Opportunity Information: Apply for RFA DA 18 023
This funding opportunity, titled "Identification of Biomarkers of HIV-1 Pathogenesis and Substance Abuse Comorbidity (R01 - Clinical Trial Not Allowed)" (RFA-DA-18-023), is a National Institutes of Health (NIH) research grant announcement from the U.S. Department of Health and Human Services. It supports investigator-driven R01 projects focused on HIV-1 disease biology in the context of substance use disorders (SUDs), with a specific emphasis on discovering and validating molecular biomarkers or broader biosignatures that help explain why HIV progresses differently in people who use substances and how substance use may worsen or alter HIV-related immune and physiological decline.
The central scientific aim is to define measurable biological indicators that reflect either (1) loss of functional reserve, meaning a reduced capacity of key systems (especially immune and host-defense pathways) to respond to stressors over time, or (2) resilience, meaning protective or compensatory mechanisms that preserve host defense despite HIV infection and substance exposure. The FOA is interested in biomarkers that can distinguish or track different phases of HIV-1 pathogenesis, so the work should be relevant to staging disease processes over time rather than capturing a single static snapshot. In practical terms, this could include research that identifies panels of markers tied to immune dysfunction, inflammation, viral persistence, neuroimmune changes, metabolic or endocrine dysregulation, tissue injury, or other molecular pathways that plausibly connect substance use with HIV-related morbidity.
A key feature of the announcement is that it is "Clinical Trial Not Allowed," indicating applications should not propose clinical trials as defined by NIH, such as prospective assignment of human participants to interventions to evaluate health-related outcomes. The research can still involve human samples, observational cohorts, secondary analyses of existing datasets, laboratory-based work using clinical specimens, or preclinical models, as long as it does not cross into interventional clinical trial territory. The goal is biomarker and biosignature definition and validation, which often involves assay development, multi-omic profiling, computational modeling, and replication in independent sample sets or cohorts.
The opportunity uses the R01 mechanism (a standard NIH research project grant). It is categorized as a discretionary grant in the Education/Health activity area and is associated with CFDA number 93.279. The anticipated number of awards listed is six, and the award ceiling is shown as 0, which typically means a specific dollar cap is not provided in the summary record and applicants should follow standard NIH R01 budget rules and any FOA-specific budget guidance in the full announcement.
Eligibility is broad and includes many types of domestic institutions and organizations that commonly apply for NIH funding. Eligible applicants include state, county, city, and 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 and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities as allowed under the FOA's additional eligibility language. The sponsoring agency is NIH within HHS, and the FOA was created on December 21, 2017, with an original closing date of April 17, 2018.
Overall, the program is aimed at strengthening the biological foundation for understanding HIV-1 pathogenesis when complicated by substance use, by producing validated molecular indicators that can stratify risk, capture disease phase-related changes, and quantify resilience versus decline in host defense mechanisms. The expected outcome is a more precise set of biological tools and signatures that researchers can use to study mechanisms, compare subgroups, and potentially guide future non-trial translational work, especially for populations experiencing both HIV infection and substance use disorders.Apply for RFA DA 18 023
- The Department of Health and Human Services, National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Identification of Biomarkers of HIV-1 Pathogenesis and Substance Abuse Comorbidity (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): 93.279.
- This funding opportunity was created on Dec 21, 2017.
- Applicants must submit their applications by Apr 17, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 6 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the title and identifier of this funding opportunity?
The funding opportunity is titled "Identification of Biomarkers of HIV-1 Pathogenesis and Substance Abuse Comorbidity (R01 - Clinical Trial Not Allowed)" and is identified as RFA-DA-18-023.
Which federal agency is sponsoring this opportunity?
This opportunity is sponsored by the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services (HHS).
What type of grant mechanism is being used?
The program uses the NIH R01 mechanism, which is the standard NIH Research Project Grant for investigator-driven research projects.
What is the main scientific focus of the FOA?
The FOA supports investigator-driven R01 projects focused on HIV-1 disease biology in the context of substance use disorders (SUDs), with a specific emphasis on discovering and validating molecular biomarkers or broader biosignatures that help explain differences in HIV progression among people who use substances and how substance use may worsen or alter HIV-related immune and physiological decline.
What kinds of outcomes is the program trying to produce?
The expected outcome is a set of validated molecular indicators (biomarkers and biosignatures) that can stratify risk, capture phase-related changes in HIV-1 pathogenesis over time, and quantify resilience versus decline in host defense mechanisms in the context of substance use comorbidity.
What does "biomarkers" or "biosignatures" mean in the context of this FOA?
In this FOA, biomarkers or biosignatures refer to measurable molecular indicators or panels of indicators that reflect biological processes relevant to HIV-1 pathogenesis and substance use comorbidity. The emphasis is on indicators that help stage or track disease processes over time rather than providing a single static snapshot.
What is meant by "loss of functional reserve" in the FOA description?
"Loss of functional reserve" refers to a reduced capacity of key systems, especially immune and host-defense pathways, to respond to stressors over time. The FOA is interested in biomarkers that reflect this kind of declining ability to maintain or restore function in the presence of HIV infection and substance exposure.
What is meant by "resilience" in this program?
Resilience refers to protective or compensatory mechanisms that preserve host defense despite HIV infection and substance exposure. The FOA highlights interest in biomarkers that indicate resilience, not only decline.
Does the FOA prefer biomarkers tied to particular biological pathways or domains?
The FOA indicates interest in biomarker panels related to immune dysfunction, inflammation, viral persistence, neuroimmune changes, metabolic or endocrine dysregulation, tissue injury, and other molecular pathways that plausibly connect substance use with HIV-related morbidity.
Is the research expected to address HIV pathogenesis over time or can it be a one-time snapshot?
The FOA emphasizes biomarkers that can distinguish or track different phases of HIV-1 pathogenesis. That framing indicates the work should be relevant to staging disease processes over time rather than capturing only a single static snapshot.
Are clinical trials allowed under this FOA?
No. The FOA is explicitly labeled "Clinical Trial Not Allowed," meaning applications should not propose clinical trials as defined by NIH (for example, prospectively assigning human participants to interventions to evaluate health-related outcomes).
What kinds of human-related research activities are still allowed if clinical trials are not allowed?
Based on the description, the research may still involve human samples, observational cohorts, secondary analyses of existing datasets, laboratory-based work using clinical specimens, or preclinical models, as long as the proposed research does not cross into interventional clinical trial territory.
Is biomarker validation part of the scope, or only discovery?
The scope includes both discovery and validation. The FOA specifically highlights discovering and validating molecular biomarkers and biosignatures, including replication in independent sample sets or cohorts.
What research approaches does the FOA suggest for biomarker and biosignature work?
The description notes that biomarker and biosignature definition and validation often involves assay development, multi-omic profiling, computational modeling, and replication in independent sample sets or cohorts.
How many awards does NIH anticipate making?
The anticipated number of awards listed in the summary is six.
Is there a maximum award amount or funding cap listed?
The award ceiling is shown as 0 in the summary record, which typically means a specific dollar cap is not provided there. Applicants are expected to follow standard NIH R01 budget rules and any FOA-specific budget guidance in the full announcement.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.279.
What activity area is this opportunity categorized under?
The opportunity is categorized as a discretionary grant in the Education/Health activity area.
Who is eligible to apply?
Eligibility is broad and includes many domestic institutions and organizations, including: state, county, city, and 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 and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities as allowed under the FOA's additional eligibility language.
Are small businesses eligible?
Yes. Small businesses are listed among eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed separately as eligible.
Are colleges and universities eligible to apply?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are both listed as eligible applicants.
Are government entities eligible?
Yes. State, county, city, special district governments, and independent school districts are listed as eligible applicants.
Are tribal entities eligible?
Yes. Federally recognized Native American tribal governments and other Native American tribal organizations are listed as eligible applicants.
When was this FOA created and what was the original closing date?
The FOA was created on December 21, 2017, and the original closing date was April 17, 2018.
What is the overarching purpose of the program?
The program aims to strengthen the biological foundation for understanding HIV-1 pathogenesis when complicated by substance use by producing validated molecular indicators that can be used to study mechanisms, compare subgroups, and support future non-trial translational work for populations experiencing both HIV infection and substance use disorders.
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| Distance Learning and Telemedicine Grant Program Apply for RUS 18 01 DLT Funding Number: RUS 18 01 DLT Agency: Department of Agriculture, Utilities Programs Category: Education, Health Funding Amount: $500,000 |
| Administrative Supplements to NCI Grant and Cooperative Agreement Awards to Support Collaborations with the Drug Resistance and Sensitivity Network (DRSN)(Admin Supp Clinical Trial Not Allowed) Apply for PAR 18 752 Funding Number: PAR 18 752 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: $250,000 |
| NCI Community Oncology Research Program (NCORP) Community Sites (UG1 Clinical Trial Required) Apply for RFA CA 18 016 Funding Number: RFA CA 18 016 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Community Oncology Research Program (NCORP) Minority/Underserved Community Sites (UG1 Clinical Trial Required) Apply for RFA CA 18 017 Funding Number: RFA CA 18 017 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Community Oncology Research Program (NCORP) Research Bases (UG1 Clinical Trial Required) Apply for RFA CA 18 015 Funding Number: RFA CA 18 015 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Approaches to Identify and Care for Individuals with Inherited Cancer Syndromes (U01 Clinical Trial Required) Apply for RFA CA 19 017 Funding Number: RFA CA 19 017 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| HIV/AIDS High Priority Drug Abuse Research (R01 Clinical Trial Optional) Apply for PAS 18 915 Funding Number: PAS 18 915 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Fusion Oncoproteins in Childhood Cancers (FusOnC2) Consortium (U54 Clinical Trial Not Allowed) Apply for RFA CA 19 016 Funding Number: RFA CA 19 016 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: $1,600,000 |
| Administrative Supplements to Cancer Center Support Grants to Strengthen the Research, Training, and Outreach Capacity of the Geographic Management of Cancer Health Disparities Program (Admin Suppl - Clinical Trial Not Allowed) Apply for PA 18 934 Funding Number: PA 18 934 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: $250,000 |
| The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Optional) Apply for RFA DA 19 008 Funding Number: RFA DA 19 008 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| NLM Grants for Scholarly Works in Biomedicine and Health (G13 Clinical Trial Not Allowed) Apply for PAR 19 032 Funding Number: PAR 19 032 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: $50,000 |
| Administrative Supplements to Cancer Center Support Grants to Strengthen NCI-Supported Community Outreach Capacity through Community Health Educators of the National Outreach Network (Admin Suppl Clinical Trial Not Allowed) Apply for PA 19 035 Funding Number: PA 19 035 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: $125,000 |
| Immuno-Oncology Translation Network (IOTN): Immuno-engineering to Improve Immunotherapy (i3) Centers (U54 Clinical Trial Not Allowed) Apply for RFA CA 19 013 Funding Number: RFA CA 19 013 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: $900,000 |
| HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Coordination and Translation Center (U2C Clinical Trial Optional) Apply for RFA DA 19 024 Funding Number: RFA DA 19 024 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: $2,500,000 |
| HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Methodology and Advanced Analytics Resource Center (U2C Clinical Trial Not Allowed) Apply for RFA DA 19 023 Funding Number: RFA DA 19 023 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: $2,500,000 |
| NCI Pathway to Independence Award for Outstanding Early Stage Postdoctoral Researchers (K99/R00 - Independent Clinical Trial Not Allowed) Apply for RFA CA 19 029 Funding Number: RFA CA 19 029 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Pathway to Independence Award for Outstanding Early Stage Postdoctoral Researchers (K99/R00 - Independent Clinical Trial Required) Apply for RFA CA 19 030 Funding Number: RFA CA 19 030 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trials Not Allowed) Apply for RFA CA 19 022 Funding Number: RFA CA 19 022 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: $300,000 |
| Innovative Biospecimen Science Technologies for Basic and Clinical Cancer Research (R21 Clinical Trials Not Allowed) Apply for RFA CA 19 021 Funding Number: RFA CA 19 021 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Advanced Development and Validation of Emerging Molecular and Cellular Analysis Technologies for Basic and Clinical Cancer Research (R33 Clinical Trials Not Allowed) Apply for RFA CA 19 020 Funding Number: RFA CA 19 020 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health Funding Amount: $300,000 |
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