SOLICITATION NOTICE
65 -- Capsule Filling Machine
- Notice Date
- 9/17/2013
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 333999
— All Other Miscellaneous General Purpose Machinery 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-P13-013770
- 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-P13-013770 and is being issued as a Request for Quotation (RFQ). The North American Industry Classification System (NAICS) Code for this procurement is 333999 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. Current Good Manufacturing Practice (cGMP) Section 501 [21 U.S.C. § 351] (a) (2) (B) of the Federal Food, Drug, and Cosmetic Act requires the methods, facilities, and controls used for the manufacturing, processing, packaging, and holding of drug products to conform to current Good Manufacturing Practices (cGMPs) in order to ensure the safety, identity, strength, quality, and purity of the drugs produced. The federal Food and Drug Administration (FDA) has general rulemaking authority to issue regulations for the efficient enforcement of the act. The FDA regulates pharmaceutical manufacturing through the Code of Federal Regulations (CFR), specifically the following sections: 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs; General Part 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR Part 600 Biological Products: General The FDA further discusses procedures and practices to meet cGMPs through various venues, including the publication of Guidance for Industry documents, several of which are applicable to the operations that take place in PDS. Two very relevant and important guidance documents include cGMP for Phase I Investigational Drugs and Sterile Drug Products Produced by Aseptic Processing - cGMPs. The requirement for maintenance and qualification of pharmaceutical machines and equipment are clear (21 CFR 211.67 Subpart D and FDA guidance and inspection documents) and linked to the regulations through these documents and venues. These regulations would be directly applicable to the upgrade of the Capsules making machines that are used to make PDS products. Regulatory Requirements for PDS Operations PDS engages in the manufacture, packaging, distribution, and holding of drugs and drug products for Phase I and Phase II clinical trials, and contributes to the submission of IND applications to the FDA. 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. STATEMENT OF OBJECTIVES The NIH Pharmaceutical Development Section is seeking to upgrade the existing capsule filling machine by purchasing a new semi -automatic capsule filling machine and related change parts to be in compliance with cGMP requirements. STATEMENT OF WORK The Contractor shall provide a capsule filling machine that has the following salient characteristics: General Requirements • The machine should be constructed of steel or aluminum to withstand cleaning with detergents. • The machine must easily accept an automatic capsule loader. • The capsule loader mechanism must feature an automatic loader for the alignment of capsules in loading trays. • The accuracy of the capsule fill must depend on the full fill of ingredients in each capsule. Specific Requirements • The maximum dimensions of the machine are 25 inches in height and 20 inches in width (to be compatible with the physical space restrictions in the PDS manufacturing area). • The maximum weight for the machine is 40 pounds. • The machine must have the capability of changing between #0, #1, #2, and #3 capsule sizes. • • The machine must be capable of loading 6,000 capsules per hour and producing at least 6,000 filled capsules per hour. PERIOD OF PERFORMANCE Delivery of unit is to occur within six (6) weeks of receipt of an executed Purchase Order. TECHNICAL EVALUATION ELEMENTS In addendum to FAR 52.212-2; the following factors shall be used to evaluate offers: Evaluation Criteria Technical Experience 100 points The contractor must be able to demonstrate an in-depth knowledge and understanding of capsule filling machines including the major parts and the machine's operation. 50 Points The contractor must be able to demonstrate an in-depth knowledge of the purpose, function, and operation of all processing equipment and related change parts for the machine. 40 Points The contractor must provide evidence that they will be able to supply replacement parts as needed in the future. 10 Points Award Criteria Selection of an Offeror for award will be based on lowest cost technically acceptable proposal. The evaluation will be based on the demonstrated capabilities of the prospective vendor to provide the products required for the requirement as set forth in the RFQ. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successfully providing the requirements of the 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 2012FAR 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 it's COR designation. NIH Information and Physical Access Security - Acquisition/Solicitation Language a. Commitment to Protect Non-Public Departmental Information and Data 1. Contractor Agreement The Contractor, and any subcontractors performing under this contract, shall not release, publish, or disclose non-public Departmental information to unauthorized personnel, and shall protect such information in accordance with provisions of the following laws and any other pertinent laws and regulations governing the confidentiality of such information: - 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records) - 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information) - Public Law 96-511 (Paperwork Reduction Act) b. Special Information Security Requirements for Foreign Contractors/Subcontractors When foreign contractors/subcontractors perform work under this acquisition at non-US Federal Government facilities, provisions of HSPD-12 do NOT apply. 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 28, 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-P13-013770 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-P13-013770/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
- SN03192136-W 20130919/130918000656-b9eb2d67cd0ae619eb40d54f69b464fe (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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