SOLICITATION NOTICE
R -- (-)-Phenserine Tartrate Purification, Encapsulation, & Testing Support Services
- Notice Date
- 7/20/2016
- 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, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-PSOL-16-456
- Archive Date
- 8/18/2016
- 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
- PRE-SOLICITATION NOTICE INFORMATION HHS-NIH-NIDA-SSSA-PSOL-16-456 Title: (-)-Phenserine Tartrate Purification, Encapsulation, & Testing Support Services Contracting Office Address: 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, MD 20892, UNITED STATES. Introduction: This is a Pre-Solicitation Notice of Intent. This is NOT a solicitation for proposals, proposal abstracts, or quotations. A solicitation will be issued on a later date. The purpose of this pre-solicitation is to notify potential offerors that the National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Institute on Aging (NIA) intends to negotiate and award a purchase order to the Regents of the University of Minnesota located at 2829 University Avenue, Suite 635, Minneapolis, MN 55414 without providing for full and open competition. The award shall be for non-research-and-development compound purification, encapsulation and testing services as identified in this pre-solicitation. Requirement Background Information: (-)-Phenserine tartrate is a small synthetic compound developed for the treatment of Alzheimer's disease (AD) by the scientists within the National Institute on Aging. The target for the drug is the enzyme acetylcholinesterase; however, the agent additionally is an inhibitor of the synthesis of amyloid precursor protein (APP) and has demonstrated neurotrophic and neuroprotective actions. Purpose and Objectives for the Requirement: The purpose of this acquisition is to procure commercial support services to purify, encapsulate, and test (-)-phenserine tartrate which shall then be used by the National Institute of Aging for human clinical research studies. Project Tasks/Requirements: The Contractor shall provide (-)-phenserine tartrate purification to meet clinical grade standard (as defined within the Chemistry Manufacturing and Controls (CMC) data within the initial FDA approved Investigational New Drug (IND) Application that supported the drug's initial evaluation in humans (IND No. 56,004), together with its Encapsulation, and Testing Support Services as follows: A.Phase 1: Preliminary Process Support Services Phase 1 Preliminary Process Support Services shall be completed within six (6) weeks of initiation and shall include the following: •Document a recrystallization purification process for (-)-phenserine tartrate and utilize previously developed test release assays •Provide a draft 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). B.Phase 2: Purification, Encapsulation, and Test Services Phase 2 Purification, Encapsulation, and Test Services shall be completed within four (4) weeks of initiation and shall include the following: •Purification by re-crystallization of up to 400 grams of (-)-phenserine tartrate provided by the Government •Analysis of the resulting purified (-)-phenserine tartrate for acceptability to release the batch for clinical use as an investigational new drug. A Certificate of Analysis of the Drug Substance must be provided. •Encapsulation and test of the purified and approved (-)-phenserine tartrate. Up to 350 grams shall be encapsulated for use and approximately 15 grams shall be used to meet FDA regulatory testing requirements. Government Furnished Property: The Government will provide (-)-phenserine tartrate for use in performing the required efforts. No additional supplies shall be provided; all other necessary chemicals and supplies shall be the responsibility of the Contractor Anticipated Period of Performance: The period of performance shall be twelve (12) weeks from date of award. Anticipated Contract Type: The NIDA anticipates the award of one (1) cost-type purchase order. Request for Proposal Release Information: Request for Proposal (RFP) No. HHS-NIH-NIDA-SSSA-RFP-16-456 will be available electronically on or about August 3, 2016. The RFP shall be accessible through FedBizOpps at http://fedbizopps.gov. All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 15 days following RFP release. Offerors must submit a proposal for all Task Areas in order to be considered for award. WE ENCOURAGE ALL RESPONSIBLE SOURCES TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY. Notes: This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. It is the Offeror's responsibility to monitor the above mentioned site for the release of the solicitation and any amendments.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-PSOL-16-456/listing.html)
- Place of Performance
- Address: Baltimore, Maryland, 21224, United States
- Zip Code: 21224
- Zip Code: 21224
- Record
- SN04189750-W 20160722/160720234910-8db369da0d6837200c27d6b8f9ab3eb2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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