SOLICITATION NOTICE
B -- Platelet Study - Appendix A
- Notice Date
- 7/21/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1133255
- Archive Date
- 8/15/2014
- Point of Contact
- Crystal G. McCoskey, Phone: 8705437267
- E-Mail Address
-
crystal.mccoskey@fda.hhs.gov
(crystal.mccoskey@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Appendix B Appendix A 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 1133255 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) 2005-74 effective July 1, 2014. The associated North American Industry Classification System (NAICS) Code is 541990- All Other Professional, Scientific, and Technical Analysis; FSC Code is B529- Scientific Data Studies. Small Business Size Standard is $14.0 Million. Acquisition is unrestricted. Contract Type: Commercial Item-Firm Fixed Price. REQUIREMENTS: Part I: General Information (Introduction/Background/Scope) The U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) has a requirement for an exploratory study of in vivo recovery and survival of autologous, leukocyte reduced, apheresis platelets stored at Room Temperature (RT) or at cold Temperature-Cycled (TC) conditions for seven (7) days. The objective of this study is to demonstrate if platelets stored under TC conditions will remain in circulation when transfused into healthy human volunteers in a manner comparable to platelets stored in conventional, RT conditions. Storing platelets in the cold would be beneficial because cold temperatures can reduce proliferation of bacteria, if the platelets were contaminated during collection. Currently bacterial contamination in platelets occurs in ~1/5000 platelet units collected. Platelet units can be stored at RT for up to five (5) days and bacteria, if present, can proliferate during the course of storage to levels high enough to have clinical impact. Upon transfusion to patients the bacteria in the platelet units can cause significant morbidity and even mortality. Storage in cold temperatures could reduce the morbidity and mortality; however, exposure of platelets to the cold produces biochemical and morphological changes in the platelets which causes them to be rapidly cleared from circulation. Historically, the rapid clearance of cold stored platelets from circulation has prevented their use for transfusion in prophylactic treatment of thrombocytopenic patients who are at risk for bleeding. Fortunately, if the cold exposures are brief (<18 hours), the changes in platelets can be reversed with warming. Preliminary experiments have shown that TC can prevent the changes in platelets associated with continuous cold storage. TC storage can produce an improvement of platelet in vitro studies, and also improve in vivo recovery in animal models of transfusion when compared to platelets stored continuously in the cold. The effects of cold on platelets can be reversed if the platelets are re-warmed before eighteen (18) hours in the cold (Kattlove, Alexander et al. 1972; McGill 1978a; McGill 1978b; White and Rao 1998). Rewarming cold stored platelets to 37o C can lead to restoration of disassembled microtubules, return of the platelet discoid shape and normalization of in vitro physiologic responses, such as increased response to agonists and loss of hypotonic shock recovery, which were altered by continuous cold exposure (McGill 1978). This temperature cycle can be repeated periodically during cold platelet storage to prevent the permanent effects of the cold. In the mid 1970's McGill proposed that TC could be used to extend platelet storage in the cold to five (5) and to seven (7) days (McGill 1978a; McGill 1978b). He reached this conclusion after extensive studies on platelet morphology and in vitro testing which showed that repeated cycles with 30 minutes warm up to 37o C after twelve (12) hours in 4o C was sufficient for platelet storage of up to five (5) days and for efficient blood bank logistics. Part II: Work Requirements Seven (7) healthy volunteers shall be selected by the Contractor using Appendix A, Donor Questionnaire. Any "no" answers in the "Checklist for Donor Inclusion in the Study" section of Appendix A or "yes" answers in the "Checklist for Donor Exclusion from the Study" section of Appendix A, shall render the volunteer ineligible for participation in the study. The Contractor is responsible for recruiting and compensating the volunteers. The Contractor shall have approval from the US Nuclear Regulatory Commission to use radioisotopes, obtain Institutional Review Board (IRB) approval (visit http://www.hhs.gov/ohrp/assurances/irb/ for registration information) to perform this clinical trial, and conduct studies under Good Laboratory Practice in accordance with Appendix B, References for clinical trial with platelet radiolabelling). All laboratory staff shall be trained by the Contractor's Radiation Safety Officer (RSO) in radiation safety in accordance with Appendix B references. The Contractor shall administer the informed consent documentation on the selected volunteers and follow the clinical trial protocol approved under Investigational New Drug (IND) in accordance with Appendix B. The study participants will be subject to occupational radiation exposure. Risks associated with exposure to low dose ionizing radiation are described in the Nuclear Regulatory Research Regulatory Guide 8 "Instructions Concerning Risks from Occupational Radiation Exposure" (See Appendix B).The RSO maintains records and conducts inspections of the laboratory to assure compliance. The Radiation Safety Committee oversees the radiation safety program and the RSO. Due to CBER's facility move expected to the address below around mid-August 2014, a Notice to Proceed (NTP) shall be issued by the Contracting Officer prior to commencement of recruitment of volunteers to ensure the remaining stored samples can be processed by the FDA researchers concurrently with the human study. The move date is subject to change but will be completed and NTP issued, worst case scenario, by no later than 31 December 2014. The Contractor shall be prepared to start work upon receipt of the NTP from anytime between the award date and the worst case date of 31 December 2014. The study shall be a prospective, open label, paired, active control design using two (2) units of autologous apheresis platelets, with one unit stored at RT for seven (7) days (control), and the identical other autologous platelet unit collected from the same donor stored for one (1) day at room temperature then six (6) days in TC conditions. To support compatibility with previous FDA study results and the protocol design specifications, the platelet collection shall be performed using a TRIMA apheresis instrument manufactured by Terumo Corporation. The cycling schedule shall consist of eleven (11) hours in 5o C and one (1) hour warming to 37o C, with agitation during the warm up period. On day five (5) of platelet storage a sample (8-10 mL) of each unit will be taken and tested for bacteria in a BacT Alert bacterial detection device (BioMeriuex Corp). If bacteria are present in any sample, only a 1/2000-5000 per unit chance, the volunteer shall be dismissed from the study and the process to replace that volunteer via the same steps above shall begin. Additionally, the Contracting Officer shall be notified immediately if any volunteer is dismissed from the study. On day seven (7) post-collection, another small sample (10-15mL), from each apheresis unit shall be incubated for approximately 20 minutes with a radioactive tracer. Each platelet sample from each apheresis unit shall be randomly assigned a distinguishing tracer, either approximately 60 uCi of Indium 111 (In111 ) or 100 uCi of Chromium 51 (Cr51). The radiolabelling of the cells shall be performed according to a standard protocol published by the Biomedical Excellence for Safer Transfusion (BEST) Collaborative (Dumont, LJ et al. Transfusion 2006) (see Appendix A). Independently, the platelets shall then be extensively washed, with only approximately 20 uCi of each isotope remaining, re-suspended in Phosphate-Buffered Saline (PBS), and simultaneously infused intravenously into the volunteer. After infusion of the radiolabelled platelets, serial blood samples shall be collected over a period of ten (10) days (one sample per day) to monitor and determine the amount of each cell-associated radioactivity remaining in circulation. The recovery and clearance of the RT and TC platelets shall be calculated from the data points, analyzed and reported in a final summary document. The remaining stored platelets shall be received in the FDA laboratory in Bethesda, MD within three (3) hours of termination of storage on day seven (7) post-collection. These remaining platelets shall be in plasma in platelet storage bags and at room temperature (20-24o C) for the duration of the transport. This time requirement is a critical factor for the viability of the cells and second stage of the experiment, which takes place at the FDA CBER internal animal facility, US Food and Drug Administration, 9000 Rockville Pike, Bethesda, MD, 20892. Deliverables • obtain and provide IRB approval to conduct this clinical trial (30 calendar days from date of award) - upon delivery project will be 5% complete • recruit healthy human volunteers provide inclusion checklist (45 calendar days from date of NTP) - upon delivery project will be 15% complete • administer the Informed Consent, collect sample data from each volunteer and follow the clinical trial protocol approved under IND (within 60 calendar days from NTP) - upon delivery project will be 20% complete • Provide/deliver apheresis platelet samples for each volunteer to be delivered to CBER, FDA on the day of infusion to the volunteer, for the animal study (200-300 ml) within 3 hours of completion of 7 day RT and TC condition storage process (within 67 calendar days from NTP) - upon delivery project will be 70% complete • analyze data and provide a summary of the data collected over the ten (10) day period for all 7 volunteers (within 100 calendar days from NTP) - upon delivery project will be 100% complete Part III: Supporting Information A. Return Address for Samples: US Food and Drug Administration Attn: COR (to be provided with award) 9000 Rockville Pike Bethesda, MD, 20892 B. Period of Performance Final summary report shall be provided within 100 days of NTP. Ultimate completion shall be no later than April 10, 2015. Schedule of Items 0001 - Platelet Study Services in accordance with requirements above, Appendix A, Checklist for Donor Inclusion in the Study (2 Pages) and Appendix B, References for clinical trial with platelet radiolabelling (2 Pages). Total tiny_mce_marker____________ 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 http://farsite.hill.af.mil/ The provision at FAR 52.212-1, Instructions to Offerors- Commercial Items applies to this solicitation. Addenda to this provision are as follows: Prices shall be valid through 09/30/2014 and award is subject to the availability of funds. Offerors shall provide price breakout for all phases of the study taking into account any potential need for separate pricing in the event of early dismissal of volunteers from the program at each stage due to contamination or early any uncontrollable withdraw from the study. Breakout pricing shall be used in potential modifications due to unforeseen circumstances, but the firm-fixed extended price shall be for the entire study for all seven (7) volunteers with no early dismissal assumed. The government is not responsible for locating or securing any information, which is not identified in the quote. To ensure information is available, offerors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. Quotes shall include technical specifications, descriptive material, literature, brochures, laboratory facility (ie, location, equipment information) Quality Assurance Plans (QAPs), Standard Operating Procedures (SOPs) and/or other information corresponding to each requirement, which demonstrates the capabilities of the Offeror to provide the service. Furthermore, experience with conducting and completing similar IFB approved clinical studies on autologous platelet in vivo recovery and survival studies, ie methods/techniques, donor recruitment processes, etc. shall be included with offer. Each offer shall identify and provide background information for the key personnel to be performing the analysis, i.e. resumes of participating principal investigators and technical assistants, laboratory certifications and permits to work with radioactivity and human subjects, previous project participation. Any relevant past performance and/or collaborative research with major universities and/or federal agencies involved in clinical studies of similar complexity and magnitude in the past three (3) years, shall be included with any resultant offer. The offer shall also include a delivery plan if the Offerors location is outside the required three (3) hour driving radius for the delivery of apheresis platelet samples. Any proprietary information shall be marked as such. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation and is hereby incorporated by reference. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: (i) technical capability; (ii) past performance/experience; (iii) price Technical capability and past performance are of equal importance, and when combined, are more significant when compared to price. Technical capability will be determined by review of information submitted by the Offeror to provide a description in sufficient detail to show that the service quoted meets the Government's requirement, demonstrate successful performance of the service requested with any specific equipment (if stated) herein and exhibits a rational plan to meet the time sensitive delivery deadlines (in particular the three (3) hour driving radius for the delivery of apheresis platelet samples). Offeror's past performance/experience will be evaluated based on the recency (within the last 3 years) and relevancy (similar methods/techniques, type, complexity and magnitude of autologous platelet in vivo recovery and survival clinical studies) of the information provided and the staff's key personnel proposed to determine the likelihood of success in performing the solicitation's requirements. Technical capability and past performance/experience 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 past performance. The Provision at FAR 52.212-3, Offeror's Representations and Certifications-Commercial Items, applies to this acquisition. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. Addenda to this clause are as follows: Inspection and Acceptance The services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. If the services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the services are not acceptable, the COR shall document the nonconforming services and immediately notify the contracting officer. Invoice Submission Payment terms net 30 days after government receipt, inspection and acceptance of the services. Invoices, upon deliverable (as identified in percentages in the specifications above) acceptance, shall be submitted 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. An original and two (2) copies shall be submitted to: FDA/OC/OA/OFO/OFS Attn: Division of Payment Services 3900 NCTR Road, HFT-324 Building 50, 6th floor, suite 616 Jefferson, AR 72079 Phone: (870) 543-7446 Fax 870-543-7224 An electronic invoice can be emailed to the following address: nctrinvoices@fda.hhs.gov II. One copy each to the Contracting Officer and Contracting Officer Representative (COR) or other program center/office designee, clearly marked "courtesy copy only": Questions regarding invoice payments should be directed to the FDA payment office at phone or email reference provided above. Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042. nctrinvoices@fda.hhs.gov. The following clauses are incorporated by reference: • FAR 52.232-40, Providing Accelerated Payments to Small Business Subcontractors • HHSAR Clauses: 352.222-70, 352.223-70, 352.231-71, 352.270-4 and 352.270-6 FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jun 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). _X__ (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] ___ (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 Rerepresentation (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). ___ (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). ___ (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) (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. ___ (39) (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. ___ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b). ___ (41) (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__ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011). _X_ (43) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83). ___ (44) (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. ___ (45) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X__ (46) 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). ___ (47) 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). ___ (48) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). ___ (49) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). ___ (50) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)). ___ (51) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). _X__ (52) 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (53) 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (54) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). ___ (55) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). ___ (56) (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. (End of Clause) 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 2:00 pm (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on July 31, 2014 to crystal.mccoskey@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attention of Crystal G. McCoskey, 3900 NCTR Road, Building 50, Room 426 Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Crystal G. McCoskey by e-mail at crystal.mccoskey@fda.hhs.gov. Questions regarding this solicitation will be accepted only via email and shall be submitted no later than 09:00 AM CST on July 28, 2014. Please reference solicitation number 1133255 in subject line of all correspondence.
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