Sol_Doc_FINAL.docx

Request for Quote (RFQ) Food and Drug Administration (FDA) Statement of Work (SOW) PDF Java Toolkit Software License and Maintenance (Brand Name or Equal)

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; proposals are being requested and a written solicitation will not be issued. This synopsis is to notify contractors that the government intends to issue a Contract on a “Brand Name or Equal” basis in accordance with FAR Part 13 for the following, under simplified acquisition procedures. The Request for Proposal number is FDA-SOL-19-1209932. Provisions and clauses in effect through Federal Acquisition Circular 05-44 are incorporated into this request. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The provisions and clauses may be accessed in full text at www.acquisition.gov/far. The NAICS code is 511120, Software Publishers. There is no set-aside for this acquisition. All qualified vendors are encouraged to submit a proposal. The purpose of this procurement is to procure Java Toolkit Software License and Maintenance as a “Brand Name or Equal” solution.

Background The Family Smoking Prevention and Tobacco Control Act of 2009 grants the Food and Drug Administration (FDA) authority to regulate the manufacturing, marketing, and distribution of tobacco products to protect public health and reduce tobacco use by minors.

The Tobacco Inspection Management System (TIMS) serves as the Office of Compliance and Enforcement’s (OCE) authoritative source for data related to the inspections of tobacco product retailers which are used to determine a retailer's compliance with federal laws and regulations. OCE currently relies on TIMS to serve as its authoritative data store for data collected from inspectors who are responsible for monitoring, and ensuring compliance of, adherence to FSPTCA (Family Smoking and Tobacco Control Act) as the Act relates to the improper sale and marketing of tobacco products in retail establishments.

The FDA Center for Tobacco Products (CTP) has a need for a product that will allow CTP OCE staff the ability to effectively review inspection images during the FDA Review Process. This product will enable the Tobacco Information Management System (TIMS) to be able to create PDF Portfolio Documents for review by CTP OCE staff. This feature would be used to create a portfolio of inspection photos after completed inspections have been synced back from mobile devices, instead of one photo at a time; thus, improving CTP OCE staff productivity.

2. Objectives Datalogics PDF Java Toolkit is a native Java library that provides high-level PDF APIs for automating PDF workflows like processing PDF forms, verifying digital signatures, and extracting text. It also offers low-level PDF APIs for working directly with the structure of the PDF for those times you need it. While written with Java developers in mind, Datalogics PDF Java Toolkit can be used with any JVM language.

CTPs objective is to obtain the Datalogics PDF Java Toolkit or equivalent product to improve CTP OCE staff productivity while reviewing the evidence of completed retail establishment inspections.

1. Requirements The Contractor shall provide PDF Java Toolkit Software License and Maintenance, Brand Name or Equal. If proposing an alternate product, to be considered for award, the Contractor shall ensure the proposed product meets the following salient functional characteristics:

1. Create and Edit PDFs Programmatically create PDF documents that meet the strictest standards of the PDF specification. In addition to the basic PDF marking operators used to add text and images to pages, the PDF Java Toolkit includes the RichTextContentGenerator, a lightweight layout engine that accepts HTML formatted rich text as input, formats it, and draws it on the page handling word wrap and font styling automatically. Regardless of the various versions of PDF required, including PDF/A, the PDF Java Toolkit can be used to easily place text and images on the page, add marked content operators, embed fonts, and perform all of the other complex functions required to result in an optimized, well performing, highly portable PDF document.

2. Extract Text and Images The PDF Java Toolkit can help quickly extract text, data and images from PDF documents for transfer to other documents or systems. The ReadingOrderTextExtractor performs a vertical and horizontal projection of words in a document. It then creates a statistical analysis of the common word starting points in documents to find column breaks resulting in the ability to programmatically read the text in the proper order regardless of how the PDF file was generated and when no document structure is available. For form data, the FDFServices and XFAService provide interfaces to manage and export field and annotation data required for processing by other systems. Images can be easily located, resampled and exported.

3. PDF Forms Support Form workflows includes support for all three PDF form types: AcroForm, the original PDF interactive forms technology, Dynamic XFA, the XML Forms Architecture, and Static-XFA, an XML-based forms architecture. There high level classes to make it easy to import and export data, but more importantly, when data is imported, the user won’t need to replicate or understand the business rules built into the form. The PDF Java Toolkit can behave as a proxy for Acrobat and run the JavaScript calculation and format scripts embedded in the document automatically. The user can tell the PDF Java Toolkit what version of Acrobat to imitate. There’s also support to allow for plug-in proxies; if the JavaScript requires a particular plug-in before it will execute, “ppklite” for example, the PDF Java Toolkit can tell the document that it’s installed. In addition, the PDF Java Toolkit can flatten AcroForm and Static XFA and add Reader Enablement for users of older versions of Adobe Reader. The PDF Java Toolkit offers the most comprehensive set of tools for working with PDF forms available.

4. Digital Signatures, PDF Portfolios, and More Use server to programmatically sign or certify PDF documents or validate signed PDF files. The PDF Java Toolkit supports the creation of signatures compliant with PDF Advanced Electronic Signatures (PAdES), an extension to the digital signatures functionality that allows for Long Term Validation (LTV). The PDF Java Toolkit supports PDF Packages and PDF Portfolios, multiple files assembled into a single PDF envelope. For example, a PDF Portfolio can include text documents, e-mail messages, spreadsheets, CAD drawings, and PowerPoint presentations. The original files retain their individual identities but are assembled into one PDF Portfolio file. The PDF Java Toolkit can programmatically create easy-to-use forms that can be submitted by users via web sites, extract data for use in other processes, and prepopulate form data. The PDF Java Toolkit can read or add notes, stamps and other annotations as well as programmatically sign PDF documents.

5. Reader Enablement The PDF Java Toolkit can add Reader Extensions to users PDF documents which allows users of the free Adobe Reader to better collaborate with the user’s organization while reducing processing costs and errors. Users can easily interact with PDF forms and documents without purchasing Acrobat, while organization improves security, archiving, and compliance. In addition to local save, Reader Extensions lets user’s document integrate with SOAP-based web services and update or decode 2D barcodes in the user’s forms.

6. Twelve (12) month standard maintenance is included with the software license. This includes dedicated on call support representative, new software releases with enhancements and bug fixes, and a developers site with detailed documentation, guides, and release notes.

Delivery locations Contractor shall deliver, within 30 days of award, all licenses listed in the Deliverables Table to the Contracting Officer’s Representative (COR), that will be noted in the award document.

Specific Tasks/Deliverables

Total:

Inspection and Acceptance The Contracting Officer Representative designated below will perform an inspection and acceptance of products and services to be provided. The performance deliverables for this contract are detailed in the statement of work under sections titled: “Specific Tasks/Deliverables.” All deliverables shall be provided in accordance with the dates provided in the deliverables table. Completion of all deliverables, quality and timeliness of delivery, as well as incidents and types of defects, will be used to evaluate the Contractor’s progress and suitability.

The Government shall have 10 working days to inspect and verify that the software is operational and functional.

Order Type Firm-Fixed Price.

Period of Performance The below period of performance (POP) is 12 (twelve) months from the date of delivery. The POP is subject to change.

March 15, 2019 to March 14, 2020 Order of Precedence The Contractor shall follow the terms and conditions of this order. 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, dated January 2017. Any indemnification and governing law language in the Contractor’s terms and conditions shall be invalid and shall be stricken and removed from this order. Any additional terms and conditions shall not be prohibited by applicable laws and regulations. Any additional terms and conditions identified with a web link and/or incorporated by reference shall be stricken and removed from this order. The Contractor shall provide all terms and conditions with their quotations as attachments, appendixes, etc.

In the event of any inconsistencies between any licensing agreement incorporated into this contract as an attachment and the FAR and HHSAR Clauses incorporated into this contract, the FAR or HHSAR Clauses shall take precedence.

Information Technology Investment Management/Master Approved Technology List The item acquired may require approval by the Food and Drug Administration (FDA) Office of Information Management (OIM) for operation in FDA’s Information Technology environment (IT Investment Management Process/Master Approved Technologies List). Any item proposed not previously tested and approved for IT environment operations may require testing by OIM before award. Offerors must provide a full set of technical specifications with their offer. FDA will determine if further testing of the item is required. Consequently, the offeror shall be prepared to provide FDA with a demonstration unit within 2 days of offer submission.

Government Point of Contact Contracting Specialist:

Michele Andrews Phone: 240-402-7522 Email: michele.andrews@fda.hhs.gov

Contracting Officer’s Representative:

To Be Determined

1. 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 http://www.hhs.gov/oirm/.

FAR / HHSAR Clauses and Provisions HHSAR Clauses:

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (DEC 2015) 352.224-70 Privacy Act (DEC 2015) 352.239-74 Electronic and Information Technology Accessibility.

(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:

For Web-Based Software Components:

For Non-Web Based Software Components:

(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 Clauses:

52.232-99 Providing Accelerated Payment to Small Business Subcontractors (AUG 2012) 52.203-19: Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements (Jan 2017) 52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) 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 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) 52.203-19, 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).

___ (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).

___ (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)).

___ (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.

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

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

_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.

___ (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)

HHSAR Provisions:

352.239-73 Electronic Information and Technology Accessibility Notice (DEC 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website http://www.hhs.gov/web/508.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

FAR Provisions:

FAR 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation (JAN 2017) 52.211-6 Brand Name or Equal (AUG 1999) 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 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

2. Instructions to Quoters Quoters shall certify their quotes to be valid for 60 days.

Equal to quotes must meet all the salient characteristics in order to be considered technically acceptable. If the part numbers are different from the vendors’ part numbers, Quoters shall map their part numbers to the vendor’s part numbers.

Compatibility: FDA is purchasing this software license on a “Brand Name or Equal” basis and the salient characteristics (physical, functional, or performance characteristic specified in this solicitation) have been provided. For the purposes of this RFQ, FDA defines compatible as meaning that there will be no communication, performance, maintainability issues in the interconnection of solutions with different configurations. A compatible solution is one that will allow for seamless integration in FDA’s current environment. Each alternate component proposed shall demonstrate:

· That there will be *no* communication, performance or maintainability issues in the interconnection of solutions with differing brand names.

· Seamless (no application change) any solution must be able to be installed with no change in application code or redevelopment. The ability to maintain service support without any changes in FDA environment

· Performance compatibility of the component vs. the brand name provided.

· Equal to quotes shall include all pricing (installation, integration, training, etc.) related to ensuring the FDA maintains the current state of functionality with no disruption or degradation of service or support.

Equal to quotes must submit a separate Technical quote with detailed point-by-point description of how the equal to product meets all the salient characteristics of this SOW. Quotes with the specified software license and maintenance service meeting all the salient characteristics of this SOW are not required to submit a separate Technical Quotes. Technical quotes shall not contain pricing information. All Quoters providing quotations must clearly state the overall cost to the Government.

Quoters shall submit all applicable terms and conditions in full text as attachments, appendix, or exhibits.

Quoters shall submit all assumptions in their quotation.

The Government reserves the right to include some or none of the quoters additional terms and conditions into any possible orders, especially when the quoter’s terms and conditions would conflict with the Federal Acquisition Regulation or any of the terms or conditions of the quoter’s award vehicles.

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

Quotes must be firm-fixed-priced, and include all quantities listed, all or none.

Quoters shall notify the Contract Specialist / Contracting Officer immediately if this requirement is registered by a reseller with the Original Equipment Manufacturer (OEM).

Quoters are advised that additional terms and conditions submitted with their quotation that is in conflict of the terms and conditions of this solicitation may be deems as technically unacceptable and may not be considered for award.

Quoters shall submit Product Accessibility Templates (PAT) in full text with their quotations: https://www.hhs.gov/web/section-508/contracting/index.html

Licensing Agreements: Quoters are notified that the Government will not sign any licensing agreement or similar user agreement provided by the Quoters. The Government may choose to incorporate an agreement into the contract resulting from this solicitation.

A completed or a similar version of the chart in Section 5, or something substantially similar, shall be included in the quote. An incomplete quotation or pricing with omission will be considered unacceptable.

System for Award Management (SAM): In accordance with FAR 52.212-4, Offerors shall be registered in the SAM database to be considered for award.

Submission of Questions and Proposals QUESTIONS: Offerors shall submit questions to the Contract Specialist, Michele Andrews via email at michele.andrews@fda.hhs.gov. Please reference the specific area and location in the RFP or SOW when asking the question. All questions must be submitted no later than 3:00PM, Eastern Time (ET), Thursday, March 7, 2019.

RFP DUE DATE: Responses to this RFP shall be submitted to Michele Andrews, via email at michele.andrews@fda.hhs.gov no later than 3:00PM ET, Thursday, March 14, 2019.

3. Award Determination All quotations will be evaluated on a Lowest Priced Technically Acceptable (LPTA) basis. The award will be made to the Quoter that demonstrates they can meet all the requirements of this solicitation at the lowest price. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award.