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(-)-Phenserine Tartrate Clinical Material Storage and Certificate of Analysis Evaluation Support Services

General Information

Document Type:PRESOL
Posted Date:Aug 25, 2017
Category: Special Studies and Analyses - Not R&D
Set Aside:N/A

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States

Description

(-)-Phenserine Tartrate Clinical Material Storage and Certificate of Analysis Evaluation Support Services Pre-Solicitation Notice of Intent to Sole Source HHS-NIH-NIDA-SSSA-NOI-17-592 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-17-592 and the solicitation is issued as a PRE-SOLICITATION, NOTICE OF INTENT, to award a contract on a noncompetitive basis to Regents of the University of Minnesota located at 200 Oak St Suite# 224 Minneapolis, MN 55455. 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 334516 with size standard of 1,000 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 Regents of the University of Minnesota is capable of providing the necessary supplies/services. Specifically, the National Institute on Aging worked with Dr. Vadim Gurvich of the University of Minnesota to successfully generate clinical grade (-)-phenserine tartrate, which was undertaken at the University of Minnesota within their FDA approved Current Good Manufacturing Practices (cGMP) facility. Two batches of clinical grade (-)-phenserine tartrate together with the ‘Reference material were developed and characterized, and currently reside at the University of Minnesota cGMP facility. Therefore, only the University of Minnesota is able to perform the required service as (i) this is where the drug was generated and is currently being stored within a FDA accredited facility, (ii) this is where the Reference material is also available, (iii) this is where the original Certificate of Analysis was generated - and all other Certificates of Analysis need to be compared with the original and reference, under the same chemical characterization conditions. 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 (-)-Phenserine tartrate is a small synthetic compound developed for the treatment of Alzheimers disease (AD) and related degenerative disorders by the scientists within the National Institute on Aging. The target for the drug is the enzyme acetylcholinesterase; however, the agent additionally has demonstrated neurotrophic and neuroprotective actions. Clinical grade material has been generated at the University of Minnesota, and the present contract is focused towards the storage of this clinical grade material under appropriate conditions to maintain its ‘clinical grade status - together with periodic chemical characterization of the material to provide a ‘Certificate of Analysis (this document defines the chemical purity of the material) Purpose and Objectives The purpose of this acquisition is to procure commercial support services to store clinical grade (-)-phenserine tartrate under appropriate conditions to maintain its clinical grade status (3 years duration) - with once yearly chemical characterization to provide a ‘Certificate of Analysis of the material. Project Requirements: The Contractor will store clinical grade (-)-phenserine tartrate under FDA approved conditions to ensure that ‘clinical grade designation is maintained (period of storage is 3 years). The Contractor will undertake chemical characterization of material once annually to provide a ‘Certificate of Analysis A.Phase 1: Clinical Grade Material Storage Services Phase 1: Support is required for the storage of clinical grade material product (-)-Phenserine tartrate under conditions to maintain its clinical grade status (storage for up to 3 years is required, 2 batches of materials (total approx. 500 g) together with reference stock). •Storage must be at a facility that is accredited with FDA Current Good Manufacturing Practices (cGMP) to support manufacture and storage of clinical grade pharmaceutical material that will be evaluated in clinical trials B.Phase 2: Certificate of Analysis - chemical characterization. Phase 2: Chemical characterization is required annually to provide a Certificate of Analysis (CoA) that defines the purity of the clinical grade (-)-phenserine tartrate that is being stored for a future clinical trial (CoA will be generated and compared to reference stock material). Facility must be FDA accredited and in accord with FDA regulations <as per: https://www.fda.gov/downloads/drugs/guidances/ucm073369.pdf> The Certificate of Analysis must compare the chemical characterization to the original Certificate of Analysis of the material generated by Dr. Vadim Gurvich, Ph.D., MBA, Associate Director, Institute for Therapeutics Discovery and Development (ITDD), Department of Medicinal Chemistry, University of Minnesota, 717 Delaware St. SE, Minneapolis, MN 55414 <vadimg@umn.edu | p. 612.626.5294> as well as to the Reference stock material. Government Responsibilities: The Government will provide (-)-phenserine tartrate clinical grade material (approx. 500 g) for storage (2 batches + reference stock). This agent has been generated for clinical trial evaluation - and storage is required until such trials are initiated and undertaken. No additional supplies shall be provided; all other necessary supplies shall be the responsibility of the Contractor Reporting Requirements: The contractor shall provide copies of the Certificate of Analysis on an annual basis. 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 / Delivery Base Year 9/11/2017 - 9/10/2018 Option Year 19/11/2018 - 9/10/2019 Option Year 2 9/11/2019 - 9/10/2020 Place of Performance: The place of performance shall be the National Institute on Aging (NIA) site located at 251 Bayview Blvd Room 02B211 Baltimore, MD 21224. 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 requirement as listed above. 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 The contractor shall detail in a technical proposal the processes and methods it will use for completion of the project requirements as well as the qualifications of the contractor employees to perform this work. The technical proposal shall be evaluated for compliance with Federal Drug Administration regulations, scientific accuracy and appropriateness, and efficiency. Factor 2: Timeliness and Delivery The contractor shall detail in a technical proposal how it shall meet the delivery timeframe and method requirements. The Government shall evaluate for ability to meet or exceed the requirements detailed in this statement of need (completion within ten weeks). Factor 3: Past Performance The Contractor shall provide a list of two (2) contracts or purchase orders completed during the past five (5) years, similar in size and scope to the maintenance requirements outlined in this Statement of Work. Experience must be specific to provision of laboratory instrument maintenance 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 (JAN 2017), applies to this acquisition. 3.A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (JAN 2017), 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 (JAN 2017) is applicable to this acquisition. 5.FAR Clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (JAN 2017) 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 Governments 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-17-592. 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.

Original Point of Contact

POC Jermaine Duncan, Phone: 3018277515

Place of Performance

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