SAM #75N98026Q00598

NIH Solicitation for Intravenous Stable Isotope Glycerol for Clinical Research

This opportunity is for the procurement of intravenous stable isotope glycerol to support clinical research at the National Institutes of Health (NIH), specifically the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). - Government Buyer: - National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) - NIH Sterile Products for Human Administration (SPHA) Executive Committee - NIH Office of Research Support and Compliance - Products/Services Requested: - Intravenous stable isotope glycerol for use in human metabolic clinical studies - Contractor must source raw materials, manufacture and/or package the product, and deliver to the NIH Clinical Center Pharmacy - Product must undergo and pass microbial and analytical testing prior to delivery - OEMs and Vendors: - No specific OEMs or vendors are named in the notice - Unique/Notable Requirements: - Product must meet NIH requirements for sterile products intended for human administration - Must comply with NIH policy for clinical research materials - Delivery required to the NIH Clinical Center Pharmacy after all quality testing is complete

Description

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life.

Stable isotopes have been used safely in clinical research for decades and have contributed seminal insights into human metabolism. In many cases, stable isotopes allow for the generation of knowledge that may not be possible by any other method. Under the directive of the National Institutes of Health (NIH) Sterile Products for Human Administration (SPHA) Executive Committee and the NIH Office of Research Support and Compliance (approved October 2021), stable isotopes used in human metabolic clinical studies must meet the outlined minimum requirements.

This requirement, initiated on behalf of NIDDK principal investigators, is for intravenous stable isotope glycerol procurement. The contractor shall be responsible for sourcing the raw material, packaging and/or manufacturing the isotope product, and submitting and releasing the product to the NIH Clinical Center Pharmacy following microbial and analytical testing.

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