Opportunity Information: Apply for RFA FD 14 088
Apply for RFA FD 14 088
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "The Use of Polyethylene Glycol in the Pediatric Population (R01)" 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 Jun 4, 2014 and posted on Jun 4, 2014.
- Applicants must submit their applications by Jul 15, 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 $325,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $325,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Small businesses Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses State governments City or township governments Public and State controlled institutions of higher education Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments Others (see text field entitled Additional Information on Eligibility for clarification).
- 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 grant opportunity titled "The Use of Polyethylene Glycol in the Pediatric Population (R01)" (Funding Opportunity Number RFA-FD-14-088) is a discretionary research grant from the U.S. Food and Drug Administration (FDA) focused on consumer protection and public health. It targets a specific safety question related to the pediatric use of polyethylene glycol 3350 (PEG 3350), a commonly used ingredient in products that treat constipation. The central aim is to generate evidence about whether certain low molecular weight (LMW) compounds associated with PEG 3350 products, along with potential PEG 3350 metabolites formed in the body, can be absorbed and accumulate in children over time, and whether that accumulation could plausibly contribute to adverse events.
At the heart of the research is concern about small, potentially harmful chemicals that may either be present as impurities in PEG 3350 formulations or created through metabolism in the gut. The announcement specifically calls out ethylene glycol and diethylene glycol as examples of LMW species of interest. The FDA is seeking studies that can measure and characterize the extent to which children taking PEG 3350 products may accumulate these LMW species and PEG-related metabolites. The logic behind the opportunity is straightforward: if these compounds are present in the administered product and/or generated in the gastrointestinal tract, and if they are subsequently absorbed into the bloodstream, repeated dosing could lead to measurable accumulation. Establishing whether this happens is framed as an important early step toward understanding whether PEG 3350 use could be linked to reported or suspected adverse events in pediatric patients through this absorption mechanism.
This opportunity uses the R01 mechanism (a standard research project grant) and anticipates making a single award. The estimated total funding is $325,000, which is also listed as the award ceiling, indicating the FDA expected one project at or below that total amount. There is no cost-sharing or matching requirement, which means applicants are not required to contribute additional non-federal funds as a condition of receiving the award. The program is associated with CFDA number 93.103 (Food and Drug Administration Research), aligning it with FDA-supported scientific research intended to inform regulatory and public health decisions.
Eligibility is broad and includes many types of organizations: public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities), for-profit organizations (including small businesses and other for-profits), and various levels of government (state, county, city/township, special district), as well as independent school districts. It also includes tribal governments and tribal organizations, and notably allows foreign participation. Non-U.S. entities (foreign institutions) are eligible to apply, and foreign components of U.S. organizations are allowed under the HHS Grants Policy Statement, which signals that the FDA was open to international expertise or study components where scientifically justified.
From a timeline standpoint, the funding announcement was posted and created on June 4, 2014, with an original and current application closing date of July 15, 2014. The archive date is August 14, 2014, indicating the opportunity is no longer active but remains available for reference. The announcement lists a grants management contact, Lisa Ko (lisa.ko@fda.hhs.gov), for issues accessing the full announcement or related administrative questions.
Overall, the grant is essentially a targeted call for research that can clarify a potential exposure and safety pathway in children using PEG 3350 for constipation: whether LMW impurities (like ethylene glycol and diethylene glycol) and/or PEG 3350 metabolites are produced or present, absorbed, and accumulated. The FDA frames this as foundational evidence needed before the field can credibly assess whether such exposure could be contributing to adverse events in pediatric patients, making the work both clinically relevant and potentially influential for product safety evaluation and future guidance.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "The Use of Polyethylene Glycol in the Pediatric Population (R01)" and the Funding Opportunity Number (FON) is RFA-FD-14-088.
Which federal agency is offering this funding?
The funding is offered by the U.S. Food and Drug Administration (FDA).
What type of grant mechanism is being used?
This opportunity uses the R01 mechanism, which is a standard research project grant mechanism.
What is the overall purpose of this grant opportunity?
The purpose is to support research that generates evidence on a specific pediatric safety question related to polyethylene glycol 3350 (PEG 3350), a commonly used ingredient in products that treat constipation. The research focus is whether certain low molecular weight (LMW) compounds associated with PEG 3350 products, along with potential PEG 3350 metabolites formed in the body, can be absorbed and accumulate in children over time, and whether that accumulation could plausibly contribute to adverse events.
What specific safety concern is the FDA asking researchers to investigate?
The FDA is concerned about small, potentially harmful chemicals that may be present as impurities in PEG 3350 formulations and/or created through metabolism in the gastrointestinal tract. The key question is whether these compounds and PEG-related metabolites can be absorbed into the bloodstream and accumulate with repeated dosing in pediatric patients.
What product ingredient and patient population does this opportunity focus on?
This opportunity focuses on polyethylene glycol 3350 (PEG 3350) and the pediatric population (children) who take PEG 3350-containing products for constipation.
What kinds of compounds are highlighted as examples of low molecular weight (LMW) species of interest?
The announcement specifically calls out ethylene glycol and diethylene glycol as examples of LMW species of interest.
What is meant by "LMW compounds associated with PEG 3350 products" in this announcement?
In the context of this announcement, LMW compounds are small chemical species that could be present in PEG 3350 formulations as impurities and/or could be generated in the body (for example, in the gut) as PEG-related metabolites. The studies sought by the FDA are intended to measure and characterize whether these compounds can be absorbed and accumulate in children.
What is the central research aim described in the opportunity?
The central aim is to generate evidence about whether LMW compounds associated with PEG 3350 products, as well as potential PEG 3350 metabolites formed in the body, can be absorbed and accumulate in children over time, and whether that accumulation could plausibly contribute to adverse events.
Why is the possibility of accumulation important in this research call?
The logic described is that if LMW compounds are present in the administered product and/or generated in the gastrointestinal tract, and if they are absorbed into the bloodstream, then repeated dosing could lead to measurable accumulation over time. Establishing whether accumulation occurs is presented as a foundational step toward evaluating whether this exposure pathway could contribute to reported or suspected adverse events in pediatric patients.
How does this research relate to pediatric adverse events?
The opportunity frames the research as an early, foundational step to determine whether an absorption-and-accumulation exposure pathway is plausible. If absorption and accumulation are demonstrated, that evidence would help inform subsequent efforts to assess whether such exposure could be linked to reported or suspected adverse events in children taking PEG 3350 products.
How many awards does the FDA anticipate making under this opportunity?
The FDA anticipated making a single award.
What is the total estimated funding amount for this opportunity?
The estimated total funding is $325,000.
What is the award ceiling for this opportunity?
The award ceiling is listed as $325,000, indicating the expectation of one project at or below that total amount.
Is cost-sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement, so applicants are not required to provide non-federal funds as a condition of receiving the award.
What is the CFDA number associated with this program?
The program is associated with CFDA number 93.103 (Food and Drug Administration Research).
What kinds of organizations are eligible to apply?
Eligibility is broad and includes public and private institutions of higher education; nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities); for-profit organizations (including small businesses and other for-profits); and various levels of government (state, county, city/township, special district), as well as independent school districts. Tribal governments and tribal organizations are also eligible.
Are for-profit organizations eligible to apply?
Yes. For-profit organizations, including small businesses and other for-profits, are listed as eligible.
Are nonprofit organizations eligible to apply?
Yes. Nonprofit organizations are eligible, including both 501(c)(3) and non-501(c)(3) entities.
Are government entities eligible to apply?
Yes. The opportunity lists multiple levels of government as eligible, including state, county, city/township, and special district governments, as well as independent school districts.
Are tribal governments and tribal organizations eligible?
Yes. The eligibility list includes tribal governments and tribal organizations.
Is foreign participation allowed?
Yes. Non-U.S. entities (foreign institutions) are eligible to apply, and foreign components of U.S. organizations are allowed under the HHS Grants Policy Statement.
What does it mean that "foreign components of U.S. organizations are allowed"?
It means that a U.S.-based applicant organization may include scientifically justified work or study components conducted outside the United States, consistent with the HHS Grants Policy Statement, and the opportunity explicitly indicates openness to such foreign components.
When was the funding opportunity posted and created?
The announcement was posted and created on June 4, 2014.
What was the application closing date?
The original and current application closing date was July 15, 2014.
Is this opportunity still open for applications?
No. The archive date is August 14, 2014, which indicates the opportunity is no longer active and is available for reference only.
Who is the grants management contact for administrative questions?
The grants management contact listed is Lisa Ko, reachable at lisa.ko@fda.hhs.gov, for issues accessing the full announcement or related administrative questions.
What public health area does this grant fall under?
It is described as a discretionary research grant focused on consumer protection and public health, with the intent of generating evidence relevant to pediatric product safety evaluation.
What kind of evidence is the FDA seeking from funded research?
The FDA is seeking studies that can measure and characterize whether children taking PEG 3350 products may absorb and accumulate LMW species (including examples like ethylene glycol and diethylene glycol) and PEG-related metabolites over time.
What is the key exposure pathway described in the opportunity?
The pathway described is: (1) LMW impurities may be present in PEG 3350 formulations and/or metabolites may be generated in the gastrointestinal tract; (2) these compounds may be absorbed into the bloodstream; and (3) repeated dosing could lead to measurable accumulation in children over time.
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