N02CP71002-72_Metabolomic_Profiling_for_Molecular_Epidemiology_Studies_Final.pdf

N02CP71002-72 – Metabolomic Profiling for Molecular Epidemiology Studies Page 1 of 33

The National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology & Genetics (DCEG), requires a Contractor to provide metabolomic profiling services for DCEG studies using liquid chromatography and gas chromatography mass spectrometry (LC-MS, GC-MS).

Contents

A. CONTRACT CLAUSES

(1) 52.212-5, Contract Terms and Conditions Required to Implement Statutes and

Executive orders;

(2) Additional Contract Clauses

B. CONTRACT DOCUMENTS, EXHIBITS, AND ATTACHMENTS

1. Background Statement

2. Base IDIQ Statement of Work

3. Reporting Requirements

4. Additional Quotation Instructions

5. Invoice and Payment Provisions (2/2014)

C. SOLICITATION PROVISIONS

1. FAR Clause 52.212-2 EVALUATION-COMMERCIAL ITEMS (OCT 2014)

2. FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS -

COMMERCIAL ITEMS

Attachment 1 - Sample Task Order 0001

Attachment 2 - Sample Task Order 0002

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A. CONTRACT CLAUSES

(1) 52.212-5, Contract Terms and Conditions Required to Implement Statutes and

Executive orders;

CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL ITEMS (June 2016)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)(Public Laws 108-77 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:

_X_ (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).

_ X _ (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

2015) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section

743 of Div. C).

_ X _ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts

(Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

_ X _ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors

Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

_ X _ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(Jul 2013) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C.

657a).

_ X _ (ii) Alternate I (Nov 2011) of 52.219-3.

__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business

Concerns (OCT 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.

_ X _ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and

(3)).

_ X _ (17)(i) 52.219-9, Small Business Subcontracting Plan (Oct 2015) (15 U.S.C. 637(d)(4)).

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/52_000.htm#P2045_297176 https://www.acquisition.gov/far/html/52_207_211.html#wp1146366 https://www.acquisition.gov/far/html/52_233_240.html#wp1113329 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_233_240.html#wp1113344 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_200_206.html#wp1137622 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_200_206.html#wp1141983 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_200_206.html#wp1144881 https://www.acquisition.gov/far/html/52_200_206.html#wp1141649 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_200_206.html#wp1151163 https://www.acquisition.gov/far/html/52_200_206.html#wp1151299 https://www.acquisition.gov/far/html/52_207_211.html#wp1140926 https://www.acquisition.gov/far/html/52_207_211.html#wp1145644 https://www.acquisition.gov/far/html/52_217_221.html#wp1135955 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1135955 https://www.acquisition.gov/far/html/52_217_221.html#wp1135970 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1135970 https://www.acquisition.gov/far/html/52_217_221.html#wp1136004 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1136017 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1136017 https://www.acquisition.gov/far/html/52_217_221.html#wp1136017 https://www.acquisition.gov/far/html/52_217_221.html#wp1136032 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1136058 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20

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

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

__ (iv) Alternate III (Oct 2015) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

__ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

_ X _ (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. 657 f).

_ X _ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15

U.S.C. 632(a)(2)).

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically

Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small

Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15

U.S.C. 637(m)).

_ X _ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

__ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Feb 2016) (E.O.

13126).

_ X _ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_ X _ (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

_ X _ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

_ X _ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

_ X _ (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

_ X _ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act

(Dec 2010) (E.O. 13496).

_ X _ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and

E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (34) 52.222-54, Employment Eligibility Verification (OCT 2015). (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.)

_ X _ (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 (June 2016) (E.O. 13693).

__ (37) 52.223–12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air

Conditioners (June 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 (June 2016) (E.O. 13693)

__ (44) 52.223–21, Foams (June 2016) (E.O. 13693).

https://www.acquisition.gov/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/far/html/52_217_221.html#wp1136174 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_217_221.html#wp1136175 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1136186 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1136387 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1139913 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1144950 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_217_221.html#wp1144420 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1147479 https://www.acquisition.gov/far/html/52_222.html#wp1147630 https://www.acquisition.gov/far/html/52_222.html#wp1147656 https://www.acquisition.gov/far/html/52_222.html#wp1147711 https://www.acquisition.gov/far/html/52_222.html#wp1158632 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_222.html#wp1162802 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+2+78++%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_222.html#wp1148123 https://www.acquisition.gov/far/html/52_222.html#wp1160019 https://www.acquisition.gov/far/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1156645 https://www.acquisition.gov/far/html/Subpart%2022_18.html#wp1089948 https://www.acquisition.gov/far/html/52_223_226.html#wp1168892 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_223_226.html#wp1168892 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t41t42+250+1286++%2842%29%20%20AND%20%28%2842%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_223_226.html#wp1168933 https://www.acquisition.gov/far/html/52_223_226.html#wp1168933 https://www.acquisition.gov/far/html/52_223_226.html#wp1194330 https://www.acquisition.gov/far/html/52_223_226.html#wp1194330 https://www.acquisition.gov/far/html/52_223_226.html#wp1194323 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_223_226.html#wp1179078 https://www.acquisition.gov/far/html/52_223_226.html#wp1179078 https://www.acquisition.gov/far/html/52_223_226.html#wp1188603

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__ (41) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

__ (42)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (May 2014) (41

U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C.

4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-

138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I (May 2014) of 52.225-3.

__ (iii) Alternate II (May 2014) of 52.225-3.

__ (iv) Alternate III (May 2014) of 52.225-3.

_ X _ (43) 52.225-5, Trade Agreements (FEB 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_ X _ (44) 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).

__ (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).

_ X _ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41

U.S.C. 4505, 10 U.S.C. 2307(f)).

_ X _ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10

U.S.C. 2307(f)).

_ X _ (50) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management

(Jul 2013) (31 U.S.C. 3332).

__ (51) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award

Management (Jul 2013) (31 U.S.C. 3332).

__ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

_ X _ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

_ X _ (54)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb

2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

_ _ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).

_ _ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

_ _ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

_ _ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price

Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C. 206 and 41 U.S.C.

chapter 67).

__ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price

Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to

Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May

2014) (41 U.S.C. chapter 67).

_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) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42

U.S.C. 1792).

_ _ (10) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)).

https://www.acquisition.gov/far/html/52_223_226.html#wp1192900 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_223_226.html#wp1169038 http://uscode.house.gov/ http://uscode.house.gov/ http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t17t20+1727+50++%2819%29%20%20AND%20%28%2819%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t17t20+1727+50++%2819%29%20%20AND%20%28%2819%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/ http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_223_226.html#wp1169038 https://www.acquisition.gov/far/html/52_223_226.html#wp1169038 https://www.acquisition.gov/far/html/52_223_226.html#wp1169038 https://www.acquisition.gov/far/html/52_223_226.html#wp1169151 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t17t20+1727+50++%2819%29%20%20AND%20%28%2819%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t17t20+1727+50++%2819%29%20%20AND%20%28%2819%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_223_226.html#wp1169608 https://www.acquisition.gov/far/html/52_223_226.html#wp1192524 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+1445+65++%2810%20U.S.C.%202302%20Note%29%20%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_223_226.html#wp1173773 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t41t42+250+1286++%2842%29%20%20AND%20%28%2842%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_223_226.html#wp1173393 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t41t42+250+1286++%2842%29%20%20AND%20%28%2842%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_232.html#wp1153230 http://uscode.house.gov/ http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_232.html#wp1153252 http://uscode.house.gov/ http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_232.html#wp1153351 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_232.html#wp1153375 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_232.html#wp1153445 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_233_240.html#wp1113650 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t05t08+2+3++%285%29%20%20AND https://www.acquisition.gov/far/html/52_247.html#wp1156217 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t45t48+351+1++%2846%29%20%20AND%20%28%2846%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+37+408++%2810%29%20%252 https://www.acquisition.gov/far/html/52_247.html#wp1156217 https://www.acquisition.gov/far/html/52_222.html#wp1147587 https://www.acquisition.gov/far/html/52_222.html#wp1160021 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1153423 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1148260 http://uscode.house.gov/ http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1148274 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1155380 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1162590 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1163027 https://www.acquisition.gov/far/html/52_223_226.html#wp1183820 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_233_240.html#wp1120023 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20

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(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the

Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the

Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

(iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015)

(v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

(vi) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(viii) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212)

(ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec

2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-

40.

(x) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

(xi)

_ X _(A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O 13627).

__(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O 13627).

(xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41

U.S.C. chapter 67).

(xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to

Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

(xiv) 52.222-54, Employment Eligibility Verification (OCT 2015) (E.O. 12989).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul

2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008;

10 U.S.C. 2302 Note).

https://www.acquisition.gov/far/html/52_215.html#wp1144470 https://www.acquisition.gov/far/html/Subpart%204_7.html#wp1082800 https://www.acquisition.gov/far/html/52_200_206.html#wp1141983 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_217_221.html#wp1136032 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_217_221.html#wp1136032 https://www.acquisition.gov/far/html/52_222.html#wp1147587 https://www.acquisition.gov/far/html/52_222.html#wp1147587 https://www.acquisition.gov/far/html/52_222.html#wp1147656 https://www.acquisition.gov/far/html/52_222.html#wp1147711 https://www.acquisition.gov/far/html/52_222.html#wp1158632 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_222.html#wp1162802 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+2+78++%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_222.html#wp1148123 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+2+78++%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_222.html#wp1160019 https://www.acquisition.gov/far/html/52_222.html#wp1160019 https://www.acquisition.gov/far/html/52_222.html#wp1160019 https://www.acquisition.gov/far/html/52_222.html#wp1160021 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1151848 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1155380 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1162590 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1156645 https://www.acquisition.gov/far/html/52_222.html#wp1163027 https://www.acquisition.gov/far/html/52_223_226.html#wp1192524 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+1445+65++%2810%20U.S.C.%202302%20Note%29%20%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+1445+65++%2810%20U.S.C.%202302%20Note%29%20%20%20%20%20%20%20%20%20%20

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(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42

U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xviii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46

U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause) https://www.acquisition.gov/far/html/52_223_226.html#wp1183820 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_223_226.html#wp1183820 https://www.acquisition.gov/far/html/52_247.html#wp1156217 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t45t48+351+1++%2846%29%20%20AND%20%28%2846%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t45t48+351+1++%2846%29%20%20AND%20%28%2846%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+37+408++%2810%29%20%252 https://www.acquisition.gov/far/html/52_247.html#wp1156217

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(2) Additional Contract Clauses

Other required provisions and clauses. Notwithstanding prescriptions contained elsewhere in the FAR, when acquiring commercial items, contracting officers shall be required to use only those provisions and clauses prescribed in this part. The provisions and clauses prescribed in this part shall be revised, as necessary, to reflect the applicability of statutes and executive orders to the acquisition of commercial items.

1. FAR Clause 52.204-16 Commercial and Government Entity Code Reporting. (July 2015)

2. FAR Clause 52.204-18 Commercial and Government Entity Code Maintenance (July 2015)

3. FAR Clause 52.209-7, Information Regarding Responsibility Matters (July 2013)

4. FAR Clause 52.232-40 Providing Accelerated Payments to Small Business Subcontractors

(December 2013)

Discretionary use of FAR provisions and clauses. The Contracting Officer may include in solicitations and contracts by addendum other FAR provisions and clauses when their use is consistent with the limitations contained in 12.302.

1. Stop Work Order, FAR Clause 52.242-15 (August 1989)

[In accordance with FAR 42.1305 (b)(1) and FAR 12.302, the clause at FAR 52.242-15, Stop Work

Order is incorporated herein. This clause is not applicable to fixed-price construction or Architect

& Engineering contracts.]

(a) The Contracting Officer may, at any time, by written order to the Contractor, require the

Contractor to stop all, or any part, of the work called for by this contract for a period of

90 days after the order is delivered to the Contractor, and for any further period to which the parties may agree. The order shall be specifically identified as a stop-work order issued under this clause. Upon receipt of the order, the Contractor shall immediately comply with its terms and take all reasonable steps to minimize the incurrence of costs allocable to the work covered by the order during the period of work stoppage. Within a period of 90 days after a stop-work is delivered to the Contractor, or within any extension of that period to which the parties shall have agreed, the Contracting Officer shall either—

(1) Cancel the stop-work order; or

(2) Terminate the work covered by the order as provided in the Default, or the Termination for Convenience of the Government, clause of this contract.

(b) If a stop-work order issued under this clause is canceled or the period of the order or any extension thereof expires, the Contractor shall resume work. The Contracting Officer shall make an equitable adjustment in the delivery schedule or contract price, or both, and the contract shall be modified, in writing, accordingly, if—

(1) The stop-work order results in an increase in the time required for, or in the Contractor’s cost properly allocable to, the performance of any part of this contract; and

(2) The Contractor asserts its right to the adjustment within 30 days after the end of the period of work stoppage; provided, that, if the Contracting Officer decides the facts justify the action, the Contracting Officer may receive and act upon the claim submitted at any time before final payment under this contract.

(c) If a stop-work order is not canceled and the work covered by the order is terminated for the convenience of the Government, the Contracting Officer shall allow reasonable costs resulting from the stop-work order in arriving at the termination settlement.

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(d) If a stop-work order is not canceled and the work covered by the order is terminated for default, the Contracting Officer shall allow, by equitable adjustment or otherwise, reasonable costs resulting from the stop-work order.

(End of clause)

2. Alternate I (April 1984) of FAR Clause 52.243-1, Changes, Fixed Price (August 1987), is hereby deleted in its entirety and Alternate II (April 1984) of FAR Clause 52.243-1, Changes, Fixed Price

(August 1987), is substituted therefor.

3. FAR Clause 52.249-4, Termination for Convenience of the Government (Services) (Short Form)

(April1984), is deleted in its entirety and FAR Clause 52.249-2, Termination for Convenience of the Government (Fixed Price) (April 2012) is substituted therefor.

4. FAR Clause 52.216-4, Economic Price Adjustment - Labor and Material (January 1997).

5. FAR Clause 52.222-29, Notification of Visa Denial (April 2015).

6. FAR Clause 52.224-1, Privacy Act Notification (April 1984).

7. FAR Clause 52.224-2, Privacy Act (April 1984).

8. FAR Clause 52.225-8, Duty-Free Entry (October 2010).

9. FAR Clause 52.232-18 Availability of Funds (April 1984).

10. FAR Clause 52.237-3, Continuity of Services (January 1991).

11. FAR Clause 52.242-4, Certification of Final Indirect Costs (January 1997).

12. FAR Clause 52.246-23, Limitation of Liability (February 1997).

13. FAR Clause 52.246-24, Limitation of Liability - High-Value Items (February 1997).

14. Alternate I (April 1984) is not applicable to this contract

15. FAR Clause 52.247-63, Preference for U.S. Flag Air Carriers (June 2003).

16. FAR Clause 52.209-9, Updates of Publicly Available Information Regarding Responsibility

Matters (July 2013)

As prescribed in 9.104-7(c), insert the following clause:

a. The Contractor shall update the information in the Federal Awardee Performance and

Integrity Information System (FAPIIS) on a semi-annual basis, throughout the life of the contract, by posting the required information in the System for Award Management (SAM) database athttp://www.acquisition.gov.

b. As required by section 3010 of the Supplemental Appropriations Act, 2010 (Pub. L. 111-

212), all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available. FAPIIS consists of two segments--

1. The non-public segment, into which Government officials and the Contractor post information, which can only be viewed by--

I. Government personnel and authorized users performing business on behalf of the Government; or

ii. The Contractor, when viewing data on itself; and

2. The publicly-available segment, to which all data in the non-public segment of

FAPIIS is automatically transferred after a waiting period of 14 calendar days, except for--

I. Past performance reviews required by subpart 42.15;

ii. Information that was entered prior to April 15, 2011; or

iii. Information that is withdrawn during the 14-calendar-day waiting period by the Government official who posted it in accordance with paragraph (c)(1) of this clause.

c. The Contractor will receive notification when the Government posts new information to the Contractor's record.

1. If the Contractor asserts in writing within 7 calendar days, to the Government official who posted the information, that some of the information posted to the non-public segment of FAPIIS is covered by a disclosure exemption under the Freedom of Information Act, the Government official who posted the information must within

7 calendar days remove the posting from FAPIIS and resolve the issue in accordance with agency Freedom of Information procedures, prior to reposting the releasable

N02CP71002-72 – Metabolomic Profiling for Molecular Epidemiology Studies Page 9 of 33 information. The contractor must cite 52.209-9 and request removal within 7 calendar days of the posting to FAPIIS.

2. The Contractor will also have an opportunity to post comments regarding information hat has been posted by the Government. The comments will be retained as long as the associated information is retained, i.e., for a total period of 6 years.

Contractor comments ill remain a part of the record unless the Contractor revises them.

3. As required by section 3010 of Pub. L. 111-212, all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available.

d. Public requests for system information posted prior to April 15, 2011, will be handled under Freedom of Information Act procedures, including, where appropriate, procedures promulgated under E.O. 12600.

16.506 -- Solicitation Provisions and Contract Clauses

1. Method Of Ordering

a. Orders issued under this contract may be placed as follows: ] in writing

[ ] via telephone

[ ] via facsimile (fax)

[X ] via electronic mail (e-mail)

[ ] Oral [Oral Orders will be confirmed in writing within days of issuance.

[ ] Other Specify:

b. The Contracting Officer is authorized to issue orders and provide written confirmation of oral orders, if applicable, under the contract.

c. Fair Opportunity

1. In accordance with FAR 16.505(b)(1)(i), each awardee will be given a fair opportunity to be considered for each order issued over $3,500 unless the following exception(s) apply:

i. The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

ii. Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

2. 52.216-18 - Ordering.

Ordering (Oct 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from the date of award through 5 years.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of Clause)

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3. Order Limitations (Oct 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $1,000 the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor --

(1) Any order for a single item in excess of $4,500,000;

(2) Any order for a combination of items in excess of $7,000,000; or

(3) A series of orders from the same ordering office within 3 days that together call for quantities exceeding the limitation in subparagraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 3 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the

Government may acquire the supplies or services from another source.

(End of Clause)

4. Indefinite Quantity (Oct 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the

Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after March 6, 2027.

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B. CONTRACT DOCUMENTS, EXHIBITS, AND ATTACHMENTS

1. Background Statement

The mission of the Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute

(NCI) is to conduct population and multidisciplinary research to discover the genetic and environmental determinants of cancer and new approaches to cancer prevention. The ability to identify molecular profiles that reflect the onset and progression of different forms of cancer is essential to DCEG’s mission.

Metabolomics, the study of small molecules within biological samples, has been shown as a promising approach to evaluating diverse cancer types such as those affecting the prostate and brain. Using liquid chromatography-mass spectrometry and gas chromatography-mass-spectrometry (LC-MS, GC-MS) metabolomic profiling in combination with findings from genomic studies holds important promise for elucidating the etiology of a wide variety of cancers.

2. Base IDIQ Statement of Work

Scope:

The scope of this contract will be to provide metabolomic profiling services for DCEG studies using liquid chromatography and gas chromatography mass spectrometry (LC-MS, GC-MS).

Independently and not as an agent of the Government, the Contractor shall be required to furnish all necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the

Government, as needed to perform the Statement of Work.

Tasks:

The Contractor shall:

1) Measure relative concentrations of at least 800 metabolites in serum, EDTA plasma, heparin plasma, and feces using liquid chromatography-mass spectrometry and gas chromatography-mass-spectrometry

(LC-MS, GC-MS) with at least 300 metabolites having known identity in all of the above types of specimens. Measured metabolites shall include metabolites from each of the following chemical classes: lipids, amino acids, peptides, xenobiotics, carbohydrates, cofactors and vitamins, nucleotides and energy metabolites. Sensitivity shall be sufficient to detect metabolites within the nanomolar range. Quality control measures shall be in place (internal QCs) to test the accuracy and validity of the results.

2) Present evidence for linear dynamic range within the range of normal physiologic concentrations. The

Contractor shall be able to analyze 30 samples or more per day, and, for any given sample set, curate data / perform metabolite identification within three or fewer months.

For reproducibility, the median coefficient of variation over the span of the measured metabolites must be 15% or less and the median intraclass correlation coefficient must be 0.8 or higher for within batch reproducibility and 0.7 for between batch reproducibility (using population-based samples). The required volume for blood or urine must be 0.2 ml or less.

3) The Contractor shall have a documented Quality Assurance/Quality Control (QA/QC) program to monitor the performance of work and shall follow SOPs for each protocol used to include SOPs on:

training, specimen receipt, processing, storage and dissemination, emergency responses, safety, and preparing specimens for shipment. SOPs shall be available for review and posting to an internal

DCEG website.

4) Unless otherwise noted, all work shall be in conformance with Best Practices for Repositories:

Collection, Storage, Retrieval and Distribution of Biological Materials for Research International

Society for Biological and Environmental Repositories, Third Edition. Published in Biopreservation and Biobanking (BIO), April 2012 issue and available at www.isber.org and the NCI Best Practices located at http://biospecimens.cancer.gov/resources/.

http://www.isber.org/ http://biospecimens.cancer.gov/resources/

N02CP71002-72 – Metabolomic Profiling for Molecular Epidemiology Studies Page 12 of 33

NOTE TO OFFERORS:

Provide SOPs or, alternately, provide a published reference explaining the materials and methods used in performing testing under this Statement of Work.

3. Reporting Requirements

All reports required herein shall be submitted in electronic format.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973.

Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under

"Making Files Accessible."

All reports required herein shall be submitted in an electronic format via email as attachments to the following NCI Branch Distribution Mailbox:

ncibrancheinvoices@mail.nih.gov

NOTE: Hard copies of reports are no longer required and shall no longer be mailed to the NCI OA. Each email submission shall contain only one deliverable. If the attached file for the deliverable exceeds 50 MB, the Contractor shall divide the deliverable into files of 50 MB each. All deliverables should be limited to five file attachments or less. In cases where it is necessary, more than five attachments will be accepted.

The subject of the email shall read as follows:

Deliverable_Contract Number_Vendor's Name_Deliverable Description_Due Date

All data transfer of PII or sensitive information to the NCI must be encrypted.

a. Technical Progress Reports

1. Monthly Progress Report This report shall include a description of the activities performed during the reporting period.

Studies that failed to make progress and any other problems encountered during the month shall be specifically described. The activity shall be presented by study and include the Cost Accounting

System (CAS) number, the BSI-II Study Code, investigator name. PI Code and Branch, where applicable. All codes will be provided to the Contractor by the COR. The report shall also include a description of the testing planned for the ensuing reporting period.

The first reporting period shall consist of the first full month of performance plus any fractional part of the initial month. The first monthly report shall de due as specified at the time of the award.

Thereafter, monthly reports shall be due on or before the 15th calendar day after the completion of each reporting period.

b. Other Reports/Deliverables

1. Emergency Response Reports The Contractor shall notify the COR by phone and e-mail within 72 hours of any emergency affecting the status of the biospecimens contained in the repository. The Contractor shall follow-up with a written report that includes details regarding the cause of the incident, steps taken to address the immediate needs, and recommendations for further actions needed to avoid similar incidents in the future.

N02CP71002-72 – Metabolomic Profiling for Molecular Epidemiology Studies Page 13 of 33

2. Specimen Damage Reports The Contractor shall notify the COR within 72 hours of any incoming shipments received in damaged condition (e.g., broken biospecimen containers) or received at a recipient location in damaged condition or in which the research value of the biospecimens or environmental sample may…