Opportunity Information: Apply for RFA FD 15 031
Apply for RFA FD 15 031
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Building towards Statistically Based Pharmaceutical Quality Standards (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 12, 2015 and posted on Apr 29, 2015.
- Applicants must submit their applications by Jul 7, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Native American tribal governments (Federally recognized) For profit organizations other than small businesses Public housing authorities/Indian housing authorities City or township governments Independent school districts Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Public and State controlled institutions of higher education Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State 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:
Building towards Statistically Based Pharmaceutical Quality Standards (U01) is a cooperative agreement funding opportunity from the U.S. Food and Drug Administration (FDA), focused on strengthening how pharmaceutical quality decisions are supported by data and statistics. The central purpose is to generate practical datasets and develop statistical sampling and analysis strategies that can directly inform FDA Center for Drug Evaluation and Research (CDER) policy. In plain terms, the agency is looking for work that helps turn pharmaceutical quality oversight into something more consistently measurable and evidence-driven, so future guidance documents and standards are based on defensible statistical approaches rather than ad hoc or purely traditional practices.
A major theme of the opportunity is "lot release" decision-making, meaning the determination that a manufactured batch (lot) of a drug product meets required quality specifications before it can be distributed. The grant aims to support the development of standards for statistical methods that are appropriate for lot release, including how to sample, how many samples to take, how to analyze results, and how to interpret uncertainty and risk. By creating and validating these statistical tools, the program is intended to encourage industry to deepen product and process understanding across a product's full lifecycle, from development through commercial manufacturing and ongoing changes. That lifecycle emphasis aligns with modern pharmaceutical quality frameworks where manufacturers are expected to monitor processes continuously, understand sources of variability, and control them proactively.
The work supported under this announcement is also explicitly tied to risk- and science-based standards. That means projects should help the FDA and the human pharmaceutical industry move toward approaches that account for factors like variability, manufacturing complexity, and the clinical consequences of quality failures. The opportunity recognizes that one-size-fits-all statistical approaches are often inadequate in pharmaceuticals, so it allows (and even encourages) projects to be divided into subsets, for example by product type (such as different dosage forms), process type (different manufacturing methods), the complexity of manufacturing operations, and/or therapeutic index (how narrow the margin is between effective and toxic doses). Structuring research this way can make the resulting standards more realistic and easier to apply to specific categories of products where risk profiles differ substantially.
Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism (U01). A cooperative agreement generally means there is expected to be substantial involvement from the FDA during the project compared to a more hands-off grant mechanism. The program was posted on April 29, 2015, with an application closing date of July 7, 2015, and it was later archived on August 6, 2015. The FDA anticipated making about two awards, with an estimated total program funding level of $2,000,000 and an award ceiling of $1,000,000 per award. No cost sharing or matching was required.
Eligibility was broad and included many types of domestic applicants such as state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities), small businesses, and for-profit organizations other than small businesses. Importantly, the announcement stated that non-U.S. entities (foreign institutions) were eligible to apply, and that foreign components of U.S. organizations were allowed under HHS policy, which signals an openness to global expertise in statistical methods and pharmaceutical manufacturing science.
The opportunity is listed under CFDA 93.103 (Food and Drug Administration Research) and the activity category is described broadly under consumer protection, food and nutrition, and health, reflecting the public health motivation: improving the reliability and scientific basis of quality standards ultimately helps prevent substandard or inconsistent medicines from reaching patients. For applicants seeking the full details at the time, the announcement directed them to the full RFA listing in the NIH Guide for Grants and Contracts, and provided a grants management contact (Lisa Ko, lisa.ko@fda.hhs.gov) for access issues.
Frequently Asked Questions (FAQs)
What is the "Building towards Statistically Based Pharmaceutical Quality Standards (U01)" opportunity?
It is a U.S. Food and Drug Administration (FDA) cooperative agreement funding opportunity focused on strengthening how pharmaceutical quality decisions are supported by data and statistics. The aim is to generate practical datasets and develop statistical sampling and analysis strategies that can directly inform FDA Center for Drug Evaluation and Research (CDER) policy.
Which FDA area is expected to use the results from funded projects?
The opportunity is intended to inform policy within the FDA Center for Drug Evaluation and Research (CDER), especially in ways that improve how pharmaceutical quality oversight is measured and supported by statistically defensible approaches.
What is the central purpose of the program?
The central purpose is to produce practical datasets and develop statistical sampling and analysis strategies that can directly inform CDER policy. In practical terms, FDA is seeking work that makes pharmaceutical quality decision-making more consistently measurable and evidence-driven, supporting future guidance documents and standards with defensible statistical methods rather than ad hoc or purely traditional practices.
What is meant by "lot release" in this announcement?
"Lot release" refers to the decision that a manufactured batch (lot) of a drug product meets required quality specifications before it can be distributed. A major theme of the program is improving statistical methods that support these lot release decisions.
What kinds of statistical methods is FDA looking to support for lot release?
The opportunity supports development of standards for statistical methods appropriate for lot release, including how to sample, how many samples to take, how to analyze results, and how to interpret uncertainty and risk.
What types of project outputs are emphasized?
The announcement emphasizes generating practical datasets and developing (and validating) statistical sampling and analysis strategies. These outputs are intended to be usable for policy development and for establishing more consistent, statistically based standards.
How does the program connect to the pharmaceutical product lifecycle?
The program is intended to encourage deeper product and process understanding across a product's full lifecycle, from development through commercial manufacturing and ongoing changes. This aligns with modern quality frameworks that emphasize continuous monitoring, understanding sources of variability, and proactive control.
What does "risk- and science-based standards" mean in this context?
It means projects should help move toward approaches that account for variability, manufacturing complexity, and the clinical consequences of quality failures. The intent is to support standards grounded in science and risk considerations rather than uniform approaches that may not fit all products.
Does the opportunity allow different approaches for different types of drug products or processes?
Yes. The announcement recognizes that one-size-fits-all statistical approaches can be inadequate and explicitly allows (and encourages) dividing projects into subsets, such as by product type (for example, different dosage forms), process type (different manufacturing methods), manufacturing complexity, and/or therapeutic index.
Why does the announcement mention therapeutic index?
Therapeutic index is referenced as one way to segment or tailor research because it reflects how narrow the margin is between effective and toxic doses. Products with different therapeutic index profiles can have substantially different risk considerations for quality failures.
What funding mechanism is used?
The opportunity uses a cooperative agreement mechanism (U01), which is a discretionary funding mechanism.
What does it mean that this is a cooperative agreement (U01)?
A cooperative agreement generally means there is expected to be substantial involvement from the FDA during the project compared to a more hands-off grant mechanism.
When was this opportunity posted, and when was the application due?
The opportunity was posted on April 29, 2015, with an application closing date of July 7, 2015.
Is this opportunity still active?
No. The announcement was later archived on August 6, 2015.
How many awards did FDA anticipate making?
FDA anticipated making about two awards under this program.
What was the estimated total program funding level?
The estimated total program funding level was $2,000,000.
What was the maximum award amount (award ceiling)?
The award ceiling was $1,000,000 per award.
Was cost sharing or matching required?
No cost sharing or matching was required.
Who was eligible to apply?
Eligibility was broad and included many types of domestic applicants, such as state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities), small businesses, and for-profit organizations other than small businesses.
Are non-U.S. (foreign) institutions eligible to apply?
Yes. The announcement stated that non-U.S. entities (foreign institutions) were eligible to apply.
Are foreign components of U.S. organizations allowed?
Yes. Foreign components of U.S. organizations were allowed under HHS policy, as stated in the announcement.
What is the CFDA number for this opportunity?
The opportunity is listed under CFDA 93.103 (Food and Drug Administration Research).
How is the activity category described?
The activity category is described broadly under consumer protection, food and nutrition, and health, reflecting the public health motivation of improving the reliability and scientific basis of pharmaceutical quality standards.
How do applicants access full details about the announcement?
Applicants were directed to the full RFA listing in the NIH Guide for Grants and Contracts for complete details.
Who was the grants management contact listed for access issues?
The announcement provided a grants management contact for access issues: Lisa Ko (lisa.ko@fda.hhs.gov).
What is the public health rationale behind this funding opportunity?
The opportunity reflects a public health goal: improving the reliability and scientific basis of quality standards helps prevent substandard or inconsistent medicines from reaching patients.
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 15 031) also looked into and applied for these:
| Funding Opportunity |
|---|
| Development and Application of Case Control Analysis for Generic Drugs (U01) Apply for RFA FD 15 027 Funding Number: RFA FD 15 027 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $200,000 |
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| Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01) Apply for RFA FD 15 036 Funding Number: RFA FD 15 036 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01) Apply for RFA FD 15 014 Funding Number: RFA FD 15 014 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Smokeless Tobacco Reference Products (UC2) Apply for RFA FD 15 026 Funding Number: RFA FD 15 026 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $3,000,000 |
| Building towards Statistically Based Pharmaceutical Quality Standards (U01) Apply for RFA FD 16 003 Funding Number: RFA FD 16 003 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
| Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01) Apply for RFA FD 16 004 Funding Number: RFA FD 16 004 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
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