SOLICITATION NOTICE
65 -- Analytical Bubble Tester
- Notice Date
- 9/17/2013
- 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
- NIH-CC-P13-013797
- Archive Date
- 10/10/2013
- Point of Contact
- Brian J. Lind, Phone: 301-402-0735
- E-Mail Address
-
LindBJ@cc.nih.gov
(LindBJ@cc.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-69 effective September 3, 2013. This acquisition will be processed under FAR Part 12, Simplified Acquisition Procedures (SAP), Acquisition of Commercial Items, and is full and open. The Solicitation Number for this acquisition is CC-P13-013797 and is being issued as a Request for Quotation (RFQ). The North American Industry Classification System (NAICS) Code for this procurement is 334516 and the Small Business Size Standard is 500 employees. BACKGROUND The Clinical Center (CC) is the clinical research facility of the National Institutes of Health (NIH) and serves as the premier center for clinical research. It provides patient care, services, training, and the environment in which NIH clinicians-scientists translate emerging knowledge into the better understanding, direction, treatment, and prevention of human diseases. The CC, through NIH's Intramural Research Program, provides patient support services for the 15 NIH Institutes that admit patients and health volunteers for the purpose of participating in the more than 1,000 intramural biomedical research studies that cover a wide spectrum of common and rare diseases. More information about the NIH Clinical Center may be found at http://clinicalcenter.nih.gov. The CC Pharmacy department provides a range of pharmaceutical care services to inpatients and outpatients enrolled in clinical trials. The Pharmacy Department's Pharmaceutical Development Section (PDS) prepares customized investigational drug products, and assists investigators in filing Investigational New Drug (IND) applications with the FDA. \ PDS supplies for the Clinical Center, the preparation, manufacturing and testing of pharmaceutical products not available from other sources. The products prepared in PDS are used in Phase I and Phase II clinical trials. These products must meet FDA current Good Manufacturing Practice (cGMP) requirements for pharmaceutical manufacturing, and for the testing of these products to ensure patient safety. The FDA makes clear that an investigational drug for use in a Phase 1 study is subject to the statutory requirements set forth at 21 U.S.C. 351(a)(2)(B). Drugs for Phase 2 or Phase 3 study must comply with all regulations set forth by 21 CFR 210-211. As such, PDS is subject to the regulatory authority of the FDA and must operate under cGMP conditions. Additionally, vendors providing equipment or services to PDS must know, understand, and apply cGMP conditions since PDS is reliant upon the manufacturer or service provider to meet many of the required quality aspects of the goods or services provided. Integrity testing sterilizing filters is a fundamental requirement of critical process filtration applications in the pharmaceutical industry. FDA Guidelines require integrity testing of filters used in the processing of sterile solutions such as large volume parenterals (LVPs) and small volume parenterals (SVPs). The FDA also requires corresponding testing documentation be included with batch product records. STATEMENT OF OBJECTIVES The NIH Pharmaceutical Development Section is seeking to upgrade the existing filter integrity testing device (known as a bubble point tester) by purchasing a new bubble point tester to be in compliance with cGMP requirements. STATEMENT OF WORK The vendor must be able to provide a bubble tester that conforms to the following requiremnts: General Requirements • The machine should be portable to facilitate use in different locations within the manufacturing area of PDS. • The machine should be 21 CFR Part 11 compliance ready. • The machine should be network compatible to allow reading, recording, and printing of test results from remote locations within the network. • The machine should provide accurate and reliable test results for the filters specified in section four of this statement of work. Specific Requirements • The machine must be able to test the following Millipore sterilizing filters, along with other similar filters manufactured by Millipore. Sterivex-GV Filter Unit 0.22 µm, Part #SVGV010RS Millipak-20 Filter Unit 0.22 µm, Part #MPGL02GH2 Millipak-40 Filter Unit 0.22 µm, Part #MPGL04GH2 Millipak-60 Filter Unit 0.22 µm, Part #MPGL06GH2 Millipak-100 Filter Unit 0.22 µm, Part # MPGL1GCA3 • The machine must be designed to be a single unit including the software and control panel with printing capabilities. PERIOD OF PERFORMANCE Delivery of unit is to occur within 45 days of receipt of an executed Purchase Order. Award Criteria Due to the nature of the procurement criteria an award will be made on the lowest cost proposal that demonstrates that they can fulfill the requirement as specified in the Statement of Work section of this RFQ. The following Provisions and Clauses apply: FAR 52.212-1 Instruction to Offerors-/Commercial Items (FEB 2012); FAR 52.212-2 Evaluation - Commercial Items (Jan 1999) (Additional Evaluation criteria set forth in the combined synopsis/solicitation; FAR 212-3, Offeror Representations and Certifications - Commercial Items (DEC 2012); FAR 52.212-4 Contract Terms and Conditions Commercial Items (FEB 2012),FAR 52.222-3 Convict Labor (JUN 2003); FAR 52.223-6 Drug Free Workplace (May 2001), and FAR 52.232-33 Payment by Electronic Funds Transfer - Central Contractor Registration (OCT 2003). Contracting Officer's Technical Representative The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract: To be determined at the time of award. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The Government may unilaterally change its COR designation. Interested Offerors may submit quotations electronically to this notice no later than 1:00 PM. (EST) September 25, 2013. Questions regarding this combined synopsis/solicitation must be received in writing by this office no later than September 23, 2013. Offerors may submit a completed FAR 52.212-3, or cite their Representations and Certifications on SAM.gov. The quotation shall include fully-burdened hourly wage rates for the Board Certified Rehabilitation Physician services. The Government intends to make a single award based upon best value to the Government, technical and price factors considered. The anticipated award date for this requirement shall be on or before September 27, 2013. Facsimile submissions are not authorized and collect calls will not be accepted. Submit offers to Mr. Brian Lind at the address listed in this solicitation. Please reference the solicitation number CC-P13-013797 on your offer. Requests for information concerning this requirement are to be addressed to Brian Lind via e-mail only to lindbj@cc.nih.gov prior to the date stated above.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/NIH-CC-P13-013797/listing.html)
- Place of Performance
- Address: National Institutes of Health, Clinical Center, 10 Center Drive, Building 10, Room 1C-166, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03192117-W 20130919/130918000641-9f87e2f180541a0d5cccb3ce9161c20f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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