Opportunity Information: Apply for PAR 13 267
Apply for PAR 13 267
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Novel NeuroAIDS Therapeutics Integrated Preclinical/Clinical Program (P01)" 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.
- This funding opportunity was created on Jul 8, 2013 and posted on Jul 8, 2013.
- Applicants must submit their applications by Jan 7, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: City or township governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Private institutions of higher education Independent school districts For profit organizations other than small businesses Small businesses County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession 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 allowed.
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Opportunity Summary:
The Novel NeuroAIDS Therapeutics Integrated Preclinical/Clinical Program (P01) (Funding Opportunity Number PAR-13-267) was a National Institute of Mental Health (NIMH), National Institutes of Health (NIH) funding opportunity designed to push forward central nervous system (CNS) focused treatments for NeuroAIDS. The core intent was to support coordinated, multi-project research programs that can move promising ideas along a clear path from discovery through preclinical development and, where appropriate, into early clinical testing. Rather than funding isolated projects, this FOA emphasized integrated, multidisciplinary efforts with strong scientific synergy across components and a milestone-driven plan that shows how the program will generate actionable therapeutic advances.
Scientifically, the FOA targeted several high-priority therapeutic goals related to HIV and the brain, especially in the modern treatment era. First, it aimed to address HIV-associated neurocognitive disorders (HAND) in people living with HIV who are already receiving highly active antiretroviral therapy (HAART). Even when systemic viral replication is controlled, many patients experience persistent or fluctuating cognitive and neurological issues, so the program encouraged therapeutic strategies explicitly intended to improve neurocognition and CNS function. Second, it sought approaches to eradicate persistent HIV-1 from the CNS during chronic infection, reflecting concern that the brain can serve as a reservoir where virus may persist despite otherwise effective therapy. Third, it supported strategies to prevent the establishment of HIV-1 in the brain during early infection, focusing on interventions that could block or limit initial CNS seeding. Fourth, it encouraged work to assess potential CNS toxicity associated with HAART regimens or with candidate drugs being tested in clinical studies aimed at HIV eradication, recognizing that drugs intended to affect viral persistence or reach sanctuary sites may carry neurological risk that needs careful evaluation.
A notable feature of the FOA was its openness to the development or adaptation of animal models of HIV-1 CNS infection when such models are needed to evaluate novel CNS-focused therapeutic candidates. This reflects a practical barrier in the field: translating CNS therapeutic concepts requires models that meaningfully capture viral persistence, neuroinflammation, and cognitive or neurological endpoints relevant to human disease. Applicants were therefore allowed to propose model creation or refinement as part of an integrated program, particularly when it directly enables preclinical testing, biomarker development, or mechanistic validation tied to the therapeutic objectives.
Program structure and management expectations were central to this announcement. Because it used the NIH P01 (Program Project Grant) mechanism, proposals were expected to include multiple interrelated projects, typically spanning complementary disciplines (for example, virology, neuroimmunology, pharmacology, neurobehavior, biomarker science, and early clinical investigation). The FOA stressed that applications should present a well-defined, synergistic plan where each component strengthens the others, and where milestones make it clear how progress will be measured and how decisions will be made about advancing candidates, refining approaches, or discontinuing unproductive lines of work. The emphasis on “hypothesis-driven research” also signaled that the program was not meant to be purely exploratory; it was intended to generate testable conclusions that can inform therapeutic development and clinical translation.
From an applicant and administrative standpoint, this was a discretionary grant opportunity in the health area (CFDA 93.242, Mental Health Research Grants) with no cost sharing or matching requirement. Eligible applicants were broad across U.S.-based organizations, including public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and various government entities (state, county, city/township, special district). The eligibility list also explicitly included organizations such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and AANAPISI institutions, as well as faith-based or community-based organizations and eligible federal agencies. Foreign institutions and non-U.S. components of U.S. organizations were not eligible to apply; however, “foreign components” as defined by NIH policy were allowed, meaning collaborations involving foreign work could be possible under NIH rules even though the applicant organization itself had to be U.S.-based.
The FOA also encouraged, but did not require, public-private partnerships, reflecting interest in accelerating therapeutic development through collaboration with industry or other non-academic partners who may contribute compounds, platforms, manufacturing expertise, or translational know-how. In practical terms, that encouragement aligned with the FOA’s overall translational focus: moving CNS-relevant NeuroAIDS therapeutics toward realistic preclinical packages and early-stage clinical readiness, while keeping patient-centered outcomes like neurocognitive improvement and safety at the forefront.
In terms of timing, the opportunity was posted on July 8, 2013, with an original and final closing date of January 7, 2016, and it was archived on February 7, 2016. Additional details were provided through the NIH grants guide page associated with PAR-13-267.
FAQs: Novel NeuroAIDS Therapeutics Integrated Preclinical/Clinical Program (P01) - PAR-13-267
What is PAR-13-267?
PAR-13-267 is the Funding Opportunity Announcement (FOA) titled "Novel NeuroAIDS Therapeutics Integrated Preclinical/Clinical Program (P01)". It was a National Institute of Mental Health (NIMH), National Institutes of Health (NIH) opportunity focused on advancing central nervous system (CNS)-targeted therapeutics for NeuroAIDS through coordinated, multi-project research programs.
Which NIH institute offered this funding opportunity?
This FOA was offered by the National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH).
What grant mechanism did this opportunity use?
The opportunity used the NIH P01 (Program Project Grant) mechanism, which is designed to support integrated, multi-project programs rather than isolated single-project studies.
What was the main purpose of this FOA?
The main purpose was to support coordinated, milestone-driven research programs that move promising CNS-focused NeuroAIDS therapeutic concepts along a path from discovery to preclinical development and, when appropriate, into early clinical testing.
What did the FOA emphasize about how research projects should be organized?
The FOA emphasized integrated, multidisciplinary efforts with strong scientific synergy across projects and components. Applications were expected to show how the parts work together and how that integration will produce actionable therapeutic advances.
What does "milestone-driven" mean in the context of this FOA?
"Milestone-driven" means the program should define clear measures of progress and decision points (for example, when to advance a candidate, refine an approach, or discontinue a line of work) so that progress toward therapeutic outcomes can be tracked in an organized and accountable way.
Was the FOA intended for exploratory research?
No. The FOA stressed hypothesis-driven research, indicating it was intended to produce testable conclusions that can inform therapeutic development and translation, rather than being purely exploratory.
What scientific problem areas did the FOA target?
The FOA targeted high-priority therapeutic goals at the intersection of HIV and the brain, especially in the modern treatment era. The focus areas included HAND in people on HAART, CNS HIV persistence/reservoir issues, prevention of early CNS infection, and evaluation of CNS toxicity risks from therapies.
What is HAND, and how did this FOA address it?
HAND refers to HIV-associated neurocognitive disorders. The FOA aimed to advance therapeutic strategies intended to improve neurocognition and CNS function in people living with HIV who are already receiving highly active antiretroviral therapy (HAART), recognizing that cognitive and neurological issues can persist or fluctuate even when systemic viral replication is controlled.
Did the FOA support efforts to eradicate HIV from the CNS?
Yes. One of the stated goals was to support approaches to eradicate persistent HIV-1 from the CNS during chronic infection, reflecting concerns that the brain can act as a reservoir where virus may persist despite otherwise effective therapy.
Did the FOA address preventing HIV from establishing infection in the brain?
Yes. The FOA included support for strategies to prevent establishment of HIV-1 in the brain during early infection, including interventions designed to block or limit initial CNS seeding.
Was drug safety in the CNS part of the FOA's focus?
Yes. The FOA encouraged work to assess potential CNS toxicity associated with HAART regimens or with candidate drugs being tested in clinical studies aimed at HIV eradication, acknowledging potential neurological risks of drugs designed to reach sanctuary sites or affect viral persistence.
Could applicants propose animal model development or refinement?
Yes. A notable feature was openness to the development or adaptation of animal models of HIV-1 CNS infection when such models are needed to evaluate novel CNS-focused therapeutic candidates and to enable preclinical testing, biomarker development, or mechanistic validation aligned with the therapeutic objectives.
Why did the FOA allow animal model work as part of the program?
The FOA recognized a practical barrier in translating CNS therapeutic concepts: the need for models that capture relevant features such as viral persistence, neuroinflammation, and cognitive or neurological endpoints that relate to human disease.
What types of disciplines or expertise were expected in a P01 application under this FOA?
Applications were expected to span complementary disciplines and integrate them into a single plan. Examples mentioned included virology, neuroimmunology, pharmacology, neurobehavior, biomarker science, and early clinical investigation.
Was this a discretionary grant, and what program area did it fall under?
Yes. It was described as a discretionary grant opportunity in the health area, associated with CFDA 93.242 (Mental Health Research Grants).
Was cost sharing or matching required?
No. The FOA stated there was no cost sharing or matching requirement.
Who was eligible to apply?
Eligibility was broad across U.S.-based organizations, including public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and a range of government entities (state, county, city/township, special district). The FOA also explicitly included various institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and AANAPISI institutions, as well as faith-based and community-based organizations and eligible federal agencies.
Were foreign institutions eligible to apply?
No. Foreign institutions and non-U.S. components of U.S. organizations were not eligible to apply as the applicant organization.
Are foreign collaborations allowed at all under this FOA?
Yes, potentially. While the applicant organization needed to be U.S.-based, the FOA allowed "foreign components" as defined by NIH policy, meaning certain foreign work could be included under NIH rules even though a foreign institution could not be the primary applicant.
Did the FOA require public-private partnerships?
No. Public-private partnerships were encouraged but not required. The FOA noted this encouragement as a way to accelerate therapeutic development through collaboration with industry or other non-academic partners.
What kinds of contributions might public-private partnerships support under this FOA?
Based on the FOA description, partnerships could help accelerate translational progress by contributing resources such as compounds, platforms, manufacturing expertise, or other translational know-how relevant to moving CNS-focused therapeutics toward early-stage clinical readiness.
When was this funding opportunity posted, and when did it close?
The FOA was posted on July 8, 2013. The original and final closing date was January 7, 2016.
Is this FOA still active?
No. The opportunity was archived on February 7, 2016, indicating it is no longer open for applications.
Where were additional details about the opportunity provided?
Additional details were provided through the NIH grants guide page associated with PAR-13-267.
What kind of outcomes was the FOA trying to drive?
The FOA was designed to generate actionable therapeutic advances for NeuroAIDS in the CNS, prioritizing progress toward interventions that can improve neurocognitive outcomes, address CNS viral persistence or prevention, and clarify neurological safety considerations in the context of HAART and HIV eradication-oriented strategies.
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