Opportunity Information: Apply for PA 12 044
Apply for PA 12 044
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Radiological/Nuclear Medical Countermeasure Product Development Program (SBIRR43/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 9, 2011.
- Applicants must submit their applications by Dec 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 Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The Radiological/Nuclear Medical Countermeasure Product Development Program (SBIR R43/R44), Funding Opportunity Number PA-12-044, is a National Institutes of Health (NIH) discretionary grant opportunity designed to push promising small-business technologies closer to real-world use in radiological or nuclear emergencies. The core purpose is not basic research for its own sake, but focused product development that moves a candidate medical countermeasure along the regulatory path toward an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) submission package for the U.S. Food and Drug Administration (FDA). In practice, this means NIH is looking for SBIR projects that take a product concept that is already sufficiently grounded and then generate the development data, testing, and documentation needed to support FDA-regulated next steps.
The funding mechanism is the Small Business Innovation Research (SBIR) program using the R43/R44 structure, which generally corresponds to Phase I (feasibility) and Phase II (full research and development) SBIR awards. The focus on “new or renewal” applications indicates that both first-time applicants and prior SBIR awardees with follow-on work were intended to be eligible, as long as the proposed work squarely targets product development activities aligned with an IND or IDE trajectory. The announcement is housed within NIH’s health research mission and is associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research), reflecting the infectious disease and biodefense-related infrastructure that often overlaps with radiation/nuclear countermeasure development.
From an applicant standpoint, eligibility is limited to small businesses. Foreign institutions are explicitly not eligible, and non-U.S. components of U.S. organizations are also not eligible. In addition, foreign components (as defined by the NIH Grants Policy Statement) are not allowed, which signals that the work and key project elements were expected to be domestic and compliant with NIH policy restrictions on foreign involvement for this particular opportunity. There is no cost sharing or matching requirement, which typically lowers the barrier for small companies that may not have large pools of non-federal capital available during early development.
Administratively, this was a grant (Funding Instrument Type: Grant) in the discretionary category, posted December 9, 2011, with key dates indicating it is now an archived opportunity (archive date January 10, 2015). The source data lists an original closing date of January 7, 2015, with a current closing date of December 11, 2014, which suggests that the final submission window may have been adjusted before the opportunity was archived. For applicants and reviewers at the time, the practical takeaway was that proposals needed to be ready for submission within those windows and structured as SBIR Phase I/Phase II efforts oriented around tangible development milestones tied to FDA submission readiness.
Strategically, the opportunity’s emphasis on IND/IDE submission packages signals the types of activities NIH expected to support: development planning, preclinical studies and validation work appropriate for radiological/nuclear indications, performance testing for candidate devices, manufacturing or formulation work needed to establish consistency, and other translational steps that reduce regulatory risk. The end goal is to strengthen national preparedness by enabling small businesses to deliver credible, regulator-ready medical countermeasure candidates that can progress into clinical evaluation or device investigation under FDA oversight.
For those who needed the full announcement details, NIH provided an Additional Information link to the NIH Grants Guide page for PA-12-044. The contact listed for access or linking issues is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV, reflecting that inquiries were primarily logistical and related to accessing the electronic notice rather than scientific program contacts in the short source excerpt provided.
Frequently Asked Questions (FAQs)
What is the Radiological/Nuclear Medical Countermeasure Product Development Program (SBIR R43/R44)?
It is an NIH discretionary grant opportunity under the SBIR program (R43/R44) intended to advance promising small-business technologies for use in radiological or nuclear emergencies. The program is focused on product development that helps move a medical countermeasure candidate closer to real-world deployment.
What is the Funding Opportunity Number for this program?
The Funding Opportunity Number is PA-12-044.
What is the main purpose of this SBIR opportunity?
The main purpose is to support focused product development (not basic research for its own sake) that generates development data, testing, and documentation needed to support FDA-regulated next steps, specifically progress toward an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) submission package.
Is this opportunity intended for basic research or for product development?
It is intended for product development activities that push a sufficiently grounded product concept along a regulatory path toward IND or IDE readiness.
What funding mechanism does this opportunity use?
The opportunity uses the Small Business Innovation Research (SBIR) program with the R43/R44 structure, which generally corresponds to Phase I (feasibility) and Phase II (full research and development) awards.
What do R43 and R44 correspond to in SBIR?
R43 generally corresponds to SBIR Phase I (feasibility work), and R44 generally corresponds to SBIR Phase II (full research and development).
Who is eligible to apply?
Eligibility is limited to small businesses.
Are foreign institutions eligible to apply?
No. Foreign institutions are explicitly not eligible under this opportunity.
Can a U.S. organization include non-U.S. components on the project?
No. Non-U.S. components of U.S. organizations are not eligible for this opportunity.
Are foreign components allowed in any form?
No. Foreign components (as defined by the NIH Grants Policy Statement) are not allowed, indicating that the work and key project elements were expected to be domestic under NIH policy restrictions for this opportunity.
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement listed for this opportunity.
What is the funding instrument type?
The funding instrument type is a Grant.
Which federal agency administers this opportunity?
The opportunity is administered by the National Institutes of Health (NIH).
What is meant by NIH "discretionary" grant opportunity in this context?
It is identified as a discretionary NIH grant opportunity in the provided description, meaning it is offered through NIH as a grant mechanism rather than, for example, a procurement contract.
What does the opportunity mean by "new or renewal" applications?
It indicates that both first-time applicants and prior SBIR awardees seeking follow-on work were intended to be eligible, as long as the proposed work targets product development activities aligned with an IND or IDE trajectory.
What types of projects does NIH appear to be looking for?
Projects that take a sufficiently grounded product concept and produce the development data, testing, and documentation needed to reduce regulatory risk and support FDA submission readiness for radiological/nuclear medical countermeasures.
What kinds of activities are emphasized by the IND/IDE submission focus?
The description highlights development planning, preclinical studies and validation work appropriate for radiological/nuclear indications, performance testing for candidate devices, manufacturing or formulation work needed to establish consistency, and other translational steps tied to FDA submission readiness.
What regulatory milestones are explicitly referenced?
The opportunity explicitly references progress toward an FDA Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) submission package.
How does this program relate to national preparedness?
The stated end goal is to strengthen national preparedness by enabling small businesses to deliver credible, regulator-ready medical countermeasure candidates that can progress under FDA oversight.
Which CFDA numbers are associated with this opportunity?
The opportunity is associated with CFDA 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).
Why are infectious disease CFDA numbers associated with a radiological/nuclear countermeasure program?
The provided description notes that these CFDA numbers reflect infectious disease and biodefense-related infrastructure that often overlaps with radiation/nuclear countermeasure development.
When was this opportunity posted?
It was posted on December 9, 2011.
Is this opportunity still open?
No. It is described as an archived opportunity with an archive date of January 10, 2015.
What were the closing dates listed for this opportunity?
The source information lists an original closing date of January 7, 2015, and a current closing date of December 11, 2014, suggesting the final submission window may have been adjusted prior to archiving.
Where can applicants find the full announcement details?
The description states that NIH provided an Additional Information link to the NIH Grants Guide page for PA-12-044.
Who is listed as the contact for access or linking issues?
The contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV, described as a logistical contact related to accessing the electronic notice.
Does the provided information include a scientific or programmatic point of contact?
No. The excerpt provided only lists a contact for access or linking issues (the NIH OER Webmaster), and does not include a scientific or program contact.
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