Parathyroid Hormone

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICIATATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Clinical Center at the National Institutes of Health, Department of Pharmacy intends to negotiate on a sole source basis, under the authority of FAR 13.106 (b) (1) a purchase order for Parathyroid Hormone (HPTH-1-34) Human Acetate Salt. The vendor will provide 1 Gram of the hormone to be used in the following on-going study Protocol's; • 92-CH-0011 - treatment of hypothyroidism with synthetic human parathyroid, • 07-D-0016 - Effects of calcitriol versus replacement therapy on bone in patients with hypothyroidism, • 08-CH-0203 - A pilot study to assess the feasibility of PTH-1-34 therapy via pump in the management of chronic hypothyroidism. The Clinical Center Pharmacy has utilized HPTH-134 from Bachem since the early 90's and have made statements to the FDA in addition to published reports (data) referring to this formulation with the source Bachem Powder. The North American Industry Classification System (NAICS) Code is 511210 and the threshold is $25 million dollars. It is critical that the these protocols continues to utilize the Bachem HPTH-134, to avoid introducing variables into the experimental results and to avoid long delays in these important protocols resulting from retesting of products from other possible substitutes. This notice is not a request for competitive proposals; however all responses received within 5 days from the date of the publication of this synopsis will be considered by the Government. Interested parties may identify their interest and capability in writing to Mr. Brian Lind at the address stated above. A determination by the Government not to compete this proposed contract action based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purposes of determining whether to conduct a competitive procurement. There is no solicitation package available. For any questions regarding this announcement please contact Mr. Brian Lind at [email protected].