PRESOL | 68 | Production of 1 miligram each of 34 scFv antibodies - RFQ document

FBO DAILY ISSUE OF JUNE 23, 2010 FBO #3133
SOLICITATION NOTICE

68 -- Production of 1 miligram each of 34 scFv antibodies - RFQ document

Notice Date: 6/21/2010
Notice Type: Combined Synopsis/Solicitation
NAICS: 541711 — Research and Development in Biotechnology
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
ZIP Code: 20857-0001
Solicitation Number: FDA-SOL-1074203
Archive Date: 7/24/2010
Point of Contact: Ariana Nijaradze, Phone: 3018277161
E-Mail Address: ariana.nijaradze@fda.hhs.gov
(ariana.nijaradze@fda.hhs.gov)
Small Business Set-Aside: Total Small Business
Description: This is the full RFQ document. Includes price chart. 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 total small business set-aside competition solicitation; proposals are being requested and a written solicitation will not be issued. Simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-41. Solicitation number FDA-SOL- 1074203 is issued as a Request for Quotation (RFQ). This synopsis, NAICS code 541711, size standard 500, is to notify contractors that the government intends to issue a Firm Fixed Price Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. Any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. PART 2: CONTRACT 2.1 Period of Performance: The Food and Drug Administration (FDA) requires a period of performance of sixty (60) days after receipt of award. 2.2 Pricing: Item Number scFv clones for soluble scFv production Price 1 E4CG 10 $ 2 E4CG 33 3 Nicotiana 2 4 Nicotiana 27 5 Nicotiana 36 6 Nicotiana 50 7 Nicotiana 52 8 Nicotiana 27 9 Nicotiana 59 10 Agaricus 7 11 Agaricus 46 12 Agaricus 38 13 Agaricus 31 14 Agaricus 19 15 Agaricus 17 16 Agaricus 28 17 Agaricus 61 18 Agaricus 52 19 Agaricus 68 20 Agaricus 60 21 Agaricus 77 22 Agaricus 58 23 Agaricus 67 24 Agaricus 54 25 Agaricus 70 26 Agaricus 53 27 Agaricus 78 28 Agaricus 75 29 Agaricus 47 30 Agaricus 65 31 Neurospora 3 32 Neurospora 14 33 Neurospora 65 34 Neurospora 81 Grand Total: $ PART 3: STATEMENT OF WORK 3.1 Background The Center for Biologics Evaluation and Research (CBER) requires the production of one (1) milligram each of 34 scFv antibodies against the following allergens: German cockroach (2), Neurospora crassa (4), Agarigus bisporus (21), and Nicotiana benthamiana/excelsiana (7). The plasmids encoding these specific antibodies have already been generated. These plasmids are in the possession of CBER and Creative Dynamics Inc, Shirley, NY. This work will be performed as part of the development of the multiplex allergen extract potency assay (MAEPA). CBER is currently in the process of developing and optimizing MAEPA for less complex allergen mixtures and is ready to move into more complex mixtures such as the cockroach allergen extract. The development of this assay will be an important step towards analyzing the allergenicity of cockroach extract as well as many other extracts currently on the market that do not have a standard of potency. We are also working to evaluate potential allergens that may exist and co-purify with vaccines produced in novel expression systems. A human scFv library used to screen these extracts will be expected to enable us to find allergens relevant to humans. 3.2 Objective The FDAs objective is to obtain one milligram (1mg) each of 34 scFv's in order to assess the overall potency of complex allergen mixtures. 3.3 Technical Requirements The contractor shall provide the following: One milligram (1 mg) each of 34 designated scFv's. The scFv's will be soluble, tagged (His and Myc), in aqueous solution, at a purity of >98%. Aside from the specified His and Myc tags, the scFv antibody should be free of fusion constructs. In order to achieve this, the encoding DNA shall be cloned into an appropriate expression vector, optimized, and expressed under optimal conditions. The expressed scFv shall be tested for allergen binding and purified. In most cases the encoding DNA will have to be optimized; contractor should note that 30 of the provided sequences contain amber stop codons. 1. Antibody expression construct for each of the 34 scFv's. See list below. 2. ELISA data supporting scFv binding to each antigen. 3. scFv antibody sequence, inferred from expression construct DNA sequence. clones for soluble scFv production 1 E4CG 10 2 E4CG 33 3 Nicotiana 2 4 Nicotiana 27 5 Nicotiana 36 6 Nicotiana 50 7 Nicotiana 52 8 Nicotiana 27 9 Nicotiana 59 10 Agaricus 7 11 Agaricus 46 12 Agaricus 38 13 Agaricus 31 14 Agaricus 19 15 Agaricus 17 16 Agaricus 28 17 Agaricus 61 18 Agaricus 52 19 Agaricus 68 20 Agaricus 60 21 Agaricus 77 22 Agaricus 58 23 Agaricus 67 24 Agaricus 54 25 Agaricus 70 26 Agaricus 53 27 Agaricus 78 28 Agaricus 75 29 Agaricus 47 30 Agaricus 65 31 Neurospora 3 32 Neurospora 14 33 Neurospora 65 34 Neurospora 81 PART 4: INSPECTION AND ACCEPTANCE 4.1 The project officer or his authorized representative(s) will perform inspection and acceptance of materials and services to be provided. The project officer will be provided at time of award. 4.2 For the purpose of this contract, the Contracting Officer Technical Representative (COTR) is the duly authorized representative of the Contracting Officer. 4.3 Inspection Procedures are as follows: 4.3.1 scFv antibodies and plasmid DNA shall be delivered by overnight courier to: Points of contact will be provided at time of award. 29 Lincoln Drive, Bldg 29 Room 130 Bethesda, MD 20892 301 496 4575 4.3.2 Upon receipt, the scFv antibodies and related plasmid DNA will be inventoried and examined by the FDA COTR using appropriate assays. The results will be obtained within 5 business days from arrival. The results will be analyzed and the contractor will be notified by telephone or email of the results. 4.3.3 Deliverables, which upon inspection are found not to be in conformance with technical requirements, shall be promptly rejected and notice of such rejection, together with appropriate instructions in writing, will be provided to the Contractor by the FDA COTR. 4.3.4 If a deliverable is rejected, the Contractor shall make all appropriate corrections within fourteen (14) calendar days from receipt of written notification and will resubmit to the Contracting Officer and the COTR for approval unless a different time period is specified in writing. If corrections are estimated to require more than fourteen (14) calendar days, the Contractor shall deliver a corrective action plan within seven (7) calendar days from receipt of written notifications of rejection. The plan shall clearly describe the corrective actions to be taken and the proposed schedule for accomplishing the actions. 4.3.5 All items to be delivered to the COTR will be deemed to have been approved thirty (30) calendar days after date of delivery, except as otherwise specified in this contract, if written approval or disapproval has not been given within such period. The Contractor shall provide proof of delivery date. The COTR's approval or revision to the items submitted shall be within the general scope of work stated in this contract. 4.4 Inspection and acceptance location Inspection and acceptance will be performed at: FDA/CBER/OVRR/DBPAP 29 Lincoln Drive Bldg 29 Room 130 Bethesda, MD 20892 301 496 4575 PART 5: DELIVERABLES 5.1 The contractor shall have access to the plasmids no later than 15 days ARO. 5.2 The contractor shall deliver one milligram (1 mg) each of 34 designated scFv's. PART 6: CONTRACT ADMINISTRATION CONTRACTING OFFICERS TECHNICAL REPRESENTATIVE (COTR) 6.1. The following COTR will represent the Government for the purpose of this contract: (To be determined upon contract award) 6.1.1. The COTR 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. 6.1.2. 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 RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. 6.1.3. The contact information for the Contracting Officer: Doreen Williams Doreen.Williams@fda.hhs.gov 301-827-3366 6.1.4 The contact information for the Contract Specialist: Ariana Nijaradze Ariana.Nijaradze@fda.hhs.gov 301-827-7161 PART 7: SPECIAL CONTRACT REQUIREMENTS 7.1. HHSAR CLAUSES INCORPORATED BY REFERENCE This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: http://www.gpoaccess.gov/cfr/index.html. 352.202-1, Definitions (Jan 2006) 352.215-70, Late proposals and revisions (Jan 2006) 352.223-70, Safety and health (Jan 2006) 352.224-70, Confidentiality of information (Jan 2006) 352.228-7, Insurance--Liability to third persons (Dec 1991) 352.232-9, Withholding of contract payments (Jan 2006) 352.233-70, Litigation and claims (Jan 2006) 352.242-71, Final decisions on audit findings (Apr 1984) 352.249-14, Excusable delays (Jan 2006) 352.270-1, Accessibility of meetings, conferences, and seminars to persons with disabilities (Jan 2001) 352.270-10 Anti-lobbying (Jan 2006) 352.270-11 Privacy Act (Jan 2006) 352.270-13 Tobacco-free facilities (Jan 2006) 7.2 INVOICING INSTRUCTIONS The Contractor shall submit invoices to the contract specialist and the project officer concurrently, via email. To constitute a proper invoice, the invoice must be submitted on company letterhead and include: 1. Name and address of the Contractor 2. Invoice date and invoice number 3. Purchase order number 4. Description, Quantity, Unit of Measure, Unit Price, and Extended Price of supplies delivered 5. Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading 6. Terms of any discount for prompt payment offered 7. Name and address of official to whom payment is to be sent (Must be the same as that in the purchase order or in a proper notice of assignment) 8. Name, title, and phone number of person to notify in event of defective invoice 9. Taxpayer identification number 10. Electronic Funds Transfer (EFT) banking information 11. Name and telephone number of the FDA COR referenced on the purchase order 12. Any other information or documentation required by the purchase order An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in 1-12 of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. PART 8: PROVISIONS AND CLAUSES 52.252-2 Clauses Incorporated by Reference This contract incorporates one of more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at http://www.arnet.gov 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (MAR 2009) 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (APR 2010) 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) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). ___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 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: x_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402). _x (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). _x (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (MAR 2009) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) __ (4) 52.204-11, American Recovery and Reinvestment Act-Reporting Requirements (Mar 2009) (Pub. L. 111-5). __ (5) 52.219-3, Notice of Total HUBZone Set-Aside (Jan 1999) (15 U.S.C. 657a). __ (6) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (JULY 2005) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). __ (7) [Reserved] _x (8)(i) 52.219-6, Notice of Total Small Business Set-Aside (June 2003) (15 U.S.C. 644). __ (ii) Alternate I (Oct 1995) of 52.219-6. __ (iii) Alternate II (Mar 2004) of 52.219-6. __ (9)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). __ (ii) Alternate I (Oct 1995) of 52.219-7. __ (iii) Alternate II (Mar 2004) of 52.219-7. __ (10) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)). __ (11)(i) 52.219-9, Small Business Subcontracting Plan (Apr 2008) (15 U.S.C. 637(d)(4)). __ (ii) Alternate I (Oct 2001) of 52.219-9. __ (iii) Alternate II (Oct 2001) of 52.219-9. __ (12) 52.219-14, Limitations on Subcontracting (Dec 1996) (15 U.S.C. 637(a)(14)). __ (13) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). __ (14)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (OCT 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer). __ (ii) Alternate I (June 2003) of 52.219-23. __ (15) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Apr 2008) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (16) 52.219-26, Small Disadvantaged Business Participation Program- Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (17) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004) (15 U.S.C. 657 f). __ (18) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2009) (15 U.S.C. 632(a)(2)). _x (19) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _x (20) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Aug 2009) (E.O. 13126). _x (21) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). _x (22) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). _x (23) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). __ (24) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793). _x (25) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). _x (26) 52.222-54, Employment Eligibility Verification (JAN 2009). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) __ (27)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (28) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b). __ (29)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (DEC 2007) (E.O. 13423). __ (ii) Alternate I (DEC 2007) of 52.223-16. _x (30) 52.225-1, Buy American Act-Supplies (Feb 2009) (41 U.S.C. 10a-10d). __ (31)(i) 52.225-3, Buy American Act-Free Trade Agreements-Israeli Trade Act (June 2009) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, and 110-138). __ (ii) Alternate I (Jan 2004) of 52.225-3. __ (iii) Alternate II (Jan 2004) of 52.225-3. __ (32) 52.225-5, Trade Agreements (AUG 2009) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). __ (33) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). __ (34) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). __ (35) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). _x (36) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). __ (37) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). _x (38) 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003) (31 U.S.C. 3332). __ (39) 52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332). __ (40) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332). __ (41) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). __ (42)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). __ (ii) Alternate I (Apr 2003) of 52.247-64. (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: __ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). __ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act-Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act-Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 351, et seq.). __ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). __ (7) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). __ (8) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)). (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 this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). (ii) 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 $550,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) [Reserved] (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (v) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). (vi) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998) (29 U.S.C. 793). (vii) [Reserved] (viii) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). (ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). ___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.). (xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). (xii) 52.222-54, Employment Eligibility Verification (JAN 2009). (xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of clause) PART 8: INSTRUCTIONS TO OFFERORS 8.1 FAR provisions Incorporated by Reference This contract incorporates one or more provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html: 52.212-1, Instructions to Offerors - Commercial Items (June 2008) All questions shall be submitted to Ariana Nijaradze via email at Ariana.Nijaradze@fda.hhs.gov. Questions are due no later than July 7, 2010 3:00PM Eastern. All quotes and revisions shall be submitted via email and be received by 3:00 PM Eastern Time on 9 July 2010 to the attention of Ariana Nijaradze, ariana.nijaradze@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. Faxed quotes shall not be accepted. 8.2 Quote Format The cover letter shall include; FOB point; a POC (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 541711; delivery date (delivery date is of the utmost importance); business size; and payment terms. 8.3 Factor 1: Technical Capability: All sub-factors are equal in weight. The contractor shall demonstrate they can provide all of the items listed under the Technical Requirements Part 3, 3.3. 8.3.1 The offeror shall demonstrate that they can provide one milligram of each of the 34 scFv. 8.3.2 The offeror shall demonstrate they are able to deliver within 60 days after receipt of award. 8.4 Factor 2: Relevant Experience: The contractor shall demonstrate that they have provided the same or similar experience, in up to three occasions to a Federal, State, or local government agency or other companies within the last 3 years. 8.5 Price Proposal The Offeror shall submit a complete pricing matrix for a firm fixed-price as indicated in PART 3, 3.3. PART 9: EVALUATION CRITERIA Award will be made to the party whose quote offers the best value to the Government. The Government may award this contract to other than the lowest price technically acceptable quote. Technical Capability and Relevant Experience combined are significantly more important than price. When all other factors are equal, price becomes the determining factor. The FDA intends to make an award soon after the response date of this notice. The offeror's ability to demonstrate the following factors as noted in PART 8. 9.1 Factor 1: Technical Capability: All sub-factors are equal in weight. The contractor shall demonstrate they can provide all of the items listed under the Technical Requirements Part 3, 3.3. 9.1.1 The offeror meets the capability to provide one milligram of each of the 34 scFv. 9.1.2 The offeror meets the capability to deliver within 60 days after receipt of award. 9.2 Factor 2: Relevant Experience: The offeror meets the requirement for relevant experience. 9.3 Price Proposal The price proposal shall represent the Offeror's response to the requirements of the solicitation. The Government will evaluate the total price of all base year contract line items. In addition, this evaluation will include an assessment of the Offeror's proposal for completeness, realism, reasonableness and risk. 9.3.1. The Offeror ability to submit a complete pricing matrix for a firm fixed-price as indicated in PART 3, 3.3. PART 10: REPRESENTATIONS and CERTIFICATIONS An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (m) of this provision." See https://www.acquisition.gov/far/ 52.212-3 Offeror Representations and Certifications-Commercial Items. (Aug 2009) An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (m) of this provision. (a) Definitions. As used in this provision- "Emerging small business" means a small business concern whose size is no greater than 50 percent of the numerical size standard for the NAICS code designated. "Forced or indentured child labor" means all work or service- (1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or (2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties. "Inverted domestic corporation" means a foreign incorporated entity which is treated as an inverted domestic corporation under 6 U.S.C. 395(b), i.e., a corporation that used to be incorporated in the United States, or used to be a partnership in the United States, but now is incorporated in a foreign country, or is a subsidiary whose parent corporation is incorporated in a foreign country, that meets the criteria specified in 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c). "Manufactured end product" means any end product in Federal Supply Classes (FSC) 1000-9999, except- (1) FSC 5510, Lumber and Related Basic Wood Materials; (2) Federal Supply Group (FSG) 87, Agricultural Supplies; (3) FSG 88, Live Animals; (4) FSG 89, Food and Related Consumables; (5) FSC 9410, Crude Grades of Plant Materials; (6)FSC 9430, Miscellaneous Crude Animal Products, Inedible; (7) FSC 9440, Miscellaneous Crude Agricultural and Forestry Products; (8) FSC 9610, Ores; (9) FSC 9620, Minerals, Natural and Synthetic; and (10) FSC 9630, Additive Metal Materials. "Place of manufacture" means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture. "Restricted business operations" means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate- (1) Are conducted under contract directly and exclusively with the regional government of southern Sudan; (2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization; (3) Consist of providing goods or services to marginalized populations of Sudan; (4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization; (5) Consist of providing goods or services that are used only to promote health or education; or (6) Have been voluntarily suspended. "Service-disabled veteran-owned small business concern"- (1) Means a small business concern- (i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and (ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran. (2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16). "Small business concern" means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation. "Veteran-owned small business concern" means a small business concern- (1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and (2) The management and daily business operations of which are controlled by one or more veterans. "Women-owned business concern" means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women. "Women-owned small business concern" means a small business concern- (1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and (2) Whose management and daily business operations are controlled by one or more women. (b) (1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications posted on the Online Representations and Certifications Application (ORCA) website. (2) The offeror has completed the annual representations and certifications electronically via the ORCA website at http://orca.bpn.gov. After reviewing the ORCA database information, the offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, have been entered or updated in 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 paragraphs ______________. [Offeror to identify the applicable paragraphs at (c) through (n) of this provision that the offeror has completed for the purposes of this solicitation only, if any. 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. 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.]
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(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1074203/listing.html)
Place of Performance: Address: 29 Lincoln Drive, BLDG 29, Room 130, Bethesda, Maryland, 20892, United States; Zip Code: 20892
Record: SN02183767-W 20100623/100621235252-1cd20775bafdcf7836ea5f32f237462f (fbodaily.com)
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68 -- Production of 1 miligram each of 34 scFv antibodies - RFQ document