FDA-SOL-1168268A.doc

FDA-SOL-1168268A - Collaborative Study of Non-Contact Infrared Thermometers for Fever Screening

PART 1 – Description This is a Combined Synopsis/Solicitation for Commercial Items prepared in accordance with the format in FAR Subparts 12.6 and 13.5 and as supplemented with additional information included in this notice. This Request for Quotation (RFQ) announcement constitutes the only solicitation that will be issued; a quote is being requested and a written solicitation will not be issued. The government contemplates a Firm-Fixed Price Purchase Order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-88 dated May 26, 2016.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541990 –All Other Professional, Scientific, and Technical Services. This action is being issued as full and open competition.

PART 2 – Supplies or Services and Prices/Costs The U.S. Food and Drug Administration (FDA), require professional a service contract for a collaborative study of Non-Contact Infrared Thermometers (NCIT) and thermal cameras for fever screening at a clinic within a 60 minute drive of the FDA White Oak campus, 190903 New Hampshire Avenue, Silver Spring, MD. The purpose of this study is to further evaluate thermal camera performance relative to NCITs, while facilitating development and regulation of thermal cameras and NCITs for highly accurate fever screening.

Pricing Table:

PART 3 -Technical Requirements

Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, facilities, equipment and otherwise do all things necessary for or incidental to the performance of the work as described below:

The FDA and local clinic will collaborate in the study of the accuracy and effectiveness of NCIT and IR Cameras in the accurate measurement of patient temperatures for the detection of fever. FDA will use the local clinics to recruit patients for the studies. FDA will provide the IR devices used in this study and pay for contract personnel involved in collecting data from patients recruited for this study. FDA will provide training for investigators working with the patients, and any special backdrops, etc. needed for the study. The local clinic will provide clinical space, coordinate IRB approval for the study and work with FDA to identify qualified contract personnel to collect thermometry and thermographic data from patients recruited for this study within the clinic. The Contracting organization shall recruit personnel who will have the necessary qualifications, clearances, experience, training, technical and clinical skills to operate within the institution and necessary to accomplish the specific tasks required for the study under the direction of an institutional co-investigator or institutionally approved clinical specialist and provide the relevant supporting institutional regulatory fees, salaries, and expensed for contract personnel.

The contracting organization shall have any necessary CRADAs in place, and pay any institutional regulatory fees, such as IRB filing fees, salaries, and expenses for contract personnel. The contractor shall recruit personnel, who will have the necessary qualifications, clearances, experience, training, technical and clinical skills to operate within the institution and necessary to accomplish the specific tasks required for the study under the direction of an institutional co-investigator. Contractor shall have the training, skills and qualifications to recruit patients, set up the measurement apparatus and verify that the space meets program requirements prior to daily measurements, to operate the NCIT and thermal cameras to collect patient data, record patient measurements according to the study protocol, store patient information in the institution in accordance to HIPAA regulations, and to properly break-down and store the apparatus at the end of the day. The contracted personnel must have the ability to discern the colors of the rainbow scale of the screening thermal camera. FDA will train the contract personnel in operation of the specific devices used in the study, to enable the personnel to set up the measurement apparatus and verify that the chosen clinical space for the study meets program requirements, to properly handle and store the equipment, and in the data collection protocols. Data will be stored in such a way that it will be routinely available to FDA personnel on a weekly basis.

The following specific tasks shall be performed under this study:

1. General

a) The contract clinical personnel will undergo training onsite at FDA’s White Oak laboratories on the capabilities and use of the FDA reference thermometers along with the six various test samples of NCITs and two samples of thermal cameras.

b) Techniques and parameters for obtaining patient temperature measurements using both the NCITs and the cameras in the clinical protocol will be further developed and refined along with FDA and the local clinical investigators. Estimated data collection time is up to 30 minutes per patient.

c) IRB approval (FDA and the local clinic) for performing the clinical studies will be obtained by the investigators.

d) Informed consent will be obtained from each human volunteer participating in the clinical study.

2. General Clinical

a) The maximum number of patients planned for this study will be up to 700 and can be adjusted by FDA based on periodic statistical evaluation of the results at specified intervals after the trial begins based on the statistical power of the

b) data collected. During any given month, the goal is to have a number of febrile patients up to 50%.

c) Data must be collected and recorded per FDA protocol for each patient. FDA will collect the results periodically during the study. Temperatures of each subject will be measured with both NCITs and thermal cameras (details in section 3f/g below). Both febrile and afebrile subjects will be measured in an identical manner, though additional measurements will be made on the afebrile patients.

d) In order to identify and minimize any bias resulting from order of measurements, the order of thermal camera/NCIT measurements will be alternated.

e) Core body temperature estimates based on oral measurements will be obtained for each patient using the FDA reference thermometer or calibrated clinical thermometer.

f) Ambient temperatures and relative humidity will be recorded for each patient with FDA provided equipment.

3. NCIT testing

a) ten sets of NCIT samples from six different NCIT manufacturers, totaling up to

60 thermometers, will be obtained and labelled by FDA and provided to the contracted staff with fresh batteries for testing. One set of six NCIT samples will be used each day for the patients recruited.

b) Each of the six NCIT manufacturers’ printed labels and instruction manuals will be reviewed to determine the optimum distance specified for obtaining temperature measurements on human subjects.

c) For each afebrile and febrile patient, each model of NCIT will be used to measure the volunteer’s temperature, at the specific manufacturer’s labeled optimum distance following the manufacturer’s instructions for use, using the following protocol: measure the temperature three times in sequence for a single NCIT.

Repeat the triplicate measurements for a single thermometer of each model of

NCIT for a total of eighteen (18) measurements.

4. Thermal camera temperature measurements

a) Two thermal cameras with different accuracy, resolution, and sensitivity levels have been obtained by FDA and will be delivered to the clinical site for use in the study. Clinical investigators will be trained to use each thermal camera and on methods for acquisition, analysis and storage of thermal images.

b) The thermal camera temperature measurements will adhere FDA protocol based on the requirements in IEC 80601-2-59 standard and ISO/TR13154 technical report for accurate fever measurements.

c) The operator will be trained by FDA investigators to be able to operate the screening thermal camera, be able to recognize common system problems or faults, be proficient in recognizing the proper alignment and positioning of a person in the thermogram, etc. The operator should be able to discern the colors of the thermal images.

d) FDA will work with the clinical collaborator to prepare the clinical measurement space. The operating area should be a stable indoor environment free from significant natural and forced convective airflow. FDA will evaluate the identified clinical space and backdrop behind the individual being screened and the surroundings that should be non-reflective, thermally uniform, high emissivity

(non-reflective in the IR spectrum) and light in color (visible spectrum), with minimal reflected IR radiation. The lighting source should not produce significant

IR emissions. Environmental IR sources such as sunlight, heaters, electrical sources, and strong lighting (e.g. incandescent, halogen, quartz tungsten halogen) should be minimized or avoided in the screening area. If standard clinical space proposes a problem, FDA will develop a backdrop and portable measurement space for taking the IR thermograms.

e) The radiometric or raw data and the converted temperature data from the sensor will be read and stored in a predetermined format on FDA supplied computers.

f) A blackbody provided by FDA will be used as an external temperature reference, with the temperature set close to normal body temperature (e.g., 35°C). Both the external temperature reference source and the face of the individual being screened should be captured. The thermogram of the face shall fill at least 3/4 of the image area.

g) The subject being screened and the external temperature reference source should be in the correct position and orientation relative to the camera for proper focal distance, depth of field and image capture. The face of the subject being screened should be dry (avoid facial washing before screening) and unobstructed by hair, eyeglasses, and other objects.

h) The screening thermal camera should be positioned perpendicular, both horizontally and vertically, to the face of the individual being screened so that both inner canthi can be imaged.

Note: Details of the clinical study protocol may be modified during the study.

3.1 Staffing and Key Personnel

The contractor shall comply with the terms of HHSAR Clause 352.270-5.

The following labor categories are considered key personnel:

Director/Senior Project Manager

PART 4 – Deliverables Table

PART 5 – Inspection and Acceptance The Contracting Officer’s Representative (COR), to be provided at time of award, will perform inspection and acceptance of equipment to be provided. For the purpose of this Part the COR is the authorized representative of the Contracting Officer. Inspection and acceptance will be performed at the location identified in part 6. Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COR within 30 days of receipt. The instrument shall not be accepted until specifications herein have been confirmed.

PART 6 – Deliveries or Performance Satisfactory performance of this contract shall be deemed to occur upon performance of the work described in the Statement of Work in PART 3 of this contract and upon delivery and acceptance by the Contracting Officer, or the COTR, of the services, plans and reports required at the dates specified within PART 4 of this contract. Deliveries of the reports are to be sent via email to the COTR's (TBD).

6.1 PERIOD OF PERFORMANCE

The period of performance for this contract is one (1) year from the award date.

6.2 PLACE OF PERFORMANCE

The contracting company may perform portions of the study at multiple locations within the clinic at the facility. The locations will be validated by the FDA to meet the lighting and draft limitations of the study for consistency in accordance with section 4.d).

PART 7 – Contract Administration Data Contracting Officers Representative (COR) The COR, to be determined upon contract award, will represent the Government for the purpose of this contract.

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.

Contracting Officer (CO) 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.

Contracting Officer: Linda Troutman

60 8th Street, NE

Atlanta, GA 30309

Linda.Troutman@fda.hhs.gov

404-253-1258

Contract Specialist:

Linda Troutman

60 8th Street, NE

Atlanta, GA 30309

Linda.Troutman@fda.hhs.gov 404-253-1258

Payments:

Contractor will be paid upon complete and acceptance of the deliverable.

FDA Invoice Requirements 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 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; and (c) any other supporting information necessary to clarify questionable expenditures; (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 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 financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact as referenced on the purchase order; and

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

An electronic invoice is acceptable if submitted 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.

Questions regarding invoice payments shall be directed to the FDA Payment Office at telephone number provided above.

PART 8 - FAR and HHSAR CLAUSES 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulation (FAR) 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: http://farsite.hill.af.mil/.

52.212-2 Evaluation – Commercial Items (Oct 2014)

52.212-3 Offeror Representations and Certifications—Commercial Items (May 2014)

An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov . If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision

FAR Clauses in Full Text

52.212-5 Contract Terms And Conditions Required To Implement Statutes Or Executive Orders Commercial

Items (Feb 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 (Apr 2010) (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 (Jul 2013) (Pub. L. 109-

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

(5) [Reserved]

(6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L.

111-117, section 743 of Div. C).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (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 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

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

(13) [Reserved]

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

(ii) Alternate I (Nov 2011).

(iii) Alternate II (Nov 2011).

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

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

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

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

(17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (15 U.S.C. 637 (d)(4)).

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

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

(iv) Alternate III (Oct 2014) 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 Representation (Jul 2013) (15 U.S.C. 632(a)(2)).

(23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business

(EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

(24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the

WOSB Program (Jul 2013) (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 2014) (E.O. 13126).

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

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

_X_ (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (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 (Jul 2014) (38 U.S.C. 4212).

_X_ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O.

13496).

_X_ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

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

_X_ (34) 52.222-54, Employment Eligibility Verification (Aug 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

(35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May

2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

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

(36) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514

(ii) Alternate I (Jun 2014) of 52.223-13.

(37) (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.

(38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

(39) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514).

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

_X_ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O.

13513).

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

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

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

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

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

(43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (44) 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).

(45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

(47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C.

5150).

(48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C.

2307(f)).

(49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

X_ (50) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31

U.S.C. 3332).

(51) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul

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

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

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

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

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

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

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

(1) 52.222-17, Non-displacement 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 2014) (E.O. 13658).

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

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

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

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

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

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

(e)

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

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($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, Non-displacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

(iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). (v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

(vi) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (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 (Jul 2014) (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 (Aug 2013).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658).

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section

862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

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

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

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

(End of Clause)

HHSAR Clauses HHSAR clause full text can be accessed electronically at: http://farsite.hill.af.mil/vfhhsara.htm 352.203-70 Anti-Lobbying (Dec 2015)

352.208-70 Printing and Duplication (Dec 2015)

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations. (Dec 2015)

PART 9: INSTRUCTIONS TO OFFERORS

9.1 This contract incorporates one or more provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html:

52.212-1 Instructions to Offerors – Commercial Items (APR 2014)

52.212-3 Offeror Representations and Certifications-Commercial Items (MAY 2014)

An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via https://www.acquisition.gov.

9.2 Quote Format

The cover letter shall include; FOB point; a POC (name and telephone number); a statement from the offeror verifying that they are SAM Registered; business size; and payment terms.

In addition to a cover letter, offerors shall submit proposals with two separate attachments preferably in adobe portable document format (pdf) or if not, in another commonly used format, such as Microsoft Word. One attachment (Volume 1) shall consistent of exclusively all technical, management and relevant past performance documentation and the other attachment (Volume 2) shall consistent of only all price and supportive documentation.

VOLUME 1: TECHNICAL PROPOSAL, MANAGEMENT/STAFFING PLAN AND RELEVANT PAST PERFORMANCE Technical Proposal:

Offerors shall submit a technical proposal that comprehensively demonstrates the offeror has the technical capability to perform all tasks described in this solicitation.

Offerors technical proposal shall not exceed 25 8.5 inch by 11 inch pages 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:

A cover page and table of contents

Resumes, although resumes shall not exceed two pages per resume.

Relevant past performance information.

Factor 1: Technical Capabilities Sub-Factor 1: The Offeror shall describe how their company developed metrics regarding successes/failures/limitations for a similar study(s).

Sub-Factor 2: The Offeror shall describe their company’s knowledge level of the recruitment for personnel for a similar study.

Sub-Factor 3: The Offeror shall describe their company’s knowledge level regarding specific technical capabilities and logistical processes for a similar study.

Sub-Factor 4: The Offeror shall describe how their company has measured successes/failures/limitations for a similar study, if applicable Factor 2: Management/Staffing Plan Sub-Factor 1: Management Plan The Offeror shall provide examples to demonstrate that your company has the following capabilities to devote to the development of a recruitment program:

a) strong program management skills b) flexibility

c) creative and innovative thought processes

Sub-Factor 2: Staffing Plan The Offeror shall describe the amount of staff and their experience that will be available or responsible for this study.

Factor 3: Relevant Past Performance:

Sub-Factor 1: Offerors shall provide a matrix of recent, relevant past performance, which shall include the following: a short description of the work, the dates of work performance, the name of the clients and their phone numbers and email addresses, so the FDA may be able to conduct a reference check. Proposals shall include a minimum of three recent, relevant references for similar requirements in terms of size, scope, duration, complexity, and price to the work described in this solicitation that have been performed within the last three years. Offerors shall also provide information on past performance problems and any resulting corrective actions.

VOLUME 2: BUSINESS/PRICE PROPOSAL Price:

Sub-Factor 1: The Offeror shall complete the pricing table as described in Part 2 and provide supportive pricing information to assist the Government in its determination that the prices quoted are fair and reasonable.

PART 10 - EVALUATION FACTORS FOR AWARDS

EVALUATION CRITERIA

The FDA’s source selection decisions will be based on a best value tradeoff process which incorporates the following four factors and sub factors listed in descending order of importance:

The Technical, Management/Staffing Plan, Relevant Past Performance, and Price evaluation criteria are described below. The FDA anticipates making a single award to a responsible offeror that offers the best value to the Government.

TECHNICAL EVALUATION

The FDA will technically evaluate each proposal based on the following scheme:

Factor 1: Technical Capabilities The Offeror’s technical capabilities will be evaluated based on their knowledge and experience with providing research support personnel familiar with operating within research protocols and making the appropriate amendments as necessary, experience in providing research support personnel to conduct IRB approved studies; existence of CRADAs and agreements to provide personnel qualified to work within the local clinic. Ability to recruit personnel with the skills and qualification needed for the above study for the duration of the study.

Factor 2: Relevant Past Performance The Government will evaluate three recent, relevant past performances which shall include three references for similar requirements in terms of size, scope, duration, complexity, and price to the work described in this solicitation that have been performed within the last three years.

Factor 3: Management/Staffing Plan The Offeror’s ability to provide a strong management and staffing plan will be evaluated. This includes program management skills, flexibility and creative and innovative thought processes. The plan could consist of examples of effective communication, staff flexibility/optimization and success at meeting project deadlines, and workload management and innovative thought process capabilities

Factor 4: Price The Offeror’s pricing table, as described in Part 2, and supportive pricing information will assist the Government in its evaluation that the prices quoted are fair, reasonable and support the relevant needs and objectives of this solicitation.

QUOTATIONS shall be submitted via email to Linda.Troutman@fda.hhs.gov, September 07, 2016, 9:00 am ET.

Note: Late proposal will not be evaluated.