Opportunity Information: Apply for RFA FD 14 015
Apply for RFA FD 14 015
- The Food Drug Administration in the health science and technology and other research and development sector is offering a public funding opportunity titled "Pharmacokinetic/Pharmacodynamic (PK/PD) Studies of Methylphenidate Extended Release Products in Attention Deficit Hyperactivity Disorder (ADHD) Patients (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 Apr 29, 2014 and posted on Apr 29, 2014.
- Applicants must submit their applications by Jun 11, 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 $1,000,000.00 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 1 candidate(s).
- Eligible applicants include: 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 County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility Others (see text field entitled Additional Information on Eligibility for clarification) State governments Native American tribal governments (Federally recognized) Special district governments Small businesses For profit organizations other than small businesses Private institutions of higher education Independent school districts.
- FOREIGN INSTITUTIONS ARE ELIGIBLE TO APPLY
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Opportunity Summary:
This funding opportunity (RFA FD 14 015) is a Food and Drug Administration (FDA) cooperative agreement (U01) focused on improving how therapeutic equivalence is evaluated for generic methylphenidate extended-release (ER) products used to treat attention deficit hyperactivity disorder (ADHD). The core goal is to run a prospective pharmacokinetic/pharmacodynamic (PK/PD) study in actual ADHD patients that directly links how methylphenidate concentrations change in the body over time (PK) with how clinical or functional effects change over time (PD). By connecting these two time courses, the project aims to determine whether there are additional PK metrics beyond the usual bioequivalence measures that meaningfully influence real-world therapeutic performance for ER formulations.
The scientific rationale behind the project is that extended-release products can produce complex concentration-time profiles, and small differences in release patterns may translate into noticeable differences in symptom control at specific times of day, even if standard summary measures used in bioequivalence testing look similar. The FDA is therefore seeking evidence that ties PK profiles to clinically relevant PD outcomes across the dosing interval, with the intent of identifying any extra or alternative PK measures that better predict comparable therapeutic effect. In practical terms, the study is meant to answer whether the conventional PK endpoints used to support generic approval fully capture the features of ER methylphenidate exposure that matter to patients, clinicians, and regulators, or whether different metrics are needed to ensure that two ER products perform similarly throughout the day.
From a regulatory and public health standpoint, the deliverable is not just a dataset but a basis for clearer scientific and regulatory standards. The FDA is explicitly positioning the findings as potentially informing how it assures therapeutic equivalence for generic methylphenidate ER products, meaning the results could influence future expectations for demonstrating equivalence, especially for formulations where timing of effect is critical. If the study identifies PK characteristics that correlate more strongly with PD response, those measures could become part of the evidence framework used to evaluate or refine bioequivalence approaches for these products.
Administratively, the award mechanism is a cooperative agreement, which typically indicates substantial programmatic involvement from the FDA compared with a standard grant. The opportunity sits in the Health Science and Technology / Research and Development category, is associated with CFDA number 93.103 (FDA Research), and was posted on April 29, 2014 with a closing date of June 11, 2014 (archived July 11, 2014). The FDA expected to make one award, with an estimated total funding level of $1,000,000. The stated award floor is $950,000 and the ceiling is $1,000,000, and there is no cost-sharing or matching requirement, meaning applicants were not required to provide non-federal funds as a condition of the award.
Eligibility was broad and included a wide range of domestic entities such as state, county, city, township, and special district governments; public and private institutions of higher education; independent school districts; nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) nonprofits); public housing authorities/Indian housing authorities; Native American tribal governments and other tribal organizations; small businesses; and other for-profit organizations. Importantly, the announcement specifies that foreign institutions were eligible to apply, which expands the potential applicant pool to experienced international research centers capable of conducting rigorous PK/PD clinical studies in ADHD populations.
The sponsoring agency is the Food and Drug Administration. For assistance accessing the full announcement, the listed grants management contact was Martin Bernard, Grants Management Specialist, reachable by phone at 240-402-7564 through the FDA office.
Frequently Asked Questions (FAQs)
What is the title or identifier of this funding opportunity?
This opportunity is identified as RFA FD 14 015.
Which federal agency is offering this award?
The sponsoring agency is the U.S. Food and Drug Administration (FDA).
What type of funding mechanism is being used?
The award mechanism is a cooperative agreement (U01), which generally means the FDA is expected to have substantial programmatic involvement compared with a standard grant.
What is the main purpose of the project?
The core goal is to improve how therapeutic equivalence is evaluated for generic methylphenidate extended-release (ER) products used to treat attention deficit hyperactivity disorder (ADHD), by generating evidence that links drug exposure over time to clinically relevant effects over time.
What study is the FDA seeking to fund?
The FDA is seeking a prospective pharmacokinetic/pharmacodynamic (PK/PD) study conducted in actual ADHD patients, designed to directly connect methylphenidate concentration-time profiles (PK) with clinical or functional effect-time profiles (PD) across the dosing interval.
What does PK/PD mean in the context of this opportunity?
PK (pharmacokinetics) refers to how methylphenidate concentrations change in the body over time. PD (pharmacodynamics) refers to how clinical or functional effects change over time. This opportunity focuses on linking these two time courses in ADHD patients.
Why is the FDA focusing on extended-release (ER) methylphenidate products?
Extended-release products can produce complex concentration-time profiles. The FDA notes that small differences in release patterns may translate into noticeable differences in symptom control at specific times of day, even when standard bioequivalence summary measures appear similar.
What problem is this project trying to address with current bioequivalence approaches?
The project is intended to help determine whether conventional PK endpoints used to support generic approval fully capture the features of ER methylphenidate exposure that matter to therapeutic performance throughout the day, or whether additional or alternative PK metrics are needed.
What are the expected scientific outcomes?
The study is expected to generate evidence linking PK profiles to clinically relevant PD outcomes across the dosing interval and to identify whether there are PK metrics beyond usual bioequivalence measures that meaningfully influence real-world therapeutic performance for ER formulations.
How could the results be used by the FDA?
The FDA positions the findings as potentially informing how it assures therapeutic equivalence for generic methylphenidate ER products. If certain PK characteristics correlate more strongly with PD response, those measures could influence future expectations or refinements in bioequivalence approaches for these products.
Is the deliverable limited to producing a dataset?
No. While data generation is central, the description emphasizes that the deliverable includes a basis for clearer scientific and regulatory standards related to therapeutic equivalence for generic methylphenidate ER products.
What category does this opportunity fall under?
The opportunity is listed under Health Science and Technology / Research and Development.
What CFDA number is associated with this opportunity?
The associated CFDA number is 93.103 (FDA Research).
How many awards did the FDA expect to make?
The FDA expected to make one award.
What is the estimated total funding level?
The estimated total funding level is $1,000,000.
What are the award floor and ceiling amounts?
The stated award floor is $950,000 and the ceiling is $1,000,000.
Is cost-sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement, meaning applicants were not required to provide non-federal funds as a condition of the award.
When was the opportunity posted and when did it close?
It was posted on April 29, 2014, with a closing date of June 11, 2014.
Is this opportunity still active?
The listing indicates it was archived on July 11, 2014.
Who was eligible to apply?
Eligibility was broad and included many domestic entity types, such as state, county, city, township, and special district governments; public and private institutions of higher education; independent school districts; nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits); public housing authorities/Indian housing authorities; Native American tribal governments and other tribal organizations; small businesses; and other for-profit organizations.
Were foreign institutions eligible to apply?
Yes. The announcement specifies that foreign institutions were eligible, expanding the applicant pool to international research centers capable of conducting rigorous PK/PD clinical studies in ADHD populations.
What therapeutic area and patient population does the study focus on?
The focus is ADHD patients receiving methylphenidate extended-release products, with the study designed to measure clinical or functional effects over time in relation to methylphenidate exposure over time.
What products are specifically in scope?
Generic methylphenidate extended-release (ER) products used to treat ADHD are the focus, with emphasis on evaluating therapeutic equivalence for ER formulations.
What is the key scientific question the FDA wants answered?
Whether there are additional PK metrics beyond standard bioequivalence measures that better predict comparable therapeutic effect for methylphenidate ER products throughout the dosing interval.
Who is the listed grants management contact for help accessing the full announcement?
The listed contact is Martin Bernard, Grants Management Specialist, reachable by phone at 240-402-7564.
What kind of FDA involvement should applicants expect under a cooperative agreement?
Because the mechanism is a cooperative agreement (U01), the description indicates substantial programmatic involvement from the FDA compared with a standard grant, although the specific form of involvement is not detailed in the provided information.
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