Opportunity Information: Apply for RFA FD 12 021
Apply for RFA FD 12 021
- The Food Drug Administration in the consumer protection health science and technology and other research and development sector is offering a public funding opportunity titled "Pharmacokinetics Studies of Tacrolimus in Transplant 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 May 10, 2012 and posted on Apr 27, 2012.
- Applicants must submit their applications by Jun 8, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,700,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $700,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses Public housing authorities/Indian housing authorities County governments Special district governments Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) State governments Independent school districts Private institutions of higher education 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.
- 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 FDA Grants Policy Statement, are allowed.
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Opportunity Summary:
The Food and Drug Administration (FDA) grant opportunity titled "Pharmacokinetics Studies of Tacrolimus in Transplant Patients (U01)" (Funding Opportunity Number RFA FD 12 021) is a discretionary research and development award that uses a cooperative agreement mechanism (U01). The central purpose of the project is to generate high-quality clinical pharmacokinetic evidence comparing the performance of two different generic tacrolimus capsule products against the branded reference product Prograf in stable transplant recipients. Tacrolimus is a critical immunosuppressant with a narrow therapeutic index, meaning small changes in drug exposure can potentially affect safety (toxicity) or effectiveness (risk of rejection). Because of that clinical reality, there has been ongoing public and professional concern about whether generic versions behave identically in real transplant populations, especially when patients are switched from one product to another. This funding opportunity is designed to directly address those concerns with a controlled switching study that measures how the body absorbs, distributes, and clears tacrolimus when patients move between brand and multiple generic sources.
The study described in the announcement focuses on stable transplant patients, which implies participants should have relatively consistent clinical status and immunosuppressive regimens so that observed differences in tacrolimus exposure can be attributed more confidently to product switching rather than changing medical conditions. A key feature is that patients will be switched between the brand product (Prograf) and generic products, and across more than one generic source. That switching aspect matters because real-world pharmacy substitution can result not only in brand-to-generic conversion, but also in generic-to-generic changes over time depending on payer formularies and pharmacy purchasing. By comparing pharmacokinetic outcomes across these switches, the project aims to determine whether the generics produce exposures that are meaningfully comparable to the reference product and to one another in the transplant setting.
The intended outcome is twofold. First, the results can help inform clinicians, patients, and the public about the clinical interchangeability of generic tacrolimus capsules, potentially reducing uncertainty and anxiety around substitution. Second, the FDA signals that the findings could be used to improve regulatory review practices for generic tacrolimus if the data indicate a need, such as refining study designs, bioequivalence expectations, or postmarket considerations for narrow therapeutic index drugs. In other words, the research is framed as both a patient-centered effort to address confidence in generics and a regulatory science effort that could shape how future generic applications for tacrolimus (and possibly similar drugs) are evaluated.
From an administrative and funding standpoint, the FDA expected to make one award under this announcement. The estimated total funding was $2,700,000, with an award ceiling of $700,000 and no stated award floor. There was no cost-sharing or matching requirement. The activity category is listed under consumer protection and health science/technology research and development, and the CFDA number associated with FDA research is 93.103. Key dates included a posted date of April 27, 2012, an original closing date of May 31, 2012, and a current closing date extension to June 8, 2012, with an archive date of June 30, 2012. The cooperative agreement format indicates the FDA anticipated substantial involvement in the project beyond what is typical for a standard grant, often meaning close collaboration on study milestones, scientific direction, data elements, or other programmatic components.
Eligibility for applicants was broad and included many types of U.S. entities such as state and local governments, tribal governments and organizations, public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations (including small businesses and other than small businesses), and certain public housing authorities. Notably, the announcement explicitly allowed non-U.S. (foreign) institutions to apply, and also allowed non-U.S. components of U.S. organizations as well as foreign components as defined in the FDA Grants Policy Statement. This wide eligibility suggests the FDA was seeking the strongest available research team and infrastructure capable of conducting rigorous pharmacokinetic studies in transplant populations, regardless of whether the research capacity resided domestically or internationally.
For applicants seeking the full technical and administrative requirements, the announcement referenced an additional information link to the full RFA and the NIH Guide for Grants and Contracts listing. The provided grants management contact for access issues was Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov.
FAQs: Pharmacokinetics Studies of Tacrolimus in Transplant Patients (U01) (RFA FD 12 021)
What is the title of this FDA grant opportunity?
The opportunity is titled "Pharmacokinetics Studies of Tacrolimus in Transplant Patients (U01)" (Funding Opportunity Number RFA FD 12 021).
What type of funding mechanism is being used?
This is a cooperative agreement (U01), which is a discretionary research and development award mechanism.
What does a cooperative agreement (U01) imply for how the project will be run?
The announcement indicates FDA anticipated substantial involvement beyond what is typical for a standard grant. This often means closer collaboration on scientific direction, study milestones, and key data elements or other programmatic components.
What is the central purpose of the project?
The purpose is to generate high-quality clinical pharmacokinetic evidence comparing two different generic tacrolimus capsule products against the branded reference product, Prograf, in stable transplant recipients.
Which drug products are being studied?
Tacrolimus capsules are being studied, specifically comparing the branded reference product Prograf to two different generic tacrolimus capsule products.
Why is tacrolimus a focus of concern in transplant patients?
Tacrolimus is a critical immunosuppressant with a narrow therapeutic index. Small changes in drug exposure can affect safety (toxicity) or effectiveness (risk of rejection), which has driven concern about switching among products.
What type of evidence is the study intended to generate?
The project is intended to generate controlled clinical pharmacokinetic evidence measuring how the body absorbs, distributes, and clears tacrolimus when patients switch between the brand product and multiple generic sources.
What patient population is the study focused on?
The study focuses on stable transplant patients, implying participants should have relatively consistent clinical status and immunosuppressive regimens so observed exposure differences can be attributed more confidently to product switching rather than changing medical conditions.
What is meant by a "controlled switching study" in this announcement?
It refers to a study design where patients are switched between Prograf and generic tacrolimus products, and also switched across more than one generic source, while pharmacokinetic outcomes are measured.
Why does the announcement emphasize switching across more than one generic product?
Because real-world pharmacy substitution can involve not only brand-to-generic changes, but also generic-to-generic switches over time due to payer formularies and pharmacy purchasing. The study is designed to evaluate exposures across these realistic switching scenarios.
What questions is the FDA trying to answer through this work?
Whether generic tacrolimus capsule products produce drug exposures that are meaningfully comparable to the reference product (Prograf) and to one another in stable transplant recipients, especially in the context of switching.
What are the intended outcomes of the research?
The intended outcomes are (1) to inform clinicians, patients, and the public about clinical interchangeability of generic tacrolimus capsules and reduce uncertainty around substitution, and (2) to provide evidence that could improve FDA regulatory review practices for generic tacrolimus if the data indicate a need (for example, refining study designs, bioequivalence expectations, or postmarket considerations for narrow therapeutic index drugs).
How might the findings affect FDA regulation or review processes?
The announcement signals results could be used to improve regulatory review practices for generic tacrolimus, potentially influencing expectations for study designs, bioequivalence approaches, or postmarket considerations for narrow therapeutic index drugs.
How many awards did FDA expect to make under this announcement?
FDA expected to make one award.
What was the estimated total funding available?
The estimated total funding was $2,700,000.
What was the maximum award amount (award ceiling)?
The award ceiling was $700,000.
Was an award minimum (award floor) specified?
No award floor was stated.
Was cost sharing or matching required?
No. The opportunity stated there was no cost-sharing or matching requirement.
What is the activity category for this funding opportunity?
The activity category is listed under consumer protection and health science/technology research and development.
What CFDA number is associated with this FDA research opportunity?
The CFDA number referenced is 93.103.
When was the opportunity posted?
The posted date was April 27, 2012.
What was the original closing date, and was it extended?
The original closing date was May 31, 2012, and it was extended to a current closing date of June 8, 2012.
When was the archive date for the announcement?
The archive date was June 30, 2012.
Who was eligible to apply?
Eligibility was broad and included many types of U.S. entities: state and local governments, tribal governments and organizations, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses and other than small businesses), and certain public housing authorities.
Were non-U.S. (foreign) institutions allowed to apply?
Yes. The announcement explicitly allowed non-U.S. (foreign) institutions to apply.
Were foreign components of U.S. organizations allowed?
Yes. The announcement allowed non-U.S. components of U.S. organizations and foreign components as defined in the FDA Grants Policy Statement.
Where could applicants find the full technical and administrative requirements?
The announcement referenced an additional information link to the full RFA and the NIH Guide for Grants and Contracts listing.
Who was the grants management contact for access issues?
Lisa Ko, Grants Management Specialist. Email: lisa.ko@fda.hhs.gov.
What is the branded reference product named in the announcement?
The branded reference product is Prograf.
How many generic products were intended to be compared in the study?
Two different generic tacrolimus capsule products were intended to be compared against the branded reference product.
What is the broader public health or patient-centered motivation described?
The announcement cites ongoing public and professional concern about whether generic versions behave identically in real transplant populations, particularly when patients are switched between products. The study is intended to address uncertainty and anxiety around substitution by producing controlled pharmacokinetic evidence.
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