Opportunity Information: Apply for RFA FD 13 021
Apply for RFA FD 13 021
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Bioequivalence of Generic Bupropion (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 2, 2013 and posted on Apr 2, 2013.
- Applicants must submit their applications by May 31, 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 $800,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $800,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) Small businesses City or township 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) Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments County governments Public and State controlled institutions of higher education For profit organizations other than small businesses Independent school districts Public housing authorities/Indian housing authorities State governments Private institutions of higher education.
- 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 FDA grant opportunity "Bioequivalence of Generic Bupropion (U01)" (Funding Opportunity Number RFA-FD-13-021) funded a single cooperative agreement study aimed at resolving real-world concerns about whether certain generic bupropion hydrochloride (HCl) modified-release products perform the same as the brand-name versions. The core scientific goal was twofold: first, to demonstrate bioequivalence at steady state in patients between generic and brand bupropion modified-release formulations that may have different drug-release patterns; and second, to determine whether patients can actually perceive those release-pattern differences in a way that translates into meaningful clinical effects, such as feeling the medication is less effective or experiencing more side effects after switching between products. In plain terms, the project was designed to connect pharmacokinetic evidence (how the drug is absorbed and released over time once dosing has reached steady state) with patient-centered outcomes (what people feel and report when they are switched from one formulation to another).
This opportunity sat within FDA's consumer protection and public health mission, focusing specifically on the quality, bioequivalence, and therapeutic equivalence of generic bupropion HCl modified-release products. Modified-release bupropion formulations can differ in how they release the active ingredient across the day, and the announcement highlights that the study would address questions that had been raised about whether such differences might matter clinically. By requiring evaluation at steady state and in patients, the announcement emphasized a setting that better reflects how these antidepressant/smoking-cessation products are used in routine care, rather than relying only on single-dose studies in healthy volunteers.
The award mechanism was a cooperative agreement (U01), meaning FDA expected to have substantial involvement in the project rather than acting only as a passive funder. The estimated total funding was $800,000, with an award ceiling of $800,000 and an expectation of one award. There was no cost-sharing or matching requirement indicated, so applicants were not required to contribute matching funds as a condition of the award.
Eligibility was broad and included many types of U.S. and non-U.S. entities. Eligible applicants listed in the announcement included federal and non-federal government entities (such as state governments, county governments, city or township governments, special district governments, and independent school districts), public housing authorities/Indian housing authorities, tribal governments (federally recognized) and other tribal organizations, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with and without 501(c)(3) status, small businesses, and other for-profit organizations (excluding small businesses in that particular category listing). Importantly, the opportunity explicitly allowed foreign participation: non-U.S. entities could apply, non-U.S. components of U.S. organizations were eligible, and foreign components as defined under HHS grants policy were allowed.
Key administrative details in the source data show the opportunity was posted on April 2, 2013, with the application closing date set for May 31, 2013, and an archive date of June 30, 2013. The program is associated with CFDA number 93.103 (Food and Drug Administration). For access issues with the full announcement, the grant listed a point of contact in FDA grants management: Lisa Ko (lisa.ko@fda.hhs.gov).
Overall, the grant was structured to produce evidence that could directly inform confidence in generic substituted products for bupropion modified-release, especially in situations where patients are switched between formulations. The intended deliverable was not just a lab-based comparison, but a clinically relevant assessment tying release characteristics and steady-state exposure to patient perceptions, efficacy signals, and adverse event experiences, with the broader aim of addressing public concerns and strengthening the scientific basis for therapeutic equivalence determinations in this drug category.
FAQs: FDA Grant - Bioequivalence of Generic Bupropion (U01)
What is the official title of this FDA grant opportunity?
The opportunity is titled "Bioequivalence of Generic Bupropion (U01)" and is associated with Funding Opportunity Number (FON) RFA-FD-13-021.
What type of award mechanism was used?
The award mechanism was a cooperative agreement (U01). This means FDA expected to have substantial involvement in the funded project rather than serving only as a passive funder.
How many awards were expected under this funding opportunity?
The announcement indicated an expectation of one award.
What was the estimated total funding amount?
The estimated total funding was $800,000.
What was the maximum (ceiling) award amount?
The award ceiling was $800,000.
Was cost sharing or matching required?
No cost-sharing or matching requirement was indicated. Applicants were not required to provide matching funds as a condition of the award.
What was the main public health issue this grant aimed to address?
The project was intended to address real-world concerns about whether certain generic bupropion hydrochloride (HCl) modified-release products perform the same as brand-name versions, particularly when patients switch between products.
What specific products or drug category did the grant focus on?
The focus was on generic bupropion HCl modified-release formulations and their comparison to brand-name modified-release versions.
Why did the announcement emphasize modified-release bupropion products?
Modified-release formulations can differ in how they release the active ingredient over time. The announcement highlighted that differences in drug-release patterns had raised questions about whether those differences could matter clinically.
What were the two core scientific goals of the study?
The first goal was to demonstrate bioequivalence at steady state in patients between generic and brand bupropion modified-release formulations that may have different drug-release patterns. The second goal was to determine whether patients can perceive release-pattern differences in ways that translate into meaningful clinical effects, such as feeling the medication is less effective or experiencing more side effects after switching products.
What does "bioequivalence at steady state" mean in the context of this project?
In this opportunity, "bioequivalence at steady state" refers to comparing how the drug is absorbed and released over time once dosing has reached steady state, rather than relying only on a single-dose comparison.
Why did the grant specify evaluation "in patients" rather than only in healthy volunteers?
The announcement emphasized evaluation at steady state and in patients to better reflect how these products are used in routine care, rather than relying only on single-dose studies in healthy volunteers.
What kinds of patient-centered outcomes were part of the grant's intent?
The opportunity described patient-centered outcomes such as whether patients report the medication feels less effective or whether they experience more side effects after switching between generic and brand (or between formulations with different release patterns).
How was the project intended to connect pharmacokinetics with real-world experience?
The project was designed to connect pharmacokinetic evidence (drug absorption and release over time at steady state) with patient-reported perceptions and clinically meaningful effects after switching formulations.
What FDA mission area did this opportunity align with?
The opportunity sat within FDA's consumer protection and public health mission, focusing on the quality, bioequivalence, and therapeutic equivalence of generic bupropion HCl modified-release products.
What practical concern about switching products was the study designed to evaluate?
It was designed to evaluate whether differences in release patterns between formulations might be noticed by patients and whether those perceived differences could correspond to changes in efficacy signals or adverse event experiences when switching products.
When was the opportunity posted?
The opportunity was posted on April 2, 2013.
What was the application closing date?
The application closing date was May 31, 2013.
When was the opportunity archived?
The archive date was June 30, 2013.
What CFDA number is associated with this program?
The program is associated with CFDA number 93.103 (Food and Drug Administration).
Who was eligible to apply?
Eligibility was broad and included federal and non-federal government entities (including state governments, county governments, city or township governments, special district governments, and independent school districts), public housing authorities/Indian housing authorities, tribal governments (federally recognized) and other tribal organizations, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with and without 501(c)(3) status, small businesses, and other for-profit organizations (excluding small businesses in that particular category listing).
Were non-U.S. (foreign) entities allowed to apply?
Yes. The opportunity explicitly allowed foreign participation: non-U.S. entities could apply, non-U.S. components of U.S. organizations were eligible, and foreign components (as defined under HHS grants policy) were allowed.
What does "substantial FDA involvement" imply for applicants?
Because this was a U01 cooperative agreement, the structure implied FDA would be substantially involved in the project, rather than simply providing funds with no active role.
What was the intended overall deliverable or outcome of the funded work?
The intended outcome was clinically relevant evidence that could inform confidence in generic substituted bupropion modified-release products, tying release characteristics and steady-state exposure to patient perceptions, efficacy-related signals, and adverse event experiences, with the aim of addressing public concerns and strengthening the scientific basis for therapeutic equivalence determinations in this drug category.
Who was the listed point of contact for access issues with the full announcement?
The listed FDA grants management point of contact was Lisa Ko at lisa.ko@fda.hhs.gov.
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