Federal contract opportunity FDA-SOL-1130640 for all other miscellaneous manufacturing at Food and Drug Administration Office of Acquisitions and Grants Services, response was due May 19, 2014.

Due
Solicitation Number
FDA-SOL-1130640
Contract Number(s)
None listed
Additional Info Link
None listed
Set-Aside
No Set-Aside Used
Synopses View

The purpose of this amendment is to provide answers to questions received and extend the response date of this combined synopsis/solicitation. Questions and Answers may be found in attached document "FDA-SOL-1130640Questions.doc". The response date of this combined synopsis/solicitation shall be extended from Friday May 16th, 2014 5:00PM EST, to Monday May 19th, 2014 5:00PM EST.




Solicitation Number FDA-SOL-1130640


 


Subject: Automated System for Translational Research and Reagents.


 


Part 1 – Description


 


The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has a need for an automated system for translational research and accompanying reagents.


 


This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice.  This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. 


 


This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures.  The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-72.  The North American Industry Classification System (NAICS) code for the proposed acquisition is 339999, All Other Miscellaneous Manufacturing.


 


Part 2 – Services and Supplies and Prices


 


2.1 Contract Type:  Firm-fixed-Price


 


2.2  Pricing Table























































Contract Line Item Number (CLIN)



Service and Supply Description



Quantity



Unit Price



Total Firm-Fixed-Price*



0001



Automated System



1



EA



$



0002



Reagent: GX CodeSet- 384rxns GXA0P1CS-384


(96 Genes  384 Rxns)



1



EA



$



0003



Reagent: GX CodeSet- 768rxns


GXA-P1CS-768


(96 Genes x 768 Rxns)



1



EA



$



0004



Reagent: GX CodeSet- 1152rxns


GXA-P1CS-1152


(96 Genes x 1152 Rxns)



1



EA



$



0005



Reagent: Master Kit- 192 rxns


NAA-AKIT-192



12



EA



$



 



TOTAL MAXIMUM POTENTIAL FIRM-FIXED-PRICE



 



 



$



 


 


*The firm-fixed-prices are inclusive of all costs, such as shipping, parts, installation, training, labor, travel, and any other warranty and service maintenance costs.  Payment is only authorized for the respective firm-fixed-prices upon successful completion of the respective CLIN, including delivery and acceptance of all deliverables, as determined by the FDA Contracting Officer’s Representative (COR), and upon submission of a proper invoice.  Proper invoice submission includes following the invoice instructions below. 


 


Part 3 – Description/Specifications


 


  3.1 Background


 


The Division of Therapeutic Proteins conducts research on assessing the quality and safety of existing drug products as well as on discovering biomarkers and targets needed to develop and/or ameliorate effective therapeutic strategies. The ongoing research activities in the Laboratory of Immunology are focused on identifying biomarkers and potential targets for infections and autoimmune disorders to modulate the host immune response and facilitate the clearance of the disease. To this end, the Laboratory of Immunology conducts a variety of assays which require the simultaneously and highly sensitive detection, measurement, and interactions with proteins of hundreds different nucleic acids with immunoregulatory functions such as messenger RNAs (mRNA), microRNA (miRNA), long non-coding RNAs (lncRNA), and DNA in a large set of samples. This acquisition calls for reagents and instruments allowing a digital gene expression analysis that is uniquely suited to the research of our laboratory.


 


3.2 Salient Characteristics of the Automated System


 


The features of the automated system to be used for translational research shall include, at a minimum, the following features and characteristics:


 


1.)    Shall have an interface that walks the user through the set up process using a stage layout map for the automated processing of samples for the digital gene expression analysis.


2.)    Shall be supported by specialized customer service for the installation and maintenance of equipment, as well as for the teaching of data processing.


3.)    Shall be capable of gene expression analysis for the analysis of the expression levels of at least 500 genes simultaneously in a single sample.


4.)    Shall be capable of single-cell expression analysis for identifying cell-to-cell differences (based on single-cell specific gene signature) within a population of cells. The single-cell expression analysis must allow the analysis of at least 500 genes simultaneously in a single-cell sample.


5.)    Shall be capable of miRNA expression analysis for the expression profiling of hundreds of miRNAs in a single reaction. The miRNA expression analysis shall accurately distinguish between highly similar miRNAs at a single-base resolution.


6.)    Shall be capable of miRGE analysis for the simultaneous profiling of both miRNAs and mRNAs in a single reaction from a single sample.


7.)    Shall be capable of copy number variation analysis to multiplex with a minimum of 500 target regions in a single reaction from a single sample. This analysis must provide high accuracy for multiallelic copy number variations.


8.)    Shall be capable of IncRNA expression analysis for validation of lncRNA discoveries and other studies requiring a rapid, cost-effective method of screening hundreds of lncRNAs across large sample sets. The assay shall allow the selection of a minimum of 500 lncRNAs for analysis in a single multiplexed reaction. This analysis shall allow the combining of probes for lncRNAs and mRNAs in the same reaction to enable simultaneous analysis of both classes of RNA in the same sample.


9.)    Shall be capable of ChIP-string expression analysis for measuring dsDNA fragments that have been enriched via chromatin immunoprecipitation. This analysis shall allow the quantification as little as 5 ng of enriched chromatin-immunoprecipitated DNA directly with no amplification.


 


The proposed instrument shall be accompanied by a one (1) year warranty, to cover all parts and labor.


 


3.4 Salient Characteristics of Reagents


 


All proposed reagents shall be compatible with the offeror’s proposed automated system as described in section 3.3.


 


The features of the reagents shall include:


1.)    Shall target-specific probes allowing the detection and counting of hundreds different types of nucleic acids in a single reaction. Each run shall be able to test at least 12 samples in parallel.


2.)     Shall have capacity of measuring simultaneously different types of nucleic acids directly in tissue, cells, and blood lysates as well as in formalin-fixed paraffin-embedded extracts without the need of intermediate steps of purification and amplification that might introduce bias into the results, thus allowing to save time and precious reagents.


3.)     No enzymes shall be required to perform assay.


4.)     Shall have a level of precision and sensitivity of >1 copy of nucleic acid per cell.


 


Master kit reagents and consumables including sample-containing glass cartridges shall be compatible with the digital gene expression analysis.


 


 


 


 


 


 


3.5 Delivery, Installation, and Training.


 


The Analysis System and reagents shall be delivered within 30 days of contract award. The vendor shall install the instrument within 15 days of delivery to the FDA. At the time of installation, the vendor shall provide installation qualification, operational qualification, training for up to three (3) individuals, and copies of all user documentation and operator manuals.


 


The delivery location is:


The U.S. Food and Drug Administration


White Oak Campus


10903 New Hampshire Ave


Building 52-72


Silver Spring, MD


 


3.6 Contract Administration


 


Contracting Officer’s Representative (COR)


 


The following COR will represent the Government for the purpose of this order: [TBD]


 


The COR is responsible for the following as required by this order: (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 evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.


 


The Contracting Officer is the only person with authority to act as an agent of the Government under this order.  Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.


 


The contact information for the Contracting Officer is the following:


 


James Chestnut


U.S. Food and Drug Administration


Office of Acquisitions and Grants Services


Rockville, MD 20857


James.Chestnut@fda.hhs.gov


(240) 402-2067


 


The contact information for the Contract Specialist is the following: 


 


Christopher McGucken


            U.S. Food and Drug Administration


            Office of Acquisitions and Grants Services


Rockville, MD 20857


Christopher.Mcgucken@fda.hhs.gov


Telephone: (240) 402-7599


 


The contact information for the Contractor is the following: [TBD]


 


 


PAYMENT


 


The Government will pay the Contractor only each respective CLIN’s firm-fixed-price delineated in the pricing table in Subpart 2.2 above, successful completion, as determined by the COR, and upon submission of a proper invoice.  Proper invoice submission includes following the invoice instructions below. 


 


 


 


INVOICE INSTRUCTIONS


 


The Contractor shall submit all invoices in the manner specified below:


 


The Contractor shall submit one original copy of each invoice to the address specified below:


 


Office of Financial Services
Food and Drug Administration


10903 New Hampshire Avenue


W032-Second Floor


Bldg. 32, Rm. 2162, Mail Hub 2145


Silver Spring MD  20993-0002


Attn: Vendor Payments


 


Phone: (301) 827-3742 or (866) 807-3742


            Email: fdavendorpaymentsteam@fda.gov


Invoices submitted under this order must comply with the requirements set forth in FAR 52.232-33 (Payment by Electronic Funds Transfer – Central Contractor Registration) and the 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 of supplies delivered or services performed, including:  (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures;
(V) Shipping number and date of shipping, 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 a 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 COR or other program center/office point of contact, as referenced on the purchase order; and,
(XII) Any other information or documentation required by the purchase order/award.


 


Questions regarding invoices shall be directed to the FDA at the telephone numbers provided above.


 


Payment will only be made on a firm-fixed-price basis.


 


 


FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (January 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)(Pub. L. 108-77, 108-78).


 


(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:


 


__X __           (1)        52.203-6, Restrictions on Subcontractor Sales to the Government (Sep 2006), with Alternate I (Oct 1995)(41 U.S.C. 253g and 10 U.S.C. 2402).


__  __             (2)        52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).


__  __             (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)       52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Jul 2010) (Pub. L. 111-15).


____               (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).


__  __             108)     52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Pub. L. 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 Set-Aside (Nov 2011)(15 U.S.C. 644).


__  __             (14)      (ii) Alternate I (Nov 2011).


__  __             (14)      (iii) Alternate II (Nov 2011).


__  __             (15)      (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003)(15 U.S.C. 644).


__  __             (15)      (ii) Alternate I (Oct 1995) of 52.219-7.


__  __             (15)      (iii) Alternate II (Mar 2004) of 52.219-7.


__X __           (16)      52.219-8, Utilization of Small Business Concerns (Jul 2013) (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)). (In accordance with DDP Memo dated 9 Sep 2013, DAR Tracking Number 2013-O0014, Class Deviation—Summary Subcontract Report Submission, this clause is replaced with DFARS Deviation dated Aug 2013. Effective until incorporated into the FAR or DFARS or until rescinded.)


__  __             (17)      (ii) Alternate I (Oct 2001) of 52.219-9.


__  __             (17)      (iii) Alternate II (Oct 2001) of 52.219-9.


__  __             (17)      (iv) Alternate III (Jul 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). (In accordance with DDP Memo dated 12 Mar 2010, DAR Tracking Number 2010-O0006, Immediate Cessation of the Use of Price Evaluation Adjustment for Small Disadvantaged Businesses, this clause is suspended in DoD. Effective until incorporated into the FAR or DFARS or until rescinded.)


__  __             (21)      (ii) Alternate I (June 2003) of 52.219-23. (In accordance with DDP Memo dated 12 Mar 2010, DAR Tracking Number 2010-O0006, Immediate Cessation of the Use of Price Evaluation Adjustment for Small Disadvantaged Businesses, this clause is suspended in DoD. Effective until incorporated into the FAR or DFARS or until rescinded.)


__  __             (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 Total Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011)(15 U.S.C. 657 f).


__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) (1 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)).


__  __             (28)      52.222-3, Convict Labor (June 2003)(E.O. 11755).


__X __           (29)      52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014)(E.O. 13126).


__X __           (30)      52.222-21, Prohibition of Segregated Facilities (Feb 1999).


__X __           (31)      52.222-26, Equal Opportunity (Mar 2007)(E.O. 11246).


__X __           (32)      52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212).


__X __           (33)      52.222-36, Affirmative Action For Workers with Disabilities (Oct 2010)(29 U.S.C. 793).


__X __           (34)      52.222-37, Employment Reports on Veterans (Sep 2010)(38 U.S.C. 4212).


__X __           (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.)


__  _               (37)      (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)


__  __             (38)      52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42.U.S.C. 8259b).


__  __             (39)      (i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423).


__  _               (39)      (ii) Alternate I, (Dec 2007) of 52.223-16.


__X __           (40)      52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011).


__  __             (41)      52.225-1, Buy American Act--Supplies (Feb 2009)(41 U.S.C. 10a-10d).


__  __             (42)      (i) 52.225-3, Buy American Act--Free Trade Agreements--Israeli Trade Act (Nov 2012) (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).


__  _               (42)      (ii) Alternate I (Mar 2012) of 52.225-3.


__  _               (42)      (iii) Alternate II (Mar 2012) of 52.225-3.


__  _               (42)      (iv) Alternate III (Nov 2012) 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, Restriction on Certain Foreign Purchases (Jun 2008)(E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of 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. 522(f), 10 U.S.C. 2307(f)).


__  __             (49)      52.232-30, Installment Payments for Commercial Items (Oct 1995)(41 U.S.C. 255(f), 10 U.S.C. 2307(f)).


__  __             (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 (Jul 2013) (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).


__  _               (54)      (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 Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).


__  __              (2)     52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).


__  __              (3)     52.222-43, Fair Labor Standards Act and Service Contract Act--Price Adjustment (Multiple Year and Option Contracts) (Sep 2009)(29 U.S.C. 206 and 41 U.S.C. 351, et seq.).


__  __              (4)     52.222-44, Fair Labor Standards Act and Service Contract Act - Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).


__  __              (5)     52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (Nov 2007) (41 U.S.C. 351 et seq.).


__  __              (6)     52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services—Requirements (Feb 2009)(41 U.S.C. 351 et seq.).


__  __              (7)     52.222-17, Nondisplacement of Qualified Workers (Jan 2013) (E.O. 13495).


__  __              (8)     52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (Mar 2009) (Pub. L. 110-247).


__  __              (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 paragraphs (e)(1) of this paragraph 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) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).


(ii) 52.219-8, Utilization of Small Business Concerns (Jul 2013) (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 (Jan 2013) (E.O. 13495). Flow Down required in accordance with paragraph (l) 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 20106) (38 U.S.C. 4212).


(vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).


(vii) 52.222-10, 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 Act of 1965 (Nov 2007),(41 U.S.C. 351, et seq.).


(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 Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (Nov 2007)(41 U.S.C. 351, et seq.).


(xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services—Requirements (Feb 2009) (41 U.S.C. 351, et seq.).


(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 (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraphs (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)


 


 


 


FAR Clauses Incorporated by Reference


 


FAR 52.252-2, Clauses Incorporated by Reference (February 1998)


 


This order incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/far/


 


52.212-4, Contract Terms and Conditions-Commercial Items (September 2013)


52.232-40, Providing Accelerated Payments to Small Business Subcontractors (December 2013)


 


HHSAR Clauses Incorporated by Reference


 


This order incorporates the following U.S. Department of Health and Human Services Acquisition Regulation (HHSAR) clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.  Also, the full text of a clause may be accessed electronically at the following website: http://www.hhs.gov/policies/hhsar/.


 


352.203-70, Anti-Lobbying (January 2006)


352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (January 2010)  


352.231-71, Pricing of adjustments (January 2001)


 


Conflicts of Interest


 


The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, it does not have any actual, potential, or apparent conflict of interests pertaining to the subject order, as defined in FAR Subpart 9.5 and HHS and FDA policies, for its organization, employees, or subcontractors working or proposed to be working under this order.


The Contractor agrees that, if after award, it discovers a conflict of interest with respect to this order, it shall make an immediate and full disclosure in writing to the FDA Contracting Officer for this order.


The Government reserves the right to exercise any remedy available at law or equity, including termination of the order for cause or convenience, should the Government determine remedial action is necessary to address any actual, potential, or apparent conflict of interest.


 


Part 4 – Instructions to Offerors


 


Cover Page


 


Offerors shall include a cover page which shall include a point of contact (name, telephone number, and email address), proposed firm-fixed-prices (i.e. complete the pricing table in Subpart 2.2), estimated delivery date, business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.), Dun and Bradstreet (DUNS) number, country of manufacturing of equipment, and certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current. 


 


Offerors shall ensure the solicitation number is visible in the header of the email transmission of their quote.  Faxed quotes will not be accepted.


 


Quotes must be valid through September 30, 2014.


 


Offerors Response Date and Time


 


All quotes and revisions shall be submitted via email to Christopher.Mcgucken@fda.hhs.gov by or before 5:00 PM Eastern Time on Monday, May 19th, 2014.


 


Note: Late QUOTES will not be evaluated.


 


 


FAR PROVISIONS Incorporated by Reference


 


FAR 52.252-1, Solicitation Provisions Incorporated by Reference (February 1998)


 


This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address: http://www.acquisition.gov/far/


 


 


FAR 52.212-1, Instructions to Offerors - Commercial Items (July 2013), applies to this acquisition and is incorporated by referenced.  Please pay special attention to 52.212-1(b)(3-7) to ensure the FDA has sufficient information to determine whether an offer is technically acceptable to perform all tasks and provide all deliverables delineated above.


 


FAR 52.212-3, Offeror Representations and Certifications -- Commercial Items (November 2013) (According to this provision, “[a]n offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov .  If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision”).


 


The FDA will evaluate quotes and make an award decision based on the lowest evaluated price meeting or exceeding the technical acceptability standards delineated above.


Solicitation Number FDA-SOL-1130640


 


Subject: Automated System for Translational Research and Reagents.


 


Part 1 – Description


 


The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has a need for an automated system for translational research and accompanying reagents.


 


This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice.  This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. 


 


This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures.  The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-72.  The North American Industry Classification System (NAICS) code for the proposed acquisition is 339999, All Other Miscellaneous Manufacturing.


 


Part 2 – Services and Supplies and Prices


 


2.1 Contract Type:  Firm-fixed-Price


 


2.2  Pricing Table























































Contract Line Item Number (CLIN)



Service and Supply Description



Quantity



Unit Price



Total Firm-Fixed-Price*



0001



Automated System



1



EA



$



0002



Reagent: GX CodeSet- 384rxns GXA0P1CS-384


(96 Genes  384 Rxns)



1



EA



$



0003



Reagent: GX CodeSet- 768rxns


GXA-P1CS-768


(96 Genes x 768 Rxns)



1



EA



$



0004



Reagent: GX CodeSet- 1152rxns


GXA-P1CS-1152


(96 Genes x 1152 Rxns)



1



EA



$



0005



Reagent: Master Kit- 192 rxns


NAA-AKIT-192



12



EA



$



 



TOTAL MAXIMUM POTENTIAL FIRM-FIXED-PRICE



 



 



$



 


 


*The firm-fixed-prices are inclusive of all costs, such as shipping, parts, installation, training, labor, travel, and any other warranty and service maintenance costs.  Payment is only authorized for the respective firm-fixed-prices upon successful completion of the respective CLIN, including delivery and acceptance of all deliverables, as determined by the FDA Contracting Officer’s Representative (COR), and upon submission of a proper invoice.  Proper invoice submission includes following the invoice instructions below. 


 


Part 3 – Description/Specifications


 


  3.1 Background


 


The Division of Therapeutic Proteins conducts research on assessing the quality and safety of existing drug products as well as on discovering biomarkers and targets needed to develop and/or ameliorate effective therapeutic strategies. The ongoing research activities in the Laboratory of Immunology are focused on identifying biomarkers and potential targets for infections and autoimmune disorders to modulate the host immune response and facilitate the clearance of the disease. To this end, the Laboratory of Immunology conducts a variety of assays which require the simultaneously and highly sensitive detection, measurement, and interactions with proteins of hundreds different nucleic acids with immunoregulatory functions such as messenger RNAs (mRNA), microRNA (miRNA), long non-coding RNAs (lncRNA), and DNA in a large set of samples. This acquisition calls for reagents and instruments allowing a digital gene expression analysis that is uniquely suited to the research of our laboratory.


 


3.2 Salient Characteristics of the Automated System


 


The features of the automated system to be used for translational research shall include, at a minimum, the following features and characteristics:


 


1.)    Shall have an interface that walks the user through the set up process using a stage layout map for the automated processing of samples for the digital gene expression analysis.


2.)    Shall be supported by specialized customer service for the installation and maintenance of equipment, as well as for the teaching of data processing.


3.)    Shall be capable of gene expression analysis for the analysis of the expression levels of at least 500 genes simultaneously in a single sample.


4.)    Shall be capable of single-cell expression analysis for identifying cell-to-cell differences (based on single-cell specific gene signature) within a population of cells. The single-cell expression analysis must allow the analysis of at least 500 genes simultaneously in a single-cell sample.


5.)    Shall be capable of miRNA expression analysis for the expression profiling of hundreds of miRNAs in a single reaction. The miRNA expression analysis shall accurately distinguish between highly similar miRNAs at a single-base resolution.


6.)    Shall be capable of miRGE analysis for the simultaneous profiling of both miRNAs and mRNAs in a single reaction from a single sample.


7.)    Shall be capable of copy number variation analysis to multiplex with a minimum of 500 target regions in a single reaction from a single sample. This analysis must provide high accuracy for multiallelic copy number variations.


8.)    Shall be capable of IncRNA expression analysis for validation of lncRNA discoveries and other studies requiring a rapid, cost-effective method of screening hundreds of lncRNAs across large sample sets. The assay shall allow the selection of a minimum of 500 lncRNAs for analysis in a single multiplexed reaction. This analysis shall allow the combining of probes for lncRNAs and mRNAs in the same reaction to enable simultaneous analysis of both classes of RNA in the same sample.


9.)    Shall be capable of ChIP-string expression analysis for measuring dsDNA fragments that have been enriched via chromatin immunoprecipitation. This analysis shall allow the quantification as little as 5 ng of enriched chromatin-immunoprecipitated DNA directly with no amplification.


 


The proposed instrument shall be accompanied by a one (1) year warranty, to cover all parts and labor.


 


3.4 Salient Characteristics of Reagents


 


All proposed reagents shall be compatible with the offeror’s proposed automated system as described in section 3.3.


 


The features of the reagents shall include:


1.)    Shall target-specific probes allowing the detection and counting of hundreds different types of nucleic acids in a single reaction. Each run shall be able to test at least 12 samples in parallel.


2.)     Shall have capacity of measuring simultaneously different types of nucleic acids directly in tissue, cells, and blood lysates as well as in formalin-fixed paraffin-embedded extracts without the need of intermediate steps of purification and amplification that might introduce bias into the results, thus allowing to save time and precious reagents.


3.)     No enzymes shall be required to perform assay.


4.)     Shall have a level of precision and sensitivity of >1 copy of nucleic acid per cell.


 


Master kit reagents and consumables including sample-containing glass cartridges shall be compatible with the digital gene expression analysis.


 


 


 


 


 


 


3.5 Delivery, Installation, and Training.


 


The Analysis System and reagents shall be delivered within 30 days of contract award. The vendor shall install the instrument within 15 days of delivery to the FDA. At the time of installation, the vendor shall provide installation qualification, operational qualification, training for up to three (3) individuals, and copies of all user documentation and operator manuals.


 


The delivery location is:


The U.S. Food and Drug Administration


White Oak Campus


10903 New Hampshire Ave


Building 52-72


Silver Spring, MD


 


3.6 Contract Administration


 


Contracting Officer’s Representative (COR)


 


The following COR will represent the Government for the purpose of this order: [TBD]


 


The COR is responsible for the following as required by this order: (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 evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.


 


The Contracting Officer is the only person with authority to act as an agent of the Government under this order.  Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.


 


The contact information for the Contracting Officer is the following:


 


James Chestnut


U.S. Food and Drug Administration


Office of Acquisitions and Grants Services


Rockville, MD 20857


James.Chestnut@fda.hhs.gov


(240) 402-2067


 


The contact information for the Contract Specialist is the following: 


 


Christopher McGucken


            U.S. Food and Drug Administration


            Office of Acquisitions and Grants Services


Rockville, MD 20857


Christopher.Mcgucken@fda.hhs.gov


Telephone: (240) 402-7599


 


The contact information for the Contractor is the following: [TBD]


 


 


PAYMENT


 


The Government will pay the Contractor only each respective CLIN’s firm-fixed-price delineated in the pricing table in Subpart 2.2 above, successful completion, as determined by the COR, and upon submission of a proper invoice.  Proper invoice submission includes following the invoice instructions below. 


 


 


 


INVOICE INSTRUCTIONS


 


The Contractor shall submit all invoices in the manner specified below:


 


The Contractor shall submit one original copy of each invoice to the address specified below:


 


Office of Financial Services
Food and Drug Administration


10903 New Hampshire Avenue


W032-Second Floor


Bldg. 32, Rm. 2162, Mail Hub 2145


Silver Spring MD  20993-0002


Attn: Vendor Payments


 


Phone: (301) 827-3742 or (866) 807-3742


            Email: fdavendorpaymentsteam@fda.gov


Invoices submitted under this order must comply with the requirements set forth in FAR 52.232-33 (Payment by Electronic Funds Transfer – Central Contractor Registration) and the 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 of supplies delivered or services performed, including:  (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures;
(V) Shipping number and date of shipping, 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 a 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 COR or other program center/office point of contact, as referenced on the purchase order; and,
(XII) Any other information or documentation required by the purchase order/award.


 


Questions regarding invoices shall be directed to the FDA at the telephone numbers provided above.


 


Payment will only be made on a firm-fixed-price basis.


 


 


FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (January 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)(Pub. L. 108-77, 108-78).


 


(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:


 


__X __           (1)        52.203-6, Restrictions on Subcontractor Sales to the Government (Sep 2006), with Alternate I (Oct 1995)(41 U.S.C. 253g and 10 U.S.C. 2402).


__  __             (2)        52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).


__  __             (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)       52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Jul 2010) (Pub. L. 111-15).


____               (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).


__  __             108)     52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Pub. L. 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 Set-Aside (Nov 2011)(15 U.S.C. 644).


__  __             (14)      (ii) Alternate I (Nov 2011).


__  __             (14)      (iii) Alternate II (Nov 2011).


__  __             (15)      (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003)(15 U.S.C. 644).


__  __             (15)      (ii) Alternate I (Oct 1995) of 52.219-7.


__  __             (15)      (iii) Alternate II (Mar 2004) of 52.219-7.


__X __           (16)      52.219-8, Utilization of Small Business Concerns (Jul 2013) (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)). (In accordance with DDP Memo dated 9 Sep 2013, DAR Tracking Number 2013-O0014, Class Deviation—Summary Subcontract Report Submission, this clause is replaced with DFARS Deviation dated Aug 2013. Effective until incorporated into the FAR or DFARS or until rescinded.)


__  __             (17)      (ii) Alternate I (Oct 2001) of 52.219-9.


__  __             (17)      (iii) Alternate II (Oct 2001) of 52.219-9.


__  __             (17)      (iv) Alternate III (Jul 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). (In accordance with DDP Memo dated 12 Mar 2010, DAR Tracking Number 2010-O0006, Immediate Cessation of the Use of Price Evaluation Adjustment for Small Disadvantaged Businesses, this clause is suspended in DoD. Effective until incorporated into the FAR or DFARS or until rescinded.)


__  __             (21)      (ii) Alternate I (June 2003) of 52.219-23. (In accordance with DDP Memo dated 12 Mar 2010, DAR Tracking Number 2010-O0006, Immediate Cessation of the Use of Price Evaluation Adjustment for Small Disadvantaged Businesses, this clause is suspended in DoD. Effective until incorporated into the FAR or DFARS or until rescinded.)


__  __             (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 Total Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011)(15 U.S.C. 657 f).


__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) (1 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)).


__  __             (28)      52.222-3, Convict Labor (June 2003)(E.O. 11755).


__X __           (29)      52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014)(E.O. 13126).


__X __           (30)      52.222-21, Prohibition of Segregated Facilities (Feb 1999).


__X __           (31)      52.222-26, Equal Opportunity (Mar 2007)(E.O. 11246).


__X __           (32)      52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212).


__X __           (33)      52.222-36, Affirmative Action For Workers with Disabilities (Oct 2010)(29 U.S.C. 793).


__X __           (34)      52.222-37, Employment Reports on Veterans (Sep 2010)(38 U.S.C. 4212).


__X __           (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.)


__  _               (37)      (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)


__  __             (38)      52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42.U.S.C. 8259b).


__  __             (39)      (i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423).


__  _               (39)      (ii) Alternate I, (Dec 2007) of 52.223-16.


__X __           (40)      52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011).


__  __             (41)      52.225-1, Buy American Act--Supplies (Feb 2009)(41 U.S.C. 10a-10d).


__  __             (42)      (i) 52.225-3, Buy American Act--Free Trade Agreements--Israeli Trade Act (Nov 2012) (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).


__  _               (42)      (ii) Alternate I (Mar 2012) of 52.225-3.


__  _               (42)      (iii) Alternate II (Mar 2012) of 52.225-3.


__  _               (42)      (iv) Alternate III (Nov 2012) 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, Restriction on Certain Foreign Purchases (Jun 2008)(E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of 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. 522(f), 10 U.S.C. 2307(f)).


__  __             (49)      52.232-30, Installment Payments for Commercial Items (Oct 1995)(41 U.S.C. 255(f), 10 U.S.C. 2307(f)).


__  __             (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 (Jul 2013) (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).


__  _               (54)      (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 Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).


__  __              (2)     52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).


__  __              (3)     52.222-43, Fair Labor Standards Act and Service Contract Act--Price Adjustment (Multiple Year and Option Contracts) (Sep 2009)(29 U.S.C. 206 and 41 U.S.C. 351, et seq.).


__  __              (4)     52.222-44, Fair Labor Standards Act and Service Contract Act - Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).


__  __              (5)     52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (Nov 2007) (41 U.S.C. 351 et seq.).


__  __              (6)     52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services—Requirements (Feb 2009)(41 U.S.C. 351 et seq.).


__  __              (7)     52.222-17, Nondisplacement of Qualified Workers (Jan 2013) (E.O. 13495).


__  __              (8)     52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (Mar 2009) (Pub. L. 110-247).


__  __              (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 paragraphs (e)(1) of this paragraph 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) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).


(ii) 52.219-8, Utilization of Small Business Concerns (Jul 2013) (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 (Jan 2013) (E.O. 13495). Flow Down required in accordance with paragraph (l) 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 20106) (38 U.S.C. 4212).


(vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).


(vii) 52.222-10, 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 Act of 1965 (Nov 2007),(41 U.S.C. 351, et seq.).


(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 Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (Nov 2007)(41 U.S.C. 351, et seq.).


(xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services—Requirements (Feb 2009) (41 U.S.C. 351, et seq.).


(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 (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraphs (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)


 


 


 


FAR Clauses Incorporated by Reference


 


FAR 52.252-2, Clauses Incorporated by Reference (February 1998)


 


This order incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/far/


 


52.212-4, Contract Terms and Conditions-Commercial Items (September 2013)


52.232-40, Providing Accelerated Payments to Small Business Subcontractors (December 2013)


 


HHSAR Clauses Incorporated by Reference


 


This order incorporates the following U.S. Department of Health and Human Services Acquisition Regulation (HHSAR) clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.  Also, the full text of a clause may be accessed electronically at the following website: http://www.hhs.gov/policies/hhsar/.


 


352.203-70, Anti-Lobbying (January 2006)


352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (January 2010)  


352.231-71, Pricing of adjustments (January 2001)


 


Conflicts of Interest


 


The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, it does not have any actual, potential, or apparent conflict of interests pertaining to the subject order, as defined in FAR Subpart 9.5 and HHS and FDA policies, for its organization, employees, or subcontractors working or proposed to be working under this order.


The Contractor agrees that, if after award, it discovers a conflict of interest with respect to this order, it shall make an immediate and full disclosure in writing to the FDA Contracting Officer for this order.


The Government reserves the right to exercise any remedy available at law or equity, including termination of the order for cause or convenience, should the Government determine remedial action is necessary to address any actual, potential, or apparent conflict of interest.


 


Part 4 – Instructions to Offerors


 


Cover Page


 


Offerors shall include a cover page which shall include a point of contact (name, telephone number, and email address), proposed firm-fixed-prices (i.e. complete the pricing table in Subpart 2.2), estimated delivery date, business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.), Dun and Bradstreet (DUNS) number, country of manufacturing of equipment, and certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current. 


 


Offerors shall ensure the solicitation number is visible in the header of the email transmission of their quote.  Faxed quotes will not be accepted.


 


Quotes must be valid through September 30, 2014.


 


Offerors Response Date and Time


 


All quotes and revisions shall be submitted via email to Christopher.Mcgucken@fda.hhs.gov by or before 5:00 PM Eastern Time on Friday, May 16th, 2014.


 


Note: Late QUOTES will not be evaluated.


 


 


FAR PROVISIONS Incorporated by Reference


 


FAR 52.252-1, Solicitation Provisions Incorporated by Reference (February 1998)


 


This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address: http://www.acquisition.gov/far/


 


 


FAR 52.212-1, Instructions to Offerors - Commercial Items (July 2013), applies to this acquisition and is incorporated by referenced.  Please pay special attention to 52.212-1(b)(3-7) to ensure the FDA has sufficient information to determine whether an offer is technically acceptable to perform all tasks and provide all deliverables delineated above.


 


FAR 52.212-3, Offeror Representations and Certifications -- Commercial Items (November 2013) (According to this provision, “[a]n offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov .  If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision”).


 


The FDA will evaluate quotes and make an award decision based on the lowest evaluated price meeting or exceeding the technical acceptability standards delineated above.


Files
Package File Description
FDA-SOL-1130640 FDA-SOL-1130640.doc FDA-SOL-1130640 Combined Synopsis/Solicitation.
Responses to Questions FDA-SOL-1130640Questions.doc Questions and Answers- "FDA-SOL-1130640Questions.doc"