SOL-16-1169382_Chemical_Constituents.pdf

SOL-16-1169382

Chemical Constituents of Cigarette Butts

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Part 1 – Description

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN

ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR

EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH

ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT

CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED. THIS

SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5.

This solicitation is being issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-88-1.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541690. Its associated Small Business size standard is $15M. This solicitation is for full and open competition.

Part 2 – Supplies or Services and Prices/Costs

Purchase Order Type: Firm-Fixed Price Base Year

Task Description Price

1 Cigarette Butt Collection, Identification of Test Methods, and Analysis Plan Development

2 Preparation of Leachate 3 Analysis of Leachate 4 Draft Final Report 5 Final Report 6 Final Briefing Total

Part 3 – Description/Specifications

3.1 Background

A major existing environmental consequence of cigarette use is the waste disposal of discarded cigarette filters, as an estimated 4.5 trillion cigarette butts are thrown away every year worldwide and 1.69 billion pounds of cigarette butts are disposed of as toxic trash each year.1,2 In addition, research has shown cigarette butt leachate to be toxic to fish.3

1 Novotny TE, Hardin SN, Hovda LR, Novonty DJ, McLean MK, Khan S. Tobacco and Cigarette Butt Consumption in Humans and Animals. Tobacco Control 2011;20(Suppl. 1):i17-i20.

2 Smith, EA and Novotny, TE. Whose butt is it? Tobacco industry research about smokers and cigarette butt waste. Tobacco Control 2011;20(Suppl. 1):i2-i9.

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The National Environmental Policy Act requires an impact analysis on the environment, as well as scenarios that could lead to human health impact, for federal actions, such as tobacco product marketing authorizations. Information about the identities and amounts of constituents that leach from cigarette butts is limited and is necessary to characterize the hazard and model the fate and transport of the constituents in the environment. A preliminary study to identify leachable constituents, including Harmful/Potentially Harmful Constituents (HPHCs), from cigarette butts will provide information to design focused, high value, cost effective fate and effects studies when needed in the future.

3.2 Statement of Work

The objectives of this study are to:

• conduct laboratory analysis of three replicates from a single cigarette butt leachate; and

• characterize and quantify the different chemical constituents and HPHCs from the lab analysis for the leachate

Under the contract, the FDA is interested in conducting a study to support characterization and quantification of specific chemical constituents and HPHCs in leachate from cigarette butts.

Tasks/Requirements The Contractor shall:

• determine appropriate “off the shelf” analytical methodologies (e.g. – EPA Methods 8270 and 8310 for organics and EPA Method 200 series for metals) for the constituents of concern identified in Task 2;

• collect cigarette butts for analysis;

• prepare cigarette butt leachate;

• measure the amounts of each chemical constituent and HPHCs in the leachate;

• identify unknown constituents that have a mass greater than 10% of the total injected mass;

• monitor, manage, and maintain data collected during the contract period; and

• submit a final report that includes the following sections: executive summary, methods, results, discussion, and conclusions.

The Contractor shall follow all federal, state, and local environmental, health, sanitation and emissions regulations. In addition, the Contractor shall follow all applicable Environmental Protection Agency (EPA) and Occupational Safety & Health Administration (OSHA) regulations. Disposal of cigarette butts, leachates and laboratory waste must follow the above environmental, health and safety regulations.

Task 1: Cigarette Butt Collection, Identification of Test Methods, and Analysis Plan Development

The Contractor shall identify the project timeline, develop and implement a cigarette butt collection plan, and develop an analytical methods plan for conducting the leachate tests. Additionally, the Contractor shall

3 Slaughter E, Gersberg RM, Watanabe K, Rudolph J, Stransky C, Novotny TE. Toxicity of cigarette butts, and their chemical components, to marine and freshwater fish. Tobacco Control 2011;20(Suppl. 1):i25-i29.

3 | P a g e conceptualize how the analysis shall be performed based on the list of chemical constituents in Task 3. The Contractor must verify that the selected test methods have been validated to achieve the study’s objectives.

The methods must be determined to be fit for purpose, which includes consideration of, but not limited to, the following method characteristics: accuracy, precision, robustness, limit of detection, limit of quantification, range, and specificity. The Contractor, with concurrence from the COR, may perform multiple tasks at one time for efficiency. The Contractor shall submit a cigarette butt collection plan, test methods for conducting leachate tests, and an analysis plan to the COR for concurrence and feedback.

The Contractor shall collect cigarette butts to use for preparing the leachate. This study is not a human subject study. This study is not a research activity involving human subjects for study recruitment. It does not involve obtaining information about living individuals. There will be no interaction or intervention with individuals. No individuals will be interviewed nor their individually identifiable information obtained. The study does not involve videotaping, recording, or surveying individuals. The Contractor shall collect only cigarette butts and will not interact with humans from whom cigarette butts are obtained.

Task 2: Preparation of Leachate

The Contractor shall prepare a leachate by placing cigarette butts in distilled or deionized water for 24 hours, making note of cigarette butt weights, number of butts used and water volume. The Contractor shall determine the appropriate volume of water and number of butts to use in order to minimize the need for, or number of, extraction and concentration steps.

Task 3: Analysis of Leachate

Using the validated analytical methods proposed in Task 4, the Contractor shall analyze three replicates of the leachate to quantify levels of each chemical constituent and HPHC. The Contractor shall provide full descriptions of methods used and descriptions of any laboratory issues encountered along with their solutions. For sample mass, the Contractor shall report the data to at least three decimal points, as well as the accuracy of the analytical balance and the date of last calibration. The Contractor shall quantify the chemical constituents and HPHCs listed below:

1,3-Butadiene Acrolein Crotonaldehyde PAHs (total) Chromium (Cr)

1-Aminonaphthalene Acrylonitrile Formaldehyde Phenol and catechol Lead (Pb)

2-Aminonaphthalene Aldehydes (total) Isoprene m-, p-, and o-cresol Mercury (Hg)

4-Aminobiphenyl Benzene Nicotine (total and free) Arsenic (As) pH

Acetaldehyde Benzo[a]pyrene NNK and NNN Cadmium (Cd)

Glycerol, propylene glycol ethylene glycol, and diethylene glycol

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In addition to the above list, the Contractor shall identify any constituents not on the list (i.e. – unknown) that have a mass greater than 10% of the injected mass. Analytical results will be reported in mg/L, mg/cigarette butt and mg/kg of cigarette butts.

Task 4: Draft Final Report

The Contractor shall submit a draft of the final report within 3 months of contract award. The Contractor shall prepare a detailed final report including: 1) an executive summary; 2) identification of the laboratory used and methods describing how the data was collected and analyzed; 3) results of the analysis; 4) discussion, including problems encountered during the study and their solutions; and 5) conclusions; and 6) related appendices. As a part of the final report, the Contractor shall submit analytical procedures (including details regarding extraction procedures and/or any other procedures used during sample preparation), validation reports, system suitability, and any other pertinent information for measuring the analytes indicated in Task 3.

Task 5: Final Report

The Contractor shall submit a Final Report within 4 months that presents the objectives, methods, results of the analyses, and summarizes the findings and conclusions of the project. The Final Report shall include the required elements outlined for the draft report (Task 4) and shall incorporate any revisions based on comments received from the FDA.

The Contractor shall provide the Final Report to the COR in the following manner:

1. An electronic version of the final report.

2. The final report delivered on a CD Rom.

Task 6: Final Briefing

Within 4 months of the award, the Contractor shall conduct a final briefing to FDA personnel via web conference. This briefing shall consist of a 30- to 40-minute presentation of the project and shall include a background on the problem, descriptions of methods used, the results of the tasks, and a brief discussion of the results and problems encountered during the study. The Contractor shall be prepared with appropriate briefing materials and shall send their presentation materials to the COR for review within two days prior to the presentation date.

Key Personnel

The Contractor shall provide the names and resumes of the key personnel assigned to this contract. The individuals cited below are key personnel

• Principal Investigator/Project Manager

• Lead Scientist

• Technician

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Part 4 Performance and Deliverables

4.1 Place of Performance

The work for this project will take place at the Contractor’s laboratory facility and contractor site. All deliverables shall be sent to the COR electronically at the following address:

COR / Point of Contact:

Food and Drug Administration Center for Tobacco Products Division of Regulatory Project Management, Branch I 10903 New Hampshire Avenue White Oak Campus, Bldg. 32, Rm 4144 Silver Spring, MD 20993

ATTN: TBD

4.2 Deliverables

Task Description Estimated Completion Date 1 Kickoff Meeting/ Initial Briefing Within 2 weeks after award

1 Develop a cigarette butt collection plan, test methods, and an analysis plan Within 2 weeks after award

1 Collect cigarette butts to use for preparing the leachate Within 1 month after award

2 Prepare leachate Within 1 ½ months after award 3 Analyze replicates of the leachate Within 2 months after award 4 Summarize findings in draft report Within 3 months after award 5 Summarize findings for Final Report Within 4 months after award 6 Prepare briefing materials 2 days prior to final briefing 6 Conduct Final Briefing Within 4 months after award

4.3 Reporting

The COR may request conference calls to discuss status of deliverables and any other issues which may arise with the contract. The COR will coordinate a schedule with the Contractor to determine when the conference calls will occur on an as needed basis.

Monthly Progress Reports

The Contractor shall furnish one electronic copy to the FDA COR by the 1st of each month. At a minimum, the progress report shall include a narrative description of the following items:

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1. Accomplishments made during the reporting period.

2. Plans for accomplishments in the next reporting period.

3. Interim results, conclusions, trends or other items of information that the Contractor believes are of interest to the FDA.

4. Problems or delays that the Contactor has experienced in the performance of his/her services, as well as any quality assurance and control measures taken during the reporting period

5. Specific action(s) that the Contactor would like the FDA to undertake to alleviate a problem.

6. Due dates for upcoming deliverables.

4.4 Period of Performance

The period of performance is four (4) months or October 1, 2016 to February 3, 2017.

Part 5 – Inspection and Acceptance

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of materials and services to be provided. For the purpose of this PART, (COR – to be determined upon contract award) is the authorized representative of the Contracting Officer.

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of materials and services to be provided.

For the purpose of this PART, (COR) is the authorized representative of the Contracting Officer.

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:

Sean Wybenga U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Sean.Wybenga@fda.hhs.gov;

mailto:Sean.Wybenga@fda.hhs.gov

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(240) 402-7629

The contact information for the Contract Specialist is the following:

Lisa Yaw U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Lisa.Yaw@fda.hhs.gov;

(240) 402-4018

The contact information for the Contractor is the following:

(TBD)

Invoice Submission:

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

Office of Financial Services Food and Drug Administration

W032- Second Floor

MAIL HUB 2145

10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145

Silver Spring MD 20993-0002 Attn: Vendor Payments

(301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – Central Contractor Registration) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(II) Invoice Date and Invoice Number;

(III) Purchase order/Award Number;

(IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; 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;

mailto:Lisa.Yaw@fda.hhs.gov mailto:fdavendorpaymentsteam@fda.gov

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(VI) Terms of any discount for prompt payment offered;

(VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice;

(IX) Taxpayer Identification Number (TIN);

(X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award.

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

Part 6 – Contract Clauses

FAR Clauses Incorporated by Reference:

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: www.acquisition.gov/far/index.html

52.203-5 Covenant Against Contingent Fees (May 2014) 52.203-7 Anti-Kickback Procedures (May 2014) 52.212-4 Contract Terms and Conditions-Commercial Items (May 2015) 52.216-24 Limitation of Government Liability (April 1984) 52.216-25 Contract Definitization (October 2010)

FAR Clauses in Full Text:

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items.

CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

ITEMS (JUNE 2016)

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

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

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

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).

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

http://www.acquisition.gov/far/index.html

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___ (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 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

___ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Oct 2015) (Pub. L.

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

___ (5) [Reserved] ___ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div.

C).

___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

___ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) (31 U.S.C. 6101 note).

___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

___ (10) [Reserved] ___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

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

___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (ii) Alternate I (Jan 2011) of 52.219-4.

___ (13) [Reserved] ___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

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

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

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

___ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)).

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

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

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

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

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

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

___ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

___ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

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___ (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).

X (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).

___ (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).

X (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

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

___ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693).

___ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

___ (38) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514 ___ (ii) Alternate I (Oct 2015) of 52.223-13.

___ (39) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-14.

___ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (41) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-16.

X (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O.

13513).

___ (43) 25.223-20, Aerosols (Jun 2016) (E.O. 13693).

___ (44) 52.223-21, Foams (Jun 2016) (E.O. 13696).

X (45) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

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___ (46) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C.

chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103- 182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).

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

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

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

___ (47) 52.225-5, Trade Agreements (Feb 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

___ (48) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (49) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

___ (50) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (51) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C.

5150).

___ (52) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).

___ (53) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C.

2307(f)).

X (54) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (55) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (56) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (57) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (58) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C.

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

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

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

___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495) ___ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).

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

chapter 67).

___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).

___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

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___ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67).

___ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67).

___ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658).

___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).

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

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

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

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

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

(e)

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

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

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

(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

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

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

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

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

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

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(ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

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

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

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

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

chapter 67.)

(xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67)

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

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

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

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

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

(xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

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

(End of Clause) Alternate I (Feb 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to “paragraphs (a), (b), (c), or (d) of this clause” in the redesignated paragraph (d) to read “paragraphs (a), (b), and (c) of this clause”.

Alternate II (Mar 2016). As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows:

(d)

(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to—

(i) Examine any of the Contractor’s or any subcontractors’ records that pertain to, and involve transactions relating to, this contract; and

(ii) Interview any officer or employee regarding such transactions.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial items, other than—

(i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P120_20013 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P120_20013

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(ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(A) 52.203–13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C.

3509).

(B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5).

(C) 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.

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

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

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

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

(H) 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.

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

(J) ____ (1) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

___ (2) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627).

(K) 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).

(L) 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).

(M) 52.222–54, Employment Eligibility Verification (Oct 2015) (Executive Order 12989).

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

(O) 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.

(P) 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

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Part 7 – Instructions to Offerors

7.1 Response Date

All quotes shall be submitted via email and received by Lisa.Yaw@fda.hhs.gov by 2:00 PM August 29, 2016.

Offerors shall ensure the solicitation number is visible in the header of the email transmission of their quote.

7.2 Proposal Instructions

The Offeror’s proposal shall consist of two (2) separate volumes. Volume 1 shall consist of the Technical Approach and Relevant Experience. Please include the resumes for the contractor personnel in this volume.

Volume 2 shall include the Price Proposal.

Volume 1: Technical Proposal:

The page limitation for the technical proposal is 20 pages (cover page, table of contents, resumes, and relevant experience are not included in this page limitation). Offerors shall use only 8.5 inch by 11 inch (210mm by 297mm) paper, single-spaced pages with margins no less than one inch on each border; number each page consecutively; do not use a font size smaller than Times New Roman 12.

Text in graphics and charts shall be no smaller than 9-point Times New Roman; text in tables shall be no smaller than 9-point Times New Roman. The size and font of headers and footnotes are not dictated.

Resumes shall be no longer than 5 pages following the same format.

The descriptions of the tasks are outlined in the SOW, Section 3.2.

Technical Requirements /Approach

1. The Offeror shall provide a comprehensive description of facilities available to perform the range of potential research studies discussed in the Statement of Work and provide Laboratory accreditation for quality and evidence of No Violations of EPA or OSHA regulations.

2. The Offeror shall demonstrate the strategy to adapt standard methods (such as published EPA methods) for analyzing constituents of interest.

3. The Offeror shall describe analytical methods for the constituents listed in Task 3 in leachate. The description should include the analytes routinely included in each method, the extraction protocols, the instruments used for separation and detection, the limit of detection, the method accuracy, and the method precision.

4. The Offeror shall provide evidence that collection of cigarette butts is in compliance with Task 1 and general environmental health and safety (EHS) practices.

5. The Offeror shall provide key personnel with expertise and work-related experience in the skills needed for successful completion of this project.

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Past Performance

The Offeror shall provide a narrative description of three (3) examples of experience on current and previous contracts over the past three (3) years which are relevant in terms of type, scope, complexity, and size.

Offerors shall cite examples of experience that demonstrate the Offeror’s ability to overcome difficulties encountered during performance with minimum impact to the program. Relevant experience submissions shall not exceed two pages for each experience provided. In addition to the narrative description described above, for each contract the Offeror shall provide the following:

Name of Contracting Activity (Federal Government Agency, Local Government, Commercial Customer);

Contract Number; Contract Type; Total Contract Value; Contract Work (Description of Experience, Degree of Involvement, Size of Organization, etc…); Contracting Officer Information, Project Officer/Contracting Officer Representative Contact Information)

Volume 2: Price:

The Offeror is required to submit a price proposal with prices filled into the Part 2 tables along with a total price for the overall project.

Part 8 – Evaluation Factors for Award

The following evaluation criteria will be used by the technical evaluation committee when reviewing the Offeror’s response to this solicitation.

Criteria 1: Price – The Government will evaluate the total price and the breakdown of prices for the each deliverable.

Criteria 2: Technical Approach –The Government will evaluate the Offeror’s demonstrated ability to:

• provide a comprehensive description of facilities available to perform the range of potential research studies discussed in the Statement of Work and provide Laboratory accreditation for quality and evidence of No Violations of EPA or OSHA regulations

• demonstrate a strategy to adapt standard methods (such as published EPA methods) for analyzing constituents of interest

• describe analytical methods for the constituents listed in Task 3 in leachate to include the analytes routinely included in each method, the extraction protocols, the instruments used for separation and detection, the limit of detection, the method accuracy, and the method precision

• provide evidence that collection of cigarette butts is in compliance with Task 1 and general environmental health and safety (EHS) practices

• provide key personnel with expertise and work-related experience in the skills needed for successful completion of this project

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Criteria 3- Past Performance -The Government will evaluate the Offeror’s demonstrated past performance of contracts relevant to the SOW.

Part 9 - Award Decision

Award will be made to the party whose proposal offers the best value to the Government based on the evaluation of the criteria above. The Government may award this contract to other than the lowest price technically acceptable proposal. Past Performance, Technical Approach, and Price are all of equal importance when making the award decision.