THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institutes of Health (NIH), Clinical Center (CC), Pharmacy Development Service (PDS), intends to enter into a contract on a sole source basis, under the authority of 41 U.S.C. 253 (c) (1) and FAR 6.302-1(a) (2) (ii) and HHSAR 306.302-1 (a) (2) (ii), a contract to purchase "600g U-13C6 D-Glucose," in order to continue the NIH/National Institute of Mental Health and other Institutes on-going protocols. PDS is tasked with procuring 600g U-13C6 D-Glucose to be used as raw material to prepare injections for ongoing NIH Clinical Center protocols. This product (injection) must meet the specifications that were stated to the Food and Drug Administration (FDA) before this protocol was allowed to proceed. Among the specifications is the description of the main constituent. The reviewers at FDA are aware of the significance of avoiding the problems that would ensue if the raw material were to be manufactured from an alternate source such that the drug may not have the same effects in the patients treated already in these studies. A substitution may put the patient's safety at risk. However, if there are other sources able to supply the required material, they must respond by submitting a capability statement within 10 days of publication of this synopsis. This notice of intent is not a request for competitive proposals. However, all proposals received prior to the closing date of this synopsis will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Deliveries should be Hand Carried or sent via other mail or package Delivery Services. NO COLLECT CALLS OR FACSIMILE TRANSMISSIONS WILL BE ACCEPTED. RESPONDENTS MAY SUBMIT THEIR CAPABILITY STATEMENTS VIA E-MAIL TO THE POINT OF CONTACT LISTED IN THIS NOTICE OF INTENT SYNOPSIS. The Clinical Center (CC) plans to procure, on a sole source basis, from Cambridge Isotope Laboratories, 3 Highway Drive, Tewksbury, MA 01876. The U-13C6 D-Glucose supply previously purchased from this company is currently in use with NIH Clinical Center patients in ongoing protocols. The purchase of this isotope from Cambridge Isotope Laboratories will allow for the continuity of the protocols involved, as the source of the raw material will be maintained. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1(b)(2) and 13.501-(a)(1) to use simplified procedures for commercial acquisitions. The North American Industry Classification System Code is 325199 and the business size standard 500 employees. Only one award will be made as a result of this solicitation. This will be a firm fixed price type contract. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. Interested Offerors should submit their capability statement not exceeding twenty (20) pages in length, excluding standard brochures. SUBMISSIONS ARE DUE no later than 9:00 a.m., Eastern Time, August11, 2014. The capabilities response shall be e-mailed to:
[email protected]. All information received in response to this notice that is marked Proprietary will be handled accordingly. Information provided in response to this notice will be used to assess alternatives available for determining how to proceed in the acquisition process. This notice is part of Government Market Research, a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for or award a competitive contract. The NIH/CC will use the information submitted in response to this notice at its discretion and will not provide comments to any submission; however, the content of any responses to this notice may be reflected in subsequent solicitation. NIH/CC/OPC reserves the right to contact any respondent to this notice for the sole purpose of enhancing NIH/CC/OPC 's understanding of the notice submission. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. It is emphasized that this is a notice for planning and information purposes only and is not be construed as a commitment by the government to enter into a contractual agreement, nor will the government pay for information solicited. Responses to this Notice of Intent shall be submitted before the closing date and time to the attention of the Contract Specialist listed below. Primary Point of Contact: Lisa Schaupp Contract Specialist
[email protected] Phone: 301 402 0735 Office of Purchasing and Contracts 6707 Democracy Blvd, Suite 106, MSC 5480 Bethesda, Maryland 20892-5480