Opportunity Information: Apply for RFA AG 16 014
Apply for RFA AG 16 014
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Alzheimers Disease Translational Center for Disease Model Resources (U54)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866 Aging Research.
- This funding opportunity was created on Jul 29, 2015 and posted on Jul 29, 2015.
- Applicants must submit their applications by Jan 11, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $5,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $3,500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Public housing authorities/Indian housing authorities Independent school districts Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Private institutions of higher education For profit organizations other than small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments State governments Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- 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 not allowed.
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Opportunity Summary:
The National Institutes of Health (NIH) announced this discretionary funding opportunity (Funding Opportunity Number RFA-AG-16-014) to create a single Alzheimer s Disease Translational Center for Disease Model Resources supported through a U54 cooperative agreement. The core goal is to strengthen the pipeline from basic discoveries to credible preclinical testing by building, validating, and openly sharing the kinds of animal model resources and testing standards that can better predict what will work in humans. Because this is a cooperative agreement, NIH is expected to have substantial involvement with the awardee in shaping milestones, coordinating activities, and ensuring the center functions as a national resource rather than a stand-alone research project.
Programmatically, the center is expected to deliver several tightly connected capabilities. First, it must develop the next generation of rodent models of Alzheimer s disease, with an emphasis on models that are more translationally relevant for human disease biology and therapeutic evaluation. Second, it must conduct extensive characterization and clinico-pathological staging of these Alzheimer s animal models using biomarkers that are translatable to humans, meaning the measures used in rodents should map as directly as possible to what clinicians and researchers can measure in patient studies (for example, imaging, fluid biomarkers, and other cross-species readouts). Third, the center is expected to develop translatable pharmacodynamic biomarkers tied to well-validated therapeutic targets, so that when a drug engages its target in animals, there is a clear, measurable biological signal that can later be carried forward into human trials as evidence of target engagement and mechanistic effect.
A major emphasis of the FOA is rigor, standardization, and transparency in preclinical research. The center is tasked with developing and implementing guidelines for standardized best practices for rigorous preclinical testing of Alzheimer s candidates. In practice, that points to expectations such as strong study design, appropriate controls, blinding and randomization where applicable, predefined endpoints, attention to reproducibility across cohorts or sites when feasible, and consistent reporting that enables other groups to interpret results accurately. The center is also expected to actually conduct preclinical testing of candidate Alzheimer s therapeutics under these best-practice standards and to report outcomes transparently, which implies that negative or null findings should be documented and communicated just as clearly as positive results to reduce wasted effort and improve decision-making across the field.
The FOA projected one award, with an estimated total funding amount of about $5,000,000 and an award ceiling of $3,500,000. There was no cost sharing or matching requirement. The opportunity was posted on July 29, 2015, with an original and current closing date of January 11, 2016, and an archive date of February 11, 2016, indicating it is no longer open. The activity category is health, and the listing falls under CFDA 93.866 (Aging Research), aligning the program with NIH s aging and Alzheimer s research mission.
Eligibility was broad across U.S.-based organizations, reflecting an intent to attract a strong, multi-disciplinary consortium capable of building national-scale resources. Eligible applicants included state and local governments, public and private institutions of higher education, nonprofit organizations (with and without 501(c)(3) status), small businesses, and for-profit organizations other than small businesses, as well as various eligible tribal entities and regional organizations. The eligibility text also explicitly included a range of mission-focused institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and other minority-serving institutions. At the same time, the FOA clearly excluded foreign institutions and foreign components: non-U.S. entities could not apply, non-U.S. components of U.S. organizations were not eligible, and foreign components as defined by the NIH Grants Policy Statement were not allowed.
Overall, this opportunity was designed to address a persistent bottleneck in Alzheimer s drug development: the mismatch between many traditional animal models and the complexity of human disease, along with inconsistent preclinical methods that can inflate false positives and undermine reproducibility. By funding a dedicated translational center to generate improved rodent models, anchor them to human-relevant biomarkers and staging, create pharmacodynamic biomarker tools for target validation, and run standardized, transparent preclinical testing, NIH aimed to create shared infrastructure that would help the field make more reliable go/no-go decisions before moving therapies into costly clinical trials. For full historical details, NIH directed applicants and readers to the archived announcement at http://grants.nih.gov/grants/guide/rfa-files/RFA-AG-16-014.html and provided NIH Office of Extramural Research (OER) webmaster contacts for access and linking issues.
FAQs: NIH RFA-AG-16-014 (Alzheimer's Disease Translational Center for Disease Model Resources, U54)
What is this funding opportunity?
This is a National Institutes of Health (NIH) discretionary funding opportunity, Funding Opportunity Number (FON) RFA-AG-16-014, to create a single Alzheimer's Disease Translational Center for Disease Model Resources supported through a U54 cooperative agreement.
What is the main purpose of the center?
The core goal is to strengthen the pipeline from basic discoveries to credible preclinical testing by building, validating, and openly sharing animal model resources and preclinical testing standards that better predict what will work in humans.
How many awards were expected under this FOA?
The FOA projected one award.
What type of award mechanism is used?
The center was to be supported through a U54 cooperative agreement.
What does a "cooperative agreement" mean in this context?
Because this is a cooperative agreement, NIH was expected to have substantial involvement with the awardee. This includes shaping milestones, coordinating activities, and ensuring the center functions as a national resource rather than a stand-alone research project.
What capabilities was the center expected to deliver?
The FOA describes several tightly connected expectations, including: (1) developing next-generation rodent models of Alzheimer's disease with improved translational relevance, (2) extensive characterization and clinico-pathological staging of those models using biomarkers translatable to humans, (3) developing translatable pharmacodynamic biomarkers tied to well-validated therapeutic targets, and (4) conducting rigorous, standardized, and transparent preclinical testing of candidate therapeutics.
What kinds of disease models were emphasized?
The FOA emphasized the next generation of rodent models of Alzheimer's disease, specifically models intended to be more translationally relevant for human disease biology and therapeutic evaluation.
What does "clinico-pathological staging" mean for the animal models in this FOA?
Based on the FOA description, it refers to extensive characterization and staging of Alzheimer's animal models using biomarkers and readouts that can be translated to human studies, with an intent to align animal measures to what clinicians and researchers can measure in patients.
What are "translatable biomarkers" as described here?
They are measures used in rodents that map as directly as possible to measures used in human patient studies. The FOA gives examples such as imaging, fluid biomarkers, and other cross-species readouts.
What are "pharmacodynamic biomarkers" in the context of this FOA?
They are translatable biomarkers tied to well-validated therapeutic targets, designed so that when a drug engages its target in animals there is a clear, measurable biological signal that can later be carried forward into human trials as evidence of target engagement and mechanistic effect.
What did the FOA say about rigor and standardization in preclinical studies?
A major emphasis was rigor, standardization, and transparency. The center was tasked with developing and implementing guidelines for standardized best practices for rigorous preclinical testing of Alzheimer's candidates.
What best-practice elements were implied for preclinical testing?
The FOA points to expectations such as strong study design, appropriate controls, blinding and randomization where applicable, predefined endpoints, attention to reproducibility across cohorts or sites when feasible, and consistent reporting that enables accurate interpretation by other groups.
Was the center expected to do testing, or only create guidelines?
It was expected to do both: develop and implement standardized best-practice guidelines and also conduct preclinical testing of candidate Alzheimer's therapeutics under those standards.
How should results be reported under this FOA?
The FOA emphasized transparent reporting of outcomes, implying that negative or null findings should be documented and communicated as clearly as positive results to reduce wasted effort and improve decision-making.
What problem in Alzheimer's drug development was this opportunity designed to address?
It was designed to address a persistent bottleneck: the mismatch between many traditional animal models and the complexity of human disease, along with inconsistent preclinical methods that can inflate false positives and undermine reproducibility.
What was the estimated total funding amount?
The FOA listed an estimated total funding amount of about $5,000,000.
What was the award ceiling?
The FOA listed an award ceiling of $3,500,000.
Was cost sharing or matching required?
No. The FOA stated there was no cost sharing or matching requirement.
What were the key dates for this opportunity?
The opportunity was posted on July 29, 2015. The original and current closing date was January 11, 2016. The archive date was February 11, 2016.
Is this funding opportunity still open?
No. The closing date (January 11, 2016) and archive date (February 11, 2016) indicate the opportunity is no longer open.
What is the activity category?
The activity category is health.
What CFDA program is associated with this opportunity?
The listing falls under CFDA 93.866 (Aging Research).
Who was eligible to apply?
Eligibility was broad across U.S.-based organizations. Eligible applicants included state and local governments, public and private institutions of higher education, nonprofit organizations (with and without 501(c)(3) status), small businesses, and for-profit organizations other than small businesses, as well as eligible tribal entities and regional organizations.
Did the eligibility language mention minority-serving institutions?
Yes. The eligibility text explicitly included institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and other minority-serving institutions.
Are foreign institutions allowed to apply?
No. The FOA excluded foreign institutions.
Are foreign components allowed (for example, a non-U.S. site within a U.S. organization)?
No. The FOA stated that non-U.S. components of U.S. organizations were not eligible, and foreign components (as defined by the NIH Grants Policy Statement) were not allowed.
Was the center expected to operate as a stand-alone project?
No. The FOA emphasized that the center should function as a national resource, with NIH involvement to help ensure that role.
Where can someone find the archived FOA announcement?
NIH directed readers to the archived announcement at http://grants.nih.gov/grants/guide/rfa-files/RFA-AG-16-014.html.
Who was listed for help with access or linking issues?
The FOA referenced NIH Office of Extramural Research (OER) webmaster contacts for access and linking issues.
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