Opportunity Information: Apply for FOR FD 20 011
The "CBER FY20 FOA for AAV vector manufacturing for diseases affecting very small populations (R01) Clinical Trial Not Allowed" opportunity (Funding Opportunity Number: FOR FD 20 011) is a discretionary federal grant program run by the U.S. Department of Health and Human Services (HHS) through the Food and Drug Administration (FDA), specifically the Center for Biologics Evaluation and Research (CBER). Its central goal is to push gene therapy development forward for ultra-rare diseases, including conditions that may affect extremely small patient groups and, in some cases, even a single identified individual. Rather than funding patient-facing studies, the focus is on solving the practical, technical, and quality challenges that make it hard to manufacture Adeno-associated virus (AAV) vectors efficiently, reliably, and at an appropriate quality level when there is little or no economy of scale.
This FOA uses the R01 grant mechanism and explicitly does not allow clinical trials. That restriction signals that the FDA is seeking projects that stay on the manufacturing, process development, and related enabling science side of gene therapy, not projects that enroll participants to test safety or efficacy. In other words, the work is meant to generate methods, data, and manufacturing innovations that would make later clinical development and eventual product availability more feasible, especially when the target population is too small to support traditional commercial manufacturing approaches. The underlying problem CBER is addressing is that for very small populations, conventional AAV production can be too expensive, too slow, and too difficult to standardize, and that can become the main barrier to getting a potential therapy to patients.
The program is oriented toward innovations in AAV vector manufacturing. In practical terms, this typically means improving upstream and downstream processes, strengthening analytical methods and quality controls, enhancing reproducibility and scalability (including small-scale and modular approaches), and developing strategies that support consistent product quality across lots when only a small number of doses are needed. It also aligns with regulatory and public health needs, since FDA/CBER is the agency that regulates biologics, including gene therapies, and manufacturing quality is often one of the most critical determinants of whether a gene therapy program can progress. By encouraging better manufacturing solutions, the FOA aims to reduce friction points that frequently delay or derail ultra-rare gene therapy development, such as inconsistent yields, impurities, limited platform comparability, and challenges around lot release testing when batch sizes are minimal.
In terms of funding details, the listed award ceiling is $400,000, and the opportunity anticipated making about two awards. These figures indicate a relatively small, targeted program intended to fund a limited number of projects with a clear manufacturing innovation payoff. The opportunity is categorized under a broader funding activity category labeled "Agriculture, Consumer Protection, Food and Nutrition" and references CFDA number 93.103, which is associated with FDA-related assistance listings. The original closing date is shown as "Archiving forecast," and the creation date in the provided record is May 25, 2021, which suggests the listing may have been posted or cataloged at that time even though the title references FY20.
Eligibility is broad and includes many common research and public interest entities. Eligible applicants include state, county, and local 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other entities as further clarified in the full announcement text. This wide eligibility range reflects the reality that useful AAV manufacturing innovations can come from academia, nonprofits, government labs, and industry, including specialized manufacturers and technology developers.
Overall, this grant opportunity is best understood as an FDA/CBER effort to strengthen the manufacturing foundation needed for gene therapies aimed at ultra-rare and even n-of-1 diseases. The emphasis is not on proving a therapy works in patients within the grant period, but on developing practical manufacturing and quality solutions that can make such therapies possible to produce and regulate responsibly, even when the patient population is too small to support standard production models.Apply for FOR FD 20 011
- 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 May 25, 2021.
- Applicants must submit their applications by Archiving forecast. (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 $400,000.00 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).
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Frequently Asked Questions (FAQs)
What is the name of this grant 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 FOR FD 20 011.
Which federal agency runs this program?
This is a discretionary federal grant program administered by the U.S. Department of Health and Human Services (HHS) through the Food and Drug Administration (FDA), specifically FDA's Center for Biologics Evaluation and Research (CBER).
What is the main goal of this FOA?
The central goal is to advance gene therapy development for ultra-rare diseases by addressing the practical, technical, and quality barriers that make it difficult to manufacture Adeno-associated virus (AAV) vectors efficiently and reliably when patient populations are extremely small (including cases where there may be only a single identified individual).
Is this funding meant for clinical studies in patients?
No. The FOA explicitly states "Clinical Trial Not Allowed," which indicates projects should not enroll participants to test safety or efficacy. The focus is on manufacturing, process development, and enabling science that can support later clinical development.
What grant mechanism does this FOA use?
This FOA uses the R01 grant mechanism.
What types of work does FDA/CBER want to support under this FOA?
The program is oriented toward innovations in AAV vector manufacturing, including efforts aimed at solving technical and quality challenges that commonly block progress for ultra-rare gene therapy programs.
What does "AAV vector manufacturing" typically include in this context?
Based on the description provided, it typically includes improving upstream and downstream processes, strengthening analytical methods and quality controls, enhancing reproducibility and scalability (including small-scale and modular approaches), and developing strategies to keep product quality consistent across lots when only a small number of doses are needed.
Why does the FOA emphasize manufacturing for very small populations?
Because for very small populations, conventional AAV production can be too expensive, too slow, and difficult to standardize. When there is little or no economy of scale, manufacturing often becomes the main barrier to getting a potential therapy to patients.
How does this FOA relate to FDA/CBER's regulatory role?
FDA/CBER regulates biologics, including gene therapies, and manufacturing quality is often a key factor in whether a gene therapy program can progress. This FOA aims to encourage manufacturing solutions that align with regulatory and public health needs.
What kinds of manufacturing challenges is the FOA trying to reduce?
The description highlights friction points that can delay or derail ultra-rare gene therapy development, including inconsistent yields, impurities, limited platform comparability, and challenges around lot release testing when batch sizes are minimal.
What is the maximum award amount (award ceiling)?
The listed award ceiling is $400,000.
How many awards are expected to be made?
The opportunity anticipated making about two awards.
What does the small number of awards suggest about the program?
It suggests a relatively small, targeted program intended to fund a limited number of projects with a clear manufacturing-innovation payoff.
What is the funding activity category listed for this opportunity?
The opportunity is categorized under "Agriculture, Consumer Protection, Food and Nutrition."
What CFDA number is associated with this opportunity?
The opportunity references CFDA number 93.103.
What does the closing date information indicate?
The original closing date is shown as "Archiving forecast," which suggests the listing may be archived or forecasted for archiving rather than presenting a standard open deadline in the provided record.
When was the record created?
The creation date shown in the provided record is May 25, 2021.
Why does the title reference FY20 if the record shows a 2021 creation date?
The information provided suggests the listing may have been posted or cataloged on May 25, 2021 even though the title references FY20.
Who is eligible to apply?
Eligibility is broad and includes state, county, and local 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other entities as further clarified in the full announcement text.
Are both nonprofit and for-profit organizations eligible?
Yes. The eligibility list includes nonprofits (with and without 501(c)(3) status, with noted exclusions as stated) as well as for-profit organizations, including small businesses and for-profit organizations other than small businesses.
Are universities and colleges eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.
Are government entities eligible?
Yes. Eligible applicants include state, county, and local governments; special district governments; independent school districts; and public housing authorities/Indian housing authorities.
Are tribal entities eligible?
Yes. Eligible applicants include federally recognized Native American tribal governments and other Native American tribal organizations.
What is the intended impact of the funded work?
The intended impact is to develop methods, data, and manufacturing innovations that make later clinical development and eventual product availability more feasible for ultra-rare and even n-of-1 diseases, particularly by making AAV vector production more efficient, reliable, and appropriately controlled for quality.
Does the FOA aim to prove a gene therapy works during the grant period?
No. The emphasis is not on demonstrating patient outcomes within the grant period, but on improving the manufacturing and quality foundation needed to support responsible development and regulation.
What is the core problem this FOA is trying to solve?
The core problem is that traditional AAV manufacturing approaches often break down for ultra-rare diseases due to high costs, slow timelines, and difficulties with standardization and consistent quality when only a very small number of doses are needed.
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