Food and Drug Administration

Description

The purpose of the proposed study is to better understand the extent of pediatric accumulation of low molecular weight (LMW) species that may be found in PEG 3350 products (e.g., ethylene and diethylene glycol) and of PEG 3350 metabolites. PEG 3350 products are used in the treatment of constipation. If present in the product when administered and/or produced in the gut and absorbed, these metabolites and LMW species may accumulate in children taking PEG 3350 products -- potentially leading to adverse events. This is an important first step needed to begin to understand if PEG 3350 use contributes to adverse events in children due to the absorption of these species.

Who can apply

• 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)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

Lisa Ko <br/>Grants Management Specialist
lisa.ko@fda.hhs.gov