SOURCES SOUGHT
65 -- Medical Supplies therapy products
- Notice Date
- 5/3/2018
- Notice Type
- Sources Sought
- NAICS
- 424210
— Drugs and Druggists' Sundries Merchant Wholesalers
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- 18-009847
- Archive Date
- 5/14/2018
- Point of Contact
- Priscilla S. Abalos, Phone: 3015943879
- E-Mail Address
-
priscilla.abalos@nih.gov
(priscilla.abalos@nih.gov)
- Small Business Set-Aside
- Emerging Small Business
- Description
- Solicitation # HHSN-NIH-CCOPC-SBSS-18-009847 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 there are small businesses, HUBZONE small businesses, service disabled veteran-owned small businesses or (8a) small businesses, veteran- owned small business, woman-owned small businesses or small disadvantaged businesses veteran owned small businesses; woman owned 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 response 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 code should not submit a response to this notice. Background Information The Department of Transfusion Medicine (DTM. is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support more than 50 intramural clinical trials. These services include (1) development, evaluation, and validation of investigational new drugs (INDs) for cellular therapies and (2) manufacture of cellular therapy products for approved clinical trials. The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product. To provide these services, CPS operates a core facility (Charles S. Carter Cellular Therapy Laboratory) for the manufacture, storage, and distribution of cellular therapy products. CPS manufactures cellular therapy products from more than 800 collections from patients or healthy donors per year. The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases. All products are manufactured using good manufacturing practices (GMP). The NIH protocols are institutional review board (IRB) approved and in the case of INDs approval by the US Food and Drug Administration (FDA) for treatment of human subjects. Each subject must consent to participate in a NIH Clinical Research Study. Purpose/Duties The purpose of this notice is to procure Hospital Media for phase I/II supplies cellular therapy products. The intended use for the AIM V media is set forth by the investigator and is protocol specific. Currently the media is used to aid in the culture of clinical cellular therapy products including but not limited to: Preparation of Autologous Transduced Lymphocytes Expressing Anti-CD22 Chimeric Antigen Receptor, T Cells expressing a fully-human anti-CD30 Chimeric Antigen Receptor for treating CD30-expressing lymphomas, and Transduction of Autologous T Cells with anti-HPV-16 E7 T-Cell Receptor I. Scope of Work 1. The contractor will supply sufficient reagents and disposables to process approximately 75 cellular therapy products per year. 2. Shelf Life-Minimum - shelf life of any unopened disposable shall be at least 6 months from receipt unless otherwise agreed to from date of delivery at the DTM Cell Processing Laboratory. 3. The reagents and disposables may include but not limited to those listed below: - AIM V Media, 1L Bottle 4. The Contractor shall supply technical support for all reagents and supplies and their performance characteristics at no additional cost to the Government. Location: The device delivery location - National Institute of Health, Clinical Center bldg. 10-3C 720 Department of Transfusion Medicine. Capability Statement is to include: Information regarding respondents; (a), including their availability, experience and informal and other training; (b) current in-house capability to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts; references, and other related information: • Respondents, DUNS number, organization name, address, point of contract, and size and type of business (e.g.8(a), HUBZone, etc) pursuant to the applicable NAICS code; • Respondents; technical and administrative points of contract including names, titles addresses, telephone and fax numbers and email addresses; • Respondents must respond to this notice by May 10, 2018 at 12:00 pm Est DISCLAIMER AND IMPORTANT NOTICES: 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 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, a pre-solicitation synopsis and solicitation maybe published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a future solicitation. Primary Point of Contact Priscilla Abalos Contract Specialist Phone Number 301/594/5918
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/18-009847/listing.html)
- Place of Performance
- Address: National Institute of Health, Department of Transfusion Medicine, 9000 Rockville Pike bldg. 10- 3C-720, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04910615-W 20180505/180503231100-789b0d12bb72e03403d595dd8ca64d01 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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