Opportunity ID: 331720
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | FOR-FD-21-006 |
| Funding Opportunity Title: | Enhancing Innovations in Advanced Manufacturing Technologies for Vaccines against Influenza and Emerging Infectious Diseases |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 25, 2021 |
| Last Updated Date: | May 25, 2021 |
| Original Closing Date for Applications: | – Archiving forecast |
| Current Closing Date for Applications: | – Archiving forecast |
| Archive Date: | May 26, 2021 |
| Estimated Total Program Funding: | $2,000,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Native American tribal governments (Federally recognized) 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 County governments Small businesses For profit organizations other than small businesses Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Special district governments Native American tribal organizations (other than Federally recognized tribal governments) State governments Private institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
CBER seeks to support the application of novel technologies for advanced manufacturing of complex biologic products, and innovative analytical approaches to improve product manufacturing and quality through active research. One such technology is continuous manufacturing, defined as manufacturing using a continuous process, rather than a batch-process approach. This emerging technology has the potential to improve agility, flexibility, cost, and robustness in the manufacturing processes for complex biologics. In general, CBER seeks to enhance development of innovative technologies with the potential to address product shortages, improve product quality, and accelerate the time to market for complex biologics such as vaccines against influenza and other emerging diseases. The supported research will advance innovations in manufacturing by developing and making technologies accessible to industry in the near term, and by bridging the gaps between discoveries and the implementation by industry. 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 technologies. Some specific areas of research could include the following and the application should clearly describe the potential impacts of the proposed technology on the readiness for broad implementation in the biological product industry, control strategy, and/or regulatory evaluation: • Development of cell lines capable of significantly improving recombinant influenza hemagglutinin protein yields ≥ 50% over current methodologies • Development of improved bioreactor technologies for intensified biomanufacturing of high quality recombinant protein vaccines • Refinement of vaccine characterization technologies to facilitate more rapid production and lot release |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gordana Zuber
Grants Management Specialist Email:gordana.zuber@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
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