RFQ (7MAY20).pdf

Request for Quote (RFQ) Food and Drug Administration (FDA)

Statement of Work (SOW) Process Modeling and Simulation Software – EDEM

(or Equivalent) Software License Support and Maintenance Services Version 5/7/2020

1. Background

The Division of Product Quality Research (DPQR) supports the modernization of pharmaceutical manufacturing by conducting regulatory science research on emerging technologies. Industry trends are increasing the regulatory challenges in quality, manufacturing and drug product development. The complexity of manufacturing processes and controls is increasing, as is the complexity of products (i.e., drug substance, formulation and/or container and closure system). Clinical designs and development timelines are evolving and accelerating, respectively, which must be supported by more agile and flexible manufacturing technology platforms.

The development of process models and simulations can be used to identify product quality risks for emerging manufacturing technologies. Discrete Element Modeling (DEM) enables the detailed analysis and visualization of the flow of particles from powders to tablets. DEM simulation software has many applications within the pharmaceutical industry including predicting pharmaceutical powder flow properties, study effects of critical process parameters for blending, coating, milling, granulation, and compaction, identify edge of process failure, evaluate control strategies, and provide key information on process otherwise difficult or impossible to measure. Currently, DPQR possesses a license for a DEM modeling and simulation software package that provides a high-level modeling for particles (including API, excipients, coating etc.). The modeling and simulation software has the capabilities to support a wide range of emerging manufacturing technology projects including continuous drug product unit operations. To maintain this capability, DPQR is requesting the acquisition or renewal of one (1) license for the process modeling and simulation software platform to support drug manufacturing process evaluation.

2. Objective

The objective is to renew a license for EDEM or equal. EDEM is a DEM modeling and simulation platform including EDEM Creator for setting up a simulation model, EDEM simulator for fast and efficient simulation, EDEM Analyst for post-processing review and analysis, EDEM Application Programming Interface for utilizing custom models, and EDEM coupling interface to couple with other computer aided engineering model platforms.

3. Requirements

3.1. DPQR is currently subscribing one (1) EDEM Research 1-year license includes EDEM 1 User plus 12 CPU plus 1 GPU and EDEM Advanced Package. The Contractor shall provide one (1) EDEM Research 1-year license subscription, brand name or equal. The salient characteristics for EDEM Research license, brand name or equal, are provided below.

Shall be able to simulate any material type (large lumps, dry, fine, sticky, cohesive, flexible).

Shall be able to accurately and realistically simulate bulk material flow.

Shall have easy and accurate repeatability of design testing conditions.

Shall be able to setup simulations using a user-friendly graphical interface.

Shall be able to import equipment geometry from a wide range of CAD files (IGES, STL, STEP and more).

Shall be able to assign equipment motion (linear, rotational, sinusoidal and more).

Shall be able to model real world particle shapes using a validated multi-sphere method.

Shall be able to select contact physics models, define material properties or add a material model straight from a platform database.

Shall be the cutting edge DEM solver parallelized for multi-core shared memory workstations.

Shall be able to utilize up to 12 CPU cores and 1 GPU for efficient simulations.

Shall be able to simulate large and complex particle systems.

Shall be able to start and stop simulations at any time to easily review progress and assess design performance.

Shall have advanced and powerful post-processing capability via extensive set of tools for visualization and analysis (coloring, graphing, bin groups).

Shall be able to create high resolution images and videos.

Shall be able to export all simulation results data in .csv format as well as an EnSight file for advanced visualization.

Shall be able to use custom contact models to model new particle–particle and particle– geometry interactions.

Shall be able to use custom particle body force models to apply new forces and effects to the particles in the simulation.

Shall be able to create new methods of particle generation – to define non-standard positions, distributions or flow-rates.

Shall be able to define and create custom particle and geometry properties, increasing the scope of user defined custom models.

Shall be able to support bi-directional coupling with other computer aided engineering platforms including finite element method (FEA), multibody dynamics (MBD), and computational fluid dynamic (CFD).

3.2. Salient characteristics for EDEM Maintenance and Technical Support, brand name or equal, are the following:

Shall deliver software updates.

Shall respond within one (1) business-day to all software defect inquiries.

Shall be available for feature (level) upgrades.

Shall be able to access to the User Forum.

3.3. The salient characteristic for EDEM Training, brand name or equal, is the following:

Shall be able to access to eLearning online courses and tutorials that include but not limited to Introduction to EDEM, Introduction to EDEM Add-in for ANSYS Workbench, Coupling EDEM with ANSYS FLUENT, EDEM Licensing, Screw Auger Tutorial, Rock Box Tutorial, SAG Mill Tutorial.

4. Deliverables

The Contractor shall provide one (1) EDEM Research License, Maintenance and Technical Support, and Training, brand name or equal, as delineated in the table below.

Software and licensing key, Software and User Manuals or equal to in a digital copy provided on a CD, DVD or digital download. CD, DVD and hard copies of deliverables shall not be required to be returned to the Contractor.

The Contractor shall deliver the EDEM Research License, brand name or equal, no later than 15 days after contract award.

Ref Deliverables Period of

Performance Quantity Unit Price

3.1 Base Period:

EDEM Research License or Equivalent

12 months One (1)

3.2 Base Period:

Maintenance and Technical Support or Equivalent

12 months One (1)

3.3 Base Period:

Training or Equivalent 12 months

As required

3.1 Option Period 1:

EDEM Research License or Equivalent

12 months One (1)

3.2 Option Period 1:

Maintenance and Technical Support or Equivalent

12 months One (1)

3.3 Option Period 1:

Training or Equivalent 12 months

Option Period 2:

EDEM Research License or Equivalent

12 months One (1)

3.2 Option Period 2:

Maintenance and Technical Support or Equivalent

12 months One (1)

3.3 Option Period 2:

Training or Equivalent 12 months

Option Period 3:

EDEM Research License or Equivalent

12 months One (1)

3.2 Option Period 3:

Maintenance and Technical Support or Equivalent

12 months One (1)

3.3 Option Period 3:

Training or Equivalent 12 months

Option Period 4:

EDEM Research License or Equivalent

12 months One (1)

3.2 Option Period 4:

Maintenance and Technical Support or Equivalent

12 months One (1)

3.3 Option Period 4:

Training or Equivalent 12 months

5. Place of Delivery

Physical deliverables are delivered to the following address:

U.S Food and Drug Administration Center for Drug Evaluation and Research / Office of Pharmaceutical Quality / Office of Testing and Research / Division of Product Quality Research 10903 New Hampshire Avenue Silver Spring, MD 20993

6. Inspection and Acceptance Criteria

Pursuant to the inspection clause, all items specified in this Statement of Work to be delivered under this order are subject to final inspection and acceptance by an authorized representative for the

Government. The authorized representative of the Government is the Government’s COR, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the

Contractor.

Working media: FDA will load the software and licensing to verify that the media is functioning properly.

The Government shall have 30 working days to inspect and verify that the software is operational, functional and compatible with FDA server and software.

The Contractor shall remediate any problems with delivery within five (5) business days from the

COR’s notification of a problem for licenses and within three (3) business day for support.

7. Period of Performance

Base Period: 12 months Option Period 1: 12 months Option Period 2: 12 months Option Period 3: 12 months Option Period 4: 12 months

8. Point of Contact

Contract Specialist (CS):

Min Jie Zeng Office of Acquisitions and Grants Services Food and Drug Administration Email: minjie.zeng@fda.hhs.gov

Contracting Officer (CO):

Steven Chang Office of Acquisitions and Grants Services Food and Drug Administration Email: tzeleong.change@fda.hhs.gov

Contracting Officer’s Representative (COR):

To Be Determined

9. Order Type

The order type is firm-fixed-price.

10. Terms of Use

Subscription License: FDA shall have the ability to purchase a new subscription after the original subscription expires to continue the use of the software and to gain access to technical support and product upgrades.

11. Contracting Officer Authority

The CO is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

The COR or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the Contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the delivery order.

12. Conformance with Applicable Laws, Regulations, Policies, and Standards

The contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov/. HHS documents are found at https://www.hhs.gov/grants/contracts/contract-policies-regulations/index.html#policies/.

13. FAR / HHSAR Clauses and Provisions

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 this address:

https://www.acquisition.gov/browse/index/far

(End of Clause)

52.203-19: Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements (Jan 2017)

52.204-25: Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2019)

52.227-19: Commercial Computer Software License (Dec 2007)

52.232-39: Unenforceability of Unauthorized Obligations (Jun 2013)

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

52.212-4: Contract Terms and Conditions-Commercial Items (Oct 2018)

52.212-5: Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jan 2020)

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

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

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

(4) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(5) 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).

___ (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 2018) (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 (Oct 2018) (41 U.S.C. 2313).

___ (10) [Reserved]

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

657a).

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

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

657a).

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

___ (13) [Reserved]

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

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

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

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

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

___ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (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 (Aug 2018) of 52.219-9.

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

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

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

637(d)(4)(F)(i)).

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

_x_ (22) 52.219-28, Post Award Small Business Program 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 (Jan 2018) (E.O.

13126).

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

_x__ (28) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

___ (ii) Alternate I (Feb 1999) of 52.222-26.

__x_ (29) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

___ (ii) Alternate I (July 2014) of 52.222-35.

_x__ (30) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

___ (ii) Alternate I (July 2014) of 52.222-36.

_x_ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

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

_x__ (33) (i) 52.222-50, Combating Trafficking in Persons (JAN 2019)

(22 U.S.C. chapter 78 and E.O. 13627).

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

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

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

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

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

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

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

___ (ii) Alternate I (Oct 2015) of 52.223-13.

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

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

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

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

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

__x_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

___ (43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

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

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

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

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

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

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

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

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

___ (48) 52.225-5, Trade Agreements (Aug 2018) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__x_ (49) 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).

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

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

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

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

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

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

_x__ (55) 52.232-33, Payment by Electronic Funds Transfer--System for Award Management (Oct 2018) (31 U.S.C. 3332).

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

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

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

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

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

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

___ (iii) Alternate II (Feb 2006) of 52.247-64.

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

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

___ (2) 52.222-41, Service Contract Labor Standards (Aug 2018) (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) (Aug 2018) (29 U.S.C.206 and 41 U.S.C. chapter 67).

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

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

chapter 67).

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

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

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

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

(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 (Jan 2019) (41 U.S.C. 3509).

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

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (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.

(v) 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.

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

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

(viii) 52.222-35, Equal Opportunity for Veterans (Oct 2019) (38 U.S.C. 4212).

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

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

(xi) 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.

(xii) 52.222-41, Service Contract Labor Standards (Aug 2018), (41 U.S.C. chapter 67).

(xiii) (A) 52.222-50, Combating Trafficking in Persons (Jan 2019) (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).

(xiv) 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.)

(xv) 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)

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

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

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

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

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

(xx) 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).

(xxi) 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.

(xxii) 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)

52.217-9: Option to Extend the Term of the Contract (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor any time prior to contract expiration.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed Five (5) years.

(End of clause)

HHSAR Clauses:

The below Health and Human Services Acquisition Regulation (HHSAR) Clauses apply. HHSAR Clauses can be viewed in full text at:

http://www.hhs.gov/policies/hhsar/subpart352.html#subpart352.1-- InstructionsforUsingProvisionsandClauses

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

352.239-74: Electronic and Information Technology Accessibility (December 18, 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

E205 Electronic Content (Appendix A, Application and Scoping Requirements)

302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

E207 Software (Appendix A, Application and Scoping Requirements)

Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical

Requirements)

NOTE: Section 508 exception has been approved for the Brand Name product.

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

FAR PROVISIONS:

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 quoter is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. 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 its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address https://www.acquisition.gov/far/current/html/FARTOCP52.html#wp372482

(End of provision)

52.203-18: Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation (Jan 2017)

52.204-24: Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Dec 2019)

52.204-26: Covered Telecommunications Equipment or Services-Representation (Dec 2019)

52.211-6: Brand Name or Equal (Aug 1999)

52.212-3: Offeror Representations and Certifications-Commercial Items (Mar 2020)

52.217-5: Evaluation of Options (Jul 1990)

HHSAR PROVISIONS:

The below Health and Human Services Acquisition Regulation (HHSAR) provision apply. HHSAR Clauses can be viewed in full text at:

http://www.hhs.gov/policies/hhsar/subpart352.html#subpart352.1-- InstructionsforUsingProvisionsandClauses

352.239-73 – Electronic and Information Technology Accessibility Notice (Dec2015)

14. Instructions to Quoters

This solicitation is issued under FAR Part 12 and 13.5 procedures. This is an unrestricted procurement. The NAICS code is 541519. The small business size standard is $30 million.

Quoters shall certify their quotes to be valid for 30 days.

Quoters shall be Original Equipment Manufacturers, authorized resellers and/or servicing agents of the software manufacturer.

Quoters should ensure that all information is provided to determine technical acceptability and that their initial submission represents their best pricing. The Government will not research items to determine compatibility; all information regarding compatibility must be contained within the quotation.

Quotations must meet all the requirements of this solicitation in order to be considered technically acceptable. Quoters shall submit all assumptions in their quotation.

All Quoters providing quotations must clearly state the overall cost to the Government.

Quoters shall submit a complete pricing for all products listed in this RFQ. Partial quotes will not be considered. Incomplete pricing or pricing with omissions may not be considered for award.

Equal To quotations must submit Technical volume with detailed point-by-point description of how the equal to product meets all the salient characteristics of this solicitation. Equal to Quotations shall be required to operate seamlessly with connecting operating software and/or hardware.

Equal To solutions shall include a breakdown of all costs associated with the integration of the proposed solution into FDA environment. These costs shall be incorporated in the overall cost to the Government.

For equal to quotations, Quoters will submit Section 508 Product Accessibility Templates (PAT) in full text with their quotations. For more information regarding PATs see:

http://www.hhs.gov/web/section-508/contracting/technology-products/product-accessiblity-template/.

Please submit questions to Min Jie Zeng via email at minjie.zeng@fda.hhs.gov by May14, 2020, 12PM Eastern Time.

Please submit quotes to Min Jie Zeng via email at minjie.zeng@fda.hhs.gov by May 22, 2020, 12PM Eastern Time.

15. Evaluation Criteria

The Government shall award a contract resulting from this solicitation to the responsible quoter as a fixed‐price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non‐cost factor (technical conformance to the requirements of the solicitation). The Quoter’s initial quotation should contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award.

END OF SOLICITATION