Opportunity Information: Apply for RFA TR 16 001
Apply for RFA TR 16 001
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Pre-clinical Research Based on Existing Repurposing Tools" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350,.
- This funding opportunity was created on Oct 21, 2015 and posted on Oct 21, 2015.
- Applicants must submit their applications by Jan 13, 2016. (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: 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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Opportunity Summary:
This government grant opportunity, titled "Pre-clinical Research Based on Existing Repurposing Tools" (Funding Opportunity Number RFA TR 16 001), is focused on supporting rigorous pre-clinical research that can credibly justify moving toward a clinical trial. What makes this program distinctive is that the central hypothesis for the project must come from an existing, published, or publicly available drug-repurposing method. In other words, the starting point cannot be a purely intuitive or purely lab-discovered idea; it must be a novel drug/indication pairing (or a combination therapy concept) that was identified using a repurposing tool that others can access or review, such as a computational prediction algorithm or a structured crowdsourcing approach.
The projects funded under this announcement are intended to explore new therapeutic uses for drugs or biologics that already exist. Eligible therapeutics include investigational agents that are ready for early clinical testing (specifically described as "phase 2a-ready"), as well as drugs that are already FDA-approved and biologics that are already licensed. The expectation is that the proposed pre-clinical work will not be exploratory in a vague sense, but will be designed to produce a clear, evidence-based rationale that could reasonably support the design and initiation of a clinical trial if the results are favorable.
A major requirement is that each application must explicitly identify the repurposing method used to arrive at the proposed therapeutic/indication match. The method must be published or publicly available, and the pre-clinical study is expected to function as a concrete "use case" demonstrating that the tool or approach can generate actionable, testable predictions. This means the program is not only funding the biological validation of a repurposing idea; it is also, indirectly, evaluating whether independent crowdsourcing efforts or computational algorithms can reliably point to new uses for existing therapeutics.
The announcement also emphasizes scientific rigor and measurability. Proposed use cases must be supported by a defensible scientific rationale, and the outcomes in the pre-clinical studies must be objective and quantifiable. In practical terms, applicants need to propose experiments where the therapeutic effect can be measured in clear endpoints (for example, biomarker changes, functional outcomes in relevant models, disease-appropriate phenotypes, or other quantitative readouts), rather than relying on subjective observations. The overall intent is to generate convincing pre-clinical evidence that reduces uncertainty and strengthens the justification for clinical translation.
Administratively, this is a discretionary grant in the health funding category administered by the National Institutes of Health (Agency listed as HHS-NIH11), with CFDA numbers 93.350. The award ceiling is listed as $250,000. The opportunity was posted on October 21, 2015, created on October 21, 2015, and had a closing date of January 13, 2016 (both original and current closing dates match, indicating it was a single-cycle solicitation at that time).
Eligibility is broad and includes many types of organizations that commonly participate in biomedical research funding. Eligible applicants include state, county, city or township 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 and other tribal organizations, public housing authorities/Indian housing authorities, nonprofits (both 501(c)(3) and non-501(c)(3), excluding higher education institutions in those categories), for-profit organizations other than small businesses, small businesses, and other entities as further clarified in the full eligibility text. This broad eligibility aligns with the program's aim of drawing on diverse groups capable of conducting robust pre-clinical validation work while also leveraging existing repurposing frameworks.
Taken together, the opportunity is aimed at accelerating drug repurposing by connecting transparent, publicly accessible repurposing methods with stringent pre-clinical validation, producing results that are both scientifically persuasive for clinical planning and informative about the real-world utility of repurposing tools.
Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Pre-clinical Research Based on Existing Repurposing Tools."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA TR 16 001.
What is the main purpose of this funding opportunity?
This program supports rigorous pre-clinical research designed to produce credible evidence that can justify moving toward a clinical trial. The goal is to generate a clear, evidence-based rationale for clinical translation if the pre-clinical results are favorable.
What makes this program different from other pre-clinical funding opportunities?
The central hypothesis must originate from an existing, published, or publicly available drug-repurposing method. The starting point cannot be purely intuitive or based only on a lab-discovered idea; it must be a novel drug/indication pairing (or a combination therapy concept) identified using a repurposing tool that others can access or review.
What does "repurposing tool" mean in the context of this announcement?
A repurposing tool is a method used to identify new therapeutic uses for existing drugs or biologics. Examples mentioned include computational prediction algorithms and structured crowdsourcing approaches, as long as the method is published or publicly available.
Do applicants have to name the specific repurposing method used?
Yes. Each application must explicitly identify the repurposing method used to arrive at the proposed therapeutic/indication match, and that method must be published or publicly available.
What types of projects are intended to be funded?
Projects are intended to explore new therapeutic uses for drugs or biologics that already exist, and to validate a repurposing prediction through rigorous, measurable pre-clinical studies that could support the design and initiation of a clinical trial.
Is this program only funding biological validation, or is it also evaluating the repurposing tools themselves?
It funds pre-clinical validation of the repurposing idea, and it also treats the project as a concrete "use case" demonstrating whether the repurposing tool or approach can generate actionable, testable predictions. In that way, it indirectly evaluates the real-world utility of the repurposing method.
What kinds of therapeutics are eligible to be studied?
Eligible therapeutics include investigational agents that are ready for early clinical testing ("phase 2a-ready"), as well as drugs that are FDA-approved and biologics that are already licensed.
Does the opportunity support studies of combination therapies?
Yes. The announcement allows for a novel drug/indication pairing or a combination therapy concept, as long as the central hypothesis comes from an existing, published, or publicly available repurposing method.
What does "phase 2a-ready" imply for investigational agents?
It indicates the investigational agent is ready for early clinical testing, and the program is positioned to support pre-clinical work that credibly justifies moving toward a clinical trial.
What level of scientific rigor is expected?
The announcement emphasizes scientific rigor and measurability. Proposed use cases must be supported by a defensible scientific rationale, and the outcomes must be objective and quantifiable.
What kinds of endpoints or outcomes should be used in the pre-clinical studies?
Endpoints should be clear and measurable, such as biomarker changes, functional outcomes in relevant models, disease-appropriate phenotypes, or other quantitative readouts. The intent is to avoid reliance on subjective observations.
Is exploratory research allowed?
The program expects the proposed pre-clinical work not to be exploratory in a vague sense. Instead, it should be designed to produce a clear, evidence-based rationale that could support clinical trial planning.
What is the award ceiling?
The listed award ceiling is $250,000.
What type of grant is this?
This is described as a discretionary grant in the health funding category.
Which agency administers this opportunity?
The opportunity is administered by the National Institutes of Health (Agency listed as HHS-NIH11).
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.350.
When was this opportunity posted and created?
It was posted on October 21, 2015, and created on October 21, 2015.
What was the closing date for applications?
The closing date was January 13, 2016. The original and current closing dates match, indicating it was a single-cycle solicitation at that time.
Who is eligible to apply?
Eligibility is broad. Eligible applicants include state, county, city or township 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (501(c)(3) and non-501(c)(3), excluding higher education institutions in those categories); for-profit organizations other than small businesses; small businesses; and other entities as further clarified in the full eligibility text.
Are both nonprofit and for-profit organizations eligible?
Yes. The eligibility list includes nonprofits (both 501(c)(3) and non-501(c)(3), with the noted exclusion related to higher education institutions) and for-profit organizations (including small businesses and for-profits other than small businesses).
Can academic institutions apply?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are included in the eligible applicant categories.
Can government entities apply?
Yes. Eligible applicants include several government entity types such as state, county, city or township governments, special district governments, and independent school districts.
Can tribal governments or tribal organizations apply?
Yes. Federally recognized Native American tribal governments and other tribal organizations are listed as eligible.
Can public housing authorities apply?
Yes. Public housing authorities and Indian housing authorities are included as eligible applicants.
What is the overall intent of this program?
The program aims to accelerate drug repurposing by connecting transparent, publicly accessible repurposing methods with stringent pre-clinical validation. It seeks results that are persuasive for clinical planning and informative about how useful repurposing tools are in real-world application.
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA TR 16 001) also looked into and applied for these:
| Funding Opportunity |
|---|
| Precision Medicine Initiative Cohort Program Participant Technologies Center (U24) Apply for RFA PM 16 003 Funding Number: RFA PM 16 003 Agency: HHS-NIH11 Category: Health Funding Amount: Case Dependent |
| Noncommunicable Disease Prevention and Health Promotion in the Region of the Americas, PAHO Apply for CDC RFA GH15 161802CONT16 Funding Number: CDC RFA GH15 161802CONT16 Agency: HHS-CDC Category: Health Funding Amount: Case Dependent |
| Pediatric Heart Network Clinical Research Centers (UG1) Apply for RFA HL 17 004 Funding Number: RFA HL 17 004 Agency: HHS-NIH11 Category: Health Funding Amount: $220,000 |
| MCH Pipeline Training Program Apply for HRSA 16 037 Funding Number: HRSA 16 037 Agency: HHS-HRSA Category: Health Funding Amount: Case Dependent |
| Ensuring Adequate Access to HIV/AIDS Screening, Care and Treatment to Key Populations in Haiti under the President’s Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA GH16 1682 Funding Number: CDC RFA GH16 1682 Agency: HHS-CDC-CGH Category: Health Funding Amount: $1,200,000 |
| Supporting the National Blood Transfusion Service (NBTS) in the implementation and expansion of Blood Safety activities in the Republic of Zambia under the President’s Emergency plan for AIDS Relief (PEPFAR) Apply for CDC RFA GH16 1709 Funding Number: CDC RFA GH16 1709 Agency: HHS-CDC Category: Health Funding Amount: $1,353,644 |
| Strengthening HIV/AIDS Prevention and Care Services for Highly Vulnerable Populations in the Republic of Côte d’Ivoire Under the President’s Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA PS10 10310501SUPP16 Funding Number: CDC RFA PS10 10310501SUPP16 Agency: HHS-CDC Category: Health Funding Amount: $3,123,298 |
| National Child Traumatic Stress Initiative, National Center for Child Traumatic Stress Apply for SM 16 003 Funding Number: SM 16 003 Agency: HHS-SAMHS Category: Health Funding Amount: $6,000,000 |
| Service Area Competition – Additional Areas (SAC-AA) – California, District of Columbia, Kansas, Nevada, New York, Oregon, Texas, and Washington Apply for HRSA 16 176 Funding Number: HRSA 16 176 Agency: HHS-HRSA Category: Health Funding Amount: Case Dependent |
| Service Area Competition – Additional Area (SAC-AA) – Baltimore, Maryland Apply for HRSA 16 177 Funding Number: HRSA 16 177 Agency: HHS-HRSA Category: Health Funding Amount: Case Dependent |
| B Cell Immunology Program for HIV-1 Vaccine Development (BCIP) (R01) Apply for RFA AI 15 055 Funding Number: RFA AI 15 055 Agency: HHS-NIH11 Category: Health Funding Amount: Case Dependent |
| Supporting the Provision of High Quality, Comprehensive, and Sustainable HIV Services in National Teaching and Referral Hospitals in the Republic of Kenya under the President’s Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA GH16 1621 Funding Number: CDC RFA GH16 1621 Agency: HHS-CDC-CGH Category: Health Funding Amount: $10,500,000 |
| Research to Advance Primary Care-Pharmacy Linkage for Medication Review to Reduce Older Adult Falls Apply for RFA CE 16 002 Funding Number: RFA CE 16 002 Agency: HHS-CDC-HHSCDCERA Category: Health Funding Amount: $350,000 |
| Increase Access to Care for Black Men Who Have Sex with Men Apply for RFA PS 16 004 Funding Number: RFA PS 16 004 Agency: HHS-CDC-HHSCDCERA Category: Health Funding Amount: $400,000 |
| Oral Health Service Expansion Apply for HRSA 16 076 Funding Number: HRSA 16 076 Agency: HHS-HRSA Category: Health Funding Amount: Case Dependent |
| NHLBI Outstanding Investigator Award (OIA) (R35) Apply for RFA HL 16 024 Funding Number: RFA HL 16 024 Agency: HHS-NIH11 Category: Health Funding Amount: $500,000 |
| Scaling Integrated, Effective and Sustainable Services for the Prevention of Mother to Child HIV Transmission (PMTCT) in the Republic of Uganda under PEPFAR Apply for CDC RFA PS10 10210501SUPP16 Funding Number: CDC RFA PS10 10210501SUPP16 Agency: HHS-CDC Category: Health Funding Amount: $2,458,270 |
| Provision of comprehensive, community-based HIV/AIDS Services and Capacity Building of Indigenous Organizations in the Republic of Uganda under the President’s Emergency Plan for AIDS Relief (PEPFAR) Apply for CDC RFA PS10 10180501SUPP16 Funding Number: CDC RFA PS10 10180501SUPP16 Agency: HHS-CDC Category: Health Funding Amount: $965,884 |
| Novel Genomic Technology Development (R21) Apply for PAR 16 015 Funding Number: PAR 16 015 Agency: HHS-NIH11 Category: Health Funding Amount: $200,000 |
| Ryan White HIV/AIDS Program Part D Grants for Coordinated HIV Services and Access to Research for Women, Infants, Children, and Youth (WICY) Supplemental Apply for HRSA 16 087 Funding Number: HRSA 16 087 Agency: HHS-HRSA Category: Health Funding Amount: Case Dependent |
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