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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Frequently Asked Questions (FAQ)
What is the name of this grant opportunity?
The opportunity is titled "Enhancing Innovations in Advanced Manufacturing Technologies for Vaccines against Influenza and Emerging Infectious Diseases."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is FOR-FD-21-006.
Which federal agency is offering this grant?
The grant is offered by the U.S. Department of Health and Human Services (HHS) through the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER).
What is the main purpose of the program?
The purpose is to speed up and strengthen how vaccines and other complex biologic products are manufactured, with a particular focus on influenza and emerging infectious diseases, by funding active research into advanced manufacturing technologies and improved analytical methods.
What kinds of products does this program focus on?
The focus is on vaccines and other complex biologic products, especially those relevant to influenza and emerging infectious diseases.
What type of work is the FDA/CBER looking to fund?
The program is aimed at active research that applies novel advanced manufacturing technologies and improved analytical methods to make biologics manufacturing more efficient, more consistent, and more confidence-inspiring in terms of quality.
Is this grant more about early-stage ideas or near-term industry adoption?
Based on the description, the program emphasizes research that can be translated into accessible, practical technologies that manufacturers can implement relatively soon, helping close the gap between discoveries and real-world adoption.
What is the role of regulatory science in this opportunity?
The opportunity emphasizes regulatory science as part of the work: generating evidence, tools, and risk-based understanding to support modernized regulatory expectations and guidance, and to enable adoption of innovative manufacturing methods without compromising safety, purity, or potency.
Why does the announcement highlight continuous manufacturing?
CBER highlights continuous manufacturing because it can make biologics manufacturing more agile and flexible, reduce costs, and improve robustness, which is especially important when demand surges or supply chains are disrupted.
Does the program support moving beyond traditional batch manufacturing?
Yes. A major theme 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.
What outcomes should proposals connect to?
Applicants are expected to connect 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.
What does the opportunity mean by strengthening manufacturing control strategies?
From the description, this refers to improving the ability to monitor and control the manufacturing process and product quality in a way that supports consistent production and supports regulatory evaluation (for example, stronger in-process monitoring and clearer quality attributes).
What does "comparability strategies when processes change" refer to in this notice?
The notice points to the need for smoother comparability strategies, meaning research should support clearer ways to evaluate and demonstrate that products remain consistent in quality when manufacturing processes are changed or modernized.
What public health needs is this opportunity tied to?
The opportunity is explicitly tied to preventing shortages, improving product quality, and shortening time to market for critical vaccines and biologics, with an emphasis on faster scale-up and response during outbreaks.
What are examples of research areas that fit the program goals?
CBER provides examples including: (1) improved cell lines that substantially increase yields of recombinant influenza hemagglutinin (HA) protein (with a target on the order of 50% higher yields compared with current methods), (2) improved bioreactor technologies enabling intensified biomanufacturing of high-quality recombinant protein vaccines (such as higher-density cultures, better mass transfer, smarter feeding strategies, or advanced reactor designs), and (3) refined vaccine characterization technologies that support faster production and faster lot release (such as better analytics, rapid assays, and high-throughput or real-time measurements).
Does the notice specify a yield improvement target for any example area?
Yes. One example calls out improving cell lines to increase yields of recombinant influenza HA protein by on the order of 50% compared with current methods.
What kinds of bioreactor improvements are mentioned?
The notice mentions intensified biomanufacturing approaches such as higher-density cultures, better mass transfer, smarter feeding strategies, and more advanced reactor designs that maintain product consistency while increasing throughput.
What does "vaccine characterization technologies" mean in the context of this opportunity?
In this notice, it refers to analytical and measurement technologies that can help enable faster production and faster lot release, including improved analytics, rapid assays, and high-throughput or real-time measurements that reduce delays between manufacturing and quality confirmation.
What is the funding instrument for this opportunity?
The opportunity uses the grant funding instrument.
What CFDA number is associated with this opportunity?
The CFDA number listed is 93.103.
How many awards are expected?
The expected number of awards is about five.
What is the maximum award amount (award ceiling)?
The award ceiling is $500,000.
Who is eligible to apply?
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.
Are small businesses eligible under this opportunity?
Yes, small businesses are listed as eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible.
Are nonprofit organizations required to have 501(c)(3) status?
No. The eligibility list includes nonprofits with or without 501(c)(3) status.
Are universities and colleges eligible?
Yes. Both public and private institutions of higher education are listed as eligible.
Are tribal governments or tribal organizations eligible?
Yes. Tribal governments and tribal organizations are listed as eligible.
What is the category listed for this opportunity?
It is categorized under Agriculture, Consumer Protection, Food and Nutrition in the listing.
When was this opportunity created?
The opportunity was created on May 25, 2021.
What does it mean that this is described as an "archiving forecast"?
Based on the provided details, the source describes the opportunity as an archiving forecast, which indicates it is presented in a forecast/archived context in the source information provided.
What is the intended long-term payoff of the funded work?
The intended payoff is a more resilient manufacturing base for influenza and emerging disease vaccines, faster scale-up and outbreak response, improved and more reliable product quality, and clearer regulatory pathways that encourage adoption of advanced manufacturing technologies across the biologics sector.
How should applicants frame the impact of their proposed technology?
Applicants are expected to clearly explain how the technology affects readiness for broad implementation across the biologics industry and how it strengthens manufacturing control strategies and regulatory evaluation, tying the innovation to practical improvements like monitoring, control, quality attributes, comparability, and release decision-making.
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