Human Primary Hepatocytes
Added: Jan 26, 2017 10:47 am 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 herein and a written solicitation will not be issued. This solicitation is being issued in conjunction with FAR Part 13.106.The solicitation number is FDA_17_223_1177415 and is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular (FAC) 2005-94, 2005-95 effective January 19, 2017.The associated North American Industry Classification System (NAICS) code for this acquisition is 541711 (Research and Development in Biotechnology); the applicable Small Business Size Standard is 1,000 employees. This requirement is solicited as a Total Set-Aside for Small Business.Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method of complete proposals to the Point of Contact (POC) listed below. Responses shall reference solicitation number FDA 17-223-1177415, and shall be received on or before Friday, February 3, 2017 by no later than 5:00 pm Central Time in Jefferson, Arkansas. Questions and requests for information regarding this solicitation should be directed to:Tim WalbertContract SpecialistU.S. Food and Drug Administration (FDA)National Center for Toxicological Research (NCTR)3900 NCTR Road | HFT-320Bldg 50, Rm 426 | Jefferson, AR 72079o. 870.543.7267 | f. 870.543.7990Background and General RequirementThe U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Genetics and Molecular Technology (DGMT) has a requirement for Human Primary Hepatocytes for an ongoing baseline project to develop Margin of Exposure (MOE) tesholds to ascertain safe exposure levels for humans. Primary hepatocytes will be used to establish methods for conducting high­toughput geno-toxicity testing assays as designed by NCTR for scientific studies. High quality human primary hepatocytes are essential for generating data more relevant to human exposure for supporting regulatory decision making.Statement of WorkPrimary human hepatocytes contain a complete phase I and phase II metabolism system and are postulated to be the closest in vitro system to in vivo studies and generate data more relevant to human exposure to support FDA regulatory decision-making. Human hepatocytes will be used in a high toughput Comet assay using CometChip technology. DNA damage induced by a series of FDA-relevant agents, known to have different mechanisms for their induction of geno-toxicity and cancer, will be measured in order to produce a large number of data points covering wide chemical concentration ranges. Several quantitative dose-response approaches (e.g., Point of Departure metrics, mutagenic potency) will be used for assessing the chemical-induced genetic toxicity data generated from the assay. Potentially, these data can also be used for predicting in vivo geno-toxicity and for setting margin of exposure (MOE) values to ascertain safe exposure levels for humans.The estimated quantity of Primary Human Hepatocytes required under this acquisition is 150 million cells, divided into tee (3) deliveries during the contract period. DGMT staff will identify person(s) authorized to place orders at the time of award, and will specify quantities and delivery dates at the time of each order during the contract period. A. Minimum Technical Requirements - Preparation and Delivery of Human Primary Hepatocytes• Human Primary Hepatocytes shall be pooled, cryopreserved, mixed gender, and plateable;• Packed on dry ice and delivered overnight;• 25 vials of Human Primary Hepatocytes divided into tee (3) deliveries of 6-7 million cells per vial for an estimated total of 150 million viable cells for the contract period;• Culture media to include Cryopreservation Recovery Media, Primary Cell Plating Media, and Hepatocyte Incubation Media;• cryopreserved human primary hepatocytes shall present high viabilities of greater than 85%;• phase I and phase II drug metabolizing enzyme expression levels shall be characterized;• Upon award vendor shall provide specific contact information, including e-mail address and telephone number, for the individual(s) assigned to develop and deliver the required quantity of Human Primary Hepatocytes.The period of performance for this acquisition is 7/1/2017 tough 9/30/2017. A total of 3 deliveries during the contract period are required. Items, quantities for each delivery, and delivery dates are as follows:Delivery for the week of 7/28/2017 Item #1Vial, 6-7 million cells, pooled cryopreserved human hepatocytes, inducible-grade, mixed gender, plateable:Quantity: 6Unit Price: _______________________Extended Price: _________________Catalog/Item/Part #: ___________Item #2Universal Cryopreservation Recovery Media, 50mlQuantity: 6Unit Price: _______________________Extended Price: _________________Catalog/Item/Part #: ___________Item #3Universal Primary Cell Plating Medium, 500mlQuantity: 1Unit Price: _______________________Extended Price: _________________Catalog/Item/Part #: ___________Item #4Hepatocyte Induction Medium, with supplements, 500ml Quantity: 1Unit Price: _______________________Extended Price: _________________Catalog/Item/Part #: ___________Item #5Collagen Coated Plate, 96-well, 5-packQuantity: 5Unit Price: _______________________Extended Price: _________________Catalog/Item/Part #: ___________Item #610X Collagenase solutionQuantity: 1Unit Price: _______________________Extended Price: _________________Catalog/Item/Part #: ___________Total, Items 1-6, delivery the week of 7/28/2017: ______________Delivery for the week of 8/28/2017 Item #7Vial, 6-7 million cells, pooled cryopreserved human hepatocytes, inducible-grade, mixed gender, plateable:Quantity: 9Unit Price: _______________________Extended Price: _________________Catalog/Item/Part #: ___________Item #8Universal Cryopreservation Recovery Media, 50mlQuantity: 9Unit Price: _______________________Extended Price: _________________Catalog/Item/Part #: ___________Total, Items 7-8, for delivery the week of 8/28/2017: ______________Delivery for the week of 9/25/2017 Item #9Vial, 6-7 million cells, pooled cryopreserved human hepatocytes, inducible-grade, mixed gender, plateable:Quantity: 10Unit Price: _______________________Extended Price: _________________Catalog/Item/Part #: ___________Item #10Universal Cryopreservation Recovery Media, 50mlQuantity: 10Unit Price: _______________________Extended Price: _________________Catalog/Item/Part #: ___________Total, Items 9-10, for delivery the week of 9/25/2017: ______________Grand Total, Items 1-10:______________________Prices quoted shall be FOB Destination, inclusive of all shipping, handling, and delivery fees. The price(s) proposed shall represent the offeror's response to the schedule of supplies/services above.Contract Type - Commercial Item - Firm fixed pricePlace of Performance:National Center for Toxicological Research3900 NCTR RoadJefferson, AR 72079Contract ClausesThe clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (May 2015), applies to this acquisition. The following FAR 52.212-4 addenda apply:The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's 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 services and immediately notify the contracting officer. No advance payment shall be made under the resulting order/contract. Partial payments shall not be made. Payment terms are net 30 days from the Government's receipt and acceptance of the services.The following additional clauses and provisions apply to this acquisition and are incorporated by reference and apply to this acquisition. Full texts of clauses and provisions can be obtained at: http://www.acquisition.gov/far/.FAR Clause 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (May 2011)FAR Clause 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013)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 Contracting Officer's Representative (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 (March 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:[Contracting Officer: check as appropriate.] X¬_ (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]_X (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. X_(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)). X_( (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)). ___(20) 52.219-16, Liquidated Damages-Subcontracting 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 Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)). __ (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)). _X (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _X_(26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014) (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). X (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). X (31) 52.222-37, Employment Reports on Veterans (Oct 2015) (38 U.S.C. 4212). __ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). X (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). X_(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.) X_(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.)X (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).X (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693). __ (38)(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. __ (39)(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. X_(40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b). X_(41)(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 (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513). X (43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).X_(44) 52.223-21, Foams (Jun 2016) (E.O. 13693). X_(45) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83). __ (46)(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. __ (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. X_(47) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). X (48) 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). __ (49) 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). __ (50) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). __ (51) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). __ (52) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). __ (53) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). X (54) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) (31 U.S.C. 3332). __ (55) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). __ (56) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). __ (57) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). __ (58)(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 (Dec 2015) (E.O. 13658). __ (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 teshold, 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 (Oct 2015) (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 (Dec 2015) (E.O. 13658). (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 ProvisionsThe following FAR provisions apply to this acquisition and are incorporated by reference:FAR 52.204-7 System for Award Management (Oct 2016)The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items (JAN 2017) 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 the solution and services offered will be technically capable of meeting or exceeding the Government's requirements. The government is not responsible for locating or securing any information, which is not identified in the proposal. Paragraph (c): Period for acceptance of offers. The offeror shall state on its quote that quoted prices are firm until September 30, 2016.The provision at FAR 52.212-2 Evaluation-Commercial Items (Oct 2014) is applicable to this solicitation.(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 subparagraph (a) factors apply:(i) Technical Capability (see FAR Provision 52.212-1 (b)(4) and addenda thereto)(ii) PriceTechnical Capability (i.e., how well the proposed services will meet or exceed the Government's requirements) is more important than price in determining the best value to the government, although price remains a significant consideration.(c) 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, Offeror Representations and Certifications-Commercial Items (NOV 2015), applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website accessed tough https://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) tough (t) of this provision.It is the offeror's responsibility to monitor the Government Point of Entry (GPE) FedBizOpps for information relevant to this solicitation, e.g., questions and answers, amendments, etc. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.
FDA_17_223_1177415 Department of Health and Human Services Food and Drug Administration
1/26/17, 10:47 AM