Opportunity Information: Apply for PA 06 432
Apply for PA 06 432
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Therapeutics Development for HIV/AIDS Associated Neuropsychological Disorders (SBIRR43/R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants 93.279 Drug Abuse and Addiction Research Programs.
- This funding opportunity was created on Jan 26, 2009 and posted on May 22, 2006.
- Applicants must submit their applications by Jan 7, 2010 Multiple Receipt Dates See Link to Full Announcement for details.. (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 $250,000.00 in funding.
- Eligible applicants include: Small businesses Others (see text field entitled Additional Information on Eligibility for clarification).
- Foreign institutions are not eligible to apply. The NIH will accept as many different applications as the applicant organization chooses. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process or service that, with non substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS FOA, including the current parent SBIR or STTR FOAs.
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Opportunity Summary:
Therapeutics Development for HIV/AIDS Associated Neuropsychological Disorders (SBIR R43/R44), Funding Opportunity Number PA-06-432, is an NIH Small Business Innovation Research grant opportunity aimed at moving practical, product-oriented research toward new treatments for the mental and neurological complications linked to HIV/AIDS. The scientific focus is on therapeutics that address HIV-associated neuropsychological disorders, including approaches that either directly target HIV persistence in the central nervous system or reduce the downstream brain and behavioral harms associated with infection and its treatment. The opportunity is led within NIH by the National Institute of Mental Health (NIMH), specifically the Center for Mental Health Research on AIDS (CMHRA), in collaboration with the National Institute on Drug Abuse (NIDA), reflecting a strong interest in the intersections between HIV, brain health, psychiatric illness, substance use, and addiction.
A core priority of the announcement is the discovery and development of novel agents and enabling technologies that can eliminate or reduce HIV reservoirs in the brain. Because the brain is a difficult compartment for drug delivery and a suspected site of viral persistence, the FOA encourages therapeutic concepts that may work directly on viral reservoirs (for example, by improving drug penetration into the CNS or by targeting infected cell populations) as well as strategies that work indirectly by interrupting pathways that sustain reservoir persistence or neuroinflammation. Alongside drugs and biologics, the FOA explicitly welcomes methods, biomarkers, and drug delivery technologies, which can include tools to measure reservoir burden, monitor neurotoxicity, and demonstrate treatment response in a way that is meaningful for CNS outcomes.
The FOA also places significant emphasis on the development of the testing infrastructure needed to advance candidates toward the clinic. Applicants are invited to propose new assays and models of neurotoxicity, along with measures of therapeutic efficacy that better reflect HIV-related CNS injury and functional outcomes. The announcement highlights interest in both in vitro and in vivo models that can be used to screen and prioritize potential therapeutics, implying that platform technologies, predictive model systems, and translational endpoints that de-risk development are within scope. In practical terms, a small business could propose anything from a novel neuronal-glial co-culture assay that captures HIV- or ART-related injury mechanisms, to an animal model or imaging/biomarker approach that links a therapeutic intervention to improvements in CNS pathology or behavior.
Another major theme is mitigating the long-term side effects of antiretroviral therapy (ART), which can be clinically complicated by psychiatric comorbidities and substance use. The FOA supports studies of agents or therapeutic strategies that protect against, improve, or treat persistent adverse effects of antiretrovirals, and it explicitly allows these studies to be framed in the presence or absence of psychotropic medications, drugs of abuse, or medications used to treat substance use disorders. This is an important part of the scope because real-world HIV care often involves polypharmacy and co-occurring mental illness or addiction, and the NIH is signaling that therapies should be evaluated with those realities in mind. Relatedly, the FOA encourages adjunctive therapies aimed at the consequences of HIV in the CNS, particularly in contexts where mental illness or drug addiction may worsen outcomes or complicate treatment.
From a funding and structure standpoint, this is an SBIR opportunity using the R43/R44 mechanisms and allows Phase I, Phase II, and Fast Track submissions. Phase I is intended to establish feasibility and early proof of concept, with budgets up to $250,000 total costs per year and project periods up to 2 years. Phase II supports further R and D and prototype or preclinical/clinical development steps, with budgets up to $450,000 total costs per year and project periods up to 3 years. The announcement notes that no specific funds have been set aside and that the number of awards and total funding are not predetermined, so competition and award levels depend on application quality, program priorities, and available NIH funds in a given cycle. The FOA also runs in parallel with a separate, scientifically identical STTR announcement (PA-06-433, R41/R42), which matters mainly for applicants deciding whether they want the SBIR structure (company-led R and D) or the STTR structure (formal small business-research institution partnership).
Eligibility is limited to United States small business concerns; foreign institutions are not eligible. The PD/PI on an SBIR must have primary employment with the small business (more than 50 percent) at the time of award and remain primarily employed by the SBC for the duration of the project, which is a key operational requirement for team planning. The FOA welcomes participation by any qualified individual and reiterates NIH’s encouragement for individuals from underrepresented racial and ethnic groups and individuals with disabilities to apply. Companies may submit more than one application as long as each is scientifically distinct, and NIH will not accept essentially identical or overlapping applications proposing the same core product with only minor variations, nor will it accept the same or essentially identical application submitted under multiple HHS funding opportunities at the same time.
Administratively, the opportunity is categorized as discretionary grant funding in the health and education domains, with CFDA numbers 93.242 (Mental Health Research Grants) and 93.279 (Drug Abuse and Addiction Research Programs). It was originally posted May 22, 2006, with multiple receipt dates, and the archived record lists closing and archive dates through early 2010, indicating this is an older FOA that was active during that period. For complete details, the full announcement was hosted through NIH’s Grants Guide at the link provided in the source record.
Frequently Asked Questions (FAQs)
What is the funding opportunity PA-06-432?
PA-06-432 is an NIH Small Business Innovation Research (SBIR) funding opportunity titled "Therapeutics Development for HIV/AIDS Associated Neuropsychological Disorders (SBIR R43/R44)." It supports practical, product-oriented research aimed at developing new treatments for the mental and neurological complications linked to HIV/AIDS.
What is the main goal of this SBIR opportunity?
The main goal is to move therapeutics and enabling technologies toward development for HIV-associated neuropsychological disorders, including strategies that address HIV persistence in the central nervous system (CNS) and/or reduce downstream brain and behavioral harms associated with HIV infection and its treatment.
Which NIH Institute leads this opportunity?
The opportunity is led by the National Institute of Mental Health (NIMH), specifically the Center for Mental Health Research on AIDS (CMHRA), in collaboration with the National Institute on Drug Abuse (NIDA).
Why is there collaboration with NIDA?
The collaboration reflects NIH interest in the intersections between HIV, brain health, psychiatric illness, substance use, and addiction, especially as these factors can affect CNS outcomes and treatment realities in HIV care.
What scientific areas are within scope?
The scope includes therapeutics and related technologies addressing HIV-associated neuropsychological disorders, including approaches that (1) directly target HIV persistence in the CNS or (2) reduce downstream CNS injury and behavioral harm associated with HIV infection and its treatment.
Is targeting HIV reservoirs in the brain a priority?
Yes. A core priority is discovery and development of novel agents and enabling technologies that can eliminate or reduce HIV reservoirs in the brain, recognizing the CNS as a difficult compartment for drug delivery and a suspected site of viral persistence.
What kinds of strategies to address CNS reservoirs are encouraged?
The FOA encourages strategies that may work directly on reservoirs (such as improving drug penetration into the CNS or targeting infected cell populations) as well as strategies that work indirectly by interrupting pathways that sustain reservoir persistence or neuroinflammation.
Are only drugs and biologics supported?
No. In addition to drugs and biologics, the FOA explicitly welcomes methods, biomarkers, and drug delivery technologies. These can include tools to measure reservoir burden, monitor neurotoxicity, and demonstrate treatment response relevant to CNS outcomes.
Does the FOA support development of assays and models?
Yes. The FOA emphasizes building testing infrastructure to advance candidates toward the clinic, including proposing new assays and models of neurotoxicity and measures of therapeutic efficacy that better reflect HIV-related CNS injury and functional outcomes.
Are in vitro and in vivo model systems both acceptable?
Yes. The announcement highlights interest in both in vitro and in vivo models that can be used to screen and prioritize therapeutics, including platform technologies, predictive model systems, and translational endpoints that reduce development risk.
Can a project focus on biomarkers or imaging approaches?
Yes. The FOA welcomes biomarkers and enabling technologies, and it notes interest in approaches that can link a therapeutic intervention to improvements in CNS pathology or behavior, including imaging and biomarker strategies.
Does the FOA address side effects of antiretroviral therapy (ART)?
Yes. Another major theme is mitigating the long-term side effects of ART. The FOA supports studies of agents or strategies that protect against, improve, or treat persistent adverse effects of antiretrovirals.
Can studies consider psychiatric comorbidities and substance use?
Yes. The FOA explicitly allows studies to be framed in the presence or absence of psychotropic medications, drugs of abuse, or medications used to treat substance use disorders, reflecting real-world polypharmacy and co-occurring mental illness or addiction in HIV care.
Are adjunctive therapies for CNS consequences of HIV included?
Yes. The FOA encourages adjunctive therapies aimed at consequences of HIV in the CNS, particularly in contexts where mental illness or drug addiction may worsen outcomes or complicate treatment.
What grant mechanisms are used?
This is an SBIR opportunity using the R43 (Phase I) and R44 (Phase II) mechanisms. It allows Phase I, Phase II, and Fast Track submissions.
What is SBIR Phase I intended to support under this FOA?
Phase I is intended to establish feasibility and early proof of concept for the proposed product-oriented research.
What is the Phase I budget limit and project period?
Phase I budgets are up to $250,000 total costs per year, with project periods up to 2 years.
What is SBIR Phase II intended to support under this FOA?
Phase II supports further research and development and can include prototype development and preclinical/clinical development steps.
What is the Phase II budget limit and project period?
Phase II budgets are up to $450,000 total costs per year, with project periods up to 3 years.
Does the FOA set aside a specific pot of money for awards?
No. The announcement states that no specific funds have been set aside, and the number of awards and total funding are not predetermined.
How are award numbers and amounts determined?
Awards depend on application quality, program priorities, and available NIH funds in a given cycle, as indicated in the FOA.
Is there a related STTR opportunity?
Yes. The FOA runs in parallel with a separate, scientifically identical STTR announcement: PA-06-433 (R41/R42).
Why does the parallel STTR announcement matter?
It matters for applicants choosing between SBIR (company-led R&D structure) and STTR (formal small business-research institution partnership structure), even though the scientific content is described as identical.
Who is eligible to apply?
Eligibility is limited to United States small business concerns (SBCs). Foreign institutions are not eligible.
What are the PD/PI employment requirements for SBIR applications?
The PD/PI must have primary employment with the small business (more than 50 percent) at the time of award and must remain primarily employed by the SBC for the duration of the project.
Does NIH encourage applications from underrepresented groups?
Yes. The FOA reiterates NIH encouragement for individuals from underrepresented racial and ethnic groups and individuals with disabilities to apply.
Can a company submit more than one application to this FOA?
Yes. Companies may submit more than one application as long as each application is scientifically distinct.
Are overlapping or essentially identical applications allowed?
No. NIH will not accept essentially identical or overlapping applications proposing the same core product with only minor variations, and it will not accept the same or essentially identical application submitted under multiple HHS funding opportunities at the same time.
What type of funding is this categorized as?
The opportunity is categorized as discretionary grant funding in the health and education domains.
What CFDA numbers are associated with this opportunity?
The FOA lists CFDA 93.242 (Mental Health Research Grants) and 93.279 (Drug Abuse and Addiction Research Programs).
When was this FOA originally posted, and is it an older announcement?
The FOA was originally posted May 22, 2006. The archived record lists closing and archive dates through early 2010, indicating it was active during that period and is an older announcement.
Where were full details available?
Full details were hosted through NIH's Grants Guide at the link provided in the source record for the opportunity.
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Next opportunity: Longitudinal Surveys of the Elderly SBIR Initiative (R43/R44)
Previous opportunity: Therapeutics Development for HIV/AIDS Associated Neuropsychological Disorders (STTRR41/R42)
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