Opportunity Information: Apply for RFA FD 18 023
Enhancing Innovations in Emerging Technologies for Advanced Manufacturing of Complex Biologic Products (R01) (Funding Opportunity Number RFA-FD-18-023) is a discretionary federal funding opportunity from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), specifically aligned with the work of the Center for Biologics Evaluation and Research (CBER). The program is focused on advancing the manufacturing science behind complex biologic products by supporting active research that applies novel, emerging technologies to how these products are made and how their quality is evaluated. In practice, the goal is to strengthen modern manufacturing capabilities for biologics by encouraging new approaches that can improve robustness, consistency, and overall product quality.
The core purpose of the opportunity is to accelerate innovation in advanced manufacturing for complex biologics, paired with innovative analytical methods that help characterize products and monitor manufacturing processes. The emphasis on both manufacturing technologies and analytical approaches reflects a full lifecycle view of quality: improving how biologics are produced while also improving the tools used to measure, verify, and maintain quality during development and production. This kind of research can include work that enables better process control, improved detection of quality attributes, or more informative measurements that help manufacturers understand variability and reduce risk to product consistency.
This opportunity uses a cooperative agreement as the funding instrument type, meaning the FDA anticipates substantial involvement with recipients beyond what is typical for a more hands-off grant. While applicants would still conduct independent research, the cooperative structure generally signals an expectation of ongoing collaboration, coordination, or technical engagement with the agency to ensure the research aligns with program priorities and delivers outputs that are broadly useful to the biologics manufacturing and regulatory science landscape.
The opportunity falls under the funding activity category of Consumer Protection and Health, and is associated with CFDA number 93.103. It was created on April 23, 2018, with an original application closing date of June 25, 2018. The maximum award amount listed (award ceiling) is $600,000, and the FDA expected to make about 5 awards under this announcement, indicating a competitive program designed to fund a small number of projects with clear relevance and strong technical merit.
Eligibility is broad and includes many types of organizations that can contribute to advanced manufacturing research. Eligible applicants include state, county, city, township, and 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. This wide eligibility suggests the program is intended to draw from academia, industry, nonprofits, and government entities that have relevant manufacturing, bioprocessing, analytical chemistry, bioengineering, or related expertise.
Overall, RFA-FD-18-023 is aimed at pushing the state of the art in how complex biologic products are manufactured and evaluated, with the FDA/CBER supporting research that can lead to more advanced, reliable, and quality-focused manufacturing approaches. The practical value of the funded work would be in generating knowledge, methods, or technologies that make biologic production more modern and resilient while improving the analytical foundations needed to demonstrate and maintain product quality.Apply for RFA FD 18 023
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, health sector is offering a public funding opportunity titled "Enhancing Innovations in Emerging Technologies for Advanced Manufacturing of Complex Biologic Products (R01)" 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 Apr 23, 2018.
- Applicants must submit their applications by Jun 25, 2018. (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 $600,000.00 in funding.
- The number of recipients for this funding is limited to 5 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.
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