SOLICITATION NOTICE
R -- Aseptic Manufacture, Filling and Sterility Testing of Mangofodipir Trisodium Injection
- Notice Date
- 9/10/2015
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-CSS-15-874
- Archive Date
- 10/1/2015
- Point of Contact
- Lauren M. Phelps, Phone: 3015942490
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Aseptic Manufacture, Filling and Sterility Testing of Mangofodipir Trisodium Injection Competitive Combined Synopsis/Solicitation HHS-NIH-NIDA-SSSA-CSS-15-874 INTRODUCTION This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures and FAR Part 12--Acquisition of Commercial Items. The solicitation number is HHS-NIH-NIDA-SSSA-CSS-15-874 and the solicitation is issued as a request for quotation (RFQ). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541990 with a Size Standard of $14 Million. SET-ASIDE STATUS This acquisition is unrestricted and available for full and open competition. ACQUISITION AUTHORITY This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures and FAR Part 12-Acquisition of Commercial Items, and IS NOT expected to exceed the simplified acquisition threshold. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-84, dated September 3, 2015. The resultant contract will include all applicable provisions and clauses in effect through this date. DESCRIPTION OF REQUIREMENT Purpose The purpose of this requirement is acquisition of professional scientific services to aseptically manufacture and fill mangofodipir trisodium injections as well as performance of sterility testing of the injections. This requirement is in support of the National Institute of Neurological Disorders and Stroke's Translational Neuroradiology Unity. Project Requirements The NINDS Translational Neuroradiology Unit requires a Contractor to perform the following services: 1. The Contractor shall compound, filter, and aspectically fill 300 mangofodipir trisodium injections into vials for clinical use. 2. Prior to creating the 300 vial batch for clinical use, the Contractor shall prepare a trial batch of mangofodipir trisodium vials for Government inspection. 3. The Contractor shall write a test method for sterility testing using a provided method suitability report. The clinical batch shall be release tested for sterility and a CoA for sterility shall be issued. pH testing shall also be carried out. Delivery Requirements/Period of Performance The Contractor shall deliver manufacturer product within four (4) weeks after receipt of order and shall be delivered between the hours of 8:00 AM to 5:00 PM, Bethesda, MD local prevailing time, Monday through Friday. A program office point of contact shall be provided at time of award and this individual should be notified by phone or email at least three days in advance of the anticipated delivery date. Contract Type The Government intends to issue a firm fixed price purchase order for this requirement. Invoicing shall be on a NET30 basis after goods are accepted. APPLICABLE CLAUSES AND PROVISIONS The following FAR clauses and provisions shall apply to this solicitation: 1. All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (April 2014), applies to this acquisition. 3. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (March 2015), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 4. FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (May 2015) apply to this acquisition. 5. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." EVALUATION CRITERIA FAR clause 52.212-2, Evaluation - Commercial Items applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provision are as follows: Factor 1: Technical Capability The Offeror shall detail its technical capability to perform the required tasks identified in this statement of work. The Government shall evaluate the Contractor's proposed approach to manufacturing, filling, and sterility testing mangafodipir trisodium per the requirements of this solicitation. Factor 2: Corporate Experience The offeror shall provide a list of two (2) contracts completed during the past five (5) years, similar in size and scope to the requirements outlined in the Statement of Work. Experience must be specific to manufacturing and filling safe chemical and medical injections. Offerors shall include the following information for each contract or purchase order listed: • Name of Contracting Organization • Contract Number • Contract Type • Total Contract Value • Description of Requirement and Specific Responsibilities of the Offeror as they relate to this SOW Award will be made to the contractor offering best value to the Government, technical factors and price considered. Technical factors shall be considered more important than price. The Government shall not, however, accept significant price increases for marginal technical superiority. RESPONSE FORMAT Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The offeror must submit 1) a technical response and 2) a separate price quotation. The technical response should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to twelve single-sided pages. The price quotation must include the requirements listed above as well as associated pricing. Contractors must provide their Company Name, Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of Contact Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." NOTE Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. CLOSING STATEMENT All responses must be received by the closing date of this announcement and must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-15-874. Responses shall be submitted electronically via email to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-CSS-15-874/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03880015-W 20150912/150911000016-9ca6cc55d851ded54108399ca498ed22 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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