Opportunity Information: Apply for RFA AG 13 014
Apply for RFA AG 13 014
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Alzheimers Disease Therapeutics Program (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273 Alcohol Research Programs 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.866 Aging Research.
- This funding opportunity was created on Oct 31, 2012 and posted on Oct 31, 2012.
- Applicants must submit their applications by Jan 14, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Independent school districts County governments Special district governments Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education State governments Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education For profit organizations other than small businesses Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Alzheimers Disease Therapeutics Program (U01) (Funding Opportunity Number RFA-AG-13-014) is a National Institutes of Health cooperative agreement designed to help move promising new small-molecule drug candidates for Alzheimers disease from early discovery into human testing. The central purpose of the program is very practical: it targets investigators who already have a credible compound in hand, but who do not have the specialized drug development infrastructure, regulatory experience, or industry-style project management needed to take that compound from the lab bench through the key milestones that enable clinical entry. Rather than funding only basic research, this opportunity is structured to support a translational, milestone-driven path aimed at producing a development-quality therapeutic candidate for the prevention or treatment of Alzheimers disease.
A defining feature of this FOA is that it functions as an adjunct to the NIH Blueprint Neurotherapeutics Program, giving funded teams access to a "virtual pharma" network. In plain terms, awardees are not expected to build a full drug development organization from scratch. Instead, the program connects investigators with contract research organizations (CROs), technical and regulatory experts, and experienced project managers who collectively provide capabilities that academic and early-stage groups often lack. That can include the kinds of work that typically determine whether a molecule can realistically become a medicine, such as medicinal chemistry optimization, preclinical testing packages, and the planning and execution steps needed to meet regulatory expectations.
The long-term aim is to advance selected projects through a clear development continuum: starting with medicinal chemistry optimization, proceeding through the preclinical studies needed to justify human testing, and extending through Phase I clinical trials. By structuring support across this span, the program is trying to de-risk early therapeutic assets enough that they become attractive for subsequent industry partnership, licensing, or other forms of private-sector development support. In other words, NIH is not only funding experiments; it is also helping build a credible, clinic-ready development story around each project so that it can continue beyond the government-funded phase.
Administratively, this is a discretionary funding opportunity using the cooperative agreement mechanism (U01). That mechanism generally implies substantial NIH involvement compared with a standard research grant, reflecting the hands-on coordination, milestone tracking, and external development resources that are central to the program. The activity category is Health, and the listed CFDA numbers include 93.866 (Aging Research), 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), and 93.273 (Alcohol Research Programs). There is no cost sharing or matching requirement noted.
Eligibility is broad and includes many U.S. entity types such as public and private institutions of higher education, nonprofits (including 501(c)(3) organizations), for-profit organizations (including small businesses and other for-profits), and various levels of government (state, county, city/township, special districts), as well as eligible tribal entities and public housing authorities/Indian housing authorities. The FOA also allows non-U.S. participation: non-domestic (foreign) organizations and institutions may apply, non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined in NIH policy. Additional eligible applicant types explicitly mentioned include HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and certain federal agencies.
Key dates show this was posted on October 31, 2012, with an original and current closing date of January 14, 2013, and an archive date of February 14, 2013. The official announcement link is provided through NIH at http://grants.nih.gov/grants/guide/rfa-files/RFA-AG-13-014.html. For access or technical issues, the contact listed is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is the Alzheimers Disease Therapeutics Program (U01) funding opportunity?
This opportunity is the Alzheimers Disease Therapeutics Program (U01), Funding Opportunity Number RFA-AG-13-014. It is a National Institutes of Health (NIH) cooperative agreement intended to move promising new small-molecule drug candidates for Alzheimers disease from early discovery toward human testing.
What is the main goal of this program?
The central goal is translational and practical: to help investigators who already have a credible compound in hand advance that compound through the development steps needed to enable entry into clinical testing. The program is designed to support a milestone-driven path toward a development-quality therapeutic candidate for prevention or treatment of Alzheimers disease.
What type of research does this program emphasize?
This program emphasizes translational, drug-development-oriented work rather than basic research alone. It supports activities that help produce a clinic-ready development package, including medicinal chemistry optimization, preclinical studies to justify human testing, and progress through Phase I clinical trials.
What kinds of projects are a good fit for this FOA?
The FOA targets teams that already have a credible small-molecule candidate but lack specialized drug development infrastructure, regulatory experience, or industry-style project management needed to advance a compound from lab findings to clinical entry milestones.
Does an applicant need to have full drug development infrastructure already in place?
No. A defining feature of the program is that awardees are not expected to build a complete drug development organization from scratch. Instead, the program provides access to a broader development network and resources intended to fill common capability gaps.
What is meant by access to a "virtual pharma" network?
Through this FOA, funded teams can access a network that functions like a "virtual pharma" capability. This includes connections to contract research organizations (CROs), technical and regulatory experts, and experienced project managers who can help execute development work that academic or early-stage groups often cannot perform internally.
What types of development activities may be supported through the program resources?
Examples described include medicinal chemistry optimization, preclinical testing packages, and planning/execution steps needed to meet regulatory expectations. These are the types of efforts that often determine whether a molecule can realistically become a medicine.
How does this program relate to the NIH Blueprint Neurotherapeutics Program?
This FOA is described as an adjunct to the NIH Blueprint Neurotherapeutics Program. In practice, that relationship is tied to providing awardees access to the "virtual pharma" network and coordinated development support.
How far can projects be advanced under this program?
The long-term aim is to advance selected projects along a clear development continuum: starting with medicinal chemistry optimization, proceeding through preclinical studies needed to justify human testing, and extending through Phase I clinical trials.
What is the intended long-term outcome beyond the NIH-funded work?
The program aims to de-risk early therapeutic assets so they become more attractive for subsequent industry partnership, licensing, or other private-sector development support. NIH is supporting not just experiments, but the creation of a credible, clinic-ready development story that can continue beyond the government-funded phase.
What funding mechanism is used for this opportunity?
The mechanism is a cooperative agreement (U01). Cooperative agreements typically involve substantial NIH involvement compared with standard research grants, consistent with this program's hands-on coordination, milestone tracking, and use of external development resources.
What does "substantial NIH involvement" imply here?
Based on the description, it implies hands-on coordination, milestone tracking, and integration of external development resources (such as CROs and expert support) as central elements of how projects are managed and advanced.
What is the activity category for this opportunity?
The activity category is Health.
What CFDA numbers are associated with this opportunity?
The listed CFDA numbers include 93.866 (Aging Research), 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), and 93.273 (Alcohol Research Programs).
Is cost sharing or matching required?
No cost sharing or matching requirement is noted in the provided information.
Who is eligible to apply in the United States?
Eligibility is broad and includes public and private institutions of higher education; nonprofits (including 501(c)(3) organizations); for-profit organizations (including small businesses and other for-profits); and multiple levels of government (state, county, city/township, special districts). It also includes eligible tribal entities and public housing authorities/Indian housing authorities.
Are non-U.S. (foreign) organizations allowed to apply?
Yes. Non-domestic (foreign) organizations and institutions may apply. In addition, non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined in NIH policy.
Are specific institution types explicitly included as eligible applicants?
Yes. The FOA explicitly mentions additional eligible applicant types such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and certain federal agencies.
When was this funding opportunity posted?
The opportunity was posted on October 31, 2012.
What was the application closing date?
The original and current closing date listed is January 14, 2013.
Is this opportunity still active?
Based on the dates provided, it was archived on February 14, 2013, which indicates it is not currently active as that specific announcement.
Where can the official announcement be found?
The official NIH announcement link provided is: http://grants.nih.gov/grants/guide/rfa-files/RFA-AG-13-014.html
Who should be contacted for access or technical issues?
The contact listed for access or technical issues is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
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