Opportunity Information: Apply for RFA FD 11 029
Apply for RFA FD 11 029
- The Food Drug Administration in the agriculture business and commerce consumer protection health sector is offering a public funding opportunity titled "Quality by Design for Orally Inhaled Drugs Chemistry, Manufacturing, and Controls (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 Jul 18, 2011 and posted on Jul 18, 2011.
- Applicants must submit their applications by Aug 15, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $160,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $160,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: For profit organizations other than small businesses 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 Native American tribal governments (Federally recognized) Independent school districts County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments.
- Non domestic (non U.S.) Entities (Foreign Organizations) are eligible to apply. Foreign (non U.S.) components of U.S. Organizations are allowed.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The Food and Drug Administration (FDA) funding opportunity RFA-FD-11-029, titled "Quality by Design for Orally Inhaled Drugs Chemistry, Manufacturing, and Controls (U01)," is a cooperative agreement focused on strengthening the chemistry, manufacturing, and controls (CMC) science behind dry powder inhaler (DPI) drug products. The central theme is applying Quality by Design (QbD) principles to better understand, measure, and control the material attributes and process factors that drive consistency and performance in orally inhaled medicines. In practical terms, the grant is aimed at improving the predictability and robustness of DPI product quality by targeting the earliest and most influential stage of the supply chain: the active pharmaceutical ingredient (API) crystal manufacturing and its downstream micronization.
A major emphasis of the project is controlling how API crystals are manufactured so that, after micronization, the resulting fine API particles are consistent from batch to batch and show low variability. For DPI products, micronized API properties can strongly influence critical aspects of aerosol performance and dose delivery, so variability at the crystal stage can cascade into variability in the finished product. The opportunity therefore prioritizes research that can identify and implement tighter control strategies during crystal production, with the goal of producing micronized materials that behave more consistently during blending, filling, and inhaler actuation.
Another core objective is defining the critical quality attributes (CQAs) of API crystals that should be measured and controlled to ensure the final DPI product meets quality expectations. This is about determining which crystal-level properties truly matter for downstream performance and establishing an evidence-based measurement and control framework. The intent aligns with QbD thinking: rather than relying on end-product testing alone, the program encourages identifying the material attributes that are predictive of quality and using them to build a more reliable control strategy across the process.
The announcement also stresses the need to clarify the relationship between the properties of API crystals and the quality of micronized API materials that will ultimately be incorporated into the final DPI drug product. In other words, the grant is seeking a deeper, mechanistic connection between "what you start with" (the crystal form and its attributes) and "what you end up with" after micronization (the fine particle material that drives aerosolization and performance). This kind of linkage supports more rational process design, better risk assessments, and more defensible specifications, all of which are central to QbD and modern pharmaceutical development expectations.
A specific technical topic highlighted is the effect of post-micronization relaxation of micronized API on product performance, with an explicit goal of understanding whether, when, and how long micronized API should be held (sometimes referred to as "lagering") or quarantined before it is used in the finished product. Micronization can introduce changes in particle surface energy, morphology, or other physical characteristics that may evolve over time, potentially altering blend uniformity, dispersion, or aerosol performance. The opportunity is pointing to a need for data-driven guidance on these post-processing hold steps so manufacturers can set appropriate quarantine times and storage conditions based on performance impact rather than tradition or conservative assumptions.
From an administrative standpoint, this was a discretionary FDA research opportunity under CFDA 93.103 (Food and Drug Administration Research) using a cooperative agreement mechanism (U01), which typically indicates substantial scientific or programmatic involvement by the funding agency during the project. The opportunity anticipated a single award, with an estimated total funding level of $160,000 and an award ceiling of $160,000 (award floor listed as $1). No cost sharing or matching was required. The posting date was July 18, 2011, with an original and current closing date of August 15, 2011, and an archive date of September 14, 2011.
Eligibility was broad and included for-profit organizations (other than small businesses), various nonprofit categories, local and county governments, independent school districts, and Native American tribal organizations and governments. Importantly, the opportunity allowed non-U.S. (foreign) organizations to apply, and also allowed foreign components of U.S. organizations, which signals an openness to international expertise where it can advance the science and practical control of DPI CMC challenges.
For applicants needing help accessing the full announcement, the listed grants management contact was Lisa Ko (lisa.ko@fda.hhs.gov), and an NIH Guide announcement link was referenced for additional details.
FAQs: FDA Grant RFA-FD-11-029 (U01) - Quality by Design for Orally Inhaled Drugs (CMC)
What is the official title and number of this funding opportunity?
The opportunity is FDA RFA-FD-11-029, titled "Quality by Design for Orally Inhaled Drugs Chemistry, Manufacturing, and Controls (U01)."
Which agency is offering this grant?
The funding opportunity is offered by the U.S. Food and Drug Administration (FDA).
What kind of award mechanism is being used?
This opportunity uses a cooperative agreement mechanism (U01). A U01 typically involves substantial scientific or programmatic involvement by the funding agency during the project.
What is the CFDA number associated with this opportunity?
The CFDA number is 93.103, listed as "Food and Drug Administration Research."
Is this considered a discretionary research opportunity?
Yes. It is described as a discretionary FDA research opportunity.
What is the overall purpose of this grant?
The central purpose is to strengthen the chemistry, manufacturing, and controls (CMC) science behind dry powder inhaler (DPI) drug products by applying Quality by Design (QbD) principles. The focus is on improving predictability and robustness of DPI product quality by better understanding, measuring, and controlling material attributes and process factors that drive consistent performance.
What product type is the program focused on?
The program is focused on orally inhaled medicines, specifically dry powder inhaler (DPI) drug products.
What part of the supply chain does the opportunity emphasize?
A major emphasis is the earliest and most influential stage: active pharmaceutical ingredient (API) crystal manufacturing and its downstream micronization.
Why is API crystal manufacturing a central focus?
The opportunity prioritizes controlling how API crystals are manufactured so that, after micronization, the resulting fine API particles are consistent from batch to batch and show low variability. The rationale is that variability introduced at the crystal stage can cascade into variability in the finished DPI product.
How does micronized API variability affect DPI products?
For DPI products, micronized API properties can strongly influence critical aspects of aerosol performance and dose delivery. If micronized API properties vary, performance and delivered dose consistency can also vary.
What does the opportunity mean by applying Quality by Design (QbD) principles here?
In this context, QbD means moving beyond reliance on end-product testing alone and instead identifying the material attributes and process factors that are predictive of quality. The goal is to use that understanding to design stronger measurement and control strategies across the manufacturing process.
What are the main scientific objectives described in the announcement?
Key objectives include: (1) tighter control strategies during API crystal production to reduce downstream variability after micronization; (2) defining which crystal-level critical quality attributes (CQAs) should be measured and controlled to ensure the final DPI product meets quality expectations; and (3) clarifying the relationship between API crystal properties and the quality of the resulting micronized API material used in the final DPI product.
What are CQAs in the context of this opportunity?
CQAs (critical quality attributes) are the API crystal properties that should be measured and controlled because they matter for downstream performance and ultimately for meeting final DPI product quality expectations. The opportunity emphasizes establishing an evidence-based measurement and control framework for these attributes.
What relationship is the FDA seeking to clarify through this research?
The announcement stresses the need to clarify a mechanistic link between "what you start with" (API crystal form and attributes) and "what you end up with" after micronization (fine particle material properties that drive aerosolization and performance). This linkage supports rational process design, better risk assessment, and more defensible specifications.
Does the opportunity mention any specific post-processing topic after micronization?
Yes. A highlighted topic is post-micronization relaxation of micronized API and the potential impact on product performance. The opportunity explicitly calls for understanding whether, when, and how long micronized API should be held (sometimes called "lagering") or quarantined before use in the finished product.
What is meant by post-micronization "relaxation" or "lagering" in this context?
The announcement describes that micronization can introduce changes in particle surface energy, morphology, or other physical characteristics that may evolve over time. "Relaxation" or "lagering" refers to holding the micronized API for a period before use, potentially allowing these properties to stabilize.
Why does the grant emphasize data-driven guidance on quarantine or hold times?
The stated intent is to enable manufacturers to set appropriate quarantine times and storage conditions based on performance impact rather than tradition or overly conservative assumptions, since time-dependent changes could affect blend uniformity, dispersion, or aerosol performance.
How many awards were anticipated?
The opportunity anticipated a single award.
What is the estimated total funding amount for this opportunity?
The estimated total funding level is $160,000.
What are the award ceiling and floor?
The award ceiling is $160,000, and the award floor is listed as $1.
Is cost sharing or matching required?
No. The opportunity states that no cost sharing or matching is required.
When was the opportunity posted?
The posting date listed is July 18, 2011.
What was the closing date for applications?
The original and current closing date listed is August 15, 2011.
When was the opportunity archived?
The archive date listed is September 14, 2011.
Who is eligible to apply?
Eligibility is broad and includes: for-profit organizations (other than small businesses), various nonprofit categories, local and county governments, independent school districts, and Native American tribal organizations and governments.
Are non-U.S. (foreign) organizations eligible?
Yes. The opportunity allows non-U.S. (foreign) organizations to apply.
Are foreign components of U.S. organizations allowed?
Yes. The opportunity allows foreign components of U.S. organizations.
What does the inclusion of foreign applicants suggest about the program?
Based on the announcement language, it signals openness to international expertise when it can advance the science and practical control strategies for DPI CMC challenges.
Who is the grants management contact for accessing the full announcement?
The listed grants management contact is Lisa Ko at lisa.ko@fda.hhs.gov.
Is there a reference to where additional details can be found?
Yes. The information mentions that an NIH Guide announcement link was referenced for additional details.
Browse more opportunities from the same agency: Food Drug Administration
Browse more opportunities from the same category: Agriculture Business and Commerce Consumer Protection Health
Next opportunity: Ethical, Legal, and Social Implications (ELSI) of Genomic Research Small Research Grant Program (R03)
Previous opportunity: Sexual Violence Prevention and Education
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA FD 11 029
[Watch] how do funding administrators access proposals?
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA FD 11 029", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.