Opportunity Information: Apply for RFA FD 14 002
Apply for RFA FD 14 002
- The Food Drug Administration in the consumer protection 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 Feb 21, 2014 and posted on Jan 14, 2014.
- Applicants must submit their applications by Mar 14, 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 $225,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $225,000.00 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) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses State governments Special district governments Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Independent school districts County governments Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Private institutions of higher education Small businesses.
- 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 Food and Drug Administration (FDA) grant opportunity titled "The Use of Polyethylene Glycol in the Pediatric Population (R01)" (Funding Opportunity Number RFA FD 14 002) supports a research project aimed at clarifying a specific pediatric drug safety question involving polyethylene glycol 3350 (PEG 3350). PEG 3350 is commonly used to treat constipation, including in children, and the FDA is looking for research that can better quantify and characterize whether children absorb small, low molecular weight impurities or related species that may be present in PEG 3350 products, such as ethylene glycol and diethylene glycol. The central concern behind the announcement is that if these low molecular weight species are absorbed systemically, they could potentially contribute to adverse events. The study described in the announcement is framed as an early but necessary step toward determining whether PEG 3350 use could be linked to certain pediatric adverse outcomes through absorption of these compounds.
This funding opportunity is categorized as a discretionary grant and uses the R01 research project grant mechanism. The activity category is listed under consumer protection and health, reflecting the FDA's interest in evidence that can inform product safety evaluation and risk assessment in real-world use, particularly for children. The announcement indicates that the FDA anticipated making one award, with an estimated total funding amount of $225,000 and an award ceiling of $225,000, meaning the single selected project would be funded up to that amount. There is no cost-sharing or matching requirement, so applicants would not be expected to provide matching funds as a condition of receiving the award.
In terms of who could apply, eligibility was broad and included many types of U.S. entities such as federal recognized tribal governments and other tribal organizations, state and local governments (including counties, cities or townships, special districts, and independent school districts), public and state-controlled institutions of higher education, private institutions of higher education, public housing authorities/Indian housing authorities, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses. Importantly, the opportunity also allowed participation by non-U.S. entities. Foreign institutions were eligible to apply, and non-U.S. components of U.S. organizations were also eligible. In addition, foreign components (as defined under the HHS Grants Policy Statement) were permitted, which signaled that the FDA was open to international expertise or collaboration if it could address the scientific questions in a rigorous way.
Key administrative dates in the listing show that the opportunity was posted on January 14, 2014, created on February 21, 2014, and had an original closing date of February 28, 2014, later extended to a current closing date of March 14, 2014. The archive date was March 30, 2014, which typically indicates when the solicitation was no longer active for new submissions. The program is associated with CFDA number 93.103, which corresponds to FDA research.
Overall, the grant call is essentially about generating solid data on exposure in children: whether low molecular weight substances potentially present in PEG 3350 products can be absorbed, and to what extent, under pediatric use conditions. The FDA positions this as foundational work needed before broader conclusions can be drawn about causality or clinical risk. By funding a focused R01 project, the agency was seeking to strengthen the evidence base that informs pediatric safety evaluations and helps determine whether there is a plausible mechanism linking PEG 3350 use to reported adverse events through systemic uptake of these small molecular species.
For applicants or interested parties who needed help accessing the full announcement, the listed grants management contact was Lisa Ko at lisa.ko@fda.hhs.gov. The listing also references an additional information link to the full announcement (noting "RFA FD 14 001" on the NIH Guide for Grants and Contracts, which appears to be a related or possibly cross-referenced announcement identifier in the source text).
Frequently Asked Questions (FAQs)
1. What is the title of this FDA grant opportunity?
The opportunity is titled "The Use of Polyethylene Glycol in the Pediatric Population (R01)."
2. What is the Funding Opportunity Number?
The Funding Opportunity Number is RFA FD 14 002.
3. What type of grant mechanism is being used?
This opportunity uses the R01 research project grant mechanism.
4. How is this funding opportunity categorized?
It is categorized as a discretionary grant, with an activity category listed under consumer protection and health.
5. What is the main research focus of the grant?
The project is aimed at clarifying a pediatric drug safety question involving polyethylene glycol 3350 (PEG 3350), a product commonly used to treat constipation, including in children.
6. What specific safety question is FDA trying to address?
The central question is whether children absorb small, low molecular weight impurities or related species that may be present in PEG 3350 products, and to better quantify and characterize that absorption under pediatric use conditions.
7. What examples of low molecular weight species are mentioned in the announcement?
The announcement specifically mentions ethylene glycol and diethylene glycol as examples of low molecular weight impurities or related species that may be present in PEG 3350 products.
8. Why is absorption of these low molecular weight species a concern?
The concern described is that if these species are absorbed systemically, they could potentially contribute to adverse events in children.
9. Is this grant intended to prove that PEG 3350 causes pediatric adverse outcomes?
No. The announcement frames the study as an early but necessary step toward determining whether PEG 3350 use could be linked to certain pediatric adverse outcomes through absorption of these compounds. It emphasizes foundational work before broader conclusions about causality or clinical risk can be drawn.
10. What kind of evidence is the FDA seeking through this project?
The FDA is seeking solid data on exposure in children, specifically whether low molecular weight substances potentially present in PEG 3350 products can be absorbed, and to what extent.
11. How many awards did the FDA anticipate making?
The FDA anticipated making one award.
12. What is the estimated total funding amount for this opportunity?
The estimated total funding amount is $225,000.
13. What is the award ceiling?
The award ceiling is $225,000, meaning the single selected project would be funded up to that amount.
14. Is there a cost-sharing or matching requirement?
No. There is no cost-sharing or matching requirement for this opportunity.
15. Who is eligible to apply?
Eligibility is broad and includes many types of U.S. entities, including: federal recognized tribal governments and other tribal organizations; state and local governments (including counties, cities or townships, special districts, and independent school districts); public and state-controlled institutions of higher education; private institutions of higher education; public housing authorities/Indian housing authorities; nonprofit organizations (with and without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses.
16. Are non-U.S. entities eligible to apply?
Yes. Foreign institutions were eligible to apply, and non-U.S. components of U.S. organizations were also eligible.
17. Are foreign components permitted under this opportunity?
Yes. Foreign components (as defined under the HHS Grants Policy Statement) were permitted, indicating openness to international expertise or collaboration.
18. When was the opportunity posted?
The opportunity was posted on January 14, 2014.
19. When was the listing created?
The listing was created on February 21, 2014.
20. What was the original closing date?
The original closing date was February 28, 2014.
21. Was the deadline extended?
Yes. The closing date was extended to a current closing date of March 14, 2014.
22. What does the archive date indicate for this opportunity?
The archive date is March 30, 2014, which typically indicates the solicitation was no longer active for new submissions after that point.
23. What is the CFDA number associated with this program?
The program is associated with CFDA number 93.103 (FDA research).
24. What is the overall purpose of the funded research from FDA's perspective?
The purpose is to strengthen the evidence base for pediatric safety evaluations and help inform product safety evaluation and risk assessment in real-world use, particularly for children.
25. Who is the listed grants management contact for help with the announcement?
The listed grants management contact is Lisa Ko at lisa.ko@fda.hhs.gov.
26. Is there a reference to where applicants could find the full announcement?
Yes. The listing references an additional information link to the full announcement and notes "RFA FD 14 001" on the NIH Guide for Grants and Contracts as a related or cross-referenced identifier in the source text.
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