Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 01, 2016 FBO #5396
SOLICITATION NOTICE

B -- DNA Isolation and16s rRNA Sequencing

Notice Date

8/30/2016
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541380 — Testing Laboratories
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
 

ZIP Code

72079
 

Solicitation Number

FDA-1168805
 

Archive Date

9/22/2016
 

Point of Contact

Jennifer L. Johnson, Phone: 8705437830
 

E-Mail Address

jennifer.johnson3@fda.hhs.gov
(jennifer.johnson3@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. It is the Government's intent to issue a Firm Fixed Priced Purchase Order in accordance with FAR Part 13. The solicitation number is FDA -1168805. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular 2005-89, dated August 15, 2016. The appropriate NAICS code for this acquisition is 541380-- Testing Laboratories; Small Business Size Standard is $15.0. This requirement is unrestricted. Schedule of Supplies or Services and Prices/Costs 0001 DNA Isolation and16s rRNA Sequencing for microbiome analysis of murine fecal samples; per the below Technical & Special Requirements. 1 Job Period of Performance: 10/1/16 – 9/30/17 Scope of Work (SOW) Background: The US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) conducts analysis of murine fecal samples and the host microbiome plays a significant role in the pathogenesis of multiple gut infections. Pathogens such as C. difficile and Vancomycin resistant Enterococcus (VRE) are typically only able to colonize the intestinal tract of humans following disruption of the hose microbiota by antibiotic therapy. The CBER laboratory is examining the role of the microbiome in each of these infections. For C. difficile, the lab will examine the role of specific components of the immune system to shape the microbiome into a resistant/susceptible state. For VRE, the CBER laboratory it is examining potential changes in the microbiome induced by phage therapy compared to standard antibiotic therapies. These studies will advance CBER laboratory understanding of how the microbiome develops the role of the immune system in driving this development, the pathogenesis of C. difficile infection, and the effect of phage therapy on the gut microbiota. Purpose/Objective: Under this contract, the vendor will isolate bacterial DNA from mouse fecal samples. The vendor will then generate 16SrRNA libraries and run subsequent sequencing from each sample. The vendor will perform all necessary troubleshooting and quality control steps throughout the process. Samples will be sent as frozen fecal pellets in MoBio PowerMag Microbiome 96-well plates and shipped on dry ice. The vendor will be required to isolate bacterial DNA from murine fecal samples. The vendor will be required to amplify bacterial DNA and generate libraries from each sample for 16s rRNA sequencing. The vendor will be required to multiplex up to 380 samples for one sequencing run. The vendor must have the capacity for high throughput, reproducible DNA isolation from fecal samples, preferably through automated methods to eliminate human error in sample preparation and processing. The vendor must have experience preparing DNA libraries and performing 16s rRNA sequencing for microbiome analysis. The vendor must perform all steps, including troubleshooting and quality control measures, starting with murine fecal samples and ending with high quality sequence data to be returned to FDA. Technical Requirements: 1. The vendor shall demonstrate the ability to isolate bacterial DNA from fecal samples that is suitable for 16S rRNA sequencing and subsequent microbiome analysis. 2. The vendor shall demonstrate the ability to prepare 16S rRNA libraries from murine fecal samples that are suitable for sequencing. Including expertise to troubleshoot problems that arise at any point during the isolation, library generation, or sequencing process. 3. The vendor shall demonstrate the ability to perform quality control measures to ensure high quality DNA libraries. These measures should include qPCR and/or Bioanalyzer or similar methods. 4. The vendor shall demonstrate the ability to perform Illumina MiSeq sequencing of bacterial 16S rRNA. 5. The vendor shall have the capability to multiplex 380 samples in a single MiSeq lane. 6. The vendor is NOT required to perform analysis of the resulting sequence data. Deliverables: 1. Completion of Task 1: 16S rRNA sequencing, WT mice vs MAIT cell KO mice. Isolation of DNA from mouse fecal pellets 950 samples spanning multiple treatments and time courses for these mice, preparation of 16S rRNA libraries for each sample, and sequencing to achieve sufficient coverage for microbiome analysis. These samples will be sent in batches of 380 samples each. Following isolation and sequencing, the vendor will return purified DNA from each sample as well as sequencing to the CBER laboratory. The lab will pay for shipping of the DNA samples. The sequencing data will be downloaded from the vendor to a secure database system that can be accessed by the lab. The data may also be mailed to the lab on a CD or external hard drive. This data will be processed by a HIVE system using appropriate FDA security procedures. Expected turnaround time for each group of 380 samples is approximately 4-6 weeks. 2. Completion of Task 2: 16S rRNA sequencing, WT mice with phage treatment vs antibiotic therapy. Isolation of DNA from mouse fecal pellets 950 samples spanning multiple treatments and time courses for these mice, preparation of 16S rRNA libraries for each sample, and sequencing to achieve sufficient coverage for microbiome analysis. These samples will be sent in batches of 380 samples each. Following isolation and sequencing, the vendor will return purified DNA from each sample as well as sequencing to the CBER laboratory. The lab will pay for shipping of the DNA samples. The sequencing data will be downloaded from the vendor to a secure database system that can be accessed by the lab. The data may also be mailed to the lab on a CD or external hard drive. This data will be processed by a HIVE system using appropriate FDA security procedures. Expected turnaround time for each group of 380 samples is approximately 4-6 weeks. 3. The total number of samples from task 1 and 2 is 1900. As stated these will be sent in batches 380 for a total of 5 batches (each batch can contain a mixture of samples from both Task 1 and Task 2). The first set of 380 samples will be ready to ship to the vendor within one (1) week after contract award. Subsequently, the remaining four (4) shipments (sets of 380 samples) will be coordinated between the laboratory and vendor. Contract Type: Commercial Item-Firm Fixed Price Period of Performance: The period of performance is twelve (12) months after contract award. Place of Performance/Ship to address: US Food and Drug Administration Center for Biologics Evaluation and Research (CBER), White Oak Campus 10903 New Hampshire Avenue Bldg. 52/72 CBER Room 3306 Silver Spring, MD 20993 POC: (To be provided at time of award) The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items (OCT 2015) applies to this solicitation. The following addenda apply: Offerors are afforded the opportunity to inspect the designated installation area by contacting the Contract Specialist, Jennifer Johnson, jennifer.johnson3@fda.hhs.gov, (870) 543-7830, to schedule an appointment. Failure to inspect install area will not relieve the successful offeror from fully meeting the requirements of the resulting contract price offerered. Prices shall be valid through 10/6/2016. All questions shall be received via email to jennifer.johnson3@fda.hhs.gov before 12:00 P.M. (Central Time) on September 1, 2016. It is the offeror's responsibility to monitor FedBizOpps for information relevant to this solicitation, e.g., questions and answers, amendments, etc. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. Proprietary information shall be clearly marked. It is absolutely essential that Offeror quotes contain sufficient Past Performance information, Technical Capability data/literature, and price details to unequivocally demonstrate: 1. A recent (within the last 3 years) and relevant past performance record for the service at issue; 2. A technical approach that addresses fully the stated requirements and that clearly demonstrates the capability to deliver the required services; and 3. The price proposed shall represent the offeror’s response to the schedule off supplies/services above. The provision at 52.212-2 Evaluation-Commercial Items (OCT 2014) is applicable to this solicitation. The following addenda apply: The government intends to award a firm-fixed-price order resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: 1. Past Performance; 2. Technical Capability; and 3. Price Past Performance and Technical Capability are equally more important when compared to price. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (APR 2016), applies to this acquisition. The following addenda apply: This solicitation is being issued under the premise that the Contractor will certify that the services are exempted from the Service Contract Act per the conditions set forth in FAR 52.222-53 & FAR 22.1006(e)(4). If this is the case and Contractor certifies exemption under the terms and conditions of 52.222-48, then clause 52.222-53 will flow per usual from this solicitation to the resulting order. In the even that a Contractor does not make this certification, traditional Service Contract Act clauses 52.2222-41 and 52.2222-43 shall be included in the resulting order award as well as Wage Determination No. 2005-2035, Revision 18. 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts For Certain Services--Certification (May 2014) (The offeror [ ] does [ ] does not certify that— (1) The services under the contract are offered and sold regularly to non-Governmental customers, and are provided by the offeror (or subcontractor in the case of an exempt subcontract) to the general public in substantial quantities in the course of normal business operations; (2) The contract services are furnished at prices that are, or are based on, established catalog or market prices. An “established catalog price” is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public. An “established market price” is a current price, established in the usual course of ordinary and usual trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; (3) Each service employee who will perform the services under the contract will spend only a small portion of his or her time (a monthly average of less than 20 percent of the available hours on an annualized basis, or less than 20 percent of available hours during the contract period if the contract period is less than a month) servicing the Government contract; and (4) The offeror uses the same compensation (wage and fringe benefits) plan for all service employees performing work under the contract as the offeror uses for these employees and for equivalent employees servicing commercial customers. (b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(d) (3) that the Service Contract Act— (1) Will not apply to this offeror, then the Service Contract Labor Standards clause in this solicitation will not be included in any resultant contract to this offeror; or (2) Will apply to this offeror, then the clause at FAR 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements, in this solicitation will not be included in any resultant contract awarded to this offer, and the offeror may be provided an opportunity to submit a new offer on that basis. (c) If the offeror does not certify to the conditions in paragraph (a) of this provision— (1) The clause of this solicitation at 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements, will not be included in any resultant contract to this offeror; and (2) The offeror shall notify the Contracting Officer as soon as possible if the Contracting Officer did not attach a Service Contract Labor Standards wage determination to the solicitation. (d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision. (End of provision) The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (MAY 2015), applies to this acquisition. The following addenda apply: Inspection/Acceptance: The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Governments Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC shall document the nonconforming items/services and immediately notify the Contracting Officer. The TPOC is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The following Technical Point of Contact (TPOC) will represent the Government for the purpose of this contract (To be provided upon contract award): Name: Email address: Phone: The contact information for the Contract Specialist: Name: Jennifer L. Johnson Email Address: jennifer.johnson3@fda.hhs.gov Phone: (870) 543-7830 Invoice Submission: The contractor shall submit one (1) original invoice (or electronic invoice) to the addresses designated in the contract to receive invoices. (Addresses will be provided at time of award) Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – Central Contractor Registration) and/or other applicable FAR clauses specified herein. 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; (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; (vi) Terms of any discount for prompt payment offered; (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) Any other information or documentation required by the purchase order/award. (xiii) Contractor is not required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes: (a) list of all invoices submitted to date under the subject award, including the following: (1) Invoice number, amount, & date submitted (2) corresponding payment amount & date received (b) total amount of all payments received to date under the subject contract or order (c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. Payments: Payment Schedule: Payment will be made upon completion of each sequencing run (380 samples) described and receipt of invoice. Payment terms net 30 days after government acceptance of the supplies/service. Payment will be made by: 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 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 FAR and HHSAR provisions and clauses, incorporated by reference, apply to this acquisition and can be obtained at https://www.acquisition.gov/far/ and http://farsite.hill.af.mil/VFHHSAR1.htm. FAR Clause 52.204-7 System for Award Management (JUL 2013) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payment to Small Business Subcontractors (DEC 2013) HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (JAN 2010) 352.223-70 Safety and Health (JAN 2006) 52.212-5 Contract Terms and Conditions required to implement Statutes or Executive Orders-Commercial Items (JUN 2016) (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 (Nov 2015) (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 (Oct 2015) (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 (Oct 2015) (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 (Oct 2015) (31 U.S.C. 6101 note). ___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313). ___ (10) [Reserved] ___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). ___ (ii) Alternate I (Nov 2011) of 52.219-3. _X__ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a). ___ (ii) Alternate I (Jan 2011) of 52.219-4. ___ (13) [Reserved] ___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644). ___ (ii) Alternate I (Nov 2011). ___ (iii) Alternate II (Nov 2011). ___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). ___ (ii) Alternate I (Oct 1995) of 52.219-7. ___ (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 2015) (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 2015) 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 Representation (Jul 2013) (15 U.S.C. 632(a)(2)). ___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)). ___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)). _X__ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). ___ (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2016) (E.O. 13126). _X__ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). _X__ (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). ___ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (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 (Feb 2016) (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 (Oct 2015). (E. O. 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) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693). ___ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693). ___ (38) (i) 52.223-13, Acquisition of EPEAT -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514 ___ (ii) Alternate I (Oct 2015) 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 (Oct 2015) (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) (E.O. 13513). ___ (43) 25.223-20, Aerosols (Jun 2016) (E.O. 13693). ___ (44) 52.223-21, Foams (Jun 2016) (E.O. 13696). ___ (45) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83). ___ (46) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43). ___ (ii) Alternate I (May 2014) of 52.225-3. _X__ (iii) Alternate II (May 2014) of 52.225-3. ___ (iv) Alternate III (May 2014) of 52.225-3. ___ (47) 52.225-5, Trade Agreements (Feb 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X__ (48) 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). ___ (49) 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). ___ (50) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). ___ (51) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). ___ (52) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)). ___ (53) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). _X__ (54) 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (55) 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (56) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). ___ (57) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). ___ (58) (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 2015) (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 (Oct 2015) (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 $700,000 ($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 (Oct 2015) (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 (Feb 2016) (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 (Oct 2015) (E. O. 12989). (xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015). (xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). (xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of Clause) All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-1168805. The quotes are due in person, by postal mail or email to the point of contact listed below on or before September 7, 2016, by 12:00 pm (CST) at the Food and Drug Administration; OO/OFBA/OAGS/DAP/FOB; Attn: Jennifer L. Johnson; 3900 NCTR Road, HFT-320; Bldg. 50, Rm. 429; Jefferson, AR 72079. For information regarding this solicitation, please contact Jennifer Johnson at (870) 543-7830, fax (870) 543-7990 or email: jennifer.johnson3@fda.hhs.gov.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-1168805/listing.html)
 

Place of Performance

Address: US Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), White Oak Campus, 10903 New Hampshire Avenue, Bldg. 52/72 CBER Room 3306, Silver Spring, Maryland, 20993, United States

Zip Code: 20993
 

Record

SN04248485-W 20160901/160831000802-3a9be6acadc40a0ee1280c9112c03e0e (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

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