SOLICITATION NOTICE
99 -- nactivated Monovalent Influenza Vaccine (bulk concentrates)
- Notice Date
- 2/24/2006
- Notice Type
- Solicitation Notice
- NAICS
- 621999
— All Other Miscellaneous Ambulatory Health Care Services
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2006-N-08412
- Response Due
- 3/13/2006
- Archive Date
- 3/28/2006
- Description
- 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. Solicitation No. 2006-N-08412 is being issued as a Request for Proposals (RFP). RFP No. 2006-N-08412 and incorporated provisions and clauses are those in effect through Federal Acquisition Circular No. 05-08, dated Jan. 26, 2006. The associated NAICS code for this acquisition is 621999. 1.0 BACKGROUND: Recent shortages of inactivated influenza vaccine have highlighted the fragility of the influenza vaccine market and the need for its expansion and stabilization. Maintaining an abundant influenza vaccine supply is critically important for protecting the public?s health and improving preparedness for an influenza pandemic in the United States (US). An increased supply of monovalent bulk inactivated influenza vaccine would help mitigate trivalent influenza vaccine shortages by increasing the amount of monovalent bulk vaccine available for final manufacturing processing as necessary. If supplies fall short, this bulk product can be turned into a finished trivalent influenza vaccine product for distribution. If supplies are sufficient, the bulk vaccine can possibly be held until the following year?s influenza season and developed into vaccines if the circulating strains remain the same. In either case the decision to fill and finish or hold the bulk concentrates would be made by the Contractor, at the Contractor?s discretion and expense. However, in no event can this product be sold for distribution outside the US. 2.0 PURPOSE: The purpose of this solicitation is to obtain proposals for services needed for the production of monovalent bulk inactivated influenza vaccine in excess of what is planned by the Contractor for the upcoming 2006-2007 influenza season and for the following season in 2007-2008. 3.0 QUANTITIES: This solicitation requires services to produce a quantity of monovalent bulk inactivated influenza vaccine to be determined by the contractor. The exact number of vaccine doses resulting from this material is dependent on the quantity of bulk product produced and its yield; however, CDC estimates that funds may be available to increase overall production between 5 million and 10 million doses of three strains of monovalent bulk vaccine. 4.0 SPECIAL REQUIREMENT: Any products proposed under this contract shall be fully licensed for distribution in the US by the US Food and Drug Administration (FDA) in accordance with the production schedule date established in Paragraph 2.0. Failure to obtain full FDA licensure of the product by the required date will result in rejection of the product by CDC. 5.0 TASKS TO BE PERFORMED: 5.1 Task 1. Production of Inactivated Monovalent Influenza Vaccine (bulk concentrates): The Contractor shall increase production of inactivated monovalent influenza vaccine bulk concentrates above what the Contractor had been planning to make for either the 2006-2007 through 2007-2008 seasons. These bulk concentrates shall be produced in accordance with current Good Manufacturing Practices and capable of being made into trivalent influenza vaccine for use in the United States for the 2006-2008 influenza seasons. This includes all steps associated with egg work, inactivated monovalent concentrate production and purification of all three viral strains 5.2 Task 2. Storage and Disposition of the Produced Product: CDC will not take possession of the inactivated monovalent bulk vaccine produced under this contract. After government inspection and testing, the Contractor may, at its option, (1) formulate and finish (pool concentrates, fill, package, label and test the trivalent vaccine in accordance with FDA requirements) and sell the vaccine on the open market, (2) retain the monovalent bulk for use in the following year?s formulation, as appropriate, or (3) dispose of the bulk product as required by law or regulation. 5.3 Task 3. Reimbursement to the Government in the Event of Product Sale: If the Contractor sells the finished trivalent vaccine on the open market, CDC shall be reimbursed for each dose sold at the per dose price agreed upon at time of award. This reimbursement shall apply to any year in which the product is sold. 6.0 PERIOD OF PERFORMANCE: The period of performance shall be from date of award until March 29th, 2008, as follows: 6.1 2006-2007 Influenza Season: The period of performance for the 2006-2007 Influenza Season shall begin on the date of contract award, which is approximately March 30th, 2006 and shall end on March 29th, 2007. 6.2 2007-2008 Influenza Season: The period of performance for the 2007-2008 Influenza Season shall begin approximately on Mach 30th 2007 and end on March 29th, 2008. 7.0 INSPECTION AND DELIVERY: 7.1 Inspection and Acceptance: The inactivated monovalent vaccine produced as a result of the services performed under this contract shall be made available to the CDC for final inspection and acceptance of the contractor's vaccine production service no later than August 31st , 2006. For vaccine produced for the 2007-2008 Influenza Season, inspection and acceptance of vaccine production service will occur no later than August 31st, 2007. Failure to pass inspection may result in rejection of the services and possible termination for cause of the contract. 7.2 Deliverables: At time of inspection stated above, the contractor shall provide 2 copies of a report that describes the quantity of excess monovalent bulk vaccine produced and the estimated yield in number of vaccine doses. Also, how/what was done to expand the production of bulk monovalent over and above what was originally intended. THE FOLLOWING FAR CLAUSES APPLY: 52.212-4, CONTRACT TERMS AND CONDITIONS?COMMERCIAL ITEMS (SEPT 2005), and 52.212-5, CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS?COMMERCIAL ITEMS (FEB 2006). (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (2) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: 52.203-6, Restrictions on Subcontractor Sales to the Government (Jul 1995), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402). 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d) (2) and (3)). (i) 52.219-9, Small Business Subcontracting Plan (July 2005) (15 U.S.C. 637(d) (4). Alternate II (Oct 2001) of 52.219-9. 52.222-3, Convict Labor (June 2003) (E.O. 11755). 52.222-19, Child Labor?Cooperation with Authorities and Remedies (Jan 2006) (E.O. 13126). 52.222-21, Prohibition of Segregated Facilities (Feb 1999). 52.222-26, Equal Opportunity (Apr 2002) (E.O. 11246). 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Dec 2001) (38 U.S.C. 4212). 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793). 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Dec 2001) (38 U.S.C. 4212). 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004); 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2006) (E.o.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). 52.232-33, Payment by Electronic Funds Transfer?Central Contractor Registration (Oct 2003) (31 U.S.C. 3332). (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: N/A. (d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records?Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor?s directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in paragraphs (i) through (vii) of this paragraph in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause? (i) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d) (2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $500,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (ii) 52.222-26, Equal Opportunity (Apr 2002) (E.O. 11246). (iii) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Dec 2001) (38 U.S.C. 4212). (iv) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998) (29 U.S.C. 793). (v) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201). (vi) 52.222-41, Service Contract Act of 1965, as Amended (July 2005), flow down required for all subcontracts subject to the Service Contract Act of 1965 (41 U.S.C. 351, et seq.). THE FOLLOWING FAR PROVISIONS APPLY TO THIS ACQUISITION: 52.212-1, INSTRUCTIONS TO OFFERORS?COMMERCIAL ITEMS (JAN 2006) and Addenda: (See also Evaluation Criteria under Provision 52.212-2 below.) Notwithstanding FAR provision 52.212-1(b), Submission of Offer, Offerors shall submit their proposals in two severable parts: PART I: The Technical Proposal, and PART II: the Business Proposal. PART I, The Technical Proposal, shall include the following baseline information for evaluation: a. Offerors anticipated production projection for 2006-2008 influenza seasons. Offerors may propose products that have not yet successfully completed the FDA Biologics License process at the time of proposal. However, evidence which would reasonably support a determination that licensure could be completed prior to the required inspection and acceptance date shall be presented. b. Total additional inactivated monovalent influenza vaccine bulk concentrate to be produced, stored, and dispositioned as a result of this contract. c. The estimated number of trivalent doses that could be produced from the additional monovalent production resulting from this contract d. The proposed per dose amount for reimbursement to the Government should the inactivated monovalent influenza vaccine bulk concentrate produced be filled, finished and sold for distribution in the United States. e. The age indication for the proposed influenza vaccine product and whether the vaccine includes thimerosal as a preservative. f. List of similar projects performed during the past 5 years including name of client company and complete address, name of contact, telephone and fax numbers, and e-mail address. CDC may contact some or all of the contacts listed to evaluate offerors? past performance. PART II, The Business Proposal, shall contain: (a) The proposed prices for the tasks and or deliverables specified above. This may include, but is not limited to, information related to pre-book (order) commitments, information related to the purchase of additional supplies or materials necessary for the increased production quantity or other supporting; (b) Clear and convincing evidence to allow the Government to determine that the vaccine produced under any resulting contract is truly in addition to planned production for the 2006-2008 influenza seasons; and (c) The proposed amount for Government reimbursement in the event the product produced under this contract is filled, finished and sold for distribution in the United States. The proposed reimbursement shall apply to any year in which the product may be sold. Offerors are responsible for providing accurate and complete information. (Failure to do so may cause rejection of the offer.) Original and 2 copies of the offer are due on March 13th, 2006, at 11:00 AM (EST), at the following address: Centers for Disease Control & Prevention, Procurement & Grants Office, Acquisition and Assistance Branch B, Attn. Berta Biltz, Ref. Sol. No. 2006-N-08412, 2920 Brandywine Road, Atlanta, GA 30341. Facsimile proposals are not authorized. Technical inquiries shall be e-mailed before March 9th, 2006 to Bbiltz at cdc.gov. Telephone inquiries will not be honored. Proposals/Offers received after the time and date set for receipt will not be considered for award. The Defense Priorities and Allocations System (DPAS) does not apply. All FAR clauses and provisions can be obtained at: www.arnet.gov. Section 8(d) of the Small Business Act (15 U.S.C. 637(d)) requires in negotiated acquisitions, each solicitation of offers to perform a contract or contract modification, that individually is expected to exceed $500,000 ($1,000,000 for construction) and that has subcontracting possibilities, shall require the apparently successful offeror to submit an acceptable subcontracting plan. Therefore, CDC may require submission of the Small Business (SB) Participation Plan of the apparently successful offeror only or of those offerors within the competitive range. The Government-wide SB subcontracting goals are: Small Business: 23 percent; HUBzone Small Business: 3 percent; Small Disadvantaged Business: 5 percent; Disabled Veteran-Owned Small Business: 3 percent; Women-Owned Small Business Concern: 5 percent. For more information visit:.knownet.hhs.gov. 52.212-2, EVALUATION-COMMERCIAL ITEMS (JAN 1999): The following evaluation factors, listed in descending order of importance, will be used to evaluate offers: (a) Impact on the overall supply of monovalent bulk inactivated influenza vaccine in excess of what is planned for the upcoming 2006-2007 and 2007-2008 influenza seasons. (Preference will be given to proposals that address the need for the 2006-2007 season.); (b) Amount proposed per dose for reimbursement to the Government should the resulting inactivated monovalent influenza vaccine bulk concentrate produced be filled, finished and sold for distribution; and (c) Length of the age indication of the proposed monovalent bulk inactivated influenza vaccine. Past performance is one indicator of the offeror?s ability to complete the contract successfully. Past Performance will be evaluated on offers deemed to be technically acceptable. An adjectival rating on the basis of Superior, Good, Satisfactory and Unsatisfactory will be assigned when evaluating Past Performance. Price is an important factor for award. However, the non-price factors, when combined, are more important than price. CDC reserves the right to award the contract to an offeror(s) who may not be the lowest in price. A single award or multiple awards may result from this RFP. Split awards per line item may also result from this RFP. Award may be made without discussions/negotiations. Offerors are advised to submit their initial offer in the best favorable terms to the government. 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS (MARCH 2005). (a)(1) Offerors shall be registered with CCR Central Contractor Registration (CCR), in accordance with subparagraph (t) of Clause 52.212-4 of this solicitation, to be eligible for award. (b) Offerors shall also complete the annual representations and certifications electronically via the Online Representations and Certifications Application (ORCA) website at orca.bpn.gov. After reviewing the ORCA database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below (offeror shall insert changes, identifying change by clause number, title, date). These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer. FAR Clause No. ; Title; Date; Change. Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on ORCA.
- Record
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