SOLICITATION NOTICE
Q -- the biosafety testing of between 1 cGMP quality master cell banks and retroviral vector supernatants
- Notice Date
- 10/15/2012
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- RFQ-NCI-130001-TG
- Archive Date
- 11/13/2012
- Point of Contact
- Terry Galloway, Phone: 301-402-4509, Anita Hughes, Phone: 301-435-3805
- E-Mail Address
-
gallowaytl@mail.nih.gov, anhughes@mail.nih.gov
(gallowaytl@mail.nih.gov, anhughes@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Boulevard, EPS Suite 600, Room 6074, Rockville, MD 20852, UNITED STATES. The National Cancer Institute (NCI) Center for Cancer Research (CCR) Pediatric Oncology Branch (POB) requires the following printing services and deliverables. This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This solicitation/request for quote: No. RFQ-NCI-130001-TG includes all applicable provisions and clauses in effect through FAC 2005-60 (August 2012) simplified procedures for commercial items. This requirement is set-aside for small business. The North American Industry Classification Code is 541380 and the business size standard is $14.0 Million. The NCI will require the biosafety testing of between 1 cGMP quality master cell banks and retroviral vector supernatants. The NCI will supply to the contractor, vial of cells from a TC71 master cell bank and/or retroviral vector supernatants for testing. The contractor shall be responsible for development of Standard Operating Procedures (SOP's), Quality Assurance (QA) practices, qualifications of production components, preparation of batch records, and the issuance of a final report containing the certificates of analysis, for the stated assays which will comply with current Points to Consider and 21CFR regulatory guidelines as stipulated by the Food and Drug Administration (FDA). Only one (1) award shall be made as a result of this solicitation. This requirement will be awarded as a firm fixed price, indefinite delivery indefinite quantity (IDIQ) type contract. Period of Performance shall be from award through twelve (12) months The following Assays are requested for this requirement: The NCI will provide 1 cGMP quality TC71 cell bank to the contractor for biosafety testing. The contractor will be responsible for conducting master cell bank certification testing based on current FDA guidelines. Subject to review and/or change of current FDA requirements, cell bank certification tests shall include the following list of assays: A. Test for the presence of bacterial and fungal contaminants: four media sterility test using a direct inoculation method. B. Test for the presence of agar-cultivable and non-cultivable mycoplasma according to 1993 PTC and 21CFR 610.30. C. Cell culture identification and characterization. D. Cocultivation of test article cells with SC-1 cells and detection of retrovirus by reverse transcriptase and XC plaque assay (Ecotropic RCR analysis including MLV) E. In vitro assay for the presence of viral contaminants. F. Test for the presence of inapparent viruses. G. Mouse antibody production (MAP) test. H. In vitro assay for the presence of bovine viruses according to 9CFR requirements. I. In vitro assay for the presence of porcine viruses according to 9CFR requirements (modified 9CFR requirements when tested in conjunction with bovine 9CFR screen). J. Polymerase chain reaction assay for the detection of Simian Virus 40 (SV40) in biological samples. K. Polymerase chain reaction assay for the detection of Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in biological samples. L. Polymerase chain reaction assay for the detection of Hepatitis B Virus (HBV) in biological samples. M. Polymerase chain reaction assay for the detection of Human Herpesvirus 6 (HHV-6) in biological samples. N. Polymerase chain reaction assay for the detection of Human Herpesvirus 7 (HHV-7) in biological samples. O. Polymerase chain reaction assay for the detection of Human Herpesvirus 8 (HHV-8) in biological samples. P. Polymerase chain reaction assay for the detection of Cytomegalovirus (CMV) in biological samples. Q. Polymerase chain reaction assay for the detection of Epstein Barr Virus (EBV) in biological samples. R. Polymerase chain reaction assay for the detection of Human T-Cell Lymphtrophic Virus Types I and II (HTLV-I/II) in biological samples. S. Polymerase chain reaction assay for the detection of Human Parvo Virus B19 in biological samples. T. RT-PCR assay for the detection of Hepatitis C Virus (HCV) in biological samples. U. Q-PCR analysis for detection of E1A sequence from Adenovirus in biological samples. V. Transmission EM for viruses and retroviruses. W. Mycoplasma Detection with Mycoplasmastasis X. Vector Identity by Southern blot analysis. PROVISIONS AND CLAUSES: The following FAR provisions and clauses apply to this acquisition: FAR clause 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (February 2012); 52.212-2 Evaluation-Commercial Items. As prescribed in 12.301(c), the Contracting Officer may insert a provision substantially as follows: Evaluation-Commercial Items (Jan 1999) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: _Past Performance___ _Price_____________ FAR clause 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS- (April 2012) FAR Clause 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (February 2012); FAR Clause 52.212-5: CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (August 2012). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition; Far Clause 52.204-10 Reporting executive compensation and First-Tier Subconract Awards (August 2012) Far Clause 52.209-6 Protecting Government' Interest When Subcontracting with Contractors Debarred, suspended, or Proposed for Debarment (December 2010) Far Clause 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns (January 2011) Far Clause 52.219-28 Post Award Small Business Program Representation (April 2012) Far Clause 52.222-3 Convict Labor (June 2003) Far Clause 52.222-19 Child Labor-Cooperation with Authorities and Remedies (April 2012) Far Clause 52.222-21 Prohibition of Segregated Facilities (February 1999) Far Clause 52.222-26 Equal Opportunity (March 2007) Far Clause 52.222-36 Affirmative Action for Workers with Disabilities (October 2010) Far Clause 52.223-18 Encouraging contractor Policy to Ban Text Messaging while Driving (August 2011) Far Clause 52.225-3 Buy-American Act - Free Trade Agreements - Israeli Trade Act (May 2012) Alternate II (March 2012) Far Clause 52.225-13 Restrictions on certain foreign purchases (June 2008) Far Clause 52.232-33 Payment by Electronic Funds Transfer- Central Contractor Registration (October 2003) Provisions and clauses that apply to this Request for Quote may be downloaded from http://acquisition.gov/comp/far/index.html OFFERORS: Offers must be submitted on an SF-1449 with a completed 52.212-3 Offeror Representations and Certifications-Commercial Items, signed by an authorized representative of the offeror OR provide a copy of the valid certification registrations of the offeror's Central Contractor Registration (CCR) and Online Representations and Certifications Applications (ORCA) from the sam.gov website. Past Performance Information: Quoters shall submit the following information as part of their response. • A list of the last 3 (three) contracts providing similar products or services for work performed and completed onsite at the clients facility during the past ten years, as well as all contracts currently in process that are similar in nature to the solicitation. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Quoters/offerors that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. Include the following information for each contract or subcontract: 1. Name of Contracting Organization 2. Contract Number (for subcontracts, provide the prime contract number and the subcontract number) 3. Contract Type 4. Total Contract Value 5. Description of Requirement 6. Contracting Officer's Name and Telephone Number 7. Program Manager's Name and Telephone Number 8. North American Industry Classification Code (NAICS) The quoter/offeror may provide information on problems encountered on the identified contracts and the quoter's/offeror's corrective actions The Government will evaluate the offeror's past performance based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. The Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror's performance. The lack of a performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror. The past performance subfactors are listed below in order of relative importance. These subfactors will be used to evaluate the quality of past performance. Past Performance Subfactors: • Record of conforming to specifications and to standards of good workmanship • Adherence to contract schedules, including the administrative aspects of performance • Reputation for reasonable and cooperative behavior and commitment to customer satisfaction • Business-like concern for the interest of the customer Each quoter/offeror will be evaluated on their performance under existing and prior contracts for similar products or services. The Government is not required to contact all references provided by the quoter/offeror. Also, references other than those identified by the quoter/offeror may be contacted by the Government to obtain additional information that will be used in the evaluation of the quoter/offeror's Past Performance. PLEASE NOTE: In order to receive an award, contractor must be registered in and have valid certifications in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA) thru the SAM.gov website. Quotations must be received in the NCI-OA contracting office by 11:00 a.m. on 10/29/2012. Please refer to solicitation number RFQ-NCI-130001-TG on all correspondence. No collect calls will be accepted. Electronic mail quotations will be accepted.
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