SOLICITATION NOTICE
68 -- Purification of two chemical intermediates
- Notice Date
- 4/28/2017
- Notice Type
- Combined Synopsis/Solicitation
- 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, 6001 Executive Boulevard, Room 3155, MSC 9593, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-NOI-17-345
- Archive Date
- 5/23/2017
- Point of Contact
- Jermaine Duncan, Phone: 3018277515
- E-Mail Address
-
jermaine.duncan@nih.gov
(jermaine.duncan@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Purification of two chemical intermediates Pre-Solicitation Notice of Intent to Sole Source HHS-NIH-NIDA-SSSA-NOI-17-345 INTRODUCTION This is a combined synopsis/pre-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-17-268 and the solicitation is issued as a PRE-SOLICITATION, NOTICE OF INTENT, to award a contract on a noncompetitive basis to Regis Technologies, Inc located at 8210 Austin Ave. Morton Grove, IL 60053. 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 2005-95, dated January 19, 2017. 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, which indicates that only Regis Technologies, Inc can fulfill the necessary requirement. Specifically, Regis Technologies, Inc is the sole source provider of the supply of 150g of each of the two intermediates for the National Center for Advancing Translational Sciences (NCATS). For this reason and to ensure continuity of scientific research data, Regis Technologies, Inc is the only contractor 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 National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives. Cancer continues to be a life-threatening disease. In 2016 alone, In 2016, an estimated 1,685,210 new cases of cancer were diagnosed in the United States and 595,690 people died from the disease. As more is learned about the underlying molecule mechanisms that drive cancer formation, especially in diverse cancer types, novel target therapies are necessary to combat this disease. Lactate dehydrogenase A (LDHA) has been identified as a potential target that is essential in several cancer types. In this regard, inhibition of LDHA is thought to be a novel mechanism to inhibit cancer growth and/or render cancer cells susceptible to additional chemotherapeutics. Two lead molecules have been developed, and we have reached the stage which requires large amounts of purified final compound. A significant hurdle in this process is the separation of regioisomers during the chemical synthesis of these compounds. Purpose and Objectives The objective of this project is to first supply 150 g of each of the two intermediates for the National Center for Advancing Translational Sciences (NCATS). Project Description Supercritical fluid separation will be performed to separate the regioisomers. The desired regioisomer will be isolated as a clean intermediate. The contractor will provide the following: On 150 g scale, one purified isomer at ≥97%re (98.5:1.5 area% ratio) and target ≥80% recovery from theoretical yield for each of two intermediates, to include: Chromatographic demonstration of separation Purity information of isolated compound Isolated yield Shipment of purified material Shipment of isolated pure compound to NCATS Non-Personal Service Statement: In accordance with FAR 37.104, this requirement is for non-personal services and does not include any inherently governmental functions; functions that are closely associated with inherently governmental functions; unauthorized personal services; critical and/or core functions. Period of Performance Period of performance is to process in 4 phases, with all 4 phases to be completed within 9 months ARO DescriptionRacemate MassLead time1 Separation #1 of 3G4D mixture (one peak, E2) Including HPLC analysis and summary~70-80g5 - 20 days Separation #2 of 3G4D mixture (one peak, E2) Including HPLC analysis and summary~70-80g5 - 20 days Separation #1 of 3-HUR mixture (one peak, tbd) Including HPLC analysis and summary~70-80g5 - 20 days Separation #2 of 3-HUR mixture (one peak, tbd) Including HPLC analysis and summary~70-80g5 - 20 days Place of Performance: The place of performance shall be at the contractor's worksite. Contract Type A Firm Fixed Price Purchase Order is contemplated. The order shall be sourced via the Open Market on a single-source basis and is not expected to exceed $150,000. RESPONSE INSTRUCTIONS Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. Offerors must provide both 1) a technical response and 2) a separate price quote. 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. PLEASE ENSURE THAT ALL EVALUATION CRITERIA ARE SPECIFICALLY ADDRESSED IN ANY RESPONSE(S) SUBMITTED. 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 contract resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price and all technical evaluation factors are detailed below. Factor 1: Technical Approach Vendor shall provide all tasks as listed in scope of work. Factor 2: Price Competitiveness Vendor shall demonstrate price competitiveness. Factor 3: Previous Experience The Contractor shall provide a list of three (2) contracts or purchase orders completed during the past five (5) years, similar in size and scope to the maintenance requirements outlined in this requirement. Experience must be specific to provision of this requirement and shall include the following information for each contract or purchase order listed: a.Name of Contracting Organization b.Total Contract Value c.Description of Requirement d. Contract Period of Performance Past Performance shall be evaluated for relevance to the current requirement. Technical proposals will be evaluated using a summary adjectival rating in accordance with the following scale: Excellent The proposal has exceptional merit and reflects an excellent approach which will clearly result in the superior attainment of all requirements and objectives. This clearly achievable approach includes several advantageous characteristics of substance, and very few disadvantages, which can be expected to result in outstanding performance. The risk of unsuccessful performance is very low as the proposal provides solutions which are unquestionably feasible and practical. These solutions are further considered very low risk in that they are exceptionally clear and precise, fully supported, and demonstrate a clear understanding of the requirements. Risk Level: Very Low Good The proposal demonstrates a sound approach which is expected to meet all requirements and objectives. This sound approach includes advantageous characteristics of substance, and few relatively minor disadvantages, which collectively can be expected to result in satisfactory performance. The risk of unsuccessful performance is low as the proposal contains solutions which are considered feasible and practical. These solutions are further considered to reflect low risk in that they are clear and precise, supported, and demonstrate an understanding of the requirements. Risk Level: Low Acceptable The proposal demonstrates an approach which is capable of meeting all requirements and objectives. The approach includes both advantageous and disadvantageous characteristics of substance, where the advantages are not outweighed by the disadvantages. Collectively, the advantages and disadvantages are likely to result in acceptable performance. The risk of unsuccessful performance is moderate, as the proposal solutions are generally feasible and practical. These solutions may also be considered to reflect moderate risk in that they may be somewhat clear and precise, partially supported, and/or demonstrate a general understanding of the requirements. Risk Level: Neutral Marginal The proposal demonstrates an approach which may not be capable of meeting all requirements and objectives. The approach has disadvantages of substance and advantages, which if they exist, are outweighed by the disadvantages. Collectively, the advantages and disadvantages present a low or questionable likelihood of resulting in satisfactory performance. The risk of unsuccessful performance is high as the proposal contains solutions which may not be feasible and practical. These solutions may also be considered to reflect high risk in that they lack clarity and precision, are generally unsupported, and/or do not demonstrate a complete understanding of the requirements. Risk Level: High Unacceptable The proposal demonstrates an approach which, based on a very high risk, will very likely not be capable of meeting all requirements and objectives. This approach has several disadvantages of substance, and advantages which, if they exist, are outweighed by disadvantages. Collectively, the advantages and disadvantages are unlikely to result in satisfactory performance. The risk of unsuccessful performance is very high as the proposal contains solutions which are not feasible and practical. The solutions may also be considered to reflect very high risk in that they lack any clarity or precision. Risk Level: Very High APPLICABLE TERMS AND CONDITIONS INCORPORATED BY REFERENCE The FAR clauses and provisions below 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 (October 2016), applies to this acquisition. 3.A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (October 2016), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 4.FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) is applicable to this acquisition. 5.FAR Clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (November 2016) apply to this acquisition. The following clauses shall be checked/included in this clause: 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note). 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) 52.222-3, Convict Labor (June 2003) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2016) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). 52.222-26, Equal Opportunity (Sept 2016) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) 52.222-50, Combating Trafficking in Persons (Mar 2015) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) 6.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. 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-17-345. Responses shall be submitted electronically to jermaine.duncan@nih.gov. Fax responses will not be accepted. For information regarding this solicitation, contact Jermaine Duncan by email at jermaine.duncan@nih.gov or by phone at (301) 827-7515.
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