SOLICITATION NOTICE
B -- Atamer-Based Bacterial Filter Development
- Notice Date
- 5/11/2015
- 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
- 1147130
- Archive Date
- 6/5/2015
- 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
- Total Small Business
- 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 1147130 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) 2005-82 effective May 7, 2015. 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 $15.0 Million. Acquisition is a small business set-aside. Contract Type: Commercial Item-Firm Fixed Price. Part I: Project Background In the United States, at least 100 reported cases of mortality or severe morbidity are attributed to bacterial contamination of transfused Platelet Concentrates (PC) each year and more cases are certainly underreported. Bacterial detection technologies are currently used to reduce the risk of transfusion-transmitted sepsis. A limitation of these technologies is that units contaminated with small numbers of bacteria are often missed; such units can cause sepsis in immunocompromised recipients. Thus, current bacterial detection is not sufficient to ensure maximum safety of PC, and alternative approaches are desirable. Based on this, the U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) has a requirement for development of a filter that removes bacteria from a PC unit, thereby rendering the unit safer to transfuse. The required device shall be a membrane-based filter containing bacteria-specific affinity ligands. The main advantage of bacterial filters, would be to remove bacteria even when present in PC in undetectable numbers. The goal of this project is to establish proof of concept for such a device. This device will improve the safety of platelet transfusions and enhance public health. Early work conducted by FDA personnel using peptide ligands showed that some peptides bound to bacteria with strong affinity in saline suspension but under physiological conditions in which bacteria were mixed with platelets the peptides bound poorly. These results suggested that higher affinity between the ligand and the bacteria cell was needed. After a literature search, the FDA concluded DNA aptamers might be better ligands. DNA aptamers are oligonucleotide structures that, in theory, should offer more selective and higher-affinity binding to bacterial cells than peptides. Aptamers that bind bacteria are selected from randomly generated aptamer libraries. Based on the aforementioned, CBER has a need for screening of aptamer libraries for binders of three bacteria: S. epidermidis, S. aureus, and E. coli. The screening selection is expected to be conducted in the presence of platelet concentrates. During the screening process, steps have to be introduced to remove non-specific aptamers and aptamers that bind plasma proteins or platelets. The process of selection must be one-step and take no longer than one (1) week for the three bacteria due to the time sensitivity and constraints of the research project. Once the FDA receives the aptamer pools from the Contractor, the cloning and sequencing will be conducted. Afterwards the sequencing information will be provided to the Contractor for ranking of the aptamers based on predicted thermostability. It is expected the Contractor will be able to identify the aptamer sequence of the two (2) best candidates per each bacteria based on the sequencing provided. Part II: Requirements A. Scope The contract shall conduct aptamer selection against three (3) bacteria S. epidermidis, S. aureus, and E. coli. using a selection method that involves only a one-step protocol. The contractor shall provide the three bacterial strains. The aptamer pools shall have been screened in the presence of platelets, and those aptamers that bind plasma proteins and platelets shall be removed. The contractor shall send the aptamer pools to FDA no later than three (3) months after the date of award. Each pool shall contain at least two (2) and up to 200 aptamer sequences. The FDA will provide the Contractor with the sequencing of all or some aptamers in the pools within six (6) months of receipt of the aptamer pools. Once the sequencing is provided, the Contractor shall conduct thermodynamic stability testing to identify consensus sequences among those aptamers identified in the pools. The contractor shall rank aptamers based on an algorithm for predicted thermostability. Within three (3) months after receipt of the sequencing from the FDA, the Contractor shall run the algorithm and provide the sequences of the top two (2) aptamers with the highest affinity to each of the three (3) bacteria strains. B. Deliverables/Milestones i) Contractor shall deliver at least 0.5 ml each of three (3) pools of aptamers within three (3) months after contract award with each pool composed by two to maximum 200 aptamers that have been selected by screening against plasma proteins and platelets for binding S. epidermidis, S. aureus, and E. coli. Project will be considered 75% complete upon acceptable delivery of these three (3) aptamers. ii) Contractor shall provide a ranking of the aptamers based on predicted thermostability to FDA and provide the best two (2) sequences for each bacterial strain tested within three (3) months of the receipt of the sequencing from the FDA. Additionally, the Contractor shall provide rationale for the selection of the two (2) best aptamers. Project will be considered 75% complete upon acceptable delivery of this data. iii) Contract shall provide monthly progress reports during development of the aptamers and the ranking processes. C. Delivery US Food and Drug Administration 10903 New Hampshire Avenue Building 52/72, room 4336 Silver Spring, MD 20993 D. Period of performance All three (3) aptamer pools shall be provided to the FDA within three (3) months of contract award. The FDA will provide the sequencing within six (6) months of receipt of the three (3) aptamers. Ranking of aptamers based on predicted aptamers' thermostability and the best two (2) sequences for each bacteria strain tested shall be provided three (3) months after receipt of aptamers' sequencing from the FDA. Total period of performance shall be one (1) calendar year from date of award. Pricing Schedule: Item No. Description Quantity Unit Price 0001 Development of Aptamer-Based 1 EA $ Bacterial Filter accordance with requirements above including all necessary labor, supplies, materials, equipment, and shipping to provide the deliverables. FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at: http://www.acquisition.gov/far/ http://farsite.hill.af.mil/vfhhsara.htm The provision at FAR 52.212-1, Instructions to Offerors- Commercial Items (Apr 2014) applies to this solicitation. Addenda to this provision are as follows: 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, details on steps/methods/patents to be used, laboratory facility (ie, location, equipment information), personnel experience/qualifications, and/or other information corresponding to each requirement, which demonstrates the capabilities of the Offeror and how they intend to provide the service. Furthermore, experience with conducting and completing similar aptamer-based bacterial filter development, ie methods/techniques, demonstrated success, commercial application, etc. shall be included with offer. Any relevant past performance involving similar methods/techniques, scope, complexity and magnitude of aptamer-based bacterial filter development in the past seven (7) years, shall be included with any resultant offer. Any proprietary information shall be marked as such. Technical capability and past performance for any intended subcontractors shall be included with offer. The provision at FAR 52.212-2 Evaluation-Commercial Items (Oct 2014) 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 of the services offered to meet the Government requirement; (ii) past performance; (iii) price Technical capability is more important than past performance, which is important than price. Technical capability will be determined by review of information submitted by the Offeror which must provide a description in sufficient detail to show that the service quoted meets the Government's requirement and demonstrate successful performance of similar services. Additionally, at a minimum, the Offeror's ability to provide the service with personnel, experience, facilities, steps/methods/patents, etc., will be considered. Offeror's past performance will be evaluated based on the recency (within the last seven (7) years) and relevancy (similar methods/techniques, scope, complexity and magnitude of aptamer-based bacterial filter development) of the information provided to determine the likelihood of success in performing the solicitation's requirements as indicated by that offeror's record of past performance. Evaluation of the prime contractor will be combined with any subcontractors to perform the work. The Government reserves the right to consider past performance information from any other source (e.g. Past Performance Information Retrieval System, Federal Awardee Performance and Integrity Information System (FAPIIS), Electronic Subcontract Reporting System (eSRS), or other databases; interviews with PMs, COs, and Fee Determining Officials; and the Defense Contract Management Agency) when evaluating past performance. The Provision at FAR 52.212-3, Offeror's Representations and Certifications-Commercial Items (Mar 2015), applies to this acquisition. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015), applies to this acquisition. Addenda to this clause are as follows: Inspection and Acceptance The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. Invoice Submission Payment terms net 30 days after government acceptance of the deliverables in accordance with the milestones and percentages complete identified above. Invoices shall be submitted after each onsite maintenance visit 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: • 52.232-39, Unenforceability of Unauthorized Obligations (Jun 2013) • 52.232-40, Providing Accelerated Payment to Small Business Subcontractors (Dec 2013) • 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Jan 2010) • 352.231-71, Pricing of Adjustments (Jan 2001) FAR 52.212-5 - Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- 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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Public Law 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161). ___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). ___ (ii) Alternate I (Nov 2011) of 52.219-3. ___ (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] _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 (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 1999). _X__ (28) 52.222-26, Equal Opportunity (Apr 2007) (E.O. 11246). ___ (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212). _X__ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). ___ (31) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212). ___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). _X__ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). ___ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627). ___ (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). _X__ (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) 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 May 21, 2015 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 or site visit request, 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 May 18, 2015. Please reference solicitation number 1147130 in subject line of all correspondence.
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