Opportunity Information: Apply for PA 09 093
Apply for PA 09 093
- 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, Immunology and Transplantation Research.
- This funding opportunity was created on Feb 9, 2009 and posted on Feb 9, 2009.
- Applicants must submit their applications by Jan 7, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The Radiological/Nuclear Medical Countermeasure Product Development Program (SBIR R43/R44), funding opportunity number PA-09-093, is an NIH Small Business Innovation Research (SBIR) grant program focused on moving practical radiological and nuclear emergency countermeasures forward through the non-clinical and pre-clinical stages of development. The core intent is to help small business concerns generate the data, prototypes, and development packages needed to advance promising candidates toward FDA-regulated pathways, with an eye toward eventual licensure and possible placement in the Strategic National Stockpile for use in a large-scale radiological incident.
The opportunity solicits projects in three main areas. First, it supports development of medical countermeasures that mitigate or treat acute radiation syndromes as well as longer-term or delayed effects of radiation exposure. This includes products aimed at reducing morbidity and mortality after lethal or near-lethal exposures and addressing sustained tissue injury that can emerge after the initial acute phase. Second, it encourages development of decorporation agents for internal radionuclide contamination, meaning drugs or other interventions designed to bind, neutralize, or accelerate elimination of radioactive materials that have entered the body, thereby reducing internal dose and associated health consequences. Third, it funds radiation biodosimetry products that can estimate an individual’s radiation exposure level, which is critical in emergency triage and medical decision-making when large numbers of people may be affected and physical dosimeters are unavailable, damaged, or not worn.
A key theme throughout the announcement is product development maturity rather than basic discovery. Applicants are expected to propose work that continues and expands non-clinical and pre-clinical efforts, such as refining a lead candidate or device concept, demonstrating proof-of-concept in relevant models, improving performance characteristics, developing and validating assays or readouts, and generating the kinds of supporting evidence regulators typically expect before authorizing clinical testing. The program is structured to support efforts leading toward submission of an Investigational New Drug (IND) application for drugs/biologics or an Investigational Device Exemption (IDE) for devices to the U.S. Food and Drug Administration. In other words, the endpoint NIH is trying to enable is a credible regulatory package that can open the door to human studies (when appropriate) and ultimately to a licensed, field-ready countermeasure.
Mechanistically, the FOA uses the SBIR grant mechanisms R43 (Phase I) and R44 (Phase II). Phase I generally aligns with establishing feasibility and reducing early technical risk, while Phase II supports more advanced development and larger-scale preclinical work needed to push a candidate toward regulatory submission and later-stage readiness. The funding instrument is a discretionary grant, and the eligible applicant pool is limited to small businesses, consistent with SBIR rules. The program is categorized under health-related federal assistance and is listed under CFDA 93.855 (Allergy, Immunology and Transplantation Research), with no cost sharing or matching requirement indicated.
Administratively, the opportunity was posted and created on February 9, 2009, and it carried an original and current closing date of January 7, 2012, with an archive date of February 7, 2012. The sponsoring agency is the National Institutes of Health, and the full announcement was available through the NIH Grants Guide (link provided in the source). For access or technical issues related to the electronic announcement, the contact point listed is the NIH Office of Extramural Research (OER) webmaster email.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This is the Radiological/Nuclear Medical Countermeasure Product Development Program (SBIR R43/R44), a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant opportunity under funding opportunity number PA-09-093.
What is the main purpose of PA-09-093?
The program is focused on moving practical radiological and nuclear emergency medical countermeasures forward through non-clinical and pre-clinical stages of development. The intent is to help small businesses generate data, prototypes, and development packages that can support FDA-regulated pathways, with the longer-term aim of eventual licensure and potential placement in the Strategic National Stockpile for use during a large-scale radiological incident.
What kinds of projects does the program support?
The announcement solicits projects in three main areas: (1) medical countermeasures for acute radiation syndromes and longer-term or delayed effects of radiation exposure, (2) decorporation agents for internal radionuclide contamination, and (3) radiation biodosimetry products that estimate an individual's radiation exposure level for triage and medical decision-making.
Does this program fund basic discovery research?
The emphasis is on product development maturity rather than basic discovery. Applicants are expected to propose work that continues and expands non-clinical and pre-clinical efforts, such as refining a lead candidate or device concept and generating evidence typically needed to support regulatory next steps.
What does the program mean by "medical countermeasures" for radiation exposure?
In the context of this opportunity, medical countermeasures include products intended to mitigate or treat acute radiation syndromes as well as longer-term or delayed effects. This can include approaches aimed at reducing morbidity and mortality after lethal or near-lethal exposure and addressing sustained tissue injury that may emerge after the acute phase.
What are "decorporation agents" in this FOA?
Decorporation agents are drugs or other interventions designed to bind, neutralize, or speed elimination of radioactive materials that have entered the body. The goal is to reduce internal dose and the health consequences of internal radionuclide contamination.
What are radiation biodosimetry products, and why are they important?
Radiation biodosimetry products estimate an individual's radiation exposure level. This is especially important for emergency triage and medical decision-making when large numbers of people may be affected and physical dosimeters are unavailable, damaged, or not worn.
What stage of development is NIH trying to support through this program?
The program targets non-clinical and pre-clinical development work. Examples described include demonstrating proof-of-concept in relevant models, improving performance characteristics, developing and validating assays or readouts, and producing supporting evidence that regulators typically expect before authorizing clinical testing.
What is the intended regulatory endpoint for funded projects?
The program is structured to support efforts leading toward submission of an Investigational New Drug (IND) application for drugs/biologics or an Investigational Device Exemption (IDE) for devices to the U.S. Food and Drug Administration (FDA). The aim is to enable a credible regulatory package that can open the door to human studies (when appropriate) and ultimately to a licensed, field-ready countermeasure.
Which grant mechanisms are used in this opportunity?
The FOA uses SBIR grant mechanisms R43 (Phase I) and R44 (Phase II).
How do Phase I (R43) and Phase II (R44) differ in this program?
Phase I generally aligns with establishing feasibility and reducing early technical risk. Phase II supports more advanced development and larger-scale preclinical work intended to push a candidate toward regulatory submission and later-stage readiness.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with SBIR rules.
What type of funding instrument is this?
The funding instrument is a discretionary grant.
Is cost sharing or matching required?
No cost sharing or matching requirement is indicated for this opportunity.
Which federal assistance category and CFDA number apply to this program?
The program is categorized under health-related federal assistance and is listed under CFDA 93.855 (Allergy, Immunology and Transplantation Research).
When was this opportunity posted and when did it close?
The opportunity was posted and created on February 9, 2009. It carried an original and current closing date of January 7, 2012, with an archive date of February 7, 2012.
Which agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
Where was the full announcement published?
The full announcement was available through the NIH Grants Guide (via the link provided in the source information for this opportunity).
Who should be contacted for access or technical issues related to the electronic announcement?
For access or technical issues related to the electronic announcement, the listed contact point is the NIH Office of Extramural Research (OER) webmaster email.
Does the program mention an intended public health or preparedness outcome?
Yes. The opportunity frames development in the context of radiological and nuclear emergencies, with the longer-term objective of producing countermeasures that could be licensed and potentially placed in the Strategic National Stockpile for use in a large-scale radiological incident.
What kinds of deliverables or outputs is the program trying to enable?
The program emphasizes generating practical development outputs such as data packages, prototypes, validated assays or readouts, and other supporting evidence that would strengthen a product's readiness for FDA-regulated next steps like IND or IDE submission.
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