SOURCES SOUGHT
Q -- Preformulation stability studies
- Notice Date
- 11/19/2015
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical 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
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SBSS-2015-32
- Archive Date
- 12/12/2015
- Point of Contact
- Andrea McGee, Phone: 3014358781
- E-Mail Address
-
amcgee@nida.nih.gov
(amcgee@nida.nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- SOLICITATION NUMBER: HHS-NIH-NIDA-SSSA-SBSS-2015-32 TITLE: Preformulation stability studies INTRODUCTION This is a Small Business 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 small business sources; (2) whether they 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) their 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. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. 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. North American Industry Classification System (NAICS) Code 325412 - Pharmaceutical Preparation Manufacturing, Size Standard of 750 employees Purpose and Objectives: The purpose of this acquisition is to determine the stability of the Lead Compound as the hydrochloride salt, in a series of short and long term studies. Project Background: The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a translational science center that prides itself on its tremensously productive pipeline and is innovative in a number of ways. First, our quantitative high troughput screening (qHTS) paradigm, which tests all compounds at multiple concentrations in the primary screen, is unique. Second, the NCATS is distinctive in its focus on collaboration with outside investigators to produce high-quality chemical probes to define and assess new biology. This focus is reflected in our unprecedented Outreach program, which reaches hundreds of potential new investigators every year, and accounts for much of the new science being done at the NCATS. Third, the NCATS is uniquely focused on new technologies and paradigms to improve the process of translational science, typified by qHTS, our informatics platform, our utilization of structural biology to accelerate probe development, development of new synthetic and analytical chemistry paradigms. Ultimately, NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve peoples lives. Included in this process is the the development of unique biological discoveries into potential pharmaceuticals which can greatly assist patients In collaboration with other NIH institutes and outside academic researchers, NCATS is facillitating the development of Lead Compound as a potential treatment for refractory Major Depressive Disorder (MDD), a disease which affects millions of Americans. As part of the Development of Lead Compound for potential use as an investigational new drug (IND), the establishment of the relative chemical stability of Lead Compound is of importance. Chemical stability is of key importance, as a molecule that lacks the requisite long-term stability will require additional formulation work in order to stabilize it. In addition, various preformulation experiments, including solubility in various solvents, water uptake and phototoxicity are necessary. Requirements NCATS will provide up to 2.0 grams of lead compound for stability testing. Contractor will provide a comprehensive report upon completion of studies, including all data and experiments. Anticipated Period of Performance The Contractor shall deliver manufacturer product within eight (8) weeks after receipt of order. Anticipated Contract Type A firm fixed price purchase order is anticipated. Invoicing shall be on a NET30 basis. CAPABILITY STATEMENT Contractors that believe they possess the ability to provide the required equipment should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. Contractors should 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 Small Business Sources Sought Notice must be submitted electronically (via email) to Andrea McGee, Contract Specialist @ andrea.mcgee@nih.gov. on or before November 27, 2015, 4:00 p.m. eastern time. The response must in in Microsoft Word, 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. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in 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 a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-SBSS-2015-32/listing.html)
- Place of Performance
- Address: 9800 Medical Center, Rockville, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN03950381-W 20151121/151119234631-a48c2056c77c1fa5aa07443d1355ed8e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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