SOURCES SOUGHT
B -- (-)-Phenserine Tartrate Clinical Material Storage and Certificate of Analysis Evaluation Support Services
- Notice Date
- 7/19/2017
- Notice Type
- Sources Sought
- 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 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SS-17-592
- Archive Date
- 8/10/2017
- 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
- Federal Business Opportunities (FBO) SOURCES SOUGHT NOTICE 1.Solicitation Number: HHS-NIH-NIDA-SSSA-SS-17-592 2.Title: (-)-Phenserine Tartrate Clinical Material Storage and Certificate of Analysis Evaluation Support Services 3.Classification Code: B - Special Studies and Analysis - not R&D equipment 4.NAICS Code: 325998 - All Other Miscellaneous Chemical Product and Preparation Manufacturing Description: This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: (-)-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. 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' 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 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. Pricing: It is requested that the Contractor also provide the industry standard pricing for a 12-month period. Government Furnished Property: 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. Anticipated Contract Type: A firm fixed price purchase order within the Simplified Acquisition threshold is anticipated. Period of Performance/Delivery Requirements: The period of performance shall be: Base - 12 month period Option Year 1 - 12 month period Option Year 3 - 12 month period Delivery Requirements: The contractor shall provide copies of the Certificate of Analysis on an annual basis. Place of Performance: The place of performance shall be the contractor's site. Capability Statement: Contractors that believe that they possess the ability to fulfill the requirements listed above should submit documentation on their ability to meet each of the project requirements to the Contract Specialist. A cover page and an executive summary may be included but is not required. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The capability statement should include 1) the total number of employees, 2) documentation of ability to provide the required equipment and warranty 3) any contractor GSA Schedule contracts by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Contractors must also provide their Company Name, DUNs number, Physical Address, and Point of Contact Information. Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government request that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted to Jermaine Duncan, Contract Specialist, via email at jermaine.duncan@nih.gov before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered. Note: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government anticipates negotiation of a firm fixed price purchase order. Contracting Office Address: 31 Center Drive Room 1B59 Bethesda, Maryland 20892 United States Primary Point of Contact: Jermaine Duncan, Contract Specialist Jermaine.duncan@nih.gov Phone: 301-827-7515
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