Sequencing of Circulating Free DNA from Small Cell Lung Cancer Patients
1.0 DESCRIPTION
The Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR) has a requirement for ultra-low pass whole genome sequencing and deep somatic whole exome sequencing of circulating free DNA (cfDNA) from 75 small cell lung cancer samples.
This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice, and shall be processed in accordance with FAR Part 13 - Simplified Acquisition Procedures. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation, 75N91019Q00111, is issued as a request for quote (RFQ) and includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2019-03 (07-12-2019) simplified acquisition procedures for commercial items.
The North American Industry Classification System code is 541380 and the business size standard is $15M.
Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price purchase order for non-severable services.
2.0 BACKGROUND
Small cell lung cancer (SCLC) is a high-grade neuroendocrine malignancy with a 5-year overall survival of approximately 5%. Among patients diagnosed with metastatic (extensive stage) disease, the median overall survival is approximately 9 to 11 months with standard treatment. The Recalcitrant Cancer Research Act of 2012 (H.R. 733) requires the U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI) to "develop scientific frameworks" that will assist in making "progress against recalcitrant or deadly cancers." Small cell lung cancer (SCLC) is a recalcitrant cancer as defined by its five-year relative survival rate of less than 7 percent and the loss of approximately 30,000 lives per year.
Neither surgical resection nor repeat tumor biopsies are standard of care in metastatic SCLC, making access to clinically relevant tissue limited. Instead, SCLC research has relied heavily on preclinical models such as established cell lines, and genetically engineered mouse models (GEMM). Given the difficulties of accessing tumor biopsies in small cell lung cancer, availability of a method to assess genomic alterations noninvasively would be very useful. Recent studies using a limited panel of genes have shown that liquid biopsies using plasma cell-free DNA (ctDNA) can potentially be applicable in patients with SCLC and can possibly provide improved monitoring of disease burden, depth of response to treatment, and timely warning of disease relapse in patients with this disease.
Circulating free DNA (cfDNA) is an emerging biomarker across a range of solid malignancies. cfDNA is shed into the bloodstream by nonmalignant and cancer cells, but in SCLC patients the proportion of tumor-derived cfDNA (ctDNA fraction) is frequently greater than 1%, enabling comprehensive tumor genome profiling. However, the relationship between clinical outcome in SCLC and cfDNA at baseline and changes with treatment are not known.
2.1 OBJECTIVE
The overall goal of this project is to understand the relationship between the landscape of genomic alterations in SCLC circulating tumor DNA and clinical outcomes among patients treated at the National Cancer Institute (NCI), Center for Cancer Research (CCR).
3.0 SCOPE
The Contractor shall perform ultra-low pass whole genome sequencing followed by deep somatic whole exome sequencing of circulating free DNA (cfDNA) from 75 small cell lung cancer samples. The Contractor shall provide all labor, material and equipment necessary to fulfill this procurement. This order shall not include fees associated with the shipment of samples to the Contractor; NCI shall coordinate the shipment of samples after award.
4.0 CONTRACT REQUIREMENTS
4.1
The Contractor Shall perform 0.1× coverage whole-genome sequencing on cfDNA from 75 small cell lung cancer samples to detect somatic copy number alterations (SCNAs) and provide estimates of tumor fractions in cfDNA. All 75 purified cfDNA samples will be provided by NCI.
Task 4.1 consists of 0.1× coverage whole-genome sequencing (ultra-low-pass whole genome sequencing [ULP-WGS]) of cfDNA from 75 small cell lung cancer samples and application of a program developed to quantify tumor content in cfDNA. The program should simultaneously segment the genome and predict large-scale copy number alterations while accounting for subclonality and tumor ploidy. Application of such a program to ULP-WGS of cfDNA offers an accurate approach (detection of at least 75% of tumor SCNAs in the plasma) to detect SCNAs that are reflective of tumor biopsies and provides accurate estimates of tumor fractions.
4.2
The Contractor shall perform whole exome sequencing 200X coverage of cfDNA from the same 75 small cell lung cancer samples in task 4.1; detect somatic mutations, insertions and deletions and copy number variations.
Task 4.2 consists of whole exome sequencing of cfDNA and compare known cancer-associated somatic alterations (for example COSMIC cancer gene census: https://cancer.sanger.ac.uk/census) between cfDNA and tumor biopsies of SCLC patients. Whole exome sequencing should be able to detect somatic mutations, insertions and deletions and copy number variations.
5.0 TYPE OF ORDER
This is a firm fixed price purchase order.
5.1 NON-SEVERABLE SERVICES
The services specified in each contract line item (CLIN) have been determined to be non-severable services - a specific undertaking or entire job with a defined end-product of value to the Government.
6.0 PERIOD OF PERFORMANCE
The period of performance shall be for twelve (12) months from the date of award.
7.0 PLACE OF PERFORMANCE
All work shall be performed at the Contractor's facility.
8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE
The NCI Technical Point of Contact (POC) shall review the contents of the deliverables. If no comments or requests for revisions are provided within 30 days, the deliverables shall be considered acceptable.
8.1 DELIVERABLE FOR TASK 4.1
0.1× coverage whole-genome sequencing data from 75 small cell lung cancer samples delivered as BAM (.bam) files on a secure online platform for data transfer. Capture Kit information (name and version of the capture kit used) shall be provided.
Due 3 months from date of award.
8.2 DELIVERABLE FOR TASK 4.2
Whole exome sequencing of cfDNA from 75 small cell lung cancer samples delivered as BAM (.bam) files on a secure online platform for data transfer. Capture Kit information (name and version of the capture kit used) shall be provided.
Due 4 months from date of award.
9.0 INSPECTION AND ACCEPTANCE CRITERIA
Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this contract is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI Technical Point of Contact (POC), who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.
Regardless of format, all digital content or communications materials produced as a deliverable under this contract, shall conform to applicable Section 508 Standards to allow Federal employees and members of the public with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees or by members of the public who are not individuals with disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.
HHS guidance regarding accessibility of documents can be found at: http://www.hhs.gov/web/section-508/making-files-accessible/index.html;
Federal Government-wide guidance regarding accessibility of documents can be found at: https://www.section508.gov/best-practices, including the documents describing the preferred method of authoring and testing documents produced in Microsoft Word 2013 or later, Microsoft Excel, and files formatted as PDF.
10.0 PAYMENT
Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the attached payment provisions listed below:
The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:
I. Invoice Requirements
A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor.
1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).
2. Remit-to address (Name and complete mailing address to send payment).
3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.
4. Invoice date.
5. Unique invoice #s for all invoices per vendor regardless of site.
6. NBS document number formats must be included for awards created in the NBS: Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.
7. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR).
8. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a Contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the Contractor's name on the face page of the award document.
9. Identify that payment is to be made using a three-way match.
10. Description of supplies/services that match the description on the award, by line billed.*
11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.
12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*
* NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.
B. Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.
C. Mail an original and 1 copy of the itemized invoice to:
National Institutes of Health
Office of Financial Management,
Commercial Accounts
2115 East Jefferson Street, Room 4B-432, MSC 8500
Bethesda, MD 20892-8500
For inquiries regarding payment call: (301) 496-6088
To facilitate the prompt payment of invoices, it is recommended that the vendor submit a photocopy of the invoice to the "Consignee" designated for the acquisition in blocks 6A - 6E of the face page of the Order/Award document.
II. Invoice Payment
A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:
1. The 30th day after the designated billing office has received a proper invoice.
2. The 30th day after Government acceptance of supplies delivered or services performed.
B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.
III. Interest Penalties
A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.
1. A proper invoice was received by the designated billing office.
2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or Contractor compliance with a term or condition.
3. In the case of a final invoice for any balance of funds due the Contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.
B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.
IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (December 2013)
a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subContractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subContractor.
b) The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.
Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.
11.0 PURCHASE ORDER CLAUSES
FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS -- COMMERCIAL ITEMS (MAY 2019)
(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) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(3) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).
(4) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).
(5) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 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:
[Contracting Officer check as appropriate.]
___ (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 (June 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 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).
___ (5) [Reserved].
___ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (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 (Oct 2018) (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 Set-Aside (Nov 2011) (15 U.S.C. 644).
___ (ii) Alternate I (Nov 2011).
___ (iii) Alternate II (Nov 2011).
___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).
___ (ii) Alternate I (Oct 1995) of 52.219-7.
___ (iii) Alternate II (Mar 2004) of 52.219-7.
___ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).
___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637 (d)(4)).
___ (ii) Alternate I (Jan 2017) of 52.219-9.
___ (iii) Alternate II (Nov 2016) of 52.219-9.
___ (iv) Alternate III (Nov 2016) of 52.219-9.
___ (v) Alternate IV (Aug 2018) 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 (Jan 2017) (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 (Jan 2018) (E.O. 13126).
_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
_X_ (28) (i) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).
___ (ii) Alternate I (Feb 1999) of 52.222-26.
___ (29) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).
___ (ii) Alternate I (July 2014) of 52.222-35.
_X_ (30) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).
___ (ii) Alternate I (July 2014) of 52.222-36.
___ (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 (Jan 2019)
(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). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)
___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)
___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)
___ (36) 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 Televisions (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) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).
___ (44) 52.223-21, Foams (Jun 2016) (E.O. 13693).
___ (45) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552 a).
___ (ii) Alternate I (Jan 2017) of 52.224-3.
___ (46) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).
___ (47) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).
___ (ii) Alternate I (May 2014) of 52.225-3.
___ (iii) Alternate II (May 2014) of 52.225-3.
___ (iv) Alternate III (May 2014) of 52.225-3.
___ (48) 52.225-5, Trade Agreements (Aug 2018) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
_X_ (49) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).
___ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
___ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).
___ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).
___ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).
___ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).
_X_ (55) 52.232-33, Payment by Electronic Funds Transfer--System for Award Management (Oct 2018) (31 U.S.C. 3332).
___ (56) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).
___ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).
___ (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
___ (59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(12)).
___ (60) (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.
___ (iii) Alternate II (Feb 2006) 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:
[Contracting Officer check as appropriate.]
___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495)
___ (2) 52.222-41, Service Contract Labor Standards (Aug 2018) (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) (Aug 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).
_X_ (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).
___ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).
___ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).
(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) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(iv) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (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.
(v) 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.
(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(vii) 52.222-26, Equal Opportunity (Sep 2015) (E.O. 11246).
(viii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).
(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).
(x) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).
(xi) 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.
(xii) 52.222-41, Service Contract Labor Standards (Aug 2018), (41 U.S.C. chapter 67).
(xiii) (A) 52.222-50, Combating Trafficking in Persons (Jan 2019) (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 and E.O. 13627).
(xiv) 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.)
(xv) 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)
(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).
(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate I (Jan 2017) of 52.224-3.
(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xxi) 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.
(xxii) 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.
FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
This contract 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/these address(es): http://www.acquisition.gov/far/ and/or http://www.hhs.gov/policies/hhsar/.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) PROVISIONS:
CLAUSE NO. TITLE
FAR 52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (OCT 2018)
FAR 52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN
INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS-REPRESENTATION (JAN 2017)
FAR 52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL
CONFIDENTIALITY AGREEMENTS OR STATEMENTS (JAN 2017)
FAR 52.204-22 ALTERNATIVE LINE ITEM PROPOSAL
HEALTH AND HUMAN SERICES ACQUISITION REGULATION (HHSAR) (48 CFR
CHAPTER 3) PROVISIONS:
CLAUSE NO. TITLE
HHSAR 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY INVESTIGATION (DEC 2015)
HHSAR 352.227-70 PUBLICATIONS AND PUBLICITY (DEC 2015)
HHSAR 352.237-74 NON-DISCRIMINATION IN SERVICE DELIVERY (DEC 2015)
12.0 SOLICITATION PROVISIONS
FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 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/these address(es):http://www.acquisition.gov/far/ and/or http://www.hhs.gov/policies/hhsar/.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) PROVISIONS:
CLAUSE NO. TITLE
FAR 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (OCT 2018)
FAR 52.212-2 EVALUATION-COMMERCIAL ITEMS (OCT 2014)
13.0 SUBMISSION INSTRUCTIONS & GENERAL INFORMATION
Quotes must stipulate that it is predicated upon all the terms and conditions of this RFQ and signed by an official authorized to bind your organization. In addition, it must contain a statement to the effect that it is firm for a period of at least 60 days from the date of receipt thereof by the Government.
Quotes must be prepared in two SEPARATE volumes: Volume I - "Technical", Volume II - "Price". Each volume shall be separate and complete in itself so that the evaluation of one may be accomplished independently of the evaluation of the other.
TECHNICAL VOLUME
The technical volume must not contain references to price; however, resource information must be contained in the technical volume so that the Respondent's understanding of the scope of work may be evaluated. Quoters must provide clear responses, including objectives and outcomes, to each task addressing the work to be performed in the SOW. The technical volume must reflect a clear understanding of the nature of the work being undertaken. Quotes which merely offer to conduct a project in accordance with the Government's requirements will not be eligible for award.
PRICE VOLUME
Quoters shall prepare a price volume that contains all information necessary to allow for a comprehensive evaluation of the prices quoted. The price quote must contain the following information:
1. Cover letter which includes the following:
a. Federal Tax Identification Number (TIN);
b. Data Universal Numbering System (DUNS) Number;
c. Business Size (e.g., small or large);
QUESTIONS
Questions must be submitted electronically via email to Contract Specialist, Adam Hernandez, at adam.hernandez@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 11:00 A.M. EST Thursday, August 8, 2019 (08/08/2019).
QUOTATIONS
Quotations must be submitted electronically via email to Contract Specialist, Adam Hernandez, at adam.hernandez@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 11:00 A.M. EST, Monday, August 12, 2019 (08/12/2019). QUOTATIONS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls will be accepted.
Please refer to solicitation no: 75N91019Q00111 on all correspondence.
This RFQ does not commit the Government to pay any of the costs associated with the preparation and submission of your quote. In addition, the Contracting Officer is the only individual authorized to legally commit the Government to the expenditure of public funds in connection with this requirement. By submitting a quote in response to this solicitation, it is understood that your quote shall become part of the official contract file. The Government is not responsible for locating or securing any information which is not identified in the quote.
14.0 BASIS FOR AWARD AND EVALUATION CRITERIA
Evaluation and award will be conducted in accordance with the requirements of FAR 13.106. The technical evaluation will be a determination based on information furnished by the Contractor. The Government is not responsible for locating or securing any information which is not identified in the quotation. The Government intends to evaluate quotations and make a single award without conducting "discussions" as defined in FAR part 15. Therefore, the Quoter's initial quote should contain the Quoter's best terms from a price and technical standpoint. However, the Government reserves the right to request quote revisions that seek additional price discounts, provide revisions to the technical quote, or clarify aspects of the quote. In the event quote revisions are requested, the Government will not necessarily be seeking revisions from all Quoters. The Government may reject any or all quotes if such action is in the public interest; accept other than the lowest quote; and waive informalities and minor irregularities in quotes received.
The Government will issue an order resulting from this request for quotation to the responsible Quoter whose quotation results in the best value to the Government, considering both price and non-price factors. The following factors will be used to evaluate quotations:
Personnel Qualifications
The experience, education, and qualifications of personnel proposed to work on the contract will be evaluated to determine their ability to perform their proposed duties. Specifically, the contractor will be evaluated on the ability to plan and execute large-scale and complex genomic sequencing techniques especially relating to sequencing of circulating DNA and generate data. The Contractor shall be able to provide robust sample management and library construction coupled with state-of-the-art high throughput DNA sequencing and analysis.
Technical capabilities
The Government will evaluate the Quoter's technical capabilities based on demonstrated relevant examples of organizational experience and expertise. The Government will also look at feasibility of methodologies and services provided for successfully completing the tasks listed in the Statement of Work. Relevant is defined as work similar in complexity and magnitude of the work described in this SOW.
Past performance
The Government will evaluate the Quoter's past performance based on information obtained from references provided by the Quoter, other recent and relevant past performance information obtained from other sources known to the Government, and any information supplied by the Quoter concerning problems encountered on the identified contracts and corrective action taken. Recent is defined as within the last three years. Relevant is defined as work similar in complexity and magnitude of the work described in this SOW.
Past performance on related contracts will be evaluated to determine, as appropriate, successful performance of contract requirements, quality and timeliness of delivery of goods and services, communications between contracting parties, proactive management and customer satisfaction, etc.
The Government will access the relevant risks associated with each Quoter. Performance risks are those associated with a Quoter's likelihood of success in performing the acquisition requirements as indicated by that Quoter's record of past performance.
Price
The Government will evaluate the Quoter's price for all items/services proposed. Price quotations will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the Government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition.
Adam J. Hernandez, Contract Specialist, Phone 2402765633, Email adam.hernandez@nih.gov - Adam J Hernandez, Phone 2402765633, Email adam.hernandez@nih.gov
