SOLICITATION NOTICE
68 -- PHARMACY DRUG
- Notice Date
- 5/15/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325199
— All Other Basic Organic Chemical 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
- NIHCL14010474
- Archive Date
- 6/3/2014
- Point of Contact
- Diania Robinson, Phone: 301-594-5917
- E-Mail Address
-
dmrobinson1@mail.nih.gov
(dmrobinson1@mail.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) 2005-73 effective April 29, 2014. This acquisition will be processed under FAR Part 12, Simplified Acquisition Procedures (SAP), and Acquisition of Commercial Items. The Solicitation Number for this acquisition is NIHCL14010474 and is being issued as a Request for Quotation (RFQ). The North American Industry Classification System (NAICS) Code for this procurement is 325199 and the Small Business Size Standard is 1,000. BACKGROUND The National Institutes of Health (NIH) Clinical Center (CC) is a clinical research hospital providing all medical services for patients participating in human research protocols of the NIH. The CC provides patient facilities and services for clinical investigations by the NIH Institutes, research in related areas and supervises residency and other training programs. The NIH Clinical Center Pharmacy Department provides pharmaceutical care and dispenses medications to inpatient and outpatients enrolled on clinical investigational studies. Clinical Center pharmacists provide research support to health care providers and investigators. Pharmacy staff members conduct and participate in research programs that enhance knowledge regarding optimal dosing and appropriate use of investigational and commercially available agents. The Pharmacy Department's Pharmaceutical Development Section (PDS) manages investigational drug inventories through a computerized information system, prepares customized investigational drug products, and assists investigators in filing Investigational New Drug (IND) applications with the FDA.. STATEMENT OF OBJECTIVES The Pharmacy Department is required to find a suitable source for raw materials needed to produce the drug dosage forms needed to complete the goals of approved clinical trials. The Pharmacy has made many hundreds of purchases over the years and the practices employed are in most cases, reviewed by the FDA. In effect, on hundreds of occasions, the FDA has agreed that Pharmacy has made a proper choice in this regard. The judgment, based on experience, of members of the Pharmacy who make these selections is a primary factor in the decision process. Compendial specifications (inclusion in the United States Pharmacopeia or National Formulary, U.S.P./N.F. or in foreign equivalents) need not be considered in this selection since there are no compendial monographs for stable isotopes. However since these compounds are being used under an IND, it is required that they be tested for microbial content and endotoxin (pyrogen) content. STATEMENT OF WORK INDs have been submitted to the FDA and numerous batches of similar drug products have been made previously. PDS wants to procure the quantities of isotopes on the list below. Isotope Enrichment Testing Quantity (g) D-Glucose 6,6,-D2 99% Microbiological/Pyrogen 380 D-Glucose 2-13C 99% Microbiological/Pyrogen 600 Glycerol 1,1,2,3,3-D5 99% Microbiological/Pyrogen 60 Deuterium Oxide 99.8% Microbiologica - 24,000 REQUIREMENTS A. The products must have a retest date at least one year from the time of delivery. B. The products must be tested for pyrogens and microbes as specified in the table above. C. The products must have the degree of enrichment stated in the table above, or higher. D. The full amounts ordered must be delivered within 4 weeks of receiving the purchase order. E. Each lot of isotope must be accompanied by a Certificate of Analysis. DELIVERABLES The vendor must provide the isotopes as listed in the Scope of Work, the same tests performed, the same level of enrichment and the same quantities. Each lot of isotope must be accompanied by a certificate of analysis. TECHNICAL EVALUATION ELEMENTS In addendum to FAR 52.212-2; the following factors shall be used to evaluate offers: Criterion Percentage Weight Points: 1. The products have a retest date at least one year from date of delivery. 30 2. The full amounts ordered will be delivered within 2 weeks of receiving the purchase order. 30 3. The degree of enrichment is at least that stated in the table above. 40 PRICE The price quoted shall be evaluated for price reasonableness. A best value analysis will be performed taking into consideration the results of the technical evaluation, price evaluation, and the ability to complete work within the Government's required schedule. 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 52.217-8 Option To Extend Services (NOV 1999); FAR 219-6 Notice of Total Small Business Set-Aside (NOV 2011); FAR 52.219.28 Post Award Small Business Program Representation (APR 2012); FAR 52.222-3 Convict Labor (JUN 2003); FAR 52.222-53 Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (FEB 2009); FAR 52.223-6 Drug Free Workplace (May 2001), FAR 52.227-14 RIGHTS IN DATA - General (Dec 2007), FAR 52.228-5 Insurance - Working On a Government Installation (JAN 1997) and FAR 52.232-33 Payment by Electronic Funds Transfer - Central Contractor Registration (OCT 2003). The Contractor shall comply with the following clauses, which are incorporated in this contract in full text, to implement provisions of law or Executive orders applicable to acquisitions of commercial items. Contracting Officer's 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. Interested Offerors may submit quotations electronically to this notice no later than 9:00 AM. (EST) May 19, 2014. Questions regarding this combined synopsis/solicitation must be received in writing by this office no later than May 17, 2014. Offerors may submit a completed FAR 52.212-3, or cite their Representations and Certifications on SAM.gov. 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 May 20, 2013. Facsimile submissions are not authorized and collect calls will not be accepted. Submit offers to Ms. Diania Robinson at the address listed in this solicitation. Please reference the solicitation number NIHCL14010474 on your offer. Requests for information concerning this requirement are to be addressed to Diania Robinson via e-mail only to dmrobinson1@cc.nih.gov prior to the closing date. NO PHONE CALL PLEASE.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/NIHCL14010474/listing.html)
- Place of Performance
- Address: 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03367007-W 20140517/140515234701-f23f8913040f7f6b04e9813c8432dc83 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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