SOLICITATION NOTICE
68 -- Virus Stock
- Notice Date
- 4/24/2015
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA_15-233-1147115_Rev
- Archive Date
- 5/16/2015
- 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_15-233-1147115_Rev. 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) 2005-80, March 2, 2015. The associated North American Industry Classification System (NAICS) Code is- 325414 - Biological Product (except Diagnostic) Manufacturing; Size standards 500 in number of employees. 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 May 1, 2015 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 development of purified concentrated stocks of five different viruses to provide specific strains to be used as reference material for standardization of Next Generation Sequencing (NGS) and long-term storage of the virus stocks for distribution. Statement of Work (SOW) The Contractor shall prepare and provide purified concentrated stocks of Human Reovirus, Porcine Circovirus, Feline Leukemia Virus, Human Respiratory Syncytial virus, and Human Herpesvirus. The Contractor shall perform additional characterization of the prepared stocks, including determination of the genome copy number and infectivity titer (e.g. TCID50). The Contractor shall also provide long-term storage of the virus stocks, starting cells, and virus seeds for for-profit and non-profit distribution of the material to requestors, upon FDA approval, with shipping and handling at the requestor's cost. Minimum Technical Specifications: • The Contractor shall: o Provide virus seeds to prepare concentrated, purified and characterized viral stocks of Human Reovirus, Feline Leukemia Virus, Human Respiratory Syncytial Virus, and Human Herpesvirus o Use viral seed provided by the FDA to prepare a purified and characterized viral stock of Porcine Circovirus; viral seed will be provided to the contractor within 10 calendar days of award. o Shall grow each virus up to the required concentration using appropriate media and optimized conditions with rigorous handling to ensure absence of any cross-contamination o Shall keep records of all biological raw materials used in virus growth and preparation of the virus final stocks, including information on source/origin, any treatment and Certificate of Analysis (for cells, viruses, sera, trypsin, media and media components, etc) and retain aliquots of each lot in case further examination is needed after initial evaluation of the virus stocks by Next Generation Sequencing (NGS). These records shall be kept throughout the entire contractual period. Records shall be provided to the FDA within 10 calendar days of request. o Complete purification of virus particles using a density gradient with a report of the virus density o After concentration and purification, provide a stock containing a minimum of ≥1x106 infectious titer per ml (e.g. TCID50 per mL or as applicable) and genome copy number of ≥1010 genome copies per mL quantified by digital droplet PCR (ddPCR) o Virus stock shall be aliquoted in 0.5ml vials prior to freeze down o Produce 500 vials of 0.5ml aliquots (meeting minimum titer and genome copy requirements per vial) for each of the virus stocks o Determine genome copy number using ddPCR and infectivity titer (e.g. TCID50) of the final product, post-freeze o All Virus Stock shall be developed within 9 months of contract award; to the extent development occurs sooner than 9 months the contractor shall maintain and distribute stock through the remainder of the 9 month duration. Subsequent storage and distribution will be annual option periods as set forth herein.  20 vials of each shall be delivered to the FDA at contractor expense within 9 months of contract award.  The remaining 480 vials, virus Stock, sufficient aliquots of the cells and virus seed lots used for generation of the virus stocks to meet future needs shall be preserved and stored in temperature controlled vessels at two different locations, in order to maintain sample integrity in the event of unforeseen circumstances at either location.  Detailed logs shall be kept for production, testing, managing, orders, and shipping biological materials.  Provide optional one (1) year periods for extended storage and distribution after the initial Base 1 year period. o Provide Certificates of Analysis within 10 calendar days upon completion of each virus stock in a formal report, containing genome copy number, infectious titer, and overview of the technical approach and the documentation employed for virus preparation, concentration, purification, and characterization analyzes. The report shall include information regarding the cell and virus lot numbers used for production. o Provide the FDA with a monthly status updates within 10 calendar days of the preceding month during the production and testing of the virus stocks. o Distribute and ship virus stock aliquots to for-profit and non-profit requestors at requester's expense upon FDA approval. o Provide the FDA an inventory log of all viruses every six (6) months within 10 calendar days of the end of the preceding 6-month period. o Any decisions regarding storage, distribution or destruction of material generated from this contract shall be made after discussion and approval of the FDA. Item #1 Human Reovirus Virus Stock Type 1 (Lang Strain) at >1x106 TCID50/vial Quantity: 500 each Of which 480 vials shall be maintained by the Contractor and 20 vials shall be delivered to the FDA. Unit Price: ______________________ Extended Price: __________________ GSA Contract Number: __________________ (if applicable) Item #2 Porcine Circovirus Stock PCV1 at >1x106 TCID50/vial Quantity: 500 each Of which 480 vials shall be maintained by the Contractor and 20 vials shall be delivered to the FDA. Unit Price: ______________________ Extended Price: __________________ GSA Contract Number: __________________ (if applicable) Item #3 Feline Leukemia Virus Stock (Thielen strain) at >1x106 TCID50/vial Quantity: 500 each Of which 480 vials shall be maintained by the Contractor and 20 vials shall be delivered to the FDA. Unit Price: ______________________ Extended Price: __________________ GSA Contract Number: __________________ (if applicable) Item #4 Human Respiratory Syncytial Virus Stock (A2 Strain) at >1x106 TCID50/vial Quantity: 500 each Of which 480 vials shall be maintained by the Contractor and 20 vials shall be delivered to the FDA. Unit Price: ______________________ Extended Price: __________________ GSA Contract Number: __________________ (if applicable) Item #5 Human Herpesvirus Stock Epstein-Barr virus (B95-8 Strain) at >1x106 TCID50/vial Quantity: 500 each Of which 480 vials shall be maintained by the Contractor and 20 vials shall be delivered to the FDA. Unit Price: ______________________ Extended Price: __________________ GSA Contract Number: __________________ (if applicable) Item #6 (1st Option Period) Temperature Controlled Storage of Virus Vials To begin upon expiration of initial development and storage period and shall continue for a Period of 1-Year Unit Price Per Month: ______________________ Extended Price: _________________ GSA Contract Number: __________________ (if applicable) Item #7 (2nd Option Period) Temperature Controlled Storage of Virus Vials To begin upon expiration of previous storage period and shall continue for 1-Year Unit Price Per Month: ______________________ Extended Price: _________________ GSA Contract Number: __________________ (if applicable) Item #8 (3rd Option Period) Temperature Controlled Storage of Virus Vials To begin upon expiration of previous storage period and shall continue for 1-Year Unit Price Per Month: ______________________ Extended Price: _________________ GSA Contract Number: __________________ (if applicable) Item #9 (4th Option Period) Temperature Controlled Storage of Virus Vials To begin upon expiration of previous storage period and shall continue for 1-Year Unit Price Per Month: ______________________ Extended Price: _________________ GSA Contract Number: __________________ (if applicable) PRICE QUOTES SHALL INCLUDE SHIPPING, HANDLING, & APPLICABLE PERMIT FEES 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. 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 Contracting Officer. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. No advance payment will be made under the resulting order/contract. Storage services shall be billed no more frequently than monthly in arrears. The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions 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 52.204-7 System for Award Management (Jul 2013) FAR Clause 52.217-8 Option to Extend Services FAR Clause 52.217-9, Option To Extend The Term Of The Contract. (a)...within one (1) calendar day of contract expiration...at least 30 calendar days... (b)...shall not exceed five (5) years exclusive of the initial delivery and storage requirements.... FAR Clause 52.232-40, Providing Accelerated Payment to Small Business Subcontractors (Deviation) (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 2015) (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 (Dec 2014) (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, 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.] ___ (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 (Apr 2010) (41 U.S.C. 3509). ___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 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 (Jul 2013) (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 (Aug 2013) (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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Public Law 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161). ___ (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 2011) (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 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 2014) (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 2014) 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-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. 657f). _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 (Feb 1999). _X_ (28) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). ___ (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (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 (Jul 2014) (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 (Aug 2013). (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 (Jun 2014) of 52.223-13. ___ (37) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (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 (Jun 2014) (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). ___ (ii) Alternate I (May 2014) of 52.225-3. _X_ (iii) Alternate II (May 2014) of 52.225-3. ___ (iv) Alternate III (May 2014) of 52.225-3. ___ (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X_ (44) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 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) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.). ___ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (3) 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). ___ (4) 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). ___ (5) 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). _X_ (6) 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). ___ (7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). ___ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). ___ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)). ___ (10) 52.222-55, Minimum Wages Under Executive Order 13658 Dec 2014)(Executive Order 13658). (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) (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 $650,000 ($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 (1) of FAR clause 52.222-17. (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (v) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212). (vi) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). (vii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212). (viii) 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. (ix) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). (x) ____ (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 E.O. 13627). (xi) 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.) (xii) 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) (xiii) 52.222-54, Employment Eligibility Verification (Aug 2013). (xiv) 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). (xv) 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. (xvi) 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. (xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014)(Executive Order 13658). (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) Submission of offers. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, offerors must furnish as part of their proposal all descriptive material necessary for the government to conclusively determine the technical capability of the offered solution(s) to meet the Government's requirements. In regards to Technical Capability, it is absolutely essential that offers submit sufficient technical data and literature to unequivocally demonstrate that proposed services meets or exceeds the stated requirements and that those services will absolutely support FDA's intended needs. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The following subparagraph (a) factors apply: (i) Technical Capability (ii) Past Performance (iii) Price Technical Capability (i.e., how well the offered solution meets the Government's requirements) and past performance are equal in value and collectively are more important than price in determining the best value to the Government though price remains a significant consideration. Past Performance will be determined by review of recent (within the past 3 years) and relevant virus development past performance information submitted by the offerer. 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. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (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, 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_15-233-1147115_Rev/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
- Zip Code: 20993
- Record
- SN03710176-W 20150426/150424234752-d765346aaec8fc049fad06f65146a240 (fbodaily.com)
- Source
-
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