FDA-RFQ_11176399.pdf

FDA-RFQ 11176399 Colonization and Internalization Studies of Tomatoes and Cantaloupes

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Part I-INTRODUCTION

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in 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.

The solicitation is issued as a Request for Quote (RFQ), using FAR 12 Acquisitions of Commercial Items and the Simplified Acquisitions Procedures of FAR 13. The solicitations document/incorporated provisions and clauses are those in effect through the current Federal Acquisition Circular: FAC 2005-95. The Government reserves the right to issue an award without discussion.

The associated North American Industry Classification System (NAICS) Code is 541712 All Other Professional, Scientific, and Technical Services with a small business size standard of 1,000 employees. This acquisition is being solicited for full and open competition.

PART 2- SERVICES AND PRICING

DESCRIPTION OF SERVICES

The Food and Drug Administration (FDA) has a requirement to conduct Colonization and Internalization

Studies of Tomatoes and Cantaloupes by Salmonella Species.

Contract Type: Commercial, FIRM-FIXED PRICE

PRICING TABLE

Item DESCRIPTION PRICE

0001 Kick off meeting

0002 Task 1: Plant Tomato and Cantaloupe

Varieties

0003 Task 2: Inoculation

Studies: Contamination of Plants

0004 Task 3: Test for the

Presence of Salmonella

0005 Task 4: The Final

Report

TOTAL FIRM FIXED PRICE AMOUNT $

PART 3-DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

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BACKGROUND AND OBJECTIVES

Food and Drug Administration/Center for Food Safety and Applied Nutrition’s has a requirement to conduct

Colonization and Internalization Studies of Tomatoes and Cantaloupes by Salmonella Species. Nontyphoidal salmonellae are the leading cause of hospitalization due to bacterial foodborne illnesses in the United States.

Despite the implementation of produce safety practices, foodborne outbreaks of fresh, ready-to-eat produce continues to result in significant outbreaks, illnesses and deaths. An estimated 14% of all foodborne outbreaks reported in North America are attributed to the consumption of raw or minimally-processed fruits and vegetables. This trend is likely to continue for two reasons: (i) the consumption of fresh produce commodities has increased due to the promotion of eating healthful, nutritious foods such as fruits and vegetables and (ii) many of these commodities are consumed raw with no kill step to eliminate any potential pathogen contaminants. Thus contamination at any step in the farm to fork continuum may result in illness to the American populace.

Much work has focused on the potential factors involved in post-harvest contamination. Not as much is known about pre-harvest contamination events, specifically if Salmonella is capable of colonizing and surviving on various plants while still in the field and, if so, at what stage of plant development, what region or part of the plant is most vulnerable to colonization, and how long is this pathogen able to persist on the plant after colonization. There is also not much known about the ability of this pathogen to internalized in the plants and transfer to the edible portions of the plant or developing fruit and thus to internally contaminated the fruit before harvest. These are critical questions to gain a greater understanding of pre-harvest contamination and to aid in the development of better Good Agricultural Practices (GAPs) that will work to prevent or greatly reduce the number of foodborne outbreaks due to the consumption of fresh fruits and vegetables.

To properly conduct these studies live, fully-virulent pathogens must be applied to the plants of interested to study their interactions. This cannot be done in an uncontrolled, open-field environment where the pathogen may migrate to unknown areas. Also full-sized plants, of the same cultivar used in at-risk areas need to be studied rather than micro or dwarf plants which are not used for commercial harvest. Thus there is a need to use a Phytotron, a BSL-3 compatible fully-enclosed greenhouse. This type of facility is large enough to accommodate full-sized plants and the number of plants that need to be studied. The study also requires unique group of individuals that are experts in the fields of public health, food safety, environmental microbiology, horticulture specifically with Solanaceous (tomato, pepper) cropping systems, plant pathology and water quality, all of which are critical to the completion of this contract.

CONTRACTOR RESPONSIBILITIES:

The contractor shall:

Independently, and not as an agent of the Government, furnish the necessary personnel, services, and otherwise do all things necessary for, or incident to, the performance of the work.

Provide staff including: a senior level scientist; lead scientist(s) and Phytotron facility support.

Provide personnel that are trained extensively in: classical and molecular microbiology, plant physiology, and biology in order to be capable of performing the tasks described in this contract to provide quality work.

Have access to a BSL-3 greenhouse within a Phytotron facility. This area shall consist of controlled access to authorized personnel only, HEPA air filtration, and equipment necessary for the disposal of contaminated

3 | P a g e soil, plants and water. Also, this facility shall have the ability to control temperature, humidity, daylight hours, and irrigation volume and timing, etc.

STATEMENT OF WORK

The contractor shall execute the following tasks:

Kick off meeting

Contractor shall arrange a kickoff meeting between all interested parties during the first 10 days after contract award.

The interested parties shall include Contractor, Project officer, COR and other persons deemed necessary.

The kickoff meeting shall include a discussion of the scope, goals of the project, milestones, timeline of activities, customized work, high-level configuration, and allocated resources and deliverables.

Recording of the meeting minutes shall be completed by the contractor and should be submitted within 3-5 days of meeting.

Upon successful completion of the kickoff meeting the Contractor shall:

TASK 1

Plant tomatoes within 60 days after award date and plant cantaloupe within 90 days after award.

Plant tomato and cantaloupe varieties in commercially available potting soil and maintain the test plants throughout the course of the studies in the BSL-3 area of a Phytotron facility.

o Tomatoes, commercially available varieties of red round tomatoes relevant to East Coast States, such as North Carolina and Virginia o Cantaloupes, commercially available cultivars including netted and non-netted, and eastern and western varieties o Record the number of each type of plant which will be determined by the specific inoculation experiment(s) performed (see Task 2) and stage of plant development when the plant will be tested for the presence of Salmonella (see Task 3) with a minimum of 20 of each, tomato, cantaloupe, and control plants per test and control group

Report of Findings

Provide within 14 days after the completion of Task 1.

o Reports shall include details of progress findings, and preliminary data on the project work plan and work to be performed in the next reporting period o Deliveries of the reports are to be sent monthly via email to CS and COR along with the invoice o

TASK 2

Conduct inoculation studies: 90 days after Task 1 completion for tomatoes and 90 days after Task 1 completion for cantaloupes

Perform inoculation studies such as those outlined in the listed publication using strains of Salmonella provided by FDA.

4 | P a g e o http://aem.asm.org/content/79/8/2494.full.pdf+html o Studies should include at a minimum:

o Study one- variation in inoculation levels, including high, medium and low inoculations plus control (20 of each, tomato, cantaloupe and control plants)using multiple Salmonella serovars to study serovar fitness within the plant.

o Study two- dose-response studies, using single serovar inoculation, in order to understand the minimum inoculation level (ie dose) needed to achieve contaminated fruit. 20 of each, tomato, cantaloupe and control plants per dose.

o Each study listed above shall include inoculations at various locations on the plant including blossoms and roots.

o Each study listed above shall consider timing of inoculation including right after transplant and during blossom development before fruit-set.

o Each study listed above shall include inoculation methods to mimic contamination as would occur in the pre-harvest environment during normal farming operations, such as drip-line irrigation contamination and aerial application of pesticide contamination.

o Each study listed above shall include appropriate control group(s)

Report of Findings:

Shall be provided within 14 days after the completion of Task 2.

o Reports shall include details of progress findings, and preliminary data on the project work plan and work to be performed in the next reporting period o Deliveries of the reports are to be sent monthly via email to CS and COR along with the invoice.

TASK 3

Test for the presence of the pathogens using appropriate FDA approved methods within 45 days after

Task 2 completion for tomatoes and 45 days after Task 2 completion for cantaloupes

For Salmonella testing:

o http://aem.asm.org/content/79/8/2494.full.pdf+html o FDA-BAM

(http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyti calManualBAM/ucm070149.htm) or any appropriate Salmonella method found in the Official Methods of Analysis (OMA: Official Methods of Analysis of AOAC INTERNATIONAL, 19th Ed., 2012. AOAC INTERNATIONAL, Gaithersburg, MD), or another appropriate method agreed upon with the COR.

For each Study (listed in Task2) the plants/fruits shall be tested for the presence of Salmonella.

Analysis should include at a minimum:

o A set of plants that are tested for the presence of Salmonella in the stem at least 7 days after root inoculation o A set of plants that are tested for the presence of Salmonella in the blossom at least 7 days after blossom inoculation o A set of plants where the fruits, at the surface and internally, are tested for the presence of Salmonella at the mature fruit stage, after root inoculation o A set of plants where the fruits, at the surface and internally, are tested for the presence of Salmonella at the mature fruit stage, after blossom inoculation

Report of Findings:

http://aem.asm.org/content/79/8/2494.full.pdf+html http://aem.asm.org/content/79/8/2494.full.pdf+html http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm070149.htm http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm070149.htm

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Shall be provided within 14 days after the completion of Task 3.

o Reports shall include details of progress findings, and preliminary data on the project work plan and work to be performed in the next reporting period o Deliveries of the reports are to be sent monthly via email to CS and COR along with the invoice.

TASK 4

Submit Final report no later than 140 days after completion of Task 3

The final report shall include all of the data generated from the project and analysis of all data collected.

o The data shall include all of the test data including but not limited to type of plant, site of inoculation, inoculation level, plant stage of development, inoculation schedule, pathogen used, growth conditions for plants, and dates of sample collection for microbial analysis.

o All data sheets for each microbiological analysis i.e. temperature, humidity, irrigation schedule, number of hours of daylight vs. night, etc. (see Task 2) shall be provided to the COR organized in appropriately bound notebooks. Additionally, results from the entire test data shall be provided in the form of a single Excel spreadsheet.

o Provide summary of the overall findings including the number and proportion of samples testing positive for Salmonella and provide a single comprehensive Excel file containing these data.

o Include tables, graphs, diagrams and photographs as necessary and in sufficient detail to comprehensively explain the results achieved.

PART 4-PERIOD OF PERFORMANCE

The period of performance for this statement of work shall be for 12 month following date of award. Dates

TBD.

PART 5-REPORTS/DELIVERABLES PAYMENT SCHEDULE

The following Schedule of Deliverables is based on FDA’s analysis of the work.

DELIVERABLE TASK WEEKS/MONTHS

AFTER AWARD

SOW SECTION

Project Kick-Off Meeting Kick-off Meeting Within 10 days of the award of the contract

Plant Tomato and

Cantaloupe Varieties

The contractor shall plant tomato and cantaloupe varieties in commercially available potting soil and maintain the test plants throughout the course of the studies in the BSL-3 area of a Phytotron facility.

60 days for tomatoes

90 days for cantaloupes

Task 1

Report of Findings Submit reports via email Within 14 days after completion of each task

Tasks 1,2, & 3

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Inoculation Studies:

Contamination of Plants

The contractor shall perform inoculation studies such as those outlined in the listed publication using strains of Salmonella provided by FDA.

150 days for tomatoes

180 days for cantaloupes

Task 2

Test for the presence of

Salmonella

The contractor shall test for the presence of the pathogen using appropriate FDA approved methods.

195 days for tomatoes

225 days for cantaloupes

Task 3

Final Report The contractor shall provide a final report summarizing all results from the period of performance. The final report shall include tables, graphs, diagrams and photographs as necessary and in sufficient detail to comprehensively explain the results achieved.

Within 140 day after completion of Task 3

Task 4

Monthly and ad hoc updates

The contractor shall provide brief ad hoc updates on an ongoing basis for the duration of the Period of

Performance for this project. Frequency will be at the discretion of the COR.

Updates shall include the current status of the project, recent progress to date, current problems which may impede progress and proposed corrective actions

Deliveries of the updates shall be sent monthly via email to CS and COR or discussed via teleconference where FDA staff will take notes

Monthly updates are not required when Reports of Findings for tasks 1-3 are due.

PART 6-CONTRACT ADMINISTRATION

CONTRACTING OFFICERS REPRESENTATIVE (COR)

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 following COR will represent the Government for the purpose of this contract: To Be Determined

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The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer:

Nicola Carmichael Rockville, MD 20857 Nicola.Carmichael@fda.hhs.gov Tel: 240-402-0109

The contact information for the Contracting Specialist:

Priscilla Harrison Rockville, MD 20857 Priscilla.Harrison@fda.hhs.gov Tel: 240-402-7609

INVOICE INSTRUCTIONS

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

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(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)

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-HHSAR AND FAR CLAUSES

HHSAR CLAUSES INCORPORATED BY REFERENCE:

To read the full text of the HHSAR Clauses as stated below, see http://www.hhs.gov/regulations/hhsar/subpart352.html

HHSAR Clause Description Date 352.203-70 Anti-Lobbying (Dec. 18, 2015) 352.208-70 Printing and Duplication (Dec. 18, 2015) 352.211-3 Paperwork Reduction Act. (Dec. 18, 2015) 352.222-70 Contractor Cooperation in Equal Employment Investigations (Dec. 18, 2015) 352.224-70 Privacy Act. (Dec. 18, 2015) 352-223-70 Safety and Health (Dec. 18, 2015) 352.237-74 Non-Discrimination in Service Delivery (Dec. 18, 2015)

FAR CLAUSES

http://www.hhs.gov/regulations/hhsar/subpart352.html

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FAR CLAUSES BY REFERENCE

52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this\these addresss(es):

http://farsite.hill.af.mil/VFHHSARA.HTM https://www.acquisition.gov/?q=browsefar

FAR Clause Description Date 52.204-16 Commercial and Government Entity Code Reporting (Jul 2016) 52.212-1 Instructions To Offerors – Commercial items (Jan 2017) 52.212-2 Evaluation -- Commercial Items (Oct 2014) 52.212-4 Contract Terms and Conditions – Commercial Items (Jan 2017) 52.213-2 Invoices (Apr 1984) 52.237-2 Protection of Government Buildings, Equipment, and Vegetation (Apr 1984)

FAR CLAUSES BY FULL TEXT

52.217-8 -- Option to Extend Services. (Nov 1999) As prescribed in 17.208(f), insert a clause substantially the same as the following: The Government may require continued performance of any services within the limits and at the rates specified in the contract.

These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 10 (Ten) days, within which the Contracting Officer may exercise the option].

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

Commercial Items (Nov 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, 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:

___ (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).

http://farsite.hill.af.mil/VFHHSARA.HTM https://www.acquisition.gov/?q=browsefar

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___ (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).

___ (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 (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Nov 2016) (15 U.S.C. 637 (d)(4)).

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___ (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 (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)).

___ (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 (Oct 2016) (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).

___ (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).

___ (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).

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___ (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.)

Per Court Injunction dated 24 Oct 2016 and OMB memo dated 25 Oct 2016 do not implement the following until further direction.

___ (35) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (Oct 2016). (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

___ (36) 52.222-60, Paycheck Transparency (Executive Order 13673) (Oct 2016).

___ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

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

___ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693).

___ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

___ (40) (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.

___ (41) (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.

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

___ (43) (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__ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

___ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

___ (46) 52.223-21, Foams (Jun 2016) (E.O. 13696).

___ (47) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

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___ (48) (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.

___ (49) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

___ (50) 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).

___ (51) 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).

___ (52) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (53) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (54) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C.

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

___ (55) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C.

2307(f)).

__x_ (56) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (57) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (58) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (59) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (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, Non displacement of Qualified Workers (May 2014) (E.O. 13495)

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

__x_ (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).

__x_ (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) 52.226-6, 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)

15 | P a g e 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 (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.

(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 (Sep 2016) (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) ____ (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).

Per Court Injunction dated 24 Oct 2016 and OMB memo dated 25 Oct 2016 do not implement the following until further direction.

(xvi) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (Oct 2016) (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through

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April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

(xvii) 52.222-60, Paycheck Transparency (Executive Order 13673) (Oct 2016).

(xviii) 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).

(xix) 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.

(xx) 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.

CONTRACTOR ADVERTISING OF CONTRACT AWARD (Sept. 2012) The Contractor shall not refer to the product or service awarded under this contract in commercial advertising, as defined in FAR 31.205-1, in any manner which states or implies the Food and Drug Administration's approval or endorsement of the product or service being provided; or, states or implies that the product or service being provided is considered to be superior to other industry products or services. The Contractor may request the Contracting Officer to make a determination as to the propriety of promotional material.

52.232-40 Providing Accelerated Payments 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.

PART 8 – SPECIAL CONTRACT REQUIREMENTS

Government Holidays Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov due to inclement weather.

January (New Year’s Day) January (Martin Luther King Day) February (President’s Day) May (Memorial Day) July (Independence Day) September (Labor Day) October (Columbus Day) November (Veterans Day) November (Thanksgiving)

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December (Christmas Day)

PART 9– INSTRUCTIONS TO THE OFFERORS CONDITIONS, AND NOTICES TO OFFERORS

Contract Type: Commercial Items-Firm Fixed Price

Evaluation award criteria: The government will award this contract to the lowest priced technically acceptable quote.

Offeror shall include a price breakout for all components for Items 0001 through Item 0005 (SEE

PART 2- PRICE FOR TABLE TO BE COMPLETED).

The government is not responsible for locating or securing any information which is not identified in the proposal. To ensure information is available, offerors shall furnish as part of their quote, all descriptive material necessary for the Government to unequivocally determine the price quote in offered meets the technical requirements and the prerequisite qualifications as stated in section 4.

Technical Proposal Format and Page Limits:

Offerors’ technical proposals shall not exceed 25 pages, 8.5 inch by 11 inch with margins no less than one inch on each boarder with a font size no smaller than 12 point, except for tables and graphics which shall have a font size no smaller than 9 point. The FDA will evaluate only the pages within the page limitations, starting at the first page and continuing up to the 25 page limit. The 25 page limit excludes the following:

Offerors shall include a cover page that includes the following: Point of contact (name, telephone number, and email address), Business size and type (e.g. small, 8(a) small business, veteran-owned small business, woman-owned small business, etc.), DUNS and TIN numbers, and as an addendum to the cover letter:

Completed representations, certifications, and other statements including certification that all company information listed in the SAM website is complete, accurate, and current (see FAR 52.212-3, Offeror

Representations and Certifications -- Commercial Items (MAR 2015))

PART 10-EVALUATION OF PROPOSALS:

This acquisition shall be conducted using the policies and procedures in the Federal Acquisition Regulation

(FAR). Performance Assessment Group (PAG) shall evaluate proposals in accordance with evaluation scheme, factors and criteria in this section of the Request for Quotations (RFQ). The PAG shall select an offeror for award. An offeror’s proposal will be eliminated from consideration prior to completion of evaluations if the proposal is so deficient or incomplete as to be rendered unacceptable and to preclude a meaningful evaluation. For example, an offeror’s proposal shall be deemed unacceptable if it does not represent a reasonable effort to address the minimum requirements of the Statement of Work (SOW). The offeror will be notified in the event his proposal is eliminated from evaluation.

The Government intends to make a single award as a result of this RFQ. However, the Government reserves the right to make no award at all.

Evaluation Factors:

Factor 1: TECHNICAL APPROACH/TECHNICAL SOLUTION

Instructions: The Offeror shall provide a narrative that demonstrates an understanding of the requirements and an overall technical approach to performing work. The Offeror’s response shall include any assumptions

18 | P a g e upon which the approach is based, any issues or risks anticipated, and a detailed plan to manage or mitigate the risks.

Factor 2: FACILITY

Instructions: The Offeror shall provide a Facilities Capability Statement describing the facility where the work will be conducted. This Statement shall include information on Biosafety level (BSL) of the facility, and the Offeror’s permission to access and use the facility including any of the BSL-3 area(s).

FACTOR 3: RELEVANT PAST PERFORMANCE

Instructions: The Offeror shall provide a narrative describing a minimum of three (3) contracts that are most similar to the Quality Assurance/Quality Inspection Review Support requirements in terms of size, scope, complexity, and type. The cited projects must be ongoing or have been completed within the last five (5) years. The narrative shall demonstrate the Offeror’s experience by describing its role and specific responsibilities, the size of the clients’ organization, and demonstrate the ability to overcome risks encountered and mitigation steps taken for these projects. Projects listed may include those entered into by the Federal Government, agencies of state and local Governments, and commercial customers including grants. Each task area in the SOW must be reflected in one or more of the relevant experiences cited. Offerors shall also provide information on past performance problems and any resulting corrective actions.

In addition to the narrative, for each project identified above, the Offeror shall submit the following information:

• Name of contracting activity (Federal Government agency, local government, commercial customer, or grant);

• Contract number;

• Contract type (e.g., firm fixed-price; labor hour, time and materials, etc.);

• Total contract value, and subcontract value (if applicable);

• Performance role, i.e. Prime or Sub-contractor;

• Contracting Officer’s contact information (name, phone number, email – if applicable);

• Project Officer/Contracting Officer’s Representative (COR) contact information (name, phone number, email – if applicable);

• Administrative Contracting Officer contact information – if different from item #6 (name, phone number, email);

• Hardware and software technologies used on the project and reason for selecting that particular technology;

• Period of Performance – these contracts must be in progress or have been completed within the past five years before the quote submission date.

Note: The list may include contracts/orders on which the Offeror served as a subcontractor, provided that the subcontract was similar in type, scope, complexity, size, and technology to this effort; and if a subcontract, contact information for the prime contractor, not the customer, should be included.

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The FDA will evaluate proposals based on the following rating system:

The following adjectival rating descriptions shall be used for Evaluation:

The Government will use the following three (3) factors to evaluate proposals and make a Lowest Price

Technically Acceptable determination (factors are listed in descending order of importance):

1. Technical (Technical Approach/Technical Solution,

2. Facilities

3. Past Experience/Past Performance

SPECIFIC EVALUATION APPROACH FOR EACH EVALUATION FACTOR

Offerors shall be evaluated based upon the following technical evaluation factors and criteria:

Note: For technical evaluation factors 1, 2, and 3, the Government will evaluate responses as they relate to the information contained within the SOW Attachments to the extent that the information directly relates to specific evaluation criteria contained within this section.

FACTOR 1: TECHNICAL UNDERSTANDING AND APPROACH

Category Definition

Excellent

Offeror convincingly demonstrated superior understanding of the solicitation requirements and proposed resources and an approach that have a very low probability of not successfully meeting the

FDA’s needs. Offeror has significant strengths and no significant weaknesses.

Very Good

Offeror demonstrated a very good understanding of the solicitation requirements and proposed resources and an approach that have a somewhat low probability of not successfully meeting the FDA’s needs. Offeror has some strengths and a few weaknesses, but the strengths more than offset the weaknesses.

Acceptable

Offeror demonstrated an adequate understanding of the solicitation requirements and proposed resources and an approach that will marginally more likely than not successfully meet the FDA’s needs.

Offeror has strengths and weaknesses, and the weaknesses are greater than the strengths.

Unacceptable

Offeror is technically unacceptable. Offeror does not demonstrate an understanding of the solicitation requirements and/or proposed resources and an approach that have a high probability of not successfully meeting the FDA’s needs. Offeror has significant weaknesses that are substantially greater than any of its strengths.

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Evaluation: The FDA will evaluate the extent to which the Offeror’s technical narrative presents a sound understanding of the type of work to be performed in each task area and identifies appropriate assumptions and risks for tasks of this type with sufficient mitigation or management strategies.

Factor 2: FACILITY

Evaluation: The FDA will evaluate the extent to which the Offeror’s facilities statement demonstrates the biosecurity level (BSL) of the facility where the work will be conducted and the permissions of the Offeror to access the facility to conduct the proposed work.

FACTOR 3: RELEVANT PAST PERFORMANCE

Evaluation: The FDA will evaluate the extent to which the Offeror’s quote demonstrates relevant past performance on current and past projects similar to the requirements of the SOW in terms of size, scope, technology, complexity, and type. The FDA will evaluate the Offeror’s ability to overcome difficulties encountered during performance without disruption to the program.

Period of acceptance of offers: The offeror shall agree to hold the prices in its offer firm until September 30, 2017.

RESPONSE DATES:

Quotes Due Date: All quotes shall be submitted via email Priscilla.harrison@fda.hhs.gov By 3:00 PM EASTERN TIME on March 20, 2017.