Opportunity Information: Apply for PAR 18 822
The National Institutes of Health (NIH) funding opportunity titled "Approaches for Understanding Disease Mechanisms and Improving Outcomes in TB Meningitis (TBM) (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR-18-822) supports research aimed at tackling one of the most severe forms of tuberculosis: tuberculosis meningitis. The overall goal is to stimulate innovative studies that clarify how TBM causes disease and disability and, based on that improved understanding, inform better therapeutic approaches. A central feature of this announcement is that it welcomes both clinical research and preclinical or other non-clinical research, as long as the proposed work is not a clinical trial. The FOA is explicitly interested in TBM both in people with TB alone and in individuals who also have HIV co-infection, reflecting the reality that HIV can substantially influence TB progression, immune responses, and outcomes.
The scientific focus of this opportunity is on disease mechanisms and improved outcomes, meaning applicants are expected to move beyond broad descriptions of TBM and instead pursue questions that can explain why the disease behaves the way it does and why current treatments often fail to prevent death or long-term neurologic injury. Projects might address the biology of Mycobacterium tuberculosis in the central nervous system, host immune and inflammatory pathways that drive tissue damage, the role of the blood-brain barrier and drug penetration, biomarkers that predict severity or response, or other mechanistic drivers that can be tied to future improvements in care. Because the FOA allows clinical research but disallows clinical trials, it is well-suited for studies such as observational cohorts, deep phenotyping of patients, analyses of clinical specimens, imaging-based investigations, laboratory experiments using patient-derived samples, animal models, or other translational approaches that build a bridge between bench and bedside without testing an intervention in a trial framework.
This is an R01 grant mechanism, which generally indicates support for substantial, hypothesis-driven projects of meaningful scope and duration. The opportunity is categorized as discretionary and uses the grant funding instrument, with the activity area listed under health. The CFDA numbers provided are 93.242 and 93.855, which correspond to NIH assistance listings relevant to infectious disease and biomedical research support. While an award ceiling is not specified in the provided data, the R01 mechanism typically funds well-justified budgets consistent with project needs and NIH policies, subject to institute-specific considerations and standard NIH review for scientific merit, feasibility, and potential impact.
Eligibility is broad and includes a wide range of domestic U.S. organizations and governmental entities, along with the ability for non-U.S. organizations to apply. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations other than small businesses; small businesses; and other applicant types as allowed by NIH. The FOA also highlights additional eligible applicant groups, emphasizing inclusion of Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); eligible federal agencies; faith-based or community-based organizations; Hispanic-serving institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American tribal governments other than federally recognized entities; tribally controlled colleges and universities (TCCUs); regional organizations; U.S. territories or possessions; and foreign organizations (non-domestic entities). This broad eligibility is consistent with the global burden of TBM and the need to support research where the disease is most prevalent, including international settings.
Administratively, the FOA was created on June 7, 2018, and the original closing date listed in the source data is September 4, 2020. The sponsoring agency is NIH. In practical terms, the announcement is designed to encourage strong mechanistic and translational science that can illuminate why TB meningitis leads to high mortality and neurologic sequelae and to lay the groundwork for more effective treatment strategies, including in the challenging context of HIV co-infection, without directly funding interventional clinical trials under this particular mechanism.Apply for PAR 18 822
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Approaches for Understanding Disease Mechanisms and Improving Outcomes in TB Meningitis (TBM) (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.855.
- This funding opportunity was created on 2018-06-07.
- Applicants must submit their applications by 2020-09-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the name of this NIH funding opportunity?
The funding opportunity is titled "Approaches for Understanding Disease Mechanisms and Improving Outcomes in TB Meningitis (TBM) (R01 Clinical Trial Not Allowed)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PAR-18-822.
Which agency is sponsoring this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What is the main goal of this FOA?
The overall goal is to stimulate innovative research that clarifies how tuberculosis meningitis (TBM) causes disease and disability and, based on that improved understanding, informs better therapeutic approaches to improve outcomes.
What disease area does this opportunity focus on?
This opportunity focuses on tuberculosis meningitis (TBM), described as one of the most severe forms of tuberculosis.
Does this FOA include TB meningitis in people with HIV?
Yes. The FOA is explicitly interested in TBM in people with TB alone and in individuals with HIV co-infection, recognizing that HIV can substantially influence TB progression, immune responses, and outcomes.
What kind of research is NIH trying to encourage through this announcement?
The FOA emphasizes mechanistic and translational research designed to explain why TBM behaves the way it does and why current treatments often fail to prevent death or long-term neurologic injury. The intent is to move beyond broad descriptions and toward studies that identify drivers of disease and disability that can inform improved care.
Are clinical trials allowed under this funding opportunity?
No. This is an R01 "Clinical Trial Not Allowed" funding opportunity, meaning proposed work must not be a clinical trial.
If clinical trials are not allowed, can applicants still do clinical research?
Yes. The FOA welcomes clinical research as well as preclinical or other non-clinical research, as long as the study is not a clinical trial.
What are examples of studies that fit this FOA (without being clinical trials)?
Examples described include observational cohorts, deep phenotyping of patients, analyses of clinical specimens, imaging-based investigations, laboratory experiments using patient-derived samples, animal models, and other translational approaches that connect bench and bedside without testing an intervention in a trial framework.
What scientific topics or mechanisms are specifically of interest?
The FOA highlights interest in topics such as: the biology of Mycobacterium tuberculosis in the central nervous system; host immune and inflammatory pathways that drive tissue damage; the role of the blood-brain barrier and drug penetration; biomarkers that predict severity or response; and other mechanistic drivers that can be tied to future improvements in care.
What does "improving outcomes" mean in the context of this FOA?
Within the description provided, improving outcomes is tied to research that can illuminate why TBM results in high mortality and neurologic sequelae and help lay the groundwork for more effective treatment strategies, without directly conducting an interventional clinical trial under this announcement.
What grant mechanism is being used?
This opportunity uses the R01 grant mechanism.
What does the R01 mechanism imply about project scope?
The R01 mechanism generally indicates support for substantial, hypothesis-driven projects of meaningful scope and duration.
Is there an award ceiling listed?
No award ceiling is specified in the provided information. The description notes that R01 budgets are typically well-justified and consistent with project needs and NIH policies, subject to institute-specific considerations and standard NIH review.
What funding instrument and category are associated with this opportunity?
The opportunity uses a grant funding instrument and is categorized as discretionary. The activity area is listed under health.
What are the CFDA (Assistance Listing) numbers associated with this FOA?
The CFDA/Assistance Listing numbers provided are 93.242 and 93.855.
Who is eligible to apply?
Eligibility is broad. It includes many domestic U.S. organizations and governmental entities, and it also allows non-U.S. (foreign) organizations to apply.
Are U.S. state and local governments eligible?
Yes. Eligible applicants include state governments, county governments, local governments, and special district governments.
Are higher education institutions eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education, as well as several categories of minority-serving and tribally controlled institutions highlighted in the FOA.
Are tribal governments and tribal organizations eligible?
Yes. Eligible applicants include federally recognized Native American tribal governments, tribal organizations that are not federally recognized, and Indian/Native American tribal governments other than federally recognized entities. Tribally controlled colleges and universities (TCCUs) are also highlighted.
Are nonprofits eligible to apply?
Yes. Nonprofit organizations with 501(c)(3) status (excluding higher education institutions in that category) and nonprofits without 501(c)(3) status (excluding higher education institutions in that category) are listed as eligible.
Are for-profit organizations eligible?
Yes. Eligible applicants include for-profit organizations other than small businesses, as well as small businesses.
Are independent school districts eligible?
Yes. Independent school districts are listed as eligible applicants.
Are public housing authorities eligible?
Yes. Public housing authorities and Indian housing authorities are listed among eligible applicants.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are highlighted as additional eligible applicant groups.
Are U.S. territories eligible?
Yes. U.S. territories or possessions are specifically highlighted as eligible.
Are foreign (non-U.S.) organizations eligible to apply?
Yes. The eligibility description includes foreign organizations (non-domestic entities) and notes that non-U.S. organizations may apply.
Why does the FOA emphasize broad and international eligibility?
Based on the provided description, the broad eligibility is consistent with the global burden of TBM and the need to support research in settings where the disease is most prevalent, including international settings.
When was this FOA created?
The FOA was created on June 7, 2018.
What is the closing date listed in the provided information?
The original closing date listed in the source data is September 4, 2020.
What is the key limitation applicants should keep in mind when designing a project?
A central limitation is that the proposed work must not be a clinical trial. The FOA is intended for mechanistic, observational, translational, preclinical, and other non-trial approaches that can inform future improvements in TBM care.
What types of outcomes or impacts is NIH hoping these projects will enable?
As described, NIH is seeking research that can explain drivers of TBM mortality and neurologic injury and provide knowledge that can guide better therapeutic approaches in the future, including in the context of HIV co-infection, without directly funding interventional trials under this FOA.
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| Exploratory Analyses of CALERIE Data and Biospecimens to Elucidate Mechanisms of Caloric Restriction (CR)-Induced Effects in Humans (R21 - Clinical Trial Not Allowed) Apply for PA 18 824 Funding Number: PA 18 824 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Paul B. Beeson Emerging Leaders Career Development Award in Aging (K76 Independent Clinical Trial Not Allowed) Apply for RFA AG 19 017 Funding Number: RFA AG 19 017 Agency: National Institutes of Health Category: Health Funding Amount: $225,000 |
| Analyses of Adherence Strategies and Data Sets from CALERIE to Explore Behavioral and Psychosocial Aspects of Sustained Caloric Restriction in Humans (R01 - Clinical Trial Not Allowed) Apply for PA 18 825 Funding Number: PA 18 825 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Exploratory Analyses of Adherence Strategies and Data Sets from CALERIE to Investigate Behavioral and Psychosocial Aspects of Sustained Caloric Restriction in Humans (R21 - Clinical Trial Not Allowed) Apply for PA 18 826 Funding Number: PA 18 826 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Paul B. Beeson Emerging Leaders Career Development Award in Aging (K76 Independent Clinical Trial Required) Apply for RFA AG 19 018 Funding Number: RFA AG 19 018 Agency: National Institutes of Health Category: Health Funding Amount: $225,000 |
| Analyses of CALERIE Data and Biospecimens to Elucidate Mechanisms of Caloric Restriction (CR)-Induced Effects in Humans (R01 - Clinical Trial Not Allowed) Apply for PA 18 823 Funding Number: PA 18 823 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Data Management and Coordinating Center (DMCC) for Rare Diseases Clinical Research Network (RDCRN) (U2C Clinical Trial Not Allowed) Apply for RFA TR 18 021 Funding Number: RFA TR 18 021 Agency: National Institutes of Health Category: Health Funding Amount: $3,500,000 |
| Sustained Release Innovation for HIV (SRI) (R61/R33 Clinical Trial Optional) Apply for RFA AI 18 006 Funding Number: RFA AI 18 006 Agency: National Institutes of Health Category: Health Funding Amount: $800,000 |
| NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required) Apply for PAR 18 828 Funding Number: PAR 18 828 Agency: National Institutes of Health Category: Health Funding Amount: $1,050,000 |
| NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required) Apply for PAR 18 829 Funding Number: PAR 18 829 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Orphans and Vulnerable Children II (OVC II) Activity Apply for 72052118R00016 Funding Number: 72052118R00016 Agency: Haiti USAID-Port Au Prince Category: Health Funding Amount: $19,950,000 |
| Developmental AIDS Research Center on Mental Health and HIV/AIDS (P30 Clinical Trial Optional) Apply for PAR 18 833 Funding Number: PAR 18 833 Agency: National Institutes of Health Category: Health Funding Amount: $750,000 |
| AIDS Research Center on Mental Health and HIV/AIDS (P30 Clinical Trial Optional) Apply for PAR 18 832 Funding Number: PAR 18 832 Agency: National Institutes of Health Category: Health Funding Amount: $1,500,000 |
| Modeling and Simulation to Optimize HIV Prevention Research (MS OPR) (R01 Clinical Trial not allowed) Apply for RFA AI 18 026 Funding Number: RFA AI 18 026 Agency: National Institutes of Health Category: Health Funding Amount: $400,000 |
| High-Priority Behavioral and Social Research Networks in Alzheimer's Disease and Alzheimer's Disease Related Dementias (R24 Clinical Trial Not Allowed) Apply for RFA AG 19 016 Funding Number: RFA AG 19 016 Agency: National Institutes of Health Category: Health Funding Amount: $250,000 |
| High-Priority Behavioral and Social Research Networks (R24 Clinical Trial Not Allowed) Apply for RFA AG 19 015 Funding Number: RFA AG 19 015 Agency: National Institutes of Health Category: Health Funding Amount: $250,000 |
| Global Infectious Disease Research Training Program (D43 Clinical Trial Optional) Apply for PAR 18 840 Funding Number: PAR 18 840 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Advancing mAbs to Achieve a Drug-free Sustained HIV Virologic Remission (U01 Clinical Trial Required) Apply for RFA AI 18 022 Funding Number: RFA AI 18 022 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Elucidating the Functional Roles of Non-Coding RNAs in Viral Infectious Diseases (R21 Clinical Trial Not Allowed) Apply for RFA AI 18 025 Funding Number: RFA AI 18 025 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Investigator Initiated Research in Computational Genomics and Data Science (R01 Clinical Trial Not Allowed) Apply for PAR 18 844 Funding Number: PAR 18 844 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
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