Opportunity Information: Apply for RFA FD 20 032
The "CBER FY20 FOA for AAV vector manufacturing for diseases affecting very small populations (R01) Clinical Trial Not Allowed" (Funding Opportunity Number RFA-FD-20-032) is a discretionary grant program from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), specifically the Center for Biologics Evaluation and Research (CBER). The core purpose of the opportunity is to push forward gene therapy development for conditions that affect extremely small patient groups, including situations where a disease may affect only a handful of people or even a single individual. The main way CBER aims to do this is by supporting new and improved approaches to manufacturing adeno-associated virus (AAV) vectors, which are widely used delivery vehicles for gene therapies. Because manufacturing challenges become especially acute when the patient population is tiny (and conventional large-batch commercial models do not fit), the focus is on innovation that can make AAV production more feasible, scalable in the right ways, and reliable for very small-batch or individualized needs.
This funding opportunity uses the NIH-style R01 research project grant mechanism, but it is administered under FDA/CDER-related assistance listings (CFDA 93.103) and is clearly oriented toward regulatory science and product development-enabling research rather than clinical testing. As stated in the title, clinical trials are not allowed under this announcement. In practice, that means the proposed work should stay in the realm of preclinical development, process development, analytical methods, platform technologies, manufacturing controls, and other research activities that improve the ability to produce AAV vectors suitable for eventual clinical use, without actually conducting human subject clinical trials as part of the funded project. The intent is to reduce technical barriers that prevent promising therapies for ultra-rare diseases from reaching a stage where they can be responsibly and efficiently evaluated in the clinic under other mechanisms.
The eligible applicant pool is broad and includes many types of organizations and government entities. Eligibility includes state, county, city or township, 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 tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities as described in the announcement's additional eligibility information. In other words, the FOA is designed to attract proposals from academia, nonprofits, industry (including small businesses), and government-affiliated organizations, reflecting the reality that manufacturing innovation for gene therapies often comes from cross-sector collaboration.
The announcement was created on April 8, 2020, with an original closing date of June 23, 2020. The award ceiling listed is $800,000, and the FDA anticipated making about two awards under this FOA. Those numbers signal a relatively targeted, competitive program intended to fund a small set of high-impact projects rather than a large portfolio. Projects funded through this mechanism would be expected to generate concrete advances in AAV vector manufacturing that could be adopted or adapted by developers working on therapies for ultra-rare diseases, where timelines, costs, and manufacturing constraints can otherwise make development impractical.
Overall, this FOA is best understood as a manufacturing-innovation initiative aimed at enabling gene therapy for very small populations by improving how AAV vectors are produced and characterized. It prioritizes the upstream and midstream work that makes eventual clinical translation possible: better production platforms, improved quality and consistency, stronger analytical and control strategies, and approaches that fit small-scale or bespoke manufacturing needs. By explicitly excluding clinical trials, it keeps the spotlight on solving the manufacturing and technical hurdles that can disproportionately block progress for rare and ultra-rare disease programs.Apply for RFA FD 20 032
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "CBER FY20 FOA for AAV vector manufacturing for diseases affecting very small populations (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): 93.103.
- This funding opportunity was created on Apr 08, 2020.
- Applicants must submit their applications by Jun 23, 2020. (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 $800,000.00 in funding.
- The number of recipients for this funding is limited to 2 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), Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled "CBER FY20 FOA for AAV vector manufacturing for diseases affecting very small populations (R01) Clinical Trial Not Allowed."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-20-032.
Which federal agency is offering this grant?
This is a discretionary grant program offered by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), through the Center for Biologics Evaluation and Research (CBER).
What is the main purpose of this FOA?
The core purpose is to advance gene therapy development for diseases affecting extremely small patient populations by supporting new and improved approaches to manufacturing adeno-associated virus (AAV) vectors.
What types of diseases is this FOA focused on?
The FOA is aimed at conditions affecting very small populations, including ultra-rare situations where a disease may affect only a handful of people or even a single individual.
Why is AAV vector manufacturing the focus?
AAV vectors are widely used delivery vehicles for gene therapies. When patient populations are tiny, conventional large-batch manufacturing models may not fit, making manufacturing challenges more acute. This FOA targets innovations that make AAV production more feasible, reliable, and appropriate for very small-batch or individualized needs.
What grant mechanism is used?
The FOA uses the NIH-style R01 research project grant mechanism.
Is this opportunity intended to support clinical trials?
No. As stated in the title, clinical trials are not allowed under this announcement.
What does "Clinical Trial Not Allowed" mean in practice?
It means proposed work should remain in areas like preclinical development, process development, analytical methods, platform technologies, manufacturing controls, and other research that improves the ability to produce AAV vectors suitable for eventual clinical use, without conducting human subject clinical trials as part of the funded project.
If clinical trials are not allowed, what kinds of activities fit this FOA?
Activities aligned with the FOA include manufacturing process innovation, improving production platforms, strengthening quality and consistency, developing or improving analytical characterization methods, and advancing control strategies and other approaches that enable small-scale or bespoke AAV manufacturing.
What is the overall emphasis: basic science or regulatory science/product-enabling work?
The FOA is oriented toward regulatory science and product development-enabling research rather than clinical testing, with the intent of reducing technical barriers that prevent promising ultra-rare disease therapies from reaching a stage appropriate for clinical evaluation under other mechanisms.
What assistance listing (CFDA) is associated with this opportunity?
The announcement references FDA/CDER-related assistance listings and identifies CFDA 93.103.
Who is eligible to apply?
Eligibility is broad and includes various government entities, academic institutions, nonprofits, and industry. Specifically listed eligible applicants include:
- State, county, city or township, 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 tribal organizations
- Public housing authorities/Indian housing authorities
- Nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education)
- For-profit organizations other than small businesses
- Small businesses
- Other entities as described in the announcement's additional eligibility information
Is the FOA intended only for academic applicants?
No. The eligible applicant pool is designed to attract proposals from academia, nonprofits, industry (including small businesses), and government-affiliated organizations, reflecting cross-sector innovation needs in gene therapy manufacturing.
When was the announcement created?
The announcement was created on April 8, 2020.
What was the original closing date?
The original closing date listed was June 23, 2020.
What is the maximum award amount (award ceiling)?
The award ceiling listed is $800,000.
How many awards did FDA anticipate making?
FDA anticipated making about two awards under this FOA.
What does the small number of anticipated awards suggest about competitiveness?
With an anticipated two awards and an $800,000 ceiling, the FOA appears targeted and competitive, aiming to fund a small number of high-impact projects rather than a large portfolio.
What outcomes is FDA/CBER looking for from funded projects?
Funded projects are expected to generate concrete advances in AAV vector manufacturing that can be adopted or adapted by developers working on therapies for ultra-rare diseases, helping address timelines, costs, and manufacturing constraints that can otherwise make development impractical.
How does this FOA help gene therapy programs for very small populations?
By improving manufacturing platforms, quality, consistency, and characterization of AAV vectors for small-scale production, the FOA aims to reduce technical and manufacturing barriers that disproportionately slow or block ultra-rare disease programs from progressing to eventual clinical evaluation.
Does this FOA fund work that directly treats patients?
Not under this announcement. The FOA focuses on manufacturing and technical development needed to enable future clinical translation, but it does not support conducting clinical trials in humans within the funded project.
What is the simplest way to summarize this opportunity?
It is an FDA/CBER R01 funding opportunity focused on improving and innovating AAV vector manufacturing for gene therapies targeting ultra-rare diseases, with clinical trials explicitly excluded.
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