports an Investigational New Drug (IND) package for therapeutics/biologics or an Investigational Device Exemption (IDE) package for devices.
How is this different from early-stage discovery research funding?
Rather than focusing only on early discovery science, this program is designed to fund documentation-heavy, milestone-driven development work aimed at getting a product ready to enter clinical testing (for drugs/biologics) or device investigation under FDA oversight (for devices).
What types of products are in scope?
Projects may involve a candidate drug, biologic, or medical device intended as a medical countermeasure for radiological or nuclear incidents, with development activities aligned to producing an IND or IDE submission package.
What does "regulated product development" mean in this context?
In this opportunity, it refers to product development work structured to meet FDA expectations and to generate the data and supporting materials needed for an IND (therapeutics/biologics) or IDE (devices) submission package.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number provided is PA 15 065.
Which agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What kind of grant is this?
The announcement is listed under the discretionary grant category and uses SBIR grant mechanisms.
Which SBIR mechanisms are used?
This opportunity uses SBIR R43 and R44 mechanisms, which correspond to SBIR Phase I and Phase II.
What is the difference between Phase I (R43) and Phase II (R44) here?
As described, Phase I generally supports feasibility and early proof of concept, while Phase II supports more advanced development and validation work. In both phases, the work is oriented toward generating the data and materials needed for IND/IDE submission packages.
What is the activity category for this opportunity?
The activity category is Health.
Which CFDA numbers are associated with this opportunity?
The opportunity is tied to CFDA 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).
Does the program require cost sharing or matching funds?
No. The announcement states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is limited to United States small business concerns. Applicants must be for-profit entities with a place of business in the U.S. and must operate primarily in the U.S. or make a significant contribution to the U.S. economy through taxes or the use of American products, materials, or labor.
Is this limited to for-profit businesses?
Yes. The eligibility description specifies applicants must be for-profit entities that qualify as a United States small business concern under SBIR requirements.
Are there employee count limits for eligibility?
Yes. The business, including affiliates, must have no more than 500 employees.
What legal entity types can qualify as a small business for this opportunity?
The small business can take common legal forms such as an individual proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative, consistent with SBIR eligibility rules.
Are joint ventures allowed?
Yes. Joint ventures are permitted, with specific limits on foreign participation when structured as a joint venture, and with the expectation that each participating entity meets applicable SBIR ownership and registration requirements.
What are the ownership and control requirements?
Ownership and control rules follow SBIR requirements, including standard majority ownership by U.S. citizens or permanent resident aliens. The description also notes that SBIR allows certain majority ownership structures involving multiple venture capital operating companies, hedge funds, or private equity firms, provided no single such entity owns more than 50 percent.
When was this opportunity posted?
The opportunity was posted and created on December 10, 2014.
What was the closing date?
The original and current closing date listed is January 7, 2018.
Is this funding opportunity still open?
No. The archive date is February 7, 2018, and the listing indicates the specific announcement as provided is no longer open.
Where was the full announcement hosted?
The full announcement was hosted through the NIH grants guide.
Who should be contacted if there are issues accessing or linking to the FOA?
Applicants having trouble accessing or linking to the FOA were directed to contact the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
What is the intended outcome of projects funded under this FOA?
The intended outcome is to support SBIR projects that directly advance regulated product development for radiological/nuclear medical countermeasures, with a clear line of sight to completing an IND or IDE submission package.
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