Opportunity Information: Apply for RFA FD 13 020
Apply for RFA FD 13 020
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Collection of Dose Adjustment and Therapeutic Monitoring Data to Aid Narrow Therapeutic Index Drug Classification (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 May 17, 2013 and posted on Apr 2, 2013.
- Applicants must submit their applications by May 17, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Native American tribal governments (Federally recognized) Independent school districts Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Public housing authorities/Indian housing authorities For profit organizations other than small businesses State governments Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Special district 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:
This funding opportunity from the U.S. Food and Drug Administration (FDA) focuses on improving how certain high-risk medicines are evaluated and regulated, especially when generic versions are involved. The grant targets what are known as narrow therapeutic index (NTI) drugs, meaning medications where even small changes in dose or blood concentration can quickly shift a patient from effective treatment into treatment failure or serious side effects. Because the safety margin is so tight, FDA has treated NTI drugs as a special case, and in 2011 the agency proposed stricter standards for drug quality and bioequivalence (BE). Bioequivalence is the evidence that a generic performs essentially the same as the brand product in the body, and the rationale here is straightforward: when the therapeutic window is narrow, small formulation differences that might be acceptable for other drugs can become clinically meaningful.
A major practical problem, and the central reason for this grant, is that FDA needs solid, real-world evidence to decide which drugs truly belong in the NTI category. The opportunity is designed to support the collection of dose adjustment and therapeutic drug monitoring data from patients in clinical practice. In routine care, clinicians often adjust doses based on lab values, measured drug blood concentrations, clinical response, and signs of toxicity. Those adjustments, and the monitoring patterns behind them, can reveal how sensitive a drug is to small changes in exposure. By systematically collecting and analyzing these real-world data, researchers can help clarify the relationship among dose, blood concentration, and patient outcomes. That evidence can then be used to inform FDA decisions about whether a drug should be classified as NTI and therefore subject to tighter review criteria for quality and BE.
The intended outcome is not simply an academic dataset. FDA is aiming for results that can directly support policy implementation, including building or refining an NTI drug list and applying NTI-specific regulatory standards more consistently. In other words, the work funded under this announcement is meant to strengthen the scientific foundation for which drugs get stricter generic equivalence standards, ultimately improving confidence that generic NTI drugs are therapeutically equivalent and safe for patients who depend on precise dosing.
Administratively, the opportunity is listed as Funding Opportunity Number RFA-FD-13-020, titled "Collection of Dose Adjustment and Therapeutic Monitoring Data to Aid Narrow Therapeutic Index Drug Classification (U01)." The funding mechanism is a cooperative agreement (U01), which typically means FDA expects substantial involvement or collaboration during the project rather than a hands-off grant. It falls under the broad activity area of consumer protection and health, and it is associated with CFDA number 93.103 (Food and Drug Administration Research). The announcement anticipated two awards, with an estimated total funding amount of $500,000 and an award ceiling of $250,000 per award. There is no cost-sharing or matching requirement.
Eligibility is broad and includes 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 those with and without 501(c)(3) status), public housing authorities/Indian housing authorities, small businesses, and other for-profit organizations (with small businesses explicitly included and other for-profits allowed). Importantly, the announcement also allows participation from outside the United States: non-U.S. entities (foreign institutions) are eligible, non-U.S. components of U.S. organizations may apply, and foreign components are permitted consistent with the HHS Grants Policy Statement.
Key dates show the posting date as April 2, 2013, with the closing date of May 17, 2013, and the archive date of June 16, 2013, indicating this is an older, archived opportunity rather than an active solicitation. The full announcement was linked through the NIH Guide for Grants and Contracts. For administrative questions or difficulty accessing the full announcement, the listed FDA grants management contact was Lisa Ko (lisa.ko@fda.hhs.gov).
Frequently Asked Questions (FAQs)
What is this FDA funding opportunity about?
This opportunity supports research to improve how certain high-risk medicines are evaluated and regulated, especially when generic versions are involved. The focus is on collecting and analyzing real-world clinical data (dose adjustments and therapeutic drug monitoring) that can help FDA decide which drugs should be classified as narrow therapeutic index (NTI) drugs.
What are narrow therapeutic index (NTI) drugs?
NTI drugs are medications where small changes in dose or blood concentration can quickly move a patient from effective therapy into treatment failure or serious side effects. Because the safety margin is very tight, even minor formulation or exposure differences may matter clinically.
Why is FDA interested in NTI drugs in the context of generic drugs?
For NTI drugs, small differences that might be acceptable for other medicines can become clinically meaningful. FDA has treated NTI drugs as a special case and proposed stricter standards for drug quality and bioequivalence (BE) to ensure that generic versions perform essentially the same as the brand product in the body.
What does bioequivalence (BE) mean in this announcement?
Bioequivalence is evidence that a generic drug performs essentially the same as the brand product in the body. In the NTI context, FDA is concerned that small differences in exposure could lead to reduced effectiveness or increased toxicity.
What problem is this grant designed to address?
A central issue is that FDA needs strong, real-world evidence to determine which drugs truly belong in the NTI category. This grant is designed to support the collection of dose adjustment and therapeutic monitoring data from routine clinical practice so researchers can better characterize how sensitive certain drugs are to small changes in exposure.
What kind of data is FDA looking to have collected?
The opportunity emphasizes real-world clinical practice data such as dose adjustment information and therapeutic drug monitoring data. In routine care, clinicians may adjust doses based on lab values, measured blood concentrations, clinical response, and signs of toxicity. The patterns and outcomes associated with these adjustments are the types of evidence this program is meant to capture and analyze.
How would collecting dose adjustment and monitoring data help classify a drug as NTI?
By systematically collecting and analyzing real-world data, researchers can clarify the relationship among dose, blood concentration, and patient outcomes (including response and toxicity). This evidence can help FDA determine whether a drug behaves like an NTI drug in practice and whether it should be subject to tighter quality and BE review criteria.
What is the intended outcome of the funded work?
The intended outcome is to generate results that can directly support policy implementation. FDA is aiming to use the evidence to build or refine an NTI drug list and apply NTI-specific regulatory standards more consistently, strengthening confidence that generic NTI drugs are therapeutically equivalent and safe for patients who require precise dosing.
What is the Funding Opportunity Number and title?
The Funding Opportunity Number is RFA-FD-13-020. The title is "Collection of Dose Adjustment and Therapeutic Monitoring Data to Aid Narrow Therapeutic Index Drug Classification (U01)."
What funding mechanism is used (and what does it imply)?
The mechanism is a cooperative agreement (U01). A U01 typically means FDA expects substantial involvement or collaboration during the project rather than a fully hands-off relationship.
What is the activity area and CFDA number associated with this opportunity?
The opportunity falls under the broad activity area of consumer protection and health. It is associated with CFDA number 93.103 (Food and Drug Administration Research).
How many awards were anticipated and what was the estimated funding?
The announcement anticipated two awards. The estimated total funding amount was $500,000, with an award ceiling of $250,000 per award.
Is there a cost-sharing or matching requirement?
No. The announcement states there is no cost-sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad and includes many types of applicants, including:
- State and local governments
- Tribal governments and tribal organizations
- Public and private institutions of higher education
- Nonprofits (including those with and without 501(c)(3) status)
- Public housing authorities/Indian housing authorities
- Small businesses
- Other for-profit organizations
Are non-U.S. (foreign) organizations eligible?
Yes. The announcement allows participation from outside the United States, including non-U.S. entities (foreign institutions). It also allows non-U.S. components of U.S. organizations to apply, and foreign components are permitted consistent with the HHS Grants Policy Statement.
What were the key dates for this opportunity?
The posting date was April 2, 2013. The closing date was May 17, 2013. The archive date was June 16, 2013.
Is this an active funding opportunity?
Based on the dates provided (including an archive date in 2013), this appears to be an older, archived opportunity rather than an active solicitation.
Where was the full announcement posted?
The full announcement was linked through the NIH Guide for Grants and Contracts.
Who is the listed contact for administrative questions or access issues?
The listed FDA grants management contact is Lisa Ko. Email: lisa.ko@fda.hhs.gov.
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Applicants who have applied for this opportunity (RFA FD 13 020) also looked into and applied for these:
| Funding Opportunity |
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| Evaluation of Dissolution Methods for Complex Parenteral Dosage Forms (U01) Apply for RFA FD 13 019 Funding Number: RFA FD 13 019 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Development of an Integrated Mathematical Model for Comparative Characterization of Complex Molecules (U01) Apply for RFA FD 14 082 Funding Number: RFA FD 14 082 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $600,000 |
| Development of Process Simulation and Modeling Tools for Integrated Pharmaceutical Manufacturing Processes (U01) Apply for RFA FD 14 083 Funding Number: RFA FD 14 083 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $200,000 |
| The Use of Polyethylene Glycol in the Pediatric Population (R01) Apply for RFA FD 14 088 Funding Number: RFA FD 14 088 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $325,000 |
| Predictive in vitro Methods for Characterizing Product Performance, Case Study Furosemide (U01) Apply for RFA FD 14 080 Funding Number: RFA FD 14 080 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $100,000 |
| Evaluating Predictive Methods and Product Performance in Healthy Adults for Pediatric Patients, Case Study Furosemide (U01) Apply for RFA FD 14 081 Funding Number: RFA FD 14 081 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $100,000 |
| Kidney Health Initiative (R18) Apply for RFA FD 14 018 Funding Number: RFA FD 14 018 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Dissolution Methods for Long acting Levonorgestrel Intrauterine System (U01) Apply for RFA FD 15 006 Funding Number: RFA FD 15 006 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $125,000 |
| Dissolution Methods for Long acting Periodontal Drug Products (U01) Apply for RFA FD 15 007 Funding Number: RFA FD 15 007 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $125,000 |
| Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01) Apply for RFA FD 15 008 Funding Number: RFA FD 15 008 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $200,000 |
| Limited Competition for Revision Applications for Evaluation of Formulation Effects of Metered Dose Inhalers on Pharmacokinetics (U01) Apply for RFA FD 15 016 Funding Number: RFA FD 15 016 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $800,000 |
| Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01) Apply for RFA FD 15 032 Funding Number: RFA FD 15 032 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $250,000 |
| Post market Surveillance of Generic Modified Release Products (U01) Apply for RFA FD 15 015 Funding Number: RFA FD 15 015 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Building towards Statistically Based Pharmaceutical Quality Standards (U01) Apply for RFA FD 15 031 Funding Number: RFA FD 15 031 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
| 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 |
| Program Expansion for Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas to add a Medical Device Module for Secure Regulatory Information Exchange (U01) Apply for RFA FD 15 040 Funding Number: RFA FD 15 040 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 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 |
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