Sol_Doc.docx

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-18-1199523. 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 511210, 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 provide MultiCASE software (CASE Ultra and META Ultra), to enhance the FDA’s capability in toxicology data mining and assessment of potential toxicity of chemicals used in tobacco products for which no, or only limited amounts, of toxicology data are available.

1.0 Background

The mission of the Food and Drug Administration (FDA) is to promote public health by assuring that foods, cosmetics, and supplements are safe, wholesome, sanitary, and properly labeled, ensuring drugs, vaccines, other biological products, and medical devices intended for human use are safe and effective, protecting the public from electronic product radiation, and regulating tobacco products. The Tobacco Control Act (2009) grants FDA authority to regulate the manufacturing, marketing, and distribution of tobacco products to protect public health.

As part of the Center for Tobacco Product’s (CTP) mission to reduce harm and health risk from the use of tobacco products, it is vitally important to understand the toxicological effects from tobacco ingredients, additive, and chemical emissions. These tobacco products often contain ingredients or additives that are Harmful and Potential Harmful Constituents (HPHCs), or that are transformed to HPHCs upon combustion. A continuing challenge in the toxicology review of tobacco products is that many of these ingredients and additives have not been or have only been partially characterized in terms of human health hazards. As a result, the Division of Nonclinical Science (DNCS) at CTP requires access to specialized (Quantitative) Structure-Activity Relationship ((Q)SAR) software to meet toxicity data mining and prediction capabilities needed for the evaluation of hundreds of chemicals present in the tobacco products that have little or no data in toxicity and adverse human health effects that may be caused by these chemicals. CASE Ultra allows rapid and accurate search of toxicity data from repositories in genetic toxicity and then harnesses these data utilizing the (Q)SAR methodology. It generates customized toxicity predictions of various endpoints, such as genetic toxicity (including mutagenicity and clastogenicity), acute respiratory toxicity, cardiovascular toxicity, teratogenicity, and repro/developmental toxicity. It is uniquely important since it analyzes chemicals based on any number of atom fragments, and has been validated for genotoxicity endpoints (e.g., DNA reactivity, clastogenicity) that are of interest in the toxicological review of chemicals found in new tobacco products.

In addition, CASE Ultra (ver 1.6.2.3) has been validated and is used by FDA’s, Center for Drug Evaluation and Research (CDER) and the Center for Food Safety and Nutrition (CFSAN), for use in predicting the mutagenic potential of chemical impurities, degradants, and food contact materials under Center review. The strong points of this software are that it generates a battery of genotoxicity and carcinogenicity predictions largely based on FDA training sets used in computational models of a chemical structure. The CASE Ultra software also provides empirical toxicity data if they are contained in the knowledge base, which includes Registry of Toxic Effects of Chemical Substances (RTECS), Japanese Registry Substance Database, US National Toxicology Program (NTP) data, ISSCAN, and many more widely recognized and accepted benchmark data sets and toxicity data repositories.

META Ultra software employs machine learning algorithms and databases of known metabolites of drugs and chemicals. The database contains approximately 15,000 known human metabolite transformations annotated with enzymes, organs, yields, reaction types and literature references. These data are then made use of to predict xenobiotic metabolites in humans, thereby providing essential data on predicting potential toxicity of chemicals that have little toxicological data. META Ultra predicts and displays potential sites of metabolism (SOMs) based on the chemicals submitted by the users using the Molecule Drawer. The resulted “metabolic tree” provides clear pictures of the most plausible sites for metabolic activations reactivity in different color densities.

It is critical to CTP’s mission to have internal capacity to data mine toxicity data in both public and private domains and to utilize this information to make valid toxicity predictions of hundreds of chemicals and additives that are present in the tobacco products under review. The use of toxicity data mining and (Q)SAR/Structure-Activity Relationships (SAR) computational toxicity software has been identified by FDA as a science priority area to modernize toxicology and is described in the agency’s strategic plan for regulatory science. The acquisition of CASE Ultra and META Ultra is one of the key analytical tools needed to generate and appraise toxicity data first-hand and to prioritize and flag potential toxic chemicals under review in CTP/OS/DNCS for further data inquiries and research efforts. It will also facilitate the development of high-throughput screening of myriads of ingredients in Electronic Nicotine Delivery Systems (ENDS) e-liquids for their potential toxicity in the future Premarket Tobacco Application (PMTA) reviews.

2.0 Objective

The FDA’s objective is to obtain the MultiCASE software, CASE Ultra and META Ultra, to enhance the FDA’s capability in toxicology data mining and assessment of potential toxicity of chemicals used in tobacco products for which no, or only limited amounts, of toxicology data are available.

3.0. Salient Characteristics and Functional Specifications

The Contractor shall provide online subscription with the following capabilities:

3.1 The contractor shall provide software licenses required to perform all of the following chemoinformatic functions:

· Identify and systematically generate a list of chemical fragments that are biologically active from a training set of non-congeneric data in order to automatically create and validate local and global (Q)SAR models using automatic computation of chemical fingerprints with machine learning methods

· Estimate the applicability domain of a chemical using structural fragments among the training set after it generates a (Q)SAR model prediction and inform users of the feedback about whether a new queried structure lies inside or outside the applicability domain based on active or inactive alerts

· Ability to predict acute respiratory toxicity, mutagenicity, and carcinogenicity endpoints using validated (Q)SAR methodology

· Ability to rapidly develop, validate, and deploy computational predictive (Q)SAR models

· Provide a user-friendly graphic interface for model building and evaluation with easy access to chemical structures and properties

· Perform fast substructure searching and provide structurally similar analogs to the query chemical based on known reactive and non-reactive structural motifs

· Ability to automatically build (Q)SAR models using fragment size and a variety of physiochemical parameters including vapor pressure, charge, partitioning coefficient (LogP) and others

· Incorporate experimental data outcomes and references from data mining through integrated PubChem searching

· Ability to predict and display potential sites of metabolism (SOM) for a given compound

· Rapid batch processing of thousands of query chemicals to predict the corresponding metabolites

· Ability to screen metabolites of queried chemicals against a variety of toxicity endpoints

· Provide technical training and scientific support on use, and interpretation of how the predictions are generated by the software programs.

3.2 Compatibility: The computational models of the software to be purchased shall be compatible to Windows version 7 Enterprise and higher.

3.3 Maintenance: 12-month standard maintenance shall be included with the software license.

3.4 The offeror’s ability to make predictions for various toxicological endpoints with an expert rule or knowledge-based computer software system that uses pre-built chemical structure-activity relationships (SAR), and in addition, another system that predicts mutagenicity and rodent carcinogenicity using pre-built statistical quantitative structure-activity relationship ((Q)SAR) models of chemicals with fragment-based methodology providing a probability score. The knowledge-base for the SAR system and training sets for the (Q)SAR model system need to have been validated.

3.5 The offeror’s ability to make predictions of toxicity using (Q)SARs for the following endpoints:

Rodent Carcinogenicity Mutagenicity Genotoxicity Reproductive and Developmental Toxicity Teratogenicity Skin and Eye Irritation and Sensitization Acute Respiratory Toxicity

3.6 Provide a structural alert analysis and unknown fragment analysis.

3.7 Provide analogues to the query compound through analysis of the model training set compounds.

3.8 Make predictions of metabolic fates of chemicals, and provide graphics for visualizing the data (e.g., metabolic trees), and the ability to screen metabolites for toxicity within the same graphical user interface.

3.9 Conduct toxicity data searching of an organic chemical based on the information in the software model training sets.

4. 0 Deliverables

The Contractor shall provide:

-CASE Ultra for Toxicity Prediction v. 1.6.2.3 -META Ultra for Human Metabolism Prediction v.1.2 or equal application

-CASE Ultra for Toxicity Prediction v. 1.6.2.3 -META Ultra for Human Metabolism Prediction v.1.2 or equal application

5.0 Period of Performance

Base Period: 12 months from award date Option Year 1: 12 months

6.0 Delivery/Place of Performance

The Contractor shall deliver the software license electronically via secure e-mail with license activation code or via CD-ROM or DVD media within 72 hours of purchase.

7.0 INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) or duly authorized representative shall perform inspection and acceptance of the products. The performance criteria for these products shall be timely delivery and closure of all activities and deliverables listed above and within the established Period of Performance.

8.0 Contract Type

Firm Fixed Price

9.0 Contracting Specialist

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

10.0 Contracting Officer Representative:

To Be Determined

11.0 Compatibility

FDA is purchasing this requirement on a “Brand Name or Equal” basis. The SOW provides salient functional characteristics (Section 3.0) of the required software, maintenance and support. In order to be considered an “equal” solution, any alternative solution proposed must include the capabilities described in this solicitation plus the currently owned licenses, maintenance agreements and capacities for the existing MutliCASE. If proposing an alternate solution the contractor shall be responsible for getting the FDA to its current state of functionality without any disruption in service.

12.0 FDA Security and Privacy Language

13.0 Section 508 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.

The following Section 508 provisions apply in accordance with WCAG 2.0 A and AA to the content or communications material identified in this SOW:

· E204 Functional Performance Criteria

· E207 Software

· E208 Support Documentation and Services

14.0 Provisions and Clauses

HHSAR Clauses

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

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

352.239-74 Electronic and Information Technology Accessibility. (DEC 2016)

(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:

1194.22 – Web-based Intranet and Internet Information and Applications.

1194.41 – Information, Documentation, and Support

FAR Clauses

52.203-18 Prohibition on Contracting with Entities that Require certain Internal Confidentiality Agreements or Statements –Representation (JAN 2017)

52.203-19 Prohibition of Requiring Certain Internal Confidentiality Agreements or Standards (JAN 2017)

52.212-4 Contract Terms and Conditions – Commercial Items (JAN 2017) 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items. (JAN 2018)

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

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

(4) 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:

__ (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 (Jan 2017) (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—Subcon-tracting 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 Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

_x_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_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) 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).

__ (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)(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 Televisions (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. 13693).

__ (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).

_x_ (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.

_x_ (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 (OCT 2016) (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 (Jul 2013) (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.

(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, Nondisplacement 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) 52.203-19, 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) 52.219-8, 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.

(iv) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

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

(vi) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

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

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

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

(x) 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.

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

(xii) 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).

(xiii) 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).

(xiv) 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).

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

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

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

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

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

(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)

52.203-99, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements (DEVIATION 2015-02)

(a) The Contractor shall not require employees or subcontractors seeking to report fraud, waste, or abuse to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(b) The contractor shall notify employees that the prohibitions and restrictions of any internal confidentiality agreements covered by this clause are no longer in effect.

(c) The prohibition in paragraph (a) of this clause does not contravene requirements applicable to Standard Form 312, Form 4414, or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(d)(1) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Resolution Appropriations Act, 2015 (Pub. L. 113-235), use of funds appropriated (or otherwise made available) under that or any other Act may be prohibited, if the Government determines that the Contractor is not in compliance with the provisions of this clause.

FAR Provisions

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

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must—

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by—

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modification the quoter plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification.

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the quoter or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the quoter clearly indicates in its offer that the product being offered is an “equal” product, the quoter shall provide the brand name product referenced in the solicitation.

(End of provision)

52.203-98, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation (DEVIATION 2015-02)

In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Resolution Appropriations Act, 2015 (Pub. L. 113-235), Government agencies are not permitted to use funds appropriated (or otherwise made available) under that or any other Act for contracts with an entity that requires employees or subcontractors of such entity seeking to report fraud, waste, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(b) The prohibition in paragraph (a) of this provision does not contravene requirements applicable to Standard Form 312, Form 4414, or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(c) Representation. By submission of its offer, the Offeror represents that it does not require employees or subcontractors of such entity seeking to report fraud, waste, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(End of provision)

15.0 Order of Precedence

The Contractor shall follow the terms and conditions of this contract. 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 Clauses 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 the 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 his contract. 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 order as an attachment and the FAR and HHSAR Clauses incorporated into this order, the FAR or HHSAR Clauses shall take precedence.

16.0 Three-way Invoice Instruction

To be provided at award.

17.0 Instructions to Offerors

Quoters are advised to provide their best prices in their quotation. The Government does not intend to have communications to allow revision of quotations. The Government reserves the right to communicate with Quoters should the Government determine it is necessary for quotation revisions prior to award.

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

All quotes will be evaluated on a Lowest Priced Technically Acceptable (LPTA) basis. FDA anticipated that this contract will be firm fixed price.

Quoters shall submit one (1) copy of their quotation with pricing information. Equal to quotes must meet all the salient characteristics in order to be considered technically acceptable.

Equal to quotes must submit a separate Technical quote with a detailed point-by-point description of how the equal to products meet all the salient characteristics of this SOW. Quotes with the specified UpToDate subscription meeting all the salient characteristics of this SOW are not required to submit separate Technical Quotes. Technical quotes shall not contain pricing information.

Quoters shall submit all applicable terms and conditions in full text as attachments, appendix, or exhibits. Quoters are advised that additional terms and conditions submitted with their quotations that are in conflict with the terms and conditions of this solicitation may be deemed as technically unacceptable and as such not be considered for award.

Quoters shall submit Product Accessibility Templates (PAT) in full text with their quotations.

Quoters shall submit all assumptions in their quotation.

Other Administrative Instructions:

In accordance with FAR 52.212-4, Quoters shall be registered in the SAM database to be considered for award. Registration is free and can be completed on-line. Please visit the System for Award Management (SAM) at: www.sam.gov to register.

Quotes shall be valid for 30 days.

Quotes are due by 3PM Eastern Time on 27 June 2018. Any questions must be addressed to Michele Andrews, Michele.Andrews@fda.hhs.gov no later than 3PM Eastern Time on 14 June 2018.

Primary Point of Contact:

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

18.0 Basis for Award

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