Opportunity Information: Apply for RFA FD 14 083
Apply for RFA FD 14 083
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Development of Process Simulation and Modeling Tools for Integrated Pharmaceutical Manufacturing Processes (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Jun 18, 2014 and posted on May 19, 2014.
- Applicants must submit their applications by Jul 7, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $400,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Public and State controlled institutions of higher education County governments Small businesses Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Special district governments Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Native American tribal governments (Federally recognized) Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments).
- Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
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Opportunity Summary:
The Food and Drug Administration (FDA) is offering a discretionary grant opportunity titled "Development of Process Simulation and Modeling Tools for Integrated Pharmaceutical Manufacturing Processes (U01)" under Funding Opportunity Number RFA-FD-14-083. This award uses a cooperative agreement mechanism (U01), which generally means the FDA expects to have an active, collaborative role during the project rather than acting only as a passive funder. The program sits within the FDA research CFDA listing (93.103) and is tied to the broader public mission areas of consumer protection, food and nutrition, and health.
At its core, the opportunity is aimed at building a process simulation and modeling platform specifically designed for integrated pharmaceutical manufacturing. The emphasis is on solid-based drug products, which represent the bulk of marketed pharmaceutical dosage forms (for example, tablets and capsules). The project is meant to support modern manufacturing approaches by giving researchers and manufacturers better tools to understand and predict how different parts of the manufacturing process interact across an end-to-end workflow, rather than treating each unit operation in isolation.
A major goal of the platform is to strengthen process understanding and quality risk management. The FDA is looking for tools that can be used to perform risk assessments of manufacturing processes and their control strategies, meaning the models should help evaluate where failures or variability are most likely to occur and how well proposed controls prevent quality problems. Another key deliverable is the ability to identify critical material attributes (CMAs) and critical process parameters (CPPs) through sensitivity analysis. In practical terms, that means using modeling to determine which raw material properties (such as particle size distribution, moisture content, flowability, or compactability) and which processing settings (such as blending time, granulation conditions, compression force, feed rates, or drying parameters) most strongly influence final product quality.
The expected impact is a clearer, more quantitative understanding of how variability in incoming raw materials and manufacturing parameters translates into final drug product quality. This kind of modeling platform can support more robust process design, better control strategy development, and more reliable scale-up and tech transfer. It also aligns with quality-by-design and lifecycle management thinking by helping teams anticipate and manage sources of variability before they become batch failures or post-approval manufacturing issues.
In terms of funding, the FDA anticipates making two awards with an estimated total funding amount of $400,000. The award ceiling is $200,000, and there is no cost-sharing or matching requirement. Key dates listed for the opportunity include a posted date of May 19, 2014, an original closing date of June 30, 2014, and a revised closing date of July 7, 2014, with archiving on July 30, 2014.
Eligibility is broad and includes many organization types, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) organizations), small businesses, other for-profit organizations, and various levels of government (state, county, city/township, special district, independent school districts, and tribal governments and tribal organizations). Importantly, foreign participation is allowed: non-U.S. entities (foreign institutions) may apply, non-U.S. components of U.S. organizations are eligible, and foreign components (as defined under HHS grants policy) are permitted.
For applicants or interested parties who need help accessing the full announcement, the listed grants management contact is Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov. The opportunity also references an additional information link labeled "Full Announcement RFA FD 14 083," which would contain the detailed technical requirements, expected deliverables, submission instructions, and any FDA-specific collaborative expectations tied to the U01 mechanism.
Frequently Asked Questions (FAQs)
1. What is the title of this FDA grant opportunity?
The opportunity is titled "Development of Process Simulation and Modeling Tools for Integrated Pharmaceutical Manufacturing Processes (U01)."
2. What is the Funding Opportunity Number (FOA)?
The Funding Opportunity Number is RFA-FD-14-083.
3. What type of award mechanism is being used?
This opportunity uses a cooperative agreement mechanism (U01). This generally indicates that the FDA expects to have an active, collaborative role during the project rather than acting only as a passive funder.
4. What is the program and CFDA listing associated with this opportunity?
The opportunity sits within the FDA research CFDA listing 93.103.
5. What public mission areas does this program relate to?
The program is tied to broader public mission areas that include consumer protection, food and nutrition, and health.
6. What is the main purpose of the grant?
The main purpose is to build a process simulation and modeling platform specifically designed for integrated pharmaceutical manufacturing processes.
7. What does "integrated pharmaceutical manufacturing" mean in the context of this FOA?
In this context, the emphasis is on understanding and predicting how different parts of the manufacturing process interact across an end-to-end workflow, rather than treating each unit operation in isolation.
8. What types of drug products are emphasized?
The opportunity emphasizes solid-based drug products, such as tablets and capsules, which represent the bulk of marketed pharmaceutical dosage forms.
9. What are the core goals of the modeling and simulation platform?
The platform is expected to strengthen process understanding and quality risk management. It is also expected to support risk assessments of manufacturing processes and their control strategies.
10. How is "quality risk management" described for this project?
The FDA is looking for tools that can be used to evaluate where failures or variability are most likely to occur in manufacturing, and how well proposed control strategies prevent quality problems.
11. What are CMAs and CPPs, and what does the platform need to do with them?
The platform is expected to help identify critical material attributes (CMAs) and critical process parameters (CPPs) through sensitivity analysis. Practically, this means using modeling to determine which input material properties and processing settings most strongly influence final product quality.
12. What are examples of critical material attributes (CMAs) mentioned in the opportunity?
Examples include particle size distribution, moisture content, flowability, and compactability.
13. What are examples of critical process parameters (CPPs) mentioned in the opportunity?
Examples include blending time, granulation conditions, compression force, feed rates, and drying parameters.
14. What kind of insights or impact is FDA expecting from the project?
The expected impact is a clearer, more quantitative understanding of how variability in incoming raw materials and manufacturing parameters translates into final drug product quality.
15. How could the platform support manufacturing activities beyond modeling?
Based on the description, the platform is intended to support more robust process design, better control strategy development, and more reliable scale-up and tech transfer by helping teams anticipate and manage sources of variability.
16. How does this opportunity relate to modern manufacturing and quality approaches?
The project aligns with quality-by-design and lifecycle management thinking by helping teams anticipate and manage variability before it leads to batch failures or post-approval manufacturing issues.
17. How many awards does FDA expect to make?
The FDA anticipates making two awards.
18. What is the estimated total funding amount?
The estimated total funding amount is $400,000.
19. What is the maximum award amount (award ceiling) per award?
The award ceiling is $200,000.
20. Is cost sharing or matching required?
No. There is no cost-sharing or matching requirement.
21. What are the key dates for this opportunity?
Key dates include a posted date of May 19, 2014, an original closing date of June 30, 2014, a revised closing date of July 7, 2014, and an archiving date of July 30, 2014.
22. Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) organizations), small businesses, other for-profit organizations, and various levels of government (including state, county, city/township, special district, independent school districts, and tribal governments and tribal organizations).
23. Are for-profit organizations eligible?
Yes. Small businesses and other for-profit organizations are included in the eligibility categories listed.
24. Are government entities eligible, and which types are included?
Yes. The opportunity lists multiple government entity types as eligible, including state, county, city/township, special district, independent school districts, and tribal governments and tribal organizations.
25. Is foreign participation allowed?
Yes. Non-U.S. entities (foreign institutions) may apply, non-U.S. components of U.S. organizations are eligible, and foreign components (as defined under HHS grants policy) are permitted.
26. Where can applicants find the detailed technical requirements and submission instructions?
The opportunity references an additional information link labeled "Full Announcement RFA FD 14 083," which would contain the detailed technical requirements, expected deliverables, submission instructions, and FDA-specific collaborative expectations tied to the U01 mechanism.
27. Who is the grants management contact for questions about accessing the full announcement?
The listed grants management contact is Lisa Ko, Grants Management Specialist.
28. What is the contact email for the grants management specialist?
Lisa Ko can be reached at lisa.ko@fda.hhs.gov.
29. Why does the FOA emphasize sensitivity analysis?
Because the opportunity explicitly calls for identifying CMAs and CPPs through sensitivity analysis, which is described as a practical way to determine which material properties and processing settings most strongly drive final product quality.
30. What manufacturing stages or operations are implied by the CPP examples provided?
The CPP examples imply a range of common solid dosage manufacturing operations, including blending, granulation, compression, feeding/material transfer (feed rates), and drying.
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