FBODaily.com | FedBizOpps: PRESOL | A | Hematological Protein Characterization Services

FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 05, 2015 FBO #5003
SOLICITATION NOTICE

A -- Hematological Protein Characterization Services

Notice Date: 8/3/2015
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 - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
ZIP Code: 20857-0001
Solicitation Number: FDA-15-223-SOL-1151450
Archive Date: 8/27/2015
Point of Contact: Sondea R Blair, Phone: 8705437469
E-Mail Address: sondea.blair@fda.hhs.gov
(sondea.blair@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 under Simplified Acquisition Procedures. The solicitation number is FDA-15-223-SOL-1151450 and 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) 2005-83 dated July 02, 2015. The associated North American Industry Classification System (NAICS) Code is 541711-Research and Development in Biotechnology; Small Business Size Standard is 500 employees. This RFQ is issued for full and open competition. Contract Type: Commercial Item - Firm Fixed Price REQUIREMENTS Part I: General Information (Introduction/Background/Scope) The U.S. Food and Drug Administration (FDA), Center for Biologics Research and Evaluation (CBER), Division of Hematology (DOH) performs experimental life-science/biomedical research on various proteins involved in blood coagulation. CBER DOH requires comprehensive characterization of post-translational modifications of recombinant human coagulation Factor IX (FIX). The characterization includes Nitrogen Linked Glycosylation (N-glycan) profiling, activation peptide analysis, Gamma-Carboxyglutamic Acid-Rich (Gla) domain mapping and peptide mapping using endoprotease C-Terminal side of Lysine Amino Acid (Lys-C). These analyses, especially activation peptide analysis and Gla-domain mapping, require expertized knowledge and experience on coagulation factors, in addition to post-translational modification analysis. The biological activity of FIX depends on a complex molecular structure that contains several posttranslational modifications. These include modification of numerous glutamate (Glu) residues to γ-carboxyglutamate (Gla), in the Gla domain. The Gla domains are a common feature of several coagulation proteins and confer affinity to calcium ions, which is critical to the protein function. In addition, FIX undergoes glycosylation, phosphorylation, and sulfation particularly in the activation peptide. Correct cleavage of the activation peptide is crucial for the generation of the active factor IX and is dependent in part on its post-translational modifications. The results of these analyses will be critical in the study of recombinant therapeutic proteins. Part II: Work Requirements 1. Hematological Protein Characterization Services The contractor will be provided sixteen (16) samples at the government's expense within 14-calendar days of contract award, and shall complete each of the following tests inclusive of complete sample preparation, desalting, buffer exchange, detergent removal, dialysis, and protein concentration: oN-glycan profiling oActivation peptide analysis oGla-domain mapping oPeptide mapping oAnalysis of the 35 amino acid residue activation peptide by using specifically designed peptide mapping and liquid chromatography - tandem mass spectrometry (LC-MS/MS) method. oAnalysis of the twelve Gla residues within 34 amino acids stretch by using peptide analysis method specifically designed for Gla domain analysis. oComplete amino acid sequence of the protein by using endoprotease Lys-C and LC-MS/MS method. 2. Deliverables •Provide the test results in Microsoft (MS) Word format, information shall include, but not be limited to, results of each test, significant findings, and implications •MS PowerPoint presentation summarizing the results •Computations in Excel format •Support data used to derive results in TIF or PDF format •Deliverables shall be delivered to the Technical Point of Contact (to be named upon contract award) via email Part III: Supporting Information A. Place of Performance Work shall be performed at the contractor's site, and deliverables shall be provided to: U.S. Food and Drug Administration Center for Biologics Research and Evaluation 10903 New Hampshire Avenue Silver Spring, MD 20993 B. Period of Performance The Government will provide 16 samples to the contractor within 14- calendar days of contract award. The contractor shall perform all required tests and submit deliverables within 45-calendar days of receipt of samples. Period of performance: 59 calendar days from issuance of contract award. Schedule of Items Item 1. Hematological Protein Characterization Services Qty 16 EA Unit Price _______ Extended Price_______________ Solicitation Provisions FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at: https://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items applies to this solicitation. The following addenda apply: (4) Respondents shall submit information to demonstrate a suitable approach to performing the work described in the Scope of Work, including a description of the offeror's understanding of the task and how the offeror intends to satisfy the technical requirements, along with the contractor's historical background information relevant to performing this requirement. (10) Recent is defined as within the last three (3) years. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. 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 factors shall be used to evaluate offers: (i) Technical Capability (ii) Recent & Relevant Past Performance (iii) Price Technical Capability and Recent & Relevant Past Performance, which are of equal importance, when combined, are more important than price though price remains an important factor. Technical Capability will be determined by review of information submitted by the Offeror to determine the suitability and feasibility of the proposed approach to satisfy the Government's requirements. to include outcomes of Offeror's Past Performance will be evaluated (based on the recency (within the last 3 years) and relevancy (service provide for same or near same requirement(s)) of the information provided to determine the likelihood of success in achieving the solicitation's requirements. Technical Capability and Recent & Relevant Past Performance for any intended subcontractors shall be included with offer. The Government reserves the right to consider past performance information from any other source (e.g. Past Performance Information Retrieval System) when evaluating Recent & Relevant Past Performance. 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. (End of Provision) The Provision at FAR 52.212-3, Offeror's Representations and Certifications - Commercial Items, applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items applies to this acquisition. The following addenda apply: This contract incorporates one or 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 this/these address(es): https://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html FAR Clause 52.222-49 Service Contract Act-Place of Performance Unknown a)...None;...9 AM Central Time, Aug 12, 2015. FAR Clause 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights; FAR Clause 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper; FAR Clause 52.223-6 Drug-Free Workplace; FAR Clause 52.225-8 Duty-Free Entry FAR Clause 52.232-40 Providing Accelerated Payment to Small Business Subcontractors; HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations HHSAR Clause 352.223-70 Safety and Health Inspection and Acceptance The services delivered hereunder shall be inspected and accepted at destination by the Government Technical Point of Contact (TPOC) specified at award. If the manuscripts are determined acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the services are not acceptable, the TPOC shall document the nonconforming services and immediately notify the contracting officer. Invoice Submission The contractor shall remit invoices to the address identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions: I. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (i) Name and address of the contractor; (ii) Invoice date and invoice number; (iii) Purchase order/award number; (iv) description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures; (v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading, if applicable; (vi) Terms of any discount for prompt payment offered, if applicable; (vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (viii) Name, title, and phone number of person to notify in event of defective invoice; (ix) Taxpayer identification number (TIN); (x) electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (xi) name and telephone number of the FDA contracting officer representative (COR) or other program center/office point of contact, as referenced on the purchase order; (xii) Companys DUNS number; and (xiii) Any other information or documentation required by the purchase order/award. II. An original and two (2) copies shall be submitted to: NCTR Accounts Payable 3900 NCTR Road Building 50, Suite 616 Jefferson, AR 72079 An electronic invoice can be emailed to the following address: nctrinvoices@fda.hhs.gov III. One copy to the Technical Point of Contact or other program center/office designee, clearly marked courtesy copy only: To be completed at time of award by Government. IV. Questions regarding invoice payments should be directed to the FDA payment office at (870) 543-7446 <img style="position: static !important; margin: 0px; width: 16px; bottom: 0px; display: inline; white-space: nowrap; float: none; height: 16px; vertical-align: middle; overflow: hidden; cursor: hand; right: 0px; top: 0px; left: 0px;" title="Call: (870) 543-7446" src="data:image/png;base64,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" alt="" /> or (870) 543-7042 <img style="position: static !important; margin: 0px; width: 16px; bottom: 0px; display: inline; white-space: nowrap; float: none; height: 16px; vertical-align: middle; overflow: hidden; cursor: hand; right: 0px; top: 0px; left: 0px;" title="Call: (870) 543-7042" src="data:image/png;base64,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" alt="" /> or electronically at nctrinvoices@fda.hhs.gov Questions regarding invoice payments should be directed to the FDA payment office at phone or email reference provided above. 52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Commercial Items (May 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: ___ (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) [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 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 (Apr 2015). _X_ (28) 52.222-26, Equal Opportunity (Apr 2015) (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). ___ (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. ___ (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) 52.222-17, 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 2014) (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 (Sep 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) (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) 52.222-21, 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 (Jul 2014) (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 (Jul 2014) (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 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 (Aug 2013). (xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (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. (End of Clause) All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number FDA-15-223-SOL-1151450. The offers are due in person, by postal mail or email to the point of contact listed below on or before August 12, 2015 before 9:00 am (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attn: Sondea Blair, 3900 NCTR Road, HFT-320, Building 50, Room 421, Jefferson, AR 72079-9502. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in Part III Supporting Information section above. For information regarding this solicitation, please contact Sondea Blair by e-mail at sondea.blair@fda.hhs.gov. Questions regarding this solicitation, will be accepted only via email and shall be submitted no later than 9:00 AM CT on August 7, 2015.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-15-223-SOL-1151450/listing.html)
Place of Performance: Address: Work shall be performed at the contractor�s site, and deliverables shall be provided to:, U.S. Food and Drug Administration, Center for Biologics Research and Evaluation, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States; Zip Code: 20993
Record: SN03821584-W 20150805/150803235627-83b7831b561a5d9901602e182fd46259 (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

| FSG Index | This Issue's Index | Today's FBO Daily Index Page |

Loren Data's SAM Daily™

A -- Hematological Protein Characterization Services