Closed · FOR-FD-21-007 · CFDA 93.103 · Discretionary
AAV Vector manufacturing for diseases affecting very small populations
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- up to $600K
- Award range
- Closed
- Status
- -
- Close date
- 5
- Expected awards
The verdict
AAV Vector manufacturing for diseases affecting very small populations is a closed discretionary listing from Food and Drug Administration that offered Up to $600,000 across 5 expected awards. Future funding cycles may be published under the same CFDA number.
- up to $600K
- award range
- Closed
- application status
- 5
- expected awards
- 93.103
- CFDA program
Opportunity snapshot. This Grants.gov announcement - AAV Vector manufacturing for diseases affecting very small populations - is cataloged under number FOR-FD-21-007 and tied to CFDA assistance listing 93.103, posted by Food and Drug Administration. Grants.gov currently shows the opportunity as closed, first posted on May 25, 2021. The funding category is Discretionary, delivered as a grant.
Award economics. The award range on file is Up to $600,000. The agency has projected $3.0 million in total estimated funding for this announcement. It expects to issue 5 awards. If the agency funds the expected 5 awards from the $3.0 million estimated pool, the average award works out to roughly $600,000. Cost sharing is not required, so applicants do not need to commit matching funds to be competitive on this opportunity. Federal award ranges are often upper bounds; actual allocations reflect program appropriations, the strength of the applicant pool, and the evaluation committee's scoring.
Deadline and action path. This opportunity is closed. Monitoring the parent program page is the most reliable way to catch re-announcements in the next funding cycle. Every Grants.gov submission requires an active SAM.gov registration and a Unique Entity ID. Review the Eligibility section below carefully, federal eligibility categories (nonprofit, state or local government, tribal, individual, educational institution, small business) have distinct registration and reporting requirements. Pre-application outreach to the listed agency contact is permitted and often welcomed, it helps clarify scope and scoring priorities. Before acting on the deadline or award figures above, verify them directly on the official Grants.gov listing, amendments can change dates and amounts after this page was last refreshed.
Award Range
Up to $600,000
Close Date
Not specified
Archiving forecast
Posted
May 25, 2021
Est. Total Funding
$3,000,000
Expected Awards
5
Instrument
Grant
Description
CBER seeks to advance the development of gene therapies for diseases affecting very small populations, potentially even single individuals, by enhancing innovations in the manufacture of Adeno-associated virus (AAV) vectors. Such innovations include the definition of critical quality attributes of AAV as vectors for gene therapy, development of advanced process analytics, development of a of non-proprietary AAV vectors, and demonstration of low-cost, non-proprietary GMP manufacturing methods for AAV vectors.This research will advance innovative manufacturing of AAV vectors for gene therapy. CBER anticipates that addressing the need for gene therapy products for diseases affecting very small populations will also lead to technical developments that will advance the entire field of gene therapy. Additionally, this research is intended to support advances in regulatory science that allow for development of science and risk-based guidelines to facilitate faster adoption of these innovative therapies. Some specific areas of research could include the following, but applications should clearly describe the potential impacts of the proposed enabling technology on readiness for broad implementation in the biological product industry, and/or regulatory evaluation:• Definition of critical quality attributes of AAV vectors for gene therapy• Development of advanced analytics to enhance AAV vector manufacturing process knowledge and monitoring of critical quality attributes• Development of a non-proprietary suite of AAV vectors suitable for gene therapy applications for diseases affecting very small populations• Demonstration of the feasibility of low-cost, non-proprietary GMP manufacturing methods for AAV vectors at a scale appropriate for very small populations (one batch provides approximately 5-20 doses)
Eligibility
Grants.gov lists this opportunity under eligibility category codes 00, 01, 02, 04, 05, 06, 07, 08, 11, 12, 13, 20, 22, 23. These codes correspond to applicant types (state/local government, tribal organization, nonprofit, educational institution, individual, small business, etc.) defined in Grants.gov's own eligibility reference. See the current Grants.gov eligibility categories or check the official listing below for this opportunity's exact eligibility statement.
Official Listing on Grants.gov
View full details, application forms, and submission instructions.
Parent Grant Program
Food and Drug Administration Research
U.S. Department of Health and Human Services
Agency Contact
Gordana Zuber Grants Management Specialist
Key Dates
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Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.
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| Sources | the SAM.gov Assistance Listings and Grants.gov |