SOLICITATION NOTICE
68 -- 400 Grams of Mangafodipir Trisodium for NINDS Translational Neuroradiology Unit
- Notice Date
- 9/10/2015
- Notice Type
- Presolicitation
- NAICS
- 325998
— All Other Miscellaneous Chemical Product and Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-NOI-15-873
- Archive Date
- 10/1/2015
- Point of Contact
- Lauren M. Phelps, Phone: 3015942490
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 400 Grams of Mangafodipir Trisodium for NINDS Translational Neuroradiology Unit HHS-NIH-NIDA-SSSA-NOI-15-873 INTRODUCTION This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures and FAR Part 12--Acquisition of Commercial Items. The solicitation number is HHS-NIH-NIDA-SSSA-NOI-15-873 and the solicitation is issued as a PRE-SOLICITATION, NOTICE OF INTENT, to award a contract on a noncompetitive basis to Albany Molecular Research Inc. located at 26 Corporate Circle, P.O. Box 15098, Albany, NY 12212-5098 USA. REGULATORY & STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13--Simplified Acquisition Procedures, Subpart 13.106-1, only one responsible source and no other supplies or services will satisfy agency requirements, and FAR Part 12--Acquisition of Commercial Items and is NOT expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13--Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6--Competition Requirements. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-84, dated September 3, 2015. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The associated NAICS code for this requirement is 325998 with size standard of 500 Employees. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The non-competitive determination is based upon the market research conducted as prescribed in FAR Part 10--Market Research, specifically the results of market research concluded that only Albany Molecular Research Inc. (AMRI) is capable of meeting the needs of this requirement to ensure continuity of science. Specifically, AMRI mangafodipir trisodium was used in an NIH Clinical Center protocol following FDA approval for use of that particular batch of compound. Unfortunately, the material was exhausted before completion of the protocol and additional quantity of the exact same quantity must be acquired to ensure patient safety and standardization of clinical research data. The material being purchased now must come from the same lot (No. 02090106) and be covered by an existing Certificate of Analysis to ensure this. Accordingly, only AMRI is capable of meeting the needs of this requirement. This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. DESCRIPTION OF REQUIREMENT Background The NINDS Translational Neuroradiology Unit (TNU) has previously used mangafodipir trisodium to perform research efforts and the batch utilized met FDA specifications for use in an NIH Clinical Center protocol. Unfortunately, the material was completely used before completion of the protocol. To continue the protocol to completion, additional material must be acquired from the original provider, Albany Molecular Research Inc. (AMRI) as it is critical to maintain the same source in order to assure safety of participants in, and data obtained under, clinical protocol (11-N-0116). Purpose and Objectives The purpose of this procurement is acquisition of 400 grams of mangafodipir trisodium for use in an ongoing NINDS Translational Neuroradiology Unit research protocol. Project Description The NINDS Translational Neuroradiology Unit requires the following: 1. The Contractor shall provide 400 grams of mangafodipir trisodium 2. The mangafodipir trisodium shall meet the following requirements: a. The mangafodipir shall be from the same lot (02090106) as the prior shipment received at the NIH on December 28, 2012. b. The original Certificate of Analysis shall be provided, irrespective of expiration date. No new Certificate of Analysis is required. c. The API shall be shipped in two separate bottles, one containing 250 g and the other 150 g of mangafodipir trisodium. 3. The mangafodipir trisodium shall be capable of storage at controlled room temperature of 15 - 30 Celsius Delivery/Period of Performance The Contractor shall deliver manufacturer product within one (1) week after receipt of order and shall be delivered between the hours of 8:00 AM to 5:00 PM, Bethesda, MD local prevailing time, Monday through Friday. Schedule is of prime importance. A designated NIH point of contact shall be notified by email at least two days in advance of the anticipated delivery date. Contract Type A firm fixed price purchase order with NET30 invoicing terms is anticipated. RESPONSE INSTRUCTIONS Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; and maintenance availability. EVALUATION CRITERIA FAR clause 52.212-2, Evaluation - Commercial Items (October 2014) applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a purchase order resulting from this solicitation on the basis of lowest price technically acceptable. Technical acceptability shall be based on the following: 1. The Contractor must meet each of the project requirements detailed in this solicitation. 2. The Contractor must be able to meet or exceed the delivery schedule requirement (delivery within one week or less). APPLICABLE TERMS AND CONDITIONS INCORPORATED BY REFERENCE The following FAR clauses and provisions shall apply to this solicitation: 1. All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (April 2014), applies to this acquisition. 3. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (March 2015), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 4. FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (May 2015) apply to this acquisition. 5. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." CLOSING STATEMENT All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. All responses must be received by the closing date of this announcement must reference solicitation number HHS-NIH-NIDA-SSSA-NOI-15-873. Responses may be submitted electronically to Lauren.Phelps@nih.gov and to NIDASSSAPurchaseRequ@mail.nih.gov. Fax responses will be accepted at (301) 480-1358. For information regarding this solicitation, contact Lauren Phelps by email at lauren.phelps@nih.gov or by phone at (301) 594-2490.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-NOI-15-873/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03880114-W 20150912/150911000118-7ab67f67fab0def496e19ac0398b2cdb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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