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).
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Browse more opportunities from the same agency: Department of Health and Human Services, Food and Drug Administration
Browse more opportunities from the same category: Agriculture, Consumer Protection, Food and Nutrition
Next opportunity: Promoting U.S. Values and Global Science Leadership
Previous opportunity: DoD Scleroderma, Idea Development Award
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for FOR FD 20 011
Applicants also applied for:
Applicants who have applied for this opportunity (FOR FD 20 011) also looked into and applied for these:
| Funding Opportunity |
|---|
| Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional Apply for FOR FD 20 007 Funding Number: FOR FD 20 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: Case Dependent |
| Incorporating cost effectiveness & societal outcomes into FDA opioids model (U01) Apply for FOR FD 20 008 Funding Number: FOR FD 20 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: Case Dependent |
| Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Products Apply for FOR FD 20 009 Funding Number: FOR FD 20 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Drug Development Science Support (U01) Apply for FOR FD 20 010 Funding Number: FOR FD 20 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: Case Dependent |
| Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed Apply for FOR FD 21 004 Funding Number: FOR FD 21 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: Case Dependent |
| AAV Vector manufacturing for diseases affecting very small populations Apply for FOR FD 21 007 Funding Number: FOR FD 21 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Enhancing Innovations in Advanced Manufacturing Technologies for Vaccines against Influenza and Emerging Infectious Diseases Apply for FOR FD 21 006 Funding Number: FOR FD 21 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Renewal - Cooperative Agreement to Support the Joint Institute for Food Safety and Applied Nutrition, JIFSAN (U01) Clinical Trial Not Allowed Apply for RFA FD 22 004 Funding Number: RFA FD 22 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,500,000 |
| Conformance with the Egg Regulatory Program Standards (U2F) (Clinical Trial Not Allowed) Apply for RFA FD 22 006 Funding Number: RFA FD 22 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Research to support the development of alternatives to antimicrobials for use in food-producing animals Apply for PAR 22 087 Funding Number: PAR 22 087 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Innovative ways to provide education on antimicrobial stewardship practices in animals. Apply for PAR 22 108 Funding Number: PAR 22 108 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Revision Applications - Development and Maintenance of the Animal Feed Regulatory Program Standards Flexible Funding Model Compliance and Enforcement Expansion Supplement (U18) (Clinical Trials Not Allowed) Apply for RFA FD 22 010 Funding Number: RFA FD 22 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $100,000 |
| Federal and State Integration Activities to Advance Cooperation and Regulatory Standards Among Animal Food Safety Regulatory Programs (U2F) Clinical Trials Not Allowed Apply for RFA FD 22 009 Funding Number: RFA FD 22 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $350,000 |
| Revision Applications - Manufactured Food Flexible Funding Model Compliance and Enforcement Expansion Supplement (U18) (Clinical Trials Not Allowed) Apply for RFA FD 22 019 Funding Number: RFA FD 22 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $100,000 |
| Retail Food Safety Regulatory Association Collaboration (U18) (Clinical Trial Not Allowed) Apply for RFA FD 22 008 Funding Number: RFA FD 22 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Renewal - Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 22 025 Funding Number: RFA FD 22 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Renewal- Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food Safety Modernization Act (FSMA) Compliance (U01) Clinical Trail Not Allowed Apply for RFA FD 22 024 Funding Number: RFA FD 22 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Funding Opportunity Title Innovation Award: Minority Health and Health Equity (U01) Clinical Trials Optional Apply for RFA FD 22 005 Funding Number: RFA FD 22 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Optional Apply for RFA FD 22 020 Funding Number: RFA FD 22 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Building Research Capacity in Global Tobacco Product Regulation Program (U18) Clinical Trials Not Allowed Apply for RFA FD 23 003 Funding Number: RFA FD 23 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "FOR FD 20 011", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.