RFQ_for_Leachables_and_Extractables.doc

Subject: Leachables and Extractables in E-liquid Bottles and Closed ENDS Products Solicitation Number: FDA-18-RFQ-1194917 Part 1 – Description

1.1 This is a Request for Quotation (RFQ) for Leachables and Extractables in E-liquid Bottles and Closed ENDS Products. This requirement will be posted full and open competition.

1.2 The associated North American Industrial Classification System (NAICS) code for this procurement is 541380.

Part 2 – Supplies or services and Prices/Costs

2.1 Description of Equipment/Services

Milestones Fixed Price

Part 3 – Description/Specifications/Work Statement

3.1 Background

Electronic Nicotine Delivery System (ENDS) products are defined as having a Closed-ENDS or Open-ENDS design. Closed-ENDS products are constructed in such a manner that the e-liquid is contained in a non-refillable reservoir. This reservoir may be enclosed with an atomizer and battery into a disposable “cigalike” form or be enclosed in the exchangeable cartridge with an atomizer (a.k.a Cartomizer) that is connected to a rechargeable battery. Open-ENDS products contain reservoirs that are accessible by the user and allow the addition of e-liquids as necessary. Open-ENDS products also include e-liquid drip tip devices designed to allow individual drops of liquids, waxes, or tobacco to be placed on the atomizing element. E-liquids are commonly packaged in plastic containers manufactured from a variety of polymers, containing co-polymers, plasticizers, colors, and other additives that may migrate or leach into the e-liquid. The transfer of these contaminants from the packaging or device to the tobacco products has been demonstrated in e-liquids obtained from the marketplace at levels that may have significant health risks. Liquids in the products facilitate the migration of the contaminants from the packaging to the product through solubility, diffusion, and other active transport systems. E-liquids used with open-ENDS products and closed-ENDS products are susceptible to leaching of plastic constituents.

3.2 Objectives

The objective of this, fixed price contract is to acquire tobacco product samples (Table 1) in and develop and validate a controlled extraction to measure extractable compounds from Low Density Polyethylene (LDPE) and Polyethylene Terephthalate (PET) plastic bottles with a plastic dropper and/or rubber stopper, closed ENDS devices, and e-liquid drip tips. If any of the extractables exceeds the safety threshold, the contracted laboratory shall develop a leachable study for identification of leachable compounds using e-cigarette solvents PG and VG at various ratios, and final packaging exposed to a long-term (shelf-life) study.

Table 1. ENDS products to be purchased for testing.

3.3 Scope of Work:

FDA expects to evaluate the amount of harmful compounds that may be present in e-liquid plastic bottles with a plastic dropper and/or rubber stopper, Closed ENDS devices, as well as e-liquid drip tips, which will allow for evaluation of the public health safety of these products, as well as information for science-based decision making during product reviews.

3.4 Tasks

Phase I

3.4.1 Samples

If the tobacco products are not sold in units listed below, the contractor shall contact FDA for approval for appropriate quantities of products prior to making any purchases.

3.4.1.2 LDPE Bottles

The contractor shall purchase the following LDPE bottles, no later than 7 days after award:

3.4.1.3 PET Bottles

The contractor shall purchase the following PET bottles, no later than 7 days after award:

3.4.1.4 Closed ENDS Products

The contractor shall purchase the following closed ENDS products, no later than 7 days after award:

*Rechargeable closed ENDS products do not need to purchase the whole kit, only the cartridge refills.

3.4.1.5 E-liquid Drip Tips

The contractor shall purchase the following closed ENDS products, no later than 7 days after award:

3.5 Sample Purchase Deliverables

a. The Contractor shall provide FDA with copies of all receipts from the tobacco product purchases for verification of the location where the samples were purchased, within five days of final purchase.

b. The Contractor shall provide FDA with the lot number, bar code/UPC number, and expiration date of the tobacco product (as applicable) in a separate document, within five days of final purchase.

c. The Contractor shall provide FDA color photos of the labeling of each tobacco product purchased, and the contractor shall place on each photo, the date, time, and location of purchase (full website address)); as well as lot number bar code/UPC number and expiration date, within five days of final purchase.

d. The tobacco products shall be shipped at ambient temperature.

e. The Contractor shall provide FDA with a copy of the shipping receipt and tracking number after the products have been shipped

Phase II

3.6 Extractables Study

The contractor shall conduct extractable studies of bottles marketed for use with e-liquids, closed ENDS devices, and e-liquid drip tips listed in Table 1. The extractable studies shall be completed as listed in the appendix to determine the extractable chemicals and compounds that could be of concern to public health safety. The contractor shall first cut open and apart the bottles, and closed ENDS devices, into approximately one-inch strips. Next, the contractor shall conduct different extractions, as listed in the appendix, using water, organic solvent, acid, alkali, and alcohol. FDA will consider alternative procedures or methods proposed by the contractor.

3.6 Analytical Testing After extractions are complete, the contractor shall perform the analytical testing listed in the appendix on the extracts, to identify and quantify the extractable chemicals and compounds present that could be of concern to public health safety under different extraction conditions.

a.

The preferred analytical methods include LC-MS for the water and alkali extracts, GC-MS for the organic and alcohol extracts and ICP-MS for the acid and alkali extracts. The methods shall meet the following acceptance criteria:

i.

Precision (not less than (NLT) 6 independent determinations): not more than (NMT) 5% RSD at 1 ng/mL of e-liquid ii.

spike recovery: NLT 95% at 1 ng/mL of e-liquid iii.

LOQ: (NMT 5% RSD at 0.1 ng/mL of e-liquid) iv.

LOD: (NMT 50% RSD at 1.0 pg/mL of e-liquid)

FDA will consider alternative procedures or methods proposed by the contractor.

3.7 Identification and Quantification of Extractable Chemicals and Compounds The contracting laboratory shall use their MS libraries to complete the identification and quantification of extractable chemicals and compounds. Once the results are completed by the contracting laboratory, CTP and the contracting laboratory will evaluate the results. If any of the identified extractable chemicals or compounds that could be of concern to public health safety or are found to be exceed the safety threshold of 0.1 ng/mL, the containers shall be included in leaching studies in Phase II.

Phase II-Optional Line Item

3.8-Leachables Study

Based on the results of phase I, any component present greater than 0.1 ng/mL shall be tested for leachability under different leaching conditions including PG, VG and a mixture of PG/VG (at various ratios). The contractor shall use the same analytical procedures listed in the appendix for the extractables to determine leachable chemicals and compounds that could be of concern to public health safety.

To each of the LDPE and PET plastic marketed e-liquid bottles, closed ENDS devices, and e-liquid drip tips, extractions using PG, VG and PG/VC shall be performed as below. Analysis using LC-MS/MS, GC-MS/MS, or ICP-MS/MS (that have been previously described) shall be performed for identifiable compounds found above 0.1 ng/mL that could be of concern for public health safety.

For PG/VG leaching, the contractor shall:

· Fill the plastic bottles or device reservoirs to 90% capacity with PG, VG, as well as PG/VG at various ratios (65%PG:35%VG, 50%PG:50%VG, 35%PG:65%VG),and close it using normal means of closure.

· Incubate at 49 C for 10 days (agitate bottles at least daily).

· Store at room temperature until determined test time incubation period begins.

Phase III

3.9 Monthly Meeting

The contractor shall schedule monthly meetings with CTP to provide research and project updates.

3.10 Final Report

The contractor shall prepare and submit a final report to the COR 3 months after completion of data collection. The final report shall contain all raw data, instrumental settings (to include all final settings and all developmental setting (with a description of outcomes), validation data, and identification and quantification of extractable and leachable chemicals and compounds from E-liquid 10mL LDPE and PET plastic bottles with a plastic dropper and/or rubber stopper, closed ENDS devices, and e-liquid drip tips.

3.11 Final Briefing

The contractor shall schedule a meeting with CTP within 1 month of the conclusion of leachables and extractables data to discuss the data that will be presented in the final report as well as the manuscript that will be jointly written.

3.12 Manuscript

The contractor shall review the FDA written manuscript of this study for accuracy prior to submission to one or more peer-reviewed scientific journals.

3.13 Conflict of Interest

Organizational Conflict of Interest

a) The purpose of this section is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. The language of section VII applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co- sponsor, joint venture, consultant, or in any similar capacity.

(c) Definition of Conflict of Interest

Conflict of interest means that because of other activities or relationships with other persons or organizations, a person is unable or potentially unable to render impartial assistance or advice to the Government, that the person's objectivity in performing the contract is or might be otherwise impaired, or that the person has or might acquire an unfair competitive advantage (see FAR 9.501).

(d) Contractor’s Conflict of Interest Responsibilities

The individual contractor must be free of interest prior to performing under this contract. Any time prior to or during the performance of the contract the individual contractor believes that a potential or actual conflict exists, the individual should notify the contract officer and project officer. The contract officer will determine whether or not a conflict of interest exists and how to resolve or mitigate it. The contractor should not commence or continue working on the contract until directed by the contract officer.

(e) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

Prior to award, contractors that disclose potential or actual conflicts of interest shall submit a mitigation of conflicts of interest plan along with their technical and business proposals.

(f) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(g) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(h) Prime Contractor Responsibilities.– The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507

(i) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

3.14 Publication of Research

FDA considers the sharing of FDA-funded research, including digital data, an important means to enhance its value and support future research. When the findings associated with research developed with FDA funds are published, they are required to be made readily available to the public. In addition, investigators seeking FDA funding, in whole or in part, via a contract, grant, or assistance agreement must have an FDA-approved Data Management Plan – a plan for digital data management and sharing – prior to commencing any related services or work.

Upon acceptance for publication, researchers are also responsible for submitting the author’s final manuscript of any peer-reviewed scientific publication resulting from research supported, in whole or in part, with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications resulting from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. FDA expects timely release and sharing of final research data from FDA-funded studies for the research community’s use in accordance with the submitted Data Management Plan. Please see the FDA Public Access Policy (provided as Attachment/Exhibit XXYY; or, available at http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/staffmanualguides/ucm479268.pdf Part 4 – Inspection and Acceptance 4.1 The Contracting Officer’s Representative (COR) (see Part 6) will perform inspection and acceptance of materials and services to be provided at location in Part 5.

Part 5 – Deliverables or Performance 5.1 Deliverable Schedule

5.2 Place of Performance

The place of performance shall be at the contractor’s site.

5.3 Period of Performance The period of performance for this contract shall be 18 months from the date of award.

Part 6 – Contract Administration Data

6.1 Contracting Officers Representative (COR) The following COR will represent the Government for the purpose of this contract:

(To Be Determined at the Time of Award)

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Government may unilaterally change its COR designation.

6.2 Contract Specialist

The contact information for the Contracting Specialist is:

Tara Hobson

5630 Fishers Lane, Room 2042

Rockville, MD 20857

Tara.Hobson@fda.hhs.gov

(240) 402-7586 Fax: (301) 827-7101

6.3 Contracting Officer

The contact information for the Contracting Officer is:

Department of Health and Human Services

Food & Drug Administration, OAGS

Attn: Tara Hobson, Room 2042 5630 Fishers Lane

Rockville, MD 20857

Phone: (240) 402-7615 Tara.Hobson@fda.hhs.gov

6.4 Contractor Point of Contact

The contact information for the Contractor Point of Contact is: (To Be Determined at the Award of the Contract)

Name:

Address:

Phone Number:

Email:

6.5 INVOICE SUBMISSION

FDA THREE-WAY-MATCHING INVOICE CLAUSE

A.

THE CONTRACTOR SHALL SUBMIT ONE (1) ORIGINAL COPY OF EACH INVOICE TO THE ADDRESS SPECIFIED BELOW:

Office of Financial Services

Food and Drug Administration

10903 New Hampshire Ave

WO32 - Second Floor

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 / System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Purchase order/award number;

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) The contractor shall include the Contract Line Item/Funding line item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

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

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer identification number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment

(xi) Name and telephone number of the FDA Contracting Officer (CO) and the Contracting Officer's Representative (COR) or other program center/office point of contact, as referenced on the order/contract;

(xii) Any other information or documentation required by the purchase order/award.

C.

An electronic invoice shall be in adobe acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D.

Questions regarding invoice payments should be directed to the FDA Payment Office at:

Food and Drug Administration/ Office of Financial Services, 10903 New Hampshire Ave

WO32 - Second Floor, MAIL HUB 2145

Silver Spring, MD 20993-0002

Attn: Vendor Payments

Phone 301-827-ERIC (3742)

(Amend as necessary)

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. SYSTEM FOR AWARD MANAGEMENT (SAM) DATABASE) AND/OR OTHER APPLICABLE FAR CLAUSES SPECIFIED HEREIN.

PART 7-CONTRACT CLAUSES

7.1 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

52.212-4 Contract Terms and Conditions-Commercial Items (Jan 2017) 52.227-14 Rights in Data-General (May 2014) 7.2 FAR Clauses by Full Text 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Jan 2018)

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

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

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

(4) 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:

_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).

___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

__x_ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

___ (5) [Reserved]

___ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

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

___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (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.

_x__ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C. 637 (d)(4)).

___ (ii) Alternate I (Nov 2016) of 52.219-9.

___ (iii) Alternate II (Nov 2016) of 52.219-9.

___ (iv) Alternate III (Nov 2016) of 52.219-9.

___ (v) Alternate IV (Nov 2016) of 52.219-9.

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

___ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

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

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

__x_ (22) 52.219-28, Post Award Small Business Program 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).

__x_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).

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

_x__ (28) 52.222-26, Equal Opportunity (Sep 2016) (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).

___ (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).

___ (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) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

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

___ (45) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

___ (ii) Alternate I (Jan 2017) of 52.224-3.

_x__ (46) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

___ (47) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).

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

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

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

___ (48) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

___ (49) 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).

___ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

___ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).

___ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__x_ (55) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (56) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(12)).

___ (60) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).

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

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

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

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

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

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

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

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

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

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

___ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

___ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).

___ (11) 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) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (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.

(iv) 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.

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

(vi) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

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

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

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

(x) 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.

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

(xii) (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).

(xiii) 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.)

(xiv) 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)

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

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

(xvii) 52.222-62, Paid sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(xviii) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xix) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xx) 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.

(xxi) 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.

7.3 FAR Clauses in Full Text

52.232-40 Providing Accelerated Payment to Small Business Subcontractors (DEC 2013)

(a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

7.4 HHSAR Clauses

Part 8– Instructions to the Offerors

8.1 FAR provisions Incorporated by Reference

An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at (System Award Management) http://sam.gov. If an offeror has not completed the annual representations and certifications electronically at the SAM website, the offeror shall complete and submit only paragraphs (c) through (m) of this provision.

FAR Clause

Description

Date

52.212-1

Instructions to Offerors-Commercial Items (Jan 2017) 52.212-3

Offeror Representations

(Nov 2017)

And Certifications-

Commercial Items

RFQ Due Date: All quotes and revisions shall be received via email to tara.hobson@fda.hhs.gov before 12:00 PM (1200) EASTERN TIME on April 25, 2018. Offerors shall ensure the RFQ number is visible in the header of the email.

Fax quotes shall not be accepted.

All Offerors shall be registered in the System Award Management (SAM) prior to the award of the contract. You may register by going to www.sam.gov.

8.2 Technical Proposal

a) The Offeror shall demonstrate that the proposed methods are in accordance with the parameters to accomplish the listed in section 3.

b) The Offeror shall demonstrate that they have their ability to complete all of the analyses required in the contract, including the option line item for the leachables study.

c) The Offeror shall demonstrate their ability to complete all of the testing in the time frame specified in the SOW, which includes a work plan.

8.3 Relevant Past Performance

The Offeror shall identify three projects that it has performed within the last three years for the same or similar requirements.

8.4 Price Proposal The Offerors shall complete pricing table in Part 2.1.

PART 9 – Evaluation Factors for Award

9.1 Evaluation Factors

The Government will evaluate the quote to ensure that it is technically acceptable in accordance with the requirements in Part 3 and that the price is fair and reasonable. Award will be made lowest price technically acceptable offer (LPTA).

9.2 Technical Capability

a) The Offeror meets the capability that they can provide the proposed methods are in accordance with the parameters to accomplish the listed in section 3.

b) The Offeror meets the capability that they can provide to complete all of the analyses required in the contract, including the option line item for the leachables study.

c) The Offeror meets the capability to complete all of the testing in the time frame specified in the SOW, which includes a work plan.

9.3 Relevant Past Performance

The offeror has demonstrated that they are capable of performing related work within the last three years for the same or similar requirements.

9.4 Price The price proposal shall represent the Offeror’s response to the requirements of the solicitation.

The Offerors ability to complete pricing table in Part 2.1.

Appendix

Extractions on LDPE, PET, and Acrylic or Epoxy Resin / POM (polyoxymethylene) for various chemicals and compounds

Extracting solution/

Solvent

· filtration

5 hrs

· decant

· filtration

· dilution 2:3 toluene:methanol

GC-MS/MS for: Phenolic and nonphenolic antioxidants, Amides, Stearates, Phthalates, PAH

· decant

5 hrs

· decant

5 hrs

· decant ICP-MS/MS for extractable metals: Al, Sb, As, Ba, Cd, Co, Ge, Hg, Mn, Ni, Pb, Ti, V, Zn

5 hrs

· decant

5 hrs

· decant

5 hrs

· decant ICP-MS/MS for extractable metals: Sb, Ge

5 hrs

· decant

· decant

*All extractions should be performed in borosilicate glass and used within 4 hrs of preparation

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