This Standard Operating Procedure (SOP) outlines the process for analyzing the particle size of hardwood chips at the National Center for Toxicological Research (NCTR), adhering to FDA Good Laboratory Practice (GLP) regulations (21 CFR 58). The procedure utilizes a sieve shaker with #8 and #20 U.S. Standard sieves and a receiver pan to separate and quantify particle sizes. Key steps include weighing empty pans, taring the balance, adding a 25.00g sample to the top sieve, shaking for 3 minutes, and then weighing the contents of each pan. Calculations determine the sample weight after shaking and the percentage of material retained in each sieve. Particle size limits are specified: no more than 10% on the #8 Sieve and no more than 0.7% in the Receiver Pan. This SOP ensures consistent and compliant particle size analysis for hardwood chips used at the NCTR.
The Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) is conducting market research to identify sources for irradiated Sani-chip bedding for housing animal species, primarily rodents, in research vivarium facilities. This bedding is essential for sanitation, animal well-being, and thermoregulation. The FDA seeks heat-treated, cube-cut hardwood chip bedding, free of contaminants and irradiated to a minimum dose of 15 kGy. The requirement includes a one-year base period and four option years, with an indefinite quantity up to 2,000 units. Delivery will be to the NCTR in Jefferson, AR. Technical specifications detail material composition (beech, birch, aspen, or maple), particle size, processing/heat-treatment, irradiation, and strict chemical contaminant restrictions. Packaging requires 2.2 cu. ft. bags, palletized with 50 bags per pallet, and marked with lot and manufacturing date. Shipments are anticipated quarterly, with minimum orders of 500 bags and maximums of 1,500 bags. Each shipment is subject to analysis for compliance, with non-compliant shipments requiring replacement within 30 days. Manufacturers must have documented SOPs for plant sanitation and a licensed integrated pest management program. Responses are due by December 15, 2025, to david.kramer@fda.hhs.gov and should include company overview, descriptive literature, past performance, requirements response, and other information like GSA schedules or informational pricing. This is for market research only and not a solicitation, with the intent to determine future procurement strategies.