FBODaily.com | FedBizOpps: PRESOL | B | Equine Ebola Antibody Production

FBO DAILY - FEDBIZOPPS ISSUE OF JULY 07, 2016 FBO #5340
SOLICITATION NOTICE

B -- Equine Ebola Antibody Production

Notice Date: 7/5/2016
Notice Type: Combined Synopsis/Solicitation
NAICS: 325414 — Biological Product (except Diagnostic) Manufacturing
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
ZIP Code: 20857-0001
Solicitation Number: FDA_16-233-1169554
Archive Date: 7/27/2016
Point of Contact: Howard Nesmith, Phone: 870-543-7459
E-Mail Address: howard.nesmith@fda.hhs.gov
(howard.nesmith@fda.hhs.gov)
Small Business Set-Aside: N/A
Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) 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. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the requirement herein using Simplified Acquisition Procedures. The solicitation number is FDA_16-233-1169554. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-88-1, June 15, 2016. The associated North American Industry Classification System (NAICS) Code is- 325414 - Biological Product (except Diagnostic) Manufacturing; with a Small Business Size standards in number of employees 1,250. The requirement will be competed unrestricted and made available to Full and Open competition, meaning any qualified vendor regardless of size status may submit a quote. Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method of their complete proposal and any additional documents before 1:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on July 12, 2016 to howard.nesmith@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OO/OFBA/OAGS, Attention of Howard Nesmith, 3900 NCTR Road, Building 50, Room 424, Jefferson, AR 72079-9502. PLEASE NOTE - The above contact information is for the Contracting Office and not the delivery address. The delivery address is indicated in the FOB Destination section below. For information regarding this solicitation, please contact Howard Nesmith by e-Mail at howard.nesmith@fda.hhs.gov. Requirement The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), requires Equine Ebola Antibody Production. Background: Ebola virus is a filovirus that causes hemorrhagic fever with an average mortality rate of 50 % (WHO, at http://www.who.int/mediacentre/factsheets/fs103/en/). There are no licensed treatments or vaccines against Ebola to date although several candidates are under study. Passive immune therapy with human or animal-derived antibodies has been successful for prevention or treatment of viruses such as rabies, vaccinia, hepatitis A, hepatitis B, and Argentine hemorrhagic fever. Non-government organizations have begun to collect convalescent plasma from Ebola survivors in an effort to study antibody therapy. Standardized tests to measure Ebola antibody activity are not well developed, in part due to lack of standard anti-Ebola antibody preparations. A well characterized high-titer neutralizing antibody preparation could be used to assure that antibody tests for diagnosis and surveillance for Ebola infections are valid and can be compared to each other. Development of standards from human convalescent serum from Ebola survivors is not feasible because a steady large volume of material with consistent titers is not available. Antibody levels vary from donor-to-donor and time-to-time in the same donor, Ebola plasma is difficult to ship due to questions of residual infectivity and international requirements, and may not be conducive to routine Biosafety Level Criteria Secondary Barriers (BSL-2) laboratory use. Furthermore, convalescent plasma does not always contain high neutralizing antibodies. In contrast, equine hyperimmune vaccine protocols to stimulate specific antibody production are well-established in general, and large quantities of immune plasma may be obtained without compromising health of the animals. The goal of the FDA is to obtain and evaluate equine Ebola immune plasma as a safe, consistent, BSL-2 reagent candidate standard. The FDA will characterize the immune plasma using neutralization, antibody-dependent cytotoxicity, and complement-mediated cytotoxicity assays, to comprehensively define the antibody function. This will be shared with other laboratories for testing and use as a reagent to facilitate development of test methods, and as a positive control/comparator for Ebola antibody therapies in development. Statement of Need: CBER requires services to develop Equine Ebola Antibody for a consistent, easily available standard to measure functional activities of human serum anti-Ebola antibodies is for assessment of candidate passive immune therapies, vaccine potency, and to better understand how effective anti-Ebola antibody function. A widely available standard should facilitate development of vaccines, tests, and treatments for Ebola virus. Minimum Technical Requirements: - The Contractor shall have a properly resourced facility for equine vaccination, blood collection, and plasmapheresis. - Prior to horse(s) vaccination the Contractor shall provide the FDA with a Certificate of Health for each horse(s) to assure horse(s) are in good health - The Contractor shall vaccinate horses with Ebola glycoprotein with or without adjuvant, intradermally or subcutaneously up to 10 times on a 1-3 week basis. - The Contractor shall have or have access to a BSL-2 laboratory for processing equine serum and plasma - The Contractor shall collect and process blood samples: a) 1-3 days prior to the first vaccination b) 14 days after first vaccination c) On the day of booster vaccination (just prior to vaccination) (The goal is to check antibody levels at their peak after vaccination (14 days), and at their lowest ebb (right before the next vaccination)) - The Contractor shall process blood into serum, and freeze at -20o C for shipment to FDA. - The Contractor shall provide, along with samples, horse identification number, time of last immunization, amount of immunogen and amount/type of adjuvant used, immunization number, and time of collection. - The Contractor shall supply 50 mL of serum and one plasmapheresis unit from a horse that has not received Ebola glycoprotein vaccination, for FDA use as a laboratory control. - After the FDA conducts neutralization testing on supplied serum and has identify high Ebola-neutralizing titers the Contractor shall plasmapherese the horse with high antibody titers, to collect not more than 20 mL/kg of plasma, which will be frozen at -20o C and shipped to FDA. - The Contractor shall ship frozen serum and plasma to arrive within 24-48 hours of shipment at FDA's Silver Spring, Maryland facility. Item #1 Equine Ebola Immune Serum and Plasma Period of Performance: Shall be no more than 1-year from date of award Quantity (1) Unit (Job) Unit Price: ______________________ Extended Price: __________________ GSA Contract Number: __________________ (if applicable) PRICE QUOTES MUST INCLUDE SHIPPING & HANDLING FOB Destination - U.S. Food and Drug Administration Center for Biologics Evaluation and Research 10903 New Hampshire Avenue Silver Spring, MD 20993 Contract Type - Commercial Item - Firm fixed price. Contract clauses- The clause at FAR 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (May 2015) The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer / representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. No advance or partial payment will be made under the resulting order/contract. A single payment will be in &lrm;made in arrears only after the Government has received, inspected, and accepted all services and deliverables. The following additional clauses, incorporated by reference, apply to this acquisition. Clauses can be obtained at http://www.acquisition.gov/far/ FAR Clause 52.204-4 Printed or Copied Double-Sided on Recycled Paper. (May 2011) FAR Clause 52.232-40, Providing Accelerated Payment to Small Business Subcontractors (Dec 2013) 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 any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract. The Contracting Officer for this order is: To be completed at time of award- Name: Phone: Email: 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 COR for this order is: To be completed at time of award- Name: Phone: Email: 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Mar 2016) (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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015) (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)(Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)). (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: __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402). __ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)). __ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) _X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) (Pub. L. 109-282) (31 U.S.C. 6101 note). __ (5) [Reserved]. __ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). __ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). _X_ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note). __ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313). __ (10) [Reserved]. __ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). __ (ii) Alternate I (Nov 2011) of 52.219-3. _X_ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). __ (ii) Alternate I (Jan 2011) of 52.219-4. __ (13) [Reserved] __ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644). __ (ii) Alternate I (Nov 2011). __ (iii) Alternate II (Nov 2011). __ (15)(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. __ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)). __ (17)(i) 52.219-9, Small Business Subcontracting Plan (Oct 2015) (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. __ (iv) Alternate III (Oct 2015) of 52.219-9. __ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)). __ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)). __ (20) 52.219-16, Liquidated Damages-Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). __ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f). _X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). __ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)). __ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)). _X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). __ (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2016) (E.O. 13126). _X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). _X_ (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). __ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212). _X_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). __ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212). __ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). __ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). __ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627). __ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (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.) __ (35)(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.) __ (36)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514). __ (ii) Alternate I (Oct 2015) of 52.223-13. __ (37)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514). __ (ii) Alternate I (Jun 2014) of 52.223-14. __ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b). __ (39)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514). __ (ii) Alternate I (Jun 2014) of 52.223-16. _X_ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513). __ (41) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83). _X_ (42)(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43. _X_ (ii) Alternate I (May 2014) of 52.225-3. __ (iii) Alternate II (May 2014) of 52.225-3. __ (iv) Alternate III (May 2014) of 52.225-3. __ (43) 52.225-5, Trade Agreements (Feb 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X_ (44) 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). __ (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). __ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). __ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). __ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). __ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). _X_ (50) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) (31 U.S.C. 3332). __ (51) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). __ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). __ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). __ (54)(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) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495). __ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67). __ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). __ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). __ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). __ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67). __ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67). __ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Mar 2016). __ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). __ (10) 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 (Oct 2015) (41 U.S.C. 3509). (ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (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 $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17. (iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) (v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). (vi) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212). (vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). (viii) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212) (ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40. (x) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67). (xi) __(A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O 13627). __(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O 13627). (xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67). (xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67). (xiv) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989). (xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Mar 2016). (xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). (xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xviii) 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. Solicitation provisions- The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation. The following FAR 52.212-1 addenda apply: Paragraph (b)(4). To ensure information is available, offerors shall furnish as part of their proposal all descriptive material necessary for the government to conclusively determine that they have or have access to a BSL-2 laboratory for processing equine serum and plasma and that the antibody production offered will satisfy the Government's requirements. The government is not responsible for locating or securing any information, which is not identified in the proposal. Paragraph (b)(10). Past performance information shall clearly demonstrate recent (within the past 3 years) and relevant experience with antibody production, which includes a brief description of services performed, contract number(s), client points of contact names, and client points of contact email addresses and phone numbers. The Government reserves the right to look to other sources of information (e.g., the Past Performance Information Retrieval System (PPIRS), etc.) to support past performance evaluations. Paragraph (k) To be considered for award an offeror shall be registered and active in SAM by the date and time set forth for receipt of quotes/proposals. FAR Clause 52.204-7 System for Award Management (Jul 2013) The provision at FAR 52.212-2 Evaluation-Commercial Items applies to this solicitation. The following subparagraph (a) factors apply: (i) Technical Capability (See FAR Provision 52.212-1 (b)(4) and addenda thereto) (ii) Past Performance (See FAR Provision 52.212-1 (b)(10) and addenda thereto) (iii) Price. Technical Capability (i.e., how well the services offered meet or exceed the Government's requirements) and Past Performance (recent and relevant) are collectively more important than price in determining the best value to the Government though price remains a significant consideration. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Provision at FAR 52.212-3, Offerors Representations and Certifications-Commercial Items, applies to this acquisition. An offeror shall complete only paragraph (b) of the provision if the offeror has completed the annual representations and certification electronically via https://www.sam.gov/portal/public/SAM/#1. If an offeror has not completed the annual representations and certifications electronically at the website, the offeror shall complete only paragraphs (c) through (o) of this provision. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any).
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA_16-233-1169554/listing.html)
Place of Performance: Address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States; Zip Code: 20993
Record: SN04171594-W 20160707/160705234832-84095443bca11505f611455a286436a2 (fbodaily.com)
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B -- Equine Ebola Antibody Production