SOURCES SOUGHT
65 -- reagents/dissposables supplies
- Notice Date
- 6/18/2018
- Notice Type
- Sources Sought
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- 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
- 18-011672
- Archive Date
- 6/27/2018
- 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-18-011672 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 National Institutes of Health (NIH) is the nation's foremost federally funded biomedical research institution. It is comprised of twenty-seven Institutes and Centers. The NIH Clinical Center (CC) is the onsite hospital for the NIH campus, providing full support for clinical studies in inpatient and outpatient settings. The NIH CC is an 870,000 square-foot facility with the capacity to serve 240 inpatient beds and 82 day-hospital stations. The Cell Processing Section (CPS), Department of Transfusion Medicine, NIH CC 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. Objective This contract is to purchase supplies aiding in the culture of cellular therapy products. The intended use for the bags is set forth in standard operating procedures set by investigators. The culture bags are specific for manufacturing in protocols including but Scope of Work The contractor will supply sufficient reagents and disposables to process approximately 150 cellular therapy products per year. Shelf Life-Minimum - shelf life of any unopened disposable shall be at least 1 year unless otherwise agreed to from date of delivery at the DTM Cell Processing Laboratory. The reagents and disposables may include but not limited to those listed below: PermaLife Cell Celture Bag, 7mL PermaLife Cell Celture Bag, 30mL PermaLife Cell Celture Bag, 70mL PermaLife Cell Celture Bag, 120mL PermaLife Cell Celture Bag, 240mL PermaLife Cell Celture Bag, 325mL Porective cap for female luer Needle free spike The Contractor shall supply technical support for all reagents and supplies and their performance characteristics at no additional cost to the Government. The Contractor shall supply technical support for all supplies and their performance characteristics at no additional cost to the Government. Period of Performance- After contract award Delivery Schedule These reagents /disposables will be shipped overnight delivery Monday Through Thursday to: These supplies will be shipped for delivery Monday through Thursday to: NIH/CC/DTM/Cell Processing Section 10 Center Drive Bldg. 10/ Rm. 3C720 Bethesda, MD 20892-1288 Attention: Thai Truong or Peta Chin Shipments will use government carrier at the expense of the government unless otherwise arranged. The contractor shall bear the cost of replacement for reagents and disposables found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments. Government Responsibilities The Cell Processing Section shall use the reagents and disposables in accordance with manufacturer's package inserts and approved IND/IDE uses if applicable. The NIH CC Cell Processing Section shall inspect shipments upon receipt and report any damage, defects or errors in shipment to the contractor. 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 June 22, 2018 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/18-011672/listing.html)
- Place of Performance
- Address: National Institute of Health, 9000 Rockville Pike, bld10-3C720, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04958745-W 20180620/180618230917-bb524849aa194f32c48ed1e597c75e5c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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