SOLICITATION NOTICE
B -- Support Services for synthesis of (-)-Phenserine Tartrate Clinical Grade Material
- Notice Date
- 9/3/2019
- Notice Type
- Presolicitation
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- 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
- ZIP Code
- 20892-9559
- Solicitation Number
- HHS-NIH-NIDA-19-010233-RFQ
- Point of Contact
- Debra C. Hawkins, Phone: 301-827-7751
- E-Mail Address
-
debra.hawkins@nih.gov
(debra.hawkins@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION. PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Office of Acquisition, on behalf of the National Institute of Neurological Disorders and Strokes (NINDS) intends to negotiate and award a contract for Support Services for the synthesis of (-)-Phenserine Tartrate Clinical Grade Material. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE. The intended procurement is classified under NAICS code is 541714-Research and Development in Biotechnology (except Nanobiotechnology). Small Business Size Standard: 1,000 employees. REGULATORY AUTHORITY. The resultant contract will include all applicable provisions and clauses of the Federal Acquisition Regulation (FAR) in effect through the Federal Acquisition Circular (FAC) 2019-05, dated August 13, 2019. STATUTORY AUTHORITY. This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source. DESCRIPTION OF REQUIREMENT. Purpose or Objective of the Requirement: The purpose of this acquisition is to procure commercial support services to generate clinical grade (-)-Phenserine tartrate that meets specifications for use in humans and is in line with the ‘Certificate of Analyses' of the material previously generated and used in clinical trials. Background / Purpose / Objective: (-)-Phenserine tartrate is a small synthetic compound developed for the treatment of Alzheimer's 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 across animal models of neurodegeneration - suggesting that it may have a combination of properties as both a symptom and disease progression modifying drug. Clinical grade material is required to support a clinical trial of the agent in humans with AD, and this material must importantly match existing clinical grade material as well as be in line with prior clinical grade material that has met regulatory standards for use in humans. Project Requirements: The Contractor will generate clinical grade (-)-phenserine tartrate that meets FDA approved standards for human use. Contractor will undertake chemical characterization of material to provide a ‘Certificate of Analysis' that is in line with prior clinical grade material. Phase 1: Acquisition of starting materials. The purchase of starting materials in line with synthetic needs - for synthesis of clinical grade (-)-Phenserine tartrate - and with appropriate documentation to meet FDA approval. The contractor 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 (i.e., clinical grade (-)-Phenserine tartrate). Phase 2: Synthesis of clinical grade (-)-Phenserine tartrate. The Contractor shall synthesize (-)-phenserine tartrate from (-)-eseroline, using the existing synthetic strategy and analytical methodology to meet clinical grade standard as defined within the Chemistry Manufacturing and Controls (CMC) data within the initial FDA approved Investigational New Drug (IND) No. 56,004 (this synthetic route is provided at the end of this document). The final API should be identical to the existing (-)-phenserine tartrate clinical batches and reference standards. The services should be completed within twelve months from initiation and include a Batch Production Record (BPR) as well as associated Standard Operating Procedures for the Active Pharmaceutical Ingredient (API). Documentation shall include quality assurance efforts and confirmation of full compliance of processes and materials with FDA regulations for clinical grade compounds (CMC shall be in line with IND 56,004). Phase 3: Certificate of Analysis - chemical characterization. Chemical characterization is required to provide a Certificate of Analysis (CoA) that defines the purity of the clinical grade (-)-phenserine tartrate. Period of Performance. The period of performance of this contract shall be from September 2019 through September 2020. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this pre-solicitation notice. Responses to this pre-solicitation notice must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria specified in the solicitation. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. 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." 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. The solicitation will be released on or about September 6, 2019, with a proposal due date of September 20, 2019. All quotations or offers are due 12:00 Noon, Eastern Time, on September 20, 2019, and must reference the solicitation number noted herein. Quotations or offers must be submitted electronically to the contact person identified herein at debra.hawkins@nih.gov. Fax responses will not be accepted. For information regarding this solicitation contact: Debra C. Hawkins Contractor, Acquisition Policy Analyst II, at 301-827-7751. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA-19-010233-RFQ/listing.html)
- Place of Performance
- Address: National Institute of Neurological Disorders and Strokes (NINDS), Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN05428392-W 20190905/190903231036-f331fd921495380f4eb8ea3bc8c3f19e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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