SOURCES SOUGHT
R -- (-)-Phenserine Tartrate Purification, Encapsulation, & Testing Support Services
- Notice Date
- 6/9/2016
- 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, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SBSS-16-401
- Archive Date
- 7/5/2016
- 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
- Request for Information/Sources Sought Notice HHS-NIH-NIDA-SSSA-SBSS-16-401 (-)-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 Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified large business and small business sources, (2) whether they small businesses are small businesses; HUBZone small businesses, service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) large and small business size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Background: (-)-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 Procurement: The purpose of this acquisition is to procure commercial support services to purify, encapsulation, and test (-)-phenserine tartrate which shall then be used by the National Institute of Aging for human clinical research studies. To ensure continuity of science and conformance with Federal Drug Administration requirements, the compound must be prepared in accordance with IND 56,004. Project 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 Drug Application that supported the drugs 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 Contract Type: A cost-type purchase order is anticipated. Invoicing shall be on a NET30 basis and payment shall be made via Electronic Funds Transfer (EFT). Period of Performance/Delivery Requirements: The period of performance shall be ten (10) weeks from date of award. The contractor shall provide copies of the draft batch production record, standard operating procedures and protocols necessary for the API, GMP-ready analytical standard operating procedures, quality assurance related documentation for API manufacturing, and a certificate of analysis for the drug substance. This information shall be submitted to the NIH project officer via email prior to the end of the award period of performance. Place of Performance: The place of performance shall be the contractor's site. Capability Statement: Contractors that believe they possess the ability to provide the required support services should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. The capability statement should include 1) the total number of employees, 2) documentation of ability to provide the required support services, 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 requests 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 Lauren Phelps, Contract Specialist, via email at lauren.phelps@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 cost-type purchase order.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-SBSS-16-401/listing.html)
- Place of Performance
- Address: Baltimore, Maryland, 21224, United States
- Zip Code: 21224
- Zip Code: 21224
- Record
- SN04144306-W 20160611/160609234521-d8a1ad7d1cc3d0919eb4b72f9a1bdcbd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |