SOLICITATION NOTICE
66 -- Chemidoc MP Imaging System
- Notice Date
- 4/3/2018
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory 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
- 18-008075
- Archive Date
- 4/18/2018
- Point of Contact
- Andre M. Moody, Phone: 3014022677
- E-Mail Address
-
moodya@cc.nih.gov
(moodya@cc.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The Government intends to award a fixed price purchase order to: Government Scientific Source, Reston, VA 20191. Chimeric Antigen Receptor (CAR) and TCR-engineered T cells are used to treat malignancies. The Cell Processing Section (CPS) manufacturers CAR T and TCR-engineered T cells to treat patients at NIH. The retroviral vectors, Gibbon Ape leukemia Virus (GALV, Accession #M26927) are used in cell processing to deliver these gene to patients T cell because of their high efficiency of integration and stable delivery of target genes. To ensure patients safety, ex vivo modified cells must be tested for replication competent retrovirus (RCR) 1-4 days prior to infusion of the cells into the patient, PCR screening assay is used to confirm the absence or presence of GALV as lot release assay. After PCR reaction, we use the gel imager to visualize the PCR result and generate the final result for clinical products release. Primary item sought: Catalog #: Quantity Description BioRad 17001402 1 Chemidoc MP Imaging System INSTALLTION/DE-INSTALLATION: The Contractor shall install the system to include, at a minimum, un-packaging of all equipment, set-up and hook-up of all equipment, start-up, and demonstration of all required specifications 30 days after receipt of goods. The Contractor shall provide qualified personnel to perform the installation and perform all activities necessary to ensure the System is 100% functional and meets original manufactures specifications. The Contractor's installation personnel shall also perform all diagnostic tests after installation in the presence of the government. All costs associated with the installation to include labor, travel, and other expenses necessary to install the equipment will be borne solely by the contractor at no additional cost to the U.S. Government. WARRANTY: The contractor shall warrant the entire system for a period of at least one year. The warranty shall include unlimited telephone/e-mail support of the contractor's obligation to repair or replace the defective item(s). All costs including parts, labor, travel, and other expenses necessary to repair or replace the imaging system shall be borne solely by the contractor at no additional cost to the U.S. Government. INSPECTION AND ACCEPTANCE: The government will inspect and accept goods and may perform operational test to ensure the equipment performs in accordance with the original equipment manufacturer (OEM) specifications. OWNER'S MANUAL: The contractor shall provide one (1) copy of the operating manual to include schematics, installation, operation and maintenance and any other applicable manuals for system. Documentation shall be provided in English in hard copy and/or CD/DVD ROM. SOFTWARE - Contractor shall provide software configuration and updates as required to the government. Applications and products planned for use on NIH's Network shall be certified either via the COTS/GOTS certification process and placed on the Agency's Evaluated Approved Product List or through the Risk Management Framework (RMF) evaluated as part of an information system. All IT components shall be supported by the original equipment manufacturer for the duration of the system lifecycle (i.e components that require a Windows Operating System (OS) will operate on Windows Server 2008 / Windows 7 or higher). ELECTRICAL - Contractor shall comply with all applicable US electrical and associated safety and health code requirements relative to the proposed equipment, component, and/or system. The contractor shall provide documentation/certification that the equipment, component, and/or system meets these codes or standards. REGULATORY COMPLIANCE: All contractor furnished products must be UL and C-UL classified, ISO (International Organization for Standardization), and CE (European Conformity) compliant. They must meet all FDA clearances, and have received ADA acceptance. 12.1 Proposed medical devices/equipment must be in compliance with the FDA Good Manufacturing Practices for medical devices and equipment. The equipment shall be in compliance with the FDA Safe Medical Devices Act, "Safety Medical Act of 1990" by Frank E. Samuel, Jr. 12.2 System components where required must possess 510K certifications and produced by a manufacturer with ISO 13485 Certification or equivalent. Contractor shall provide a copy of their certification with their offer. 510k Certification: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm and/or ISO 13485 Certification: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm212795.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=ISO%2013485%20Certification&utm_content=1 Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have. The approval process for new drug and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMP. FDA inspectors determine whether the firm has the necessary facilities, equipment, and skills to manufacture the new drug for which it has applied for approval. Decisions regarding compliance with CGMP regulations are based upon inspection of the facilities, sample analyses, and compliance history of the firm. This information is summarized in reports which represent several years of history of the firms. FDA can issue a warning letter or initiate other regulatory actions against a company that fails to comply with Current Good Manufacturing Practice regulations. Failure to comply can also lead to a decision by FDA not to approve an application to market a drug. This web page provides links to resources to help drug manufacturers comply with the Current Good Manufacturing Practice regulations. Federal Regulations [Add as necessary to suit your Requirement] Code of Federal Regulations (CFR)1. The final regulations published in the Federal Register2 (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR. The CFR is divided into 50 titles which represent broad areas subject to Federal regulations. The FDA's portion of the CFR interprets the Federal Food, Drug and Cosmetic Act3 and related statutes. Section 21 of the CFR contains most regulations pertaining to food and drugs. The regulations document the actions of drug sponsors that are required under Federal law. ● 21 Code of Federal Regulations Part 2104. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs. ● 21 Code of Federal Regulations Part 2115. Current Good Manufacturing Practice for Finished Pharmaceuticals.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/18-008075/listing.html)
- Place of Performance
- Address: National Institutes of Health, 6707 Democracy Blvd., Suite 106, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04876778-W 20180405/180403231824-bbcaddff199df8849104ef6e864ed81f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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