Opportunity Information: Apply for PAR 19 216
The funding opportunity titled "Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01) - Clinical Trial Optional" (Funding Opportunity Number PAR 19-216) is a U.S. Food and Drug Administration (FDA) cooperative agreement program designed to strengthen regulatory science in modern pharmaceutical manufacturing. Its central purpose is to speed up and improve the FDA-relevant science needed to evaluate, support, and responsibly broaden the use of continuous manufacturing and other advanced process monitoring and control approaches across the drug and biologics industry. In practical terms, the program is aimed at helping the field move from traditional batch manufacturing toward more innovative, continuously controlled production models, while also generating evidence and best practices that regulators and manufacturers can use to assess quality, consistency, and safety.
A key focus of the program is continuous manufacturing and closely related technologies that enable more real-time understanding and control of manufacturing processes. Continuous manufacturing generally refers to producing drug substances or drug products in an ongoing flow rather than in discrete batches, often paired with advanced sensors, automation, and analytics that can detect process shifts early and enable rapid corrective actions. The FDA is seeking work that makes these systems easier to implement, easier to validate, and easier to assess from a regulatory perspective. The scope explicitly includes both small-molecule pharmaceuticals and biological products, with examples such as monoclonal antibodies and therapeutic enzymes, which often come with additional complexity around process variability, product characterization, and control strategies.
The types of projects encouraged under this announcement are those that study, develop, refine, or recommend improvements to advanced manufacturing approaches and the methods used to monitor and control them. Examples include developing or modifying novel manufacturing processes, which can cover early design work, scale-up studies, and even commercial-scale considerations. The opportunity also supports research on improved control methods, meaning strategies for keeping critical process parameters in the right ranges to ensure consistent product quality, and advances in testing technology, such as new analytical methods or in-line/at-line measurements that can support faster, more informative release decisions. Overall, the expectation is that funded efforts will produce practical outcomes that help clarify how continuous manufacturing systems should be designed, monitored, and evaluated, and how quality can be assured in a way that aligns with regulatory expectations.
This is a discretionary funding opportunity offered by the U.S. Department of Health and Human Services (HHS), specifically the FDA, and it uses the cooperative agreement mechanism (U01). A cooperative agreement typically signals that the funding agency expects to have substantial involvement during the project, such as scientific collaboration, steering input, or coordinated planning, rather than acting purely as a passive funder. The activity category listed for the announcement is "Agriculture, Consumer Protection, Food and Nutrition" under CFDA number 93.103, reflecting FDA's broader mission and budget structure even though the technical work is centered on pharmaceutical manufacturing science.
Eligibility is geared toward research and mission-driven organizations capable of conducting advanced pharmaceutical manufacturing and control research. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations with 501(c)(3) status, and nonprofits without 501(c)(3) status (other than institutions of higher education). The listing also includes an "Others" category with additional eligibility details referenced in the full announcement, which typically covers certain specialized organizations that meet program requirements.
In terms of funding scale, the award ceiling is listed as $6,000,000, and the FDA anticipated making about two awards under this announcement. That combination suggests the agency was looking for a small number of relatively substantial projects with clear relevance to regulatory science and meaningful potential to influence how continuous manufacturing and advanced control strategies are evaluated and adopted. The announcement also notes that awards may be funded in part by appropriations under the 21st Century Cures Act, section 3016, which is significant because that provision has supported FDA efforts to modernize regulatory science, including the tools and standards needed to keep pace with new technologies.
The opportunity had multiple submission deadlines across several years, reflecting an ongoing or periodically open announcement structure. The creation date was March 13, 2019, and listed deadlines included May 14, 2019, April 4, 2020, and April 5, 2021, with each deadline set at 11:59 PM Eastern Time. The original closing date is shown as April 5, 2021, indicating the final deadline in that series. The "Clinical Trial Optional" label means applicants could propose studies that may include clinical trial components if justified, but clinical trials were not required as the core emphasis is manufacturing science, monitoring, process control, and regulatory evaluation frameworks rather than testing therapeutic effects in patients.
Taken together, this grant opportunity is best understood as an FDA-backed effort to generate credible, regulatorily relevant data and methodologies that reduce uncertainty around continuous manufacturing and advanced control technologies. By funding universities and nonprofits to develop improved processes, control systems, and testing approaches for both drugs and biologics, the program aims to help the pharmaceutical sector adopt manufacturing innovations that can increase reliability, enhance quality assurance, and potentially improve supply robustness, while also giving regulators better tools to assess these modern systems consistently and efficiently.Apply for PAR 19 216
- 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 "Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional" 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 Mar 13, 2019.
- Applicants must submit their applications by Apr 05, 2021 This announcement has multiple deadlines Current Close Date May 14,2019 by 1159 PM Eastern Time. April 4, 2020, by 1159 PM Eastern Time. April 5, 2021, by 1159 PM Eastern Time.. (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 $6,000,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education, 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, Others (see text field entitled Additional Information on Eligibility for clarification).
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 19 216) also looked into and applied for these:
| Funding Opportunity |
|---|
| Implementation of the Animal Feed Regulatory Program Standards (U18 Clinical Trial Not Allowed) Apply for RFA FD 19 021 Funding Number: RFA FD 19 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Novel Approaches to Translational Evidence Generation to Advance Coordinated Registry Networks (CRNs) via Big Data Analytics Using Disparate Data Sources (U01 Clinical Trial Optional) Apply for RFA FD 19 020 Funding Number: RFA FD 19 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 019 Funding Number: RFA FD 19 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trial Required Apply for RFA FD 19 015 Funding Number: RFA FD 19 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $37,500,000 |
| Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities. (U01) Clinical Trial Not Allowed Apply for RFA FD 19 013 Funding Number: RFA FD 19 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,500,000 |
| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 19 016 Funding Number: RFA FD 19 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U01) Clinical Trials Not Allowed Apply for RFA FD 19 026 Funding Number: RFA FD 19 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Information Sharing System for State-Regulated Drug Compounding Activities (U01) Clinical Trial Not Allowed Apply for RFA FD 19 025 Funding Number: RFA FD 19 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,600,000 |
| Renewal Application: Critical Path Public Private Partnerships (U18) Clinical Trials Optional Apply for RFA FD 19 027 Funding Number: RFA FD 19 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $100,000,000 |
| Implementation of U.S. Food Safety Modernization Act - Identifying, Researching, and Implementing Alternative Methods to Expand the Reach across the Global Supply Chain (U01) - Clinical Trials Not Allowed Apply for RFA FD 19 022 Funding Number: RFA FD 19 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,750,000 |
| Cigar Tobacco Reference Products Program (UC2) Clinical Trials Not Allowed Apply for RFA FD 20 002 Funding Number: RFA FD 20 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,400,000 |
| Rare Disease Clinical Outcome Assessment Consortium (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 029 Funding Number: RFA FD 19 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 028 Funding Number: RFA FD 19 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Heart Failure Collaboratory (R18) Clinical Trials Optional Apply for RFA FD 20 005 Funding Number: RFA FD 20 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,150,000 |
| Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food Safety Modernization Act (FSMA) Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 20 006 Funding Number: RFA FD 20 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 20 004 Funding Number: RFA FD 20 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Bioequivalence of Topical Products: Elucidating Fundamental Principles of Dermal Pharmacokinetics for Microdialysis or Microperfusion Techniques (U01) Clinical Trials Not Allowed Apply for RFA FD 20 019 Funding Number: RFA FD 20 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Physiologically-based pharmacokinetic/pharmacodynamic model extrapolation to human from rabbit for ophthalmic drug products (U01) Clinical Trials Not Allowed Apply for RFA FD 20 018 Funding Number: RFA FD 20 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Transferring Harmonized Laboratory Data from Healthcare Institutions to Registries Using FHIR Protocol (U01) Clinical Trials Not Allowed Apply for RFA FD 20 017 Funding Number: RFA FD 20 017 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $800,000 |
| Center for Collaborative Research on Complex Generics (U18) Clinical Trials Optional Apply for RFA FD 20 007 Funding Number: RFA FD 20 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
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