Opportunity Information: Apply for RFA FD 16 033
Apply for RFA FD 16 033
- The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Study of Fluid Amounts Taken with Oral Drug Products (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Apr 01, 2016 and posted on Apr 01, 2016.
- Applicants must submit their applications by Jun 03, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $300,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses.
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Opportunity Summary:
The Study of Fluid Amounts Taken with Oral Drug Products (U01) funding opportunity (RFA FD 16 033) is a discretionary cooperative agreement offered by the U.S. Department of Health and Human Services, Food and Drug Administration (HHS-FDA). It falls under activity areas tied to consumer protection, food and nutrition, and health (CFDA 93.103). The core aim is straightforward but important for real-world medication use: to collect representative data on how well patients follow directions about drinking fluids when taking oral drug products, specifically the amount of liquid people actually consume at the time they take a pill, capsule, or similar oral dosage form.
At a practical level, the project is meant to produce a realistic picture of patient behavior rather than idealized "label compliant" behavior. Many oral medications include instructions such as "take with a full glass of water" or otherwise imply or require some amount of fluid for proper swallowing, tolerability, and performance. This opportunity targets the gap between what labeling expects and what patients do in daily life, by sampling patient compliance around concomitant fluid ingestion. The emphasis on "representative samples" indicates the FDA is looking for data that reflect typical patient populations and real-world conditions, not just small convenience samples that may skew toward highly compliant participants.
The award mechanism is a cooperative agreement (U01), which generally means substantial involvement from the funding agency is expected during the project period compared with a standard grant. In other words, the FDA is likely to collaborate with the recipient on the study approach, milestones, and the type of evidence generated, to ensure the resulting dataset is useful for regulatory science and public health decision-making.
Eligibility is broad and includes many types of organizations that could credibly carry out human behavior or compliance research at scale. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; and small businesses. This wide eligibility suggests the FDA is open to academic research groups, public health entities, and private-sector research organizations that have the infrastructure to recruit participants, collect data reliably, and analyze compliance patterns.
The opportunity was posted and created on April 1, 2016, with an application closing date of June 3, 2016 (original and current closing dates are the same). The expected funding level is up to an award ceiling of $300,000, and the FDA anticipated making one award. With only a single expected award, the intent appears to be funding one primary study effort capable of generating a sufficiently robust and generalizable dataset, rather than splitting funding across multiple smaller projects.
In summary, this FDA cooperative agreement sought one strong partner to conduct a study that measures how much fluid patients actually drink when taking oral drug products, producing representative evidence about compliance with fluid co-ingestion directions. The work would support FDA interests in understanding real-world medication use behaviors that can affect swallowing, safety, tolerability, and potentially the performance of oral drug products.
Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled "The Study of Fluid Amounts Taken with Oral Drug Products (U01)" and is identified as RFA FD 16 033.
Which federal agency is offering this award?
The award is offered by the U.S. Department of Health and Human Services, Food and Drug Administration (HHS-FDA).
What type of funding mechanism is this?
This is a discretionary cooperative agreement under the U01 mechanism.
What does a U01 cooperative agreement imply about FDA involvement?
Because it is a cooperative agreement (U01), substantial involvement from the FDA is expected during the project period compared with a standard grant. The FDA is likely to collaborate with the recipient on elements such as the study approach, milestones, and the type of evidence generated so the resulting dataset is useful for regulatory science and public health decision-making.
What is the core aim of the project?
The core aim is to collect representative data on how well patients follow directions about drinking fluids when taking oral drug products, specifically the amount of liquid people actually consume at the time they take an oral dosage form such as a pill or capsule.
What behavior is the study trying to measure in real-world medication use?
The study is intended to measure what patients actually do in daily life regarding fluid intake when taking oral drug products, rather than assuming idealized, label-compliant behavior (for example, always taking medication with "a full glass of water").
Why is the FDA interested in how much fluid people drink with oral medications?
Many oral drug products include instructions such as "take with a full glass of water" or otherwise imply or require some amount of fluid. Understanding real-world fluid intake can matter for swallowing, safety, tolerability, and potentially the performance of oral drug products.
What kinds of medication directions are relevant to this opportunity?
Directions related to concomitant fluid ingestion when taking oral medications, including common instructions such as "take with a full glass of water," are directly relevant.
What does the opportunity mean by "representative samples"?
The emphasis on "representative samples" indicates the FDA is looking for data that reflect typical patient populations and real-world conditions, rather than small convenience samples that could skew toward unusually compliant participants.
What activity areas and CFDA listing are associated with this opportunity?
The opportunity falls under activity areas tied to consumer protection, food and nutrition, and health, and it is listed under CFDA 93.103.
Who is eligible to apply?
Eligibility is broad and includes the following types of applicants:
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Other Native American tribal organizations
- Public housing authorities / Indian housing authorities
- Nonprofits with 501(c)(3) status (excluding institutions of higher education in those categories)
- Nonprofits without 501(c)(3) status (excluding institutions of higher education in those categories)
- For-profit organizations other than small businesses
- Small businesses
Does the eligibility list include both nonprofit and for-profit organizations?
Yes. The eligibility list includes nonprofits (with and without 501(c)(3) status, with certain exclusions for institutions of higher education in those categories), for-profit organizations other than small businesses, and small businesses.
Does the eligibility list include academic institutions?
Yes. Both public/state-controlled institutions of higher education and private institutions of higher education are eligible.
Does the eligibility list include government entities and tribal organizations?
Yes. Multiple government levels are eligible (state, county, city/township, special district) as well as federally recognized Native American tribal governments and other tribal organizations.
How much funding is available?
The expected funding level is up to an award ceiling of $300,000.
How many awards did the FDA anticipate making?
The FDA anticipated making one award.
What does it suggest that only one award was anticipated?
With only a single expected award, the intent appears to be supporting one primary study effort capable of generating a sufficiently robust and generalizable dataset, rather than splitting the funding across multiple smaller projects.
When was the opportunity posted and created?
The opportunity was posted and created on April 1, 2016.
What was the application closing date?
The application closing date was June 3, 2016. The original and current closing dates were the same.
What kinds of organizations seem well-positioned to carry out the work?
Based on the eligibility description, organizations with the infrastructure to recruit participants, collect data reliably, and analyze compliance patterns at scale are likely to be well-positioned, including academic research groups, public health entities, and private-sector research organizations.
What is the expected output or value of the study for the FDA?
The project is expected to produce a realistic, representative dataset describing how much fluid patients actually consume when taking oral drug products, supporting FDA interests in understanding real-world medication use behaviors that can influence swallowing, safety, tolerability, and potentially product performance.
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