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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 24, 2014 FBO #4656
SOLICITATION NOTICE

A -- Multiplex Nucleic Acid Study - FDA-14-223-SOL-1135011 with Deliverables and Timeline

Notice Date

8/22/2014
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541711 — Research and Development in Biotechnology
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-14-223-SOL-1135011
 

Archive Date

9/13/2014
 

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

Total Small Business
 

Description

FDA-14-223-SOL-1135011 with Deliverables and Timeline This is a 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-14-223-SOL-1135011 and the 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) 2005-76 effective July 25, 2014. The associated North American Industry Classification System (NAICS) Code is 541711- Research and Development in Biotechnology; Small Business Size Standard is 500 employees. This acquisition is issued as a small business set-aside. Contract Type: Commercial Item-Firm Fixed Price. Schedule of Services: CLIN 0001 The Government will provide up to 300 samples for: Assembly, Validation, and Multiplex Device Testing for a Multiplex Nucleic Acid Study Price per Sample:__________________ Extended Price (300 samples):_________________ Offerors shall provide a price breakdown for the services as appropriate to the completion of each phase. Part I: General Information Introduction: The US Food and Drug Administration (FDA) Laboratory of Emerging Pathogens, Division of Emerging and Transfusion Transmitted Diseases (DETTD), Office of Blood Research and Review within the Center for Biologics Evaluation and Research (CBER) requires services for a Multiplex Nucleic Acid Study. Background: Diagnostics are a crucial component of the public health strategy to reduce the burden of infectious diseases. A series of diagnostic devices and platforms are being developed to detect National Institute of Allergy and Infectious Diseases (NIAID) priority biodefense pathogens. Development of diagnostics for these Medical Counter Measure-related pathogens however, is complicated by the low prevalence of many of the pathogens. As such, there may not be sufficient clinical samples available to conduct clinical sensitivity studies required for FDA clearance. To address this regulatory scientific challenge, the FDA will consider use of mock (spiked) clinical samples to support clinical sensitivity studies for the evaluation of diagnostic devices that detect low prevalence pathogens. Scope: The premise of the study is to demonstrate that a commercially available multiplex nucleic acid testing device can achieve acceptable sensitivity specificity and reproducibility on spiked samples extracted from human whole blood and plasma. Data from the study will be used for standardization of methods associated with assisting diagnostics developers with performing clinical sensitivity studies required for FDA clearance of diagnostic devices to detect low prevalence pathogens. Part II: Work Requirements A. Phase I through Phase VI Requirements Contractor shall perform the following according to the timeline detailed in Part III Deliverables and Timeline: • Develop two sets of primers and probes for each of the three following pathogens: Francisella tularensis, Escherichia coli, and Babesia microti that are capable of sensitive and specific Polymerase Chain Reaction (PCR) amplification of the pathogens. ~CBER scientists have amplified genomic targets with primer and probe sets (assays) for the pathogens that can be an optional starting point for testing on a contractor's platform. The contractor's platform shall be capable of nucleic acid based simultaneously testing the three (3) target pathogens. • Assembly, Validation, and Multiplex Device Testing ~The Government will supply a minimum of 201 and a maximum of 300 coded spiked blood and plasma samples comprised of at least 20 replicates of 3 different concentrations each of the 3 pathogens and additional non-spiked whole blood samples. ~The Government will provide the contractor 9 samples with purified pathogen nucleic acid samples within 90-days of contract issuance (see Deliverables and Timeline 2.2). There will be at least 3 replicate samples of nucleic acid for each pathogen at sufficient concentration to allow the contractor to perform dilutions to the lowest detectible level. ~The Government will provide the contractor 42 samples of identified pathogen spiked blood and plasma within 150-days of contract issuance (see Deliverables and Timeline 2.5). There will be four replicate samples at each of 3 concentrations to evaluate reproducibility near the lowest detectible level for each pathogen. Additionally 6 non-spiked controls will be included. ~The Government will provide the contractor 150 samples of coded pathogen spiked samples within 180-days of contract issuance (see Deliverables and Timeline 3.1). There will be 25 samples at each of 3 concentrations for each pathogen including non-spiked controls. ~The cumulative number of samples at a minimum is 201 samples. The Government, in consultation with the contractor, may decide that testing additional samples up to a maximum of 300 is needed to achieve the desired validation and reproducibility. ~Contractor shall assemble and validate the multiplex device by testing with purified pathogen nucleic acid and spiked samples of known concentration. o Validation shall be inclusive of testing the device with Government supplied samples to demonstrate reproducibility and sensitivity of detection. ~The contractor shall choose the high throughput mupltiplex device used for testing, and shall ensure the device performs detection of pathogens in nucleic acid samples with adequate sensitivity, specificity, and reproducibility, and the system is commercially available ~Contractor shall analyze and compile the data and submit the data to the designated CBER scientists (to be named upon award) for comparison to the identity of pathogen spiked in each specimen ~Analysis shall depict the quantitative value that corresponds to the amount and identity of the pathogen present in the spiked sample ~The values for all samples in which the same pathogen is detected with the same quantity shall be presented with the mean and standard deviation of the group ~Values and statistics shall be presented in tables and sent email format as attachments ~The contractor shall conduct telephone meetings with CBER scientists to evaluate the results and collaborate on planned additional testing as required due to deficiencies revealed in the samples sent by FDA or invalid testing results that prevented reaching the minimum requirement that could be replaced by further testing ~The Government will requests meetings via email and telephone as needed with an estimated frequency of bi-weekly • Publication-ready data analysis and conference ~Submission of final data analysis shall be provided to the Government in publication-ready form ~Reports shall be sent in electronic format with data in a format that can be manipulated, such as Microsoft Word and or Excel. ~Data shall represent a complete history of the findings with the information about the assay conditions, dates of performances, and analysis of the meaning of the data. ~Report shall include summary tables tying to the support documentation to depict a pictorial review of the analysis ~Contractor shall conduct a teleconference with CBER scientists to discuss analysis of the decoded results Part III Deliverables and Timeline (See Attached PDF File: FDA-14-223-SOL-1135011 with Deliverables and Timelines) The contractor shall meet with CBER scientists to discuss and evaluate the testing results upon completion of each Phase and as determined necessary by CBER scientist. The contractor will be paid on an interim basis, upon completion, receipt, and government acceptance of deliverables associated with Phases II,III, and VI. Part IV: Supporting Information A. Place of Performance Work shall be performed on-site at the contractor location with deliverables sent to the following Government location: US Food and Drug Administration (Point of Contact will be provided at time of award) Center for Biologics Evaluation and Research DETTD/OBRR/CBER Bethesda, MD 20892 Silver Spring, MD 20993 B. Period of Performance September 22, 2014 to September 21, 2015 FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at: http://www.acquisition.gov/far/ http://www.dhhs.gov/asfr/ogapa/acquisition/acquisitionpolicies.html Solicitation Provisions The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (April 2014) applies to this solicitation. The following addenda apply: The provision at FAR 52.212-2 Evaluation-Commercial Items (Jan 1999) is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: (i) Technical Capability (ii) Recent and Relevant Past Performance (iii) Price When combined, technical capability, and past performance are more important than price in determining the best value to the Government. If the Government determines non-price factors to be essentially equal, price becomes more important as the discriminating factor. Technical Capability Technical capability will be determined by review of information submitted by the offeror demonstrating corporate ability and experience in conducting multiplex nucleic acid testing with high sensitivity and ability to adapt the multiplex testing platform to new assays for pathogens to be targeted. Describe in detail the existing facility and equipment that will be dedicated to successful performance of the required services identified above. Address the professional qualifications and experience of key staff who may be assigned in the production of the materials and delivery of services. Discuss specific software that will be used in data acquisition, statistics, quality control, data storage and archiving. Recent and Relevant Past Performance Identify all two to three projects (within the last 3 years from date of this solicitation) relevant to these requirements in terms of type, scope, complexity, and size. For each of these past performance references, provide a detailed description of the work, the period of performance, the dollar value of the work, your role and responsibilities as either a prime or subcontractor, the client name and address and client point of contact name, phone number, and email address. Any relevant past performance and/or collaborative research with major universities and/or federal agencies involved in publishing results in the assembly, testing, and analysis of multiplex nucleic acid testing. The Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. Offerors shall provide detailed costs supporting their firm fixed price, ensuring that the price proposal is consistent with the technical proposal in all respects since the price proposal may be used as an aid to further determine the Offeror's understanding of the technical requirements. 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 unequivocally determine whether the service meets the technical requirements. The Government reserves the right to make an award without discussions. The Provision at FAR 52.212-3, Offeror's Representations and Certifications - Commercial Items (May 2014), 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 (May 2014) applies to this acquisition. The following addenda have been added: Inspection and Acceptance The deliverables and/or services delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the deliverables 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. Invoice Submission Invoices shall be submitted in arrears as described in Part III Deliverables, to the attention of the Office of Financial Services 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) Company's DUNS number; and (xiii) Any other information or documentation required by the purchase order/award. Invoices shall be submitted quarterly in arrears of service to the attention of the Office of Financial Services identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions. II. An original and two (2) copies shall be submitted to: FDA Payment Office 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 Contracting Officer Representative (COR) 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; top: 0px; cursor: hand; right: 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; top: 0px; cursor: hand; right: 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 The following clauses are incorporated by reference: HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Jan 2010) HHSAR Clause 352.223-70 Safety and Health (Jan 2006) FAR 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (May 2011) FAR 52.204-7 System for Award Management (July 2013) FAR 52.223-6 Drug-Free Workplace (May 2014) FAR 52.232-40 Providing Accelerated Payment to Small Business Subcontractors (Dec 2013) FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (July 2014) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)). ____ Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)). (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (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) 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) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). _ _ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a). ___ (13) [Reserved] _X__ (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 (May 2014) (15 U.S.C. 637(d)(2) and (3)). ___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jul 2013) (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 (July 2010) 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) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer). ___ (ii) Alternate I (June 2003) of 52.219-23. ___ (22) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Jul 2013) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). ___ (23) 52.219-26, Small Disadvantaged Business Participation Program-Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). ___ (24) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f). _X_ (25) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C. 632(a)(2)). ___ (26) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)). ___ (27) 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_ (28) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _X__ (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126). _X_ (30) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). _X_ (31) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). _X__ (32) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212). _X_ (33) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). _X_ (34) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212). ___ (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). ___ (36) 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.) ___ (37) (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.) ___ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b). ___ (39) (i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423). ___ (ii) Alternate I (Dec 2007) of 52.223-16. _X_ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011). ___ (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. 2303 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). ___ (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)). (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 (May 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 (Sep 2010) (38 U.S.C. 4212). (vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). (vii) 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. (viii) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). (ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). ___ Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (x) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.) (xi) 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) (xii) 52.222-54, Employment Eligibility Verification (Aug 2013). (xiii) 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). (xiv) 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. (xv) 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. Additional Information It is the offeror's responsibility to monitor the internet site for the release of any information related to this combined synopsis/solicitation. Offerors are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 9:00 am (Central Time - Local Prevailing Time in Jefferson, Arkansas) on August 29, 2014 to sondea.blair@fda.hhs.gov, Fax (870) 543-7990 <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; top: 0px; cursor: hand; right: 0px; left: 0px;" title="Call: (870) 543-7990" src="data:image/png;base64,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" alt="" />, or mail to the U. S. Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attention of Sondea Blair, 3900 NCTR Road, Building 50, Room 421 Jefferson, AR 72079-9502. 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 must be received no later than August 25, 2014. Please reference solicitation number FDA-14-223-SOL-1135011 in subject line of all correspondence.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-14-223-SOL-1135011/listing.html)
 

Place of Performance

Address: Center for Biologics Evaluation and Research, DETTD/OBRR/CBER, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States

Zip Code: 20993
 

Record

SN03476519-W 20140824/140822234756-dddea849ff3ae39747018dbdeb337c1a (fbodaily.com)
 

Source

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