SOLICITATION NOTICE
65 -- Keyhole Limpet Hemocyanin
- Notice Date
- 8/7/2013
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325411
— Medicinal and Botanical 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
- CC-P13-011466
- Archive Date
- 9/6/2013
- 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 supplies 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) 2005-68 effective June 26, 2013. This acquisition will be processed under FAR Part 12, Simplified Acquisition Procedures (SAP), Acquisition of Commercial Items, and is publicized as a full and open requirement. The Solicitation Number for this acquisition is P13-011466 and is being issued as a Request for Quotation (RFQ). The North American Industry Classification System (NAICS) Code for this procurement is 325411 and the Small Business Size Standard is 750employees. 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 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 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. STATEMENT OF OBJECTIVES The purpose of this solicitation is to procure raw materials need to produce drug dosage forms needed for 3 ongoing NIH protocols. This raw material must be from the same Keyhole Limpet colony as the FDA has approved previously for these protocols. In addition the Keyhole Limpet Hemocyanin (KLH) must meet the following characteristics: • Compendial specifications (inclusion in the United States Pharmacopeia or National Formulary, U.S.P./N.F, or in foreign equivalents). • Chemical must be made under current Good Manufacturing Practices (cGMP), STATEMENT OF WORK The Contractor shall provide 750 mg of Keyhole Limpet Hemocyanin that complies with the following specifications: • Must be a blue colloidal liquid, • Must be at least 95% pure by SEC-HPLC, • Must attain a protein content of 4.5 - 5.5 mg\ml, • Must have a purity by SDS PAGE of a single band > 200 KDA with minor bands, • Endotoxin limit must be NMT 7 EU/mg, • Must show a negative results by PCR for the following: o Hepatitis A o Norwalk Virus o Rota Virus • Must show a negative results by BAM for the following: o Vibrio Cholera o V. Parahaemolyticus o V. Vulnificus PERIOD OF PERFORMANCE Delivery must be within 5 days of issuance of an award. TECHNICAL EVALUATION ELEMENTS In addendum to FAR 52.212-2; the following factors shall be used to evaluate offers: The item specified under the statement of work are considered mandatory, thus only products that meet these qualifications will be considered for an award. The Government intends to make this award to the lowest cost technically acceptable proposal based on the requirements stated above. 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 Supplies (NOV 1999); 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). 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 10:00 AM. (EST) August 22, 2013. Questions regarding this combined synopsis/solicitation must be received in writing by this office no later than August 12, 2013. 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. The anticipated award date for this requirement shall be on or before August 24, 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 P13-011466 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 closing date.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/CC-P13-011466/listing.html)
- Place of Performance
- Address: National Institutes of Health, Clinical Center, 10 Center Drive, Room 1C-266, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03140966-W 20130809/130808000314-279a739ae0399ce66ed979dae7cbccc5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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