RFP-2019-1214498_Diagnostic_Ultrasound_System__.docx

Notice Type: Combined Synopsis/Solicitation

Subject: Request for Quotes: FDA-RFP-2019-1214498 - Diagnostic Ultrasound System.

Section 1 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotes are being requested and a written solicitation will not be issued.

Solicitation Number # FDA-RFP-2019-1214498 is being issued as a Request for Quotations (RFQ). The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2019-01. This requirement is being solicited under full and open competition using the Simplified Acquisition Procedures per FAR Subpart 13.5.

The associated NAICS Code is: 334516 (Analytical Laboratory Instrument Manufacturing).

Background.

The U. S Food & Drug Administration, Office of Acquisitions and Grants Services has a requirement for the procurement of a Diagnostic Ultrasound System. At the FDA White Oak Campus (WO), there are three research groups in Office of Science and Engineering Laboratories (OSEL) that are involved with regulatory research related to diagnostic ultrasound systems:

1. The “Diagnostic Ultrasound” group in Division of Imaging, Diagnostics and Software Reliability (DIDSR).

2. The “Medical Ultrasound” Lab in the Division of Applied Mechanics (DAM).

3. The “Photoacoustic Laboratory” in the Division of Biomedical Physics (BDP).

Research currently being conducted includes development of new phantoms and associated test methods for ultrasound elastography, quantitative ultrasound, and bench tests to replace clinical imaging tests of ultrasound systems for acceptance testing, QA and regulatory substantial equivalence evaluation (DIDSR), photoacoustic imaging and oximetry (DBP) and acoustic output testing methods for evolving newer ultrasound modalities (DAM). These FDA cutting-edge programs are focused on the evaluation of leading-edge ultrasound systems.

Section 2. Contract Type The Government intends to award a Firm Fixed-Price Contract.

Section 3 Description

3.1. Specifications/Salient Characteristics.

The requested system shall at a minimum, have the following salient and functional characteristics:

1. An ultrasound scanner with the following features

a. A cart-based touch screen system with softkey controls to minimize hardware keys and knobs.

b. 21 in (diagonal) monitor HD resolution or better with 16x9 aspect ratio.

c. Wired and wireless connectivity.

d. Minimum 2TB internal storage for images and other data.

e. Standard operating modes: b-mode, m-mode, spectral Doppler, Color Doppler Imaging, Power Doppler Imaging, Harmonic Imaging, 3D acquisition and display, 4D acquisition and Display, Strain Elastographic Imaging, Acoustic Radiation Force Impulse Elastography, Shear Wave Point Quantification and SW Elastographic imaging.

f. External Triggering for ECG and Respiratory Gated Acquisition.

g. Pinless transducer connections.

h. Spatial Compounding.

i. Speckle reduction image post-processing.

j. Grayscale and edge optimization image post-processing.

k. Multimodality image review.

l. Doppler Optimization Post-Processing.

m. Panoramic (wide field of view) imaging.

n. Video clip storage and capture.

o. Video Output via HDMI or Display port.

p. Export of image files in DICOM, JPEG, AVI formats.

q. Image fusion capable.

r. Deep abdominal imaging to at least 30cm.

s. Shear Wave Elastography to at least 12cm depth.

t. Strain and Shear Wave Elastography implemented on both linear and curved array transducers.

u. Cardiac Acquisition Package.

v. Measurement packages for Abdominal, small parts, OB and cardiac.

w. Research License with automatic and manual acquisition of RF data for research purposes in a standard file format.

2. Ultrasound Transducers for the Ultrasound system.

a. 2.0 – 2.5 MHz center frequency multi-row (1.5D or better) Deep Abdominal Curved Array Transducer.

b. 3-4 MHz center frequency standard abdominal/ OB transducer.

c. 5 – 6 MHz center frequency high frequency curved array transducer.

d. 5 – 6 MHz center frequency linear array transducer.

e. 7.5 – 8 MHz center frequency small parts/vascular linear array transducer 38mm or longer.

f. 9 – 11 MHz center frequency small parts linear array transducer 38mm or longer.

g. 5 – 8 MHz center frequency curved array endovaginal / endocavitary transducer.

h. 2 – 4 MHz center frequency phased array transducer.

i. 6 – 9 MHz center frequency tightly curved array or phased array suitable for neonatal head imaging.

3.2. Deliverables.

The following shall be delivered to FDA:

Note****: Grey market or refurbished products will not be accepted.

3.3. Other Considerations.

a) Warranty: The vendor shall provide a one-year warranty (12 Months) to cover parts and services.

b) 16 hours of on-site applications training/support.

c) On-line and printed/printable manuals.

d) On-line and email support for research interface/license.

e) System Delivery: 90 days.

3.4. Packing, Marking, Delivery and Shipping/Place of Performance:

At a minimum, all deliverables shall be marked with the contract number and Contractor’s name and delivered within 90 days after contract award at the US Food and Drug Administration (FDA) facility address listed below:

FDA White Oak Campus:

Food and Drug Administration Attention: TBD U.S. Food and Drug Administration’s 10903 New Hampshire Avenue White Oak 62 Room 3131 (Ultrasound Laboratory) Silver Spring, MD 20993

All required materials shall be delivered in immediate new, usable and acceptable condition. The Contractor shall deliver all requested items to the FDA White Oak Campus, unless otherwise instructed via contract modification.

3.5. Contracting Officer’s Technical Point of Contact (TPOC)

The TPOC is responsible for the acceptance of the items or services requested.

3.5.1. Technical Direction

A. Performance of the work under the resultant contract shall be subject to the technical direction of the TPOC. The term "technical direction" is defined to include the following:

i). Technical directions to the Contractor which shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual scope of work;

ii). Providing information to the Contractor for assistance in the interpretation of specifications, or technical portions of the work description, and iii). Reviewing and, where required by the contract, approving of technical reports, specifications, and technical information to be delivered by the Contractor to the Government under the requirement.

B. Technical direction shall be within the general scope of work stated in the contract. The TPOC does not have the authority to, and may not, issue any technical direction which (1) constitutes an assignment of additional work outside the general scope of the contract; (2) constitutes a change as defined in the contract clause entitled "Changes, FAR 52.212 – 4 (c)." (3) in any manner causes an increase or decrease in the total contract price; or (4) changes any of the expressed terms, conditions, or specifications of the contract.

C. All technical directions shall be issued in writing by the TPOC or shall be confirmed by him/her in writing within five (5) working days.

D. The Contractor shall proceed promptly with the performance of technical directions duly issued by the TPOC in the manner prescribed by this clause and within his/her authority under the provisions of this clause.

E. If, in the opinion of the Contractor, any instruction or direction issued by the TPOC is within one of the categories as defined in B. (1) through B. (4) above, the Contractor shall not proceed but shall notify the Contracting Officer, in writing, within five (5) working days after the receipt of any such instruction or direction and shall request the Contracting Officer to modify the Contract accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor, in writing, that, in his/her opinion, the technical directions are within the scope of this clause and do not constitute a change under the "Changes" clause of the contract. The Contractor shall thereupon proceed immediately with the direction given. Any failure of the parties to agree upon the nature of the instruction or direction, or upon the contract action to be taken with respect thereto, shall be subject to the provisions of the contract clause entitled "Disputes."

3.5.2. Contracting Officer’s Authority

The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of the statement of work. In the event the Contractor effects any changes at the direction of any person other than the CO or the TPOC the changes shall be considered to have been made without authority and no adjustment shall be made in the contract price to cover any increase in costs incurred as a result thereof. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract and modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds.

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

Section 4. Contract Clauses

4.1 FAR 52.212-4 - Contract Terms and Conditions – Commercial – Items (Oct 2018).

4.2. FAR 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 these addresses:

www.acquisition.gov/far/index.html and http://www.hhs.gov/policies/hhsar/subpart301-1.html.

Health and Human Services Acquisition Regulation (HHSAR) Clauses can be viewed in full text at: http://www.hhs.gov/policies/hhsar/subpart352.html#Subpart352.1-InstructionsforUsingProvisionsandClauses

4.3. Service Records and Reports: The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA TPOC and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month; negative reports are required.

4.4. FAR 52.217-8 - Option to Extend Services. (Nov 1999)

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].

4.5. Security and Privacy

Contractor personnel performing work under the Contract r shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems. The contractor agrees that contractor personnel will not divulge or release data or information developed or obtained in connection with the performance of the Contract, unless made public by FDA or upon written approval from the Government. Except as may otherwise be permitted by a data owner, the contractor personnel agrees not to use, disclose or reproduce proprietary data, other than as required in performance of the contact; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the contractor without such limitation.

The Contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the requirement that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the TPOC, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the Contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. Each Contractor/Subcontractor employee who may have access to non-public Department information and/or sensitive information under the Contract may be required to sign a Confidentiality form and/or a FDA Form 3398: Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement available upon request from the FDA Intranet site. A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the TPOC or designee prior to performing any work under the Contract. The TPOC or designee will inform the Contractor of the forms and training that are required.

However, it is the responsibility of the Contractor to assure that such forms have been signed.

4.6. Contractor Performance Evaluation(s)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 30 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3 year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm. There is no fee for registration or use of the CPARS.

4.7. Holidays FDA personnel observe the FDA following days as holidays:

i) New Year's Day

ii) Columbus Day

iii) Washington's Birthday

iv) Veterans' Day

v) Memorial Day

vi) Thanksgiving Day

vii) Independence Day

viii) Christmas Day

ix) Labor Day

x) Martin Luther King's Birthday

xi) Any other day designated by Federal statue

xii) Any other day designated by Executive Order

xiii) Any other day designated by the President's Observance of such days by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, estimated cost, or fee(s), if any, except as set forth in the Contract.

Except for designated around-the-clock or emergency operations, Contractor personnel shall not be able to perform on-site under the Contract with FDA on holidays set forth above. The Contractor shall not charge any holiday as direct charge to the Contract In the event Contractor personnel work during a holiday observed by the Contractor other than those above, no form of holiday or other premium compensation will be reimbursed as either a direct or indirect cost. However, this does not preclude reimbursement for authorized overtime work.

In the event the FDA grants administrative leave to its Government employees at the site, on-site Contractor personnel shall also be dismissed if the site is being closed. However, the Contractor shall continue to provide sufficient personnel to perform around-the-clock requirements of critical efforts already in progress or scheduled and shall be guided by the instructions issued by the Contracting Officer or her/his duly appointed representative. In each instance when the site is closed to Contractor personnel as a result of inclement weather, potentially hazardous conditions, explosions, or other special circumstances, the Contractor shall direct its staff as necessary to take actions such as reporting to its own site(s) or taking appropriate leave consistent with its policies. The cost of salaries and wages to the Contractor for the period of any such site closure shall be a reimbursable item of direct cost under the Contract for employees whose regular time is normally a direct charge if they continue to perform on the work; otherwise, the costs are reimbursable as indirect costs in accordance with the Contractor's established accounting policy.

4.8. Disclosure of Information. Contractors are reminded that information furnished under the solicitation and contract may be subject to disclosure under the Freedom of Information Act (FOIA). Therefore, all items that are confidential to business, or contain trade secrets, proprietary, or personnel information shall be clearly marked. Marking of items will not necessarily preclude disclosure when the U.S. Office of Personnel Management (OPM or The Government) determines disclosure is warranted by FOIA. However, if such items are not marked, all information contained within the submitted documents will be deemed to be releasable.

Any information made available to the Contractor by the Government shall be used only for the purpose of carrying out the provisions of the contract and m shall ust not be divulged or made known in any manner to any person except as may be necessary in the performance of the contract.

In performance of the contract, the Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its subcontractors shall be under the supervision of the Contractor or the Contractor's responsible employees.

Each officer or employee of the Contractor or any of its subcontractors to whom any Government record may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such officer or employee can be used only for a purpose and to the extent authorized herein, and that further disclosure of any such information, by any means, for a purpose or to an extent unauthorized herein, may subject the offender to criminal sanctions imposed by 19 U.S.C. § 641. That section provides, in pertinent part, that whoever knowingly converts to their use or the use of another, or without authority, sells, conveys, or disposes of any record of the United States or whoever receives the same with intent to convert it to their use or gain, knowing it to have been converted, shall be guilty of a crime punishable by a fine of up to $10,000, or imprisoned up to ten years, or both.

4.9. Inspection and Acceptance:

4.9.1. The TPOC–upon contract award) shall perform inspection and acceptance of materials and services to be provided. Invoices shall be submitted for review and approval by the TPOC (See invoicing instructions). For the purpose of this section, the TPOC is the authorized representative of the Contracting Officer.

Inspection and acceptance will be performed at: the locations identified in this RFQ.

4.9.2. Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer or TPOC within 30 days of receipt.

4.10. FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items. (JAN 2019)

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

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

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

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

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

[Contracting Officer check as appropriate.] ____ (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 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_x_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 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 Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

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

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

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

__ (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)).

__ (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. 657 f).

__x__ (22) 52.219-28, Post Award Small Business Program Re-representation (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 (Oct 2016) (E.O. 13126).

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

_x_ (28) 52.222-26, Equal Opportunity (Sept 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).

_x_ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

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

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

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

__ (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).

Note to paragraph (b)(35): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

__ (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 Televisions (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. 13693).

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

__ (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).

_x_ (50) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (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 (Jan 2017) (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:

[Contracting Officer check as appropriate.] __ (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 2015).

__ (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 (Sept 2008) (31 U.S.C. 5112(p)(1)).

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

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

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

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

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

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

(ii) 52.219-8, Utilization of Small Business Concerns (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, Non-displacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

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

(v) 52.222-26, Equal Opportunity (Sept 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) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O 13627). Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O 13627).

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

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

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

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

(xvi) 52.222-59, 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).

Note to paragraph (e)(1)(xvi): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

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

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

(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.

(End of clause) (End of Clause)

4.11. FAR 52.247-34 -F.O.B Destination (Nov 1991)

4.12. Section 508 Standard requirement.

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

Unless an agency exception to this requirement exists, the Contractor must conform to applicable Section 508 standards and must apply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products.

4.13. Order of Precedence

The contractor shall follow the terms and conditions of this RFQ. Should the contractor include any additional terms and conditions resulting in conflicts between this document and the contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212-4. Any additional terms and conditions shall not be prohibited by applicable laws and regulations.

4.14. FAR 52.223-15 ENERGY EFFICIENCY IN ENERGY-CONSUMING PRODUCTS (DEC 2007)

(a) Definition. As used in this clause- “Energy-efficient product”-

(1) Means a product that-

(i) Meets Department of Energy and Environmental Protection Agency criteria for use of the Energy Star trademark label; or

(ii) Is in the upper 25 percent of efficiency for all similar products as designated by the Department of Energy’s Federal Energy Management Program.

(2) The term “product” does not include any energy-consuming product or system designed or procured for combat or combat-related missions (42 U.S.C. 8259b).

(b) The Contractor shall ensure that energy-consuming products are energy efficient products (i.e., ENERGY STAR® products or FEMP-designated products) at the time of contract award, for products that are-

(1) Delivered;

(2) Acquired by the Contractor for use in performing services at a Federally-controlled facility;

(3) Furnished by the Contractor for use by the Government; or

(4) Specified in the design of a building or work, or incorporated during its construction, renovation, or maintenance.

(c) The requirements of paragraph (b) apply to the Contractor (including any subcontractor) unless-

(1) The energy-consuming product is not listed in the ENERGY STAR® Program or FEMP; or

(2) Otherwise approved in writing by the Contracting Officer.

(d) Information about these products is available for-

(1) ENERGY STAR® at http://www.energystar.gov/products; and

(2) FEMP at http://www1.eere.energy.gov/femp/procurement/eep_requirements.html.

4.15. FAR 52.204-23-Prohibition On Contracting For Hardware, Software, And Services Developed Or Provided By Kaspersky Lab And Other Covered Entities (Jul 2018).

4.16. FDA Invoice Submission Instructions.

FDA Three-Way Match Invoicing Procedures A. The Contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov *** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR or Technical Point of Contact (TPOC). The COR/TPOC is (TBD) 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; Duns Number

(iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(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 award 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 (Prompt Payment terms other than NET 30);

(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) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

Section 5 – Solicitations Provisions

5.1. FAR 52.252-1. Solicitation Provisions Incorporated by Reference (Feb 1998).

This solicitation incorporates one or more solicitation 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. The offeror is cautioned that the listed provisions may include blocks that shall be completed by the offeror and submitted with the proposal. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with the proposal. Also, the full text of a solicitation provision may be accessed electronically at this address: www.acquisition.gov/far/index.html.

5.2. Inquiries and Notices:

All questions regarding this RFQ shall be submitted in writing to Emmanuel.mbah@fda.hhs.gov, no later than 12.00 p.m. Eastern, 05/30/2019. Phone or fax inquiries will not receive a response.

5.3. Response Dates and Time

RFQ Due Date: All proposals shall be submitted electronically via email to Emmanuel.mbah@fda.hhs.gov before 12:00 Eastern Time on 6/04/2019.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1 (f). Instructions to Offerors - Commercial Items (Oct 2018)

5.4. Period for Acceptance of Offers:

The offeror agrees to hold the offered prices firm through September 30, 2019.

5.5. Proposal Preparation Instructions:

All responsible sources should submit a proposal, which will be considered if received by the due date.

The subject line shall read: FDA-RFP-2019-1214498 - Diagnostic Ultrasound System and a statement from the offeror verifying that they are SAM/CCR. The associated NAICS Code is: 334516 (Analytical Laboratory Instrument Manufacturing.

Faxed proposals shall not be accepted. Information requested by the Government herein, shall be furnished in writing and be fully and completely in compliance with RFQ instructions. The information requested, and the manner of submission is essential to permit prompt evaluation of all proposals on a fair and uniform basis.

Offerors that fail to submit all required documentation, or do not complete the…