Opportunity Information: Apply for FOR FD 21 006
The Department of Health and Human Services (HHS), through the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), is offering a discretionary grant opportunity focused on speeding up and strengthening how vaccines and other complex biologic products are made, especially for influenza and emerging infectious diseases. The core aim is to fund active research that applies novel advanced manufacturing technologies and improved analytical methods so that biologics can be produced more efficiently, more consistently, and with higher confidence in quality. A major theme in the announcement is pushing beyond traditional batch manufacturing and supporting approaches such as continuous manufacturing, where production runs as an ongoing process rather than in discrete batches. CBER highlights continuous manufacturing because it can make biologics manufacturing more agile and flexible, reduce costs, and improve robustness, which matters when demand surges or supply chains are disrupted.
This program is designed to help close the gap between promising discoveries and near-term, real-world adoption by industry. In other words, the agency is not only interested in early-stage scientific ideas, but in research that can be translated into accessible, practical technologies that manufacturers can implement relatively soon. Alongside technology development, the opportunity also emphasizes regulatory science: generating the evidence, tools, and risk-based understanding needed to support modernized regulatory expectations and guidance. The intent is to help FDA and the field develop science-based frameworks that make it easier and faster to adopt innovative manufacturing methods without compromising safety, purity, or potency.
Applicants are expected to clearly explain how their proposed technology would affect readiness for broad implementation across the biologics industry and how it would strengthen manufacturing control strategies and regulatory evaluation. That means proposals should connect the technical innovation to practical manufacturing outcomes, such as improved process control, better in-process monitoring, clearer quality attributes, smoother comparability strategies when processes change, and faster decision-making for product release. The opportunity is explicitly tied to public health needs like preventing shortages, improving product quality, and shortening time to market for critical vaccines and biologics.
CBER provides examples of research areas that fit the goals. One example is developing improved cell lines that can substantially increase yields of recombinant influenza hemagglutinin (HA) protein, with the notice calling out a target on the order of 50% higher yields compared with current methods. Another is the development of improved bioreactor technologies that enable intensified biomanufacturing of high-quality recombinant protein vaccines, which can include higher-density cultures, better mass transfer, smarter feeding strategies, or more advanced reactor designs that maintain product consistency while increasing throughput. A third example is refining vaccine characterization technologies to enable faster production and faster lot release, which generally points to better analytics, rapid assays, high-throughput or real-time measurements, and approaches that reduce delays between manufacturing and quality confirmation.
The funding opportunity is listed as “Enhancing Innovations in Advanced Manufacturing Technologies for Vaccines against Influenza and Emerging Infectious Diseases” (Funding Opportunity Number: FOR-FD-21-006). It uses the grant funding instrument, is associated with CFDA number 93.103, and is categorized under Agriculture, Consumer Protection, Food and Nutrition in the listing. The expected number of awards is about five, with an award ceiling of $500,000. A wide range of applicants are eligible, including state and local governments, tribal governments and organizations, public and private institutions of higher education, nonprofits with or without 501(c)(3) status, public housing authorities/Indian housing authorities, for-profit organizations (other than small businesses), and small businesses. The opportunity was created on May 25, 2021, and is described as an archiving forecast in the provided source details.
Overall, the grant is aimed at practical, industry-relevant innovations that modernize vaccine and biologics manufacturing and the analytics that support quality, with a strong emphasis on continuous or otherwise advanced manufacturing approaches. The intended payoff is a more resilient manufacturing base for influenza and emerging disease vaccines, faster scale-up and response during outbreaks, improved and more reliable product quality, and clearer regulatory pathways that encourage adoption of these technologies across the biologics sector.Apply for FOR FD 21 006
- 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 "Enhancing Innovations in Advanced Manufacturing Technologies for Vaccines against Influenza and Emerging Infectious Diseases" 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 $500,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: State governments, County 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.
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