RFQ_-_NCPDP_subscription.pdf

FDA-19-RFQ-1211449 Page 1 of 15 NCPDP dataQ Database Subscription

Offeror Name DUNS

PART 1 – GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 and 13.1 as supplemented with additional information in this notice. Quotes are being requested and this announcement constitutes the only solicitation. The Government contemplates issuing a firm fixed-price purchase order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-01 dated January 22, 2019.

The associated North American Industrial Classification System (NAICS) code for this procurement is 519130 – Internet Publishing and Broadcasting and Web Search Portals, with an associated size standard of 1,000 employees.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

Contract Type: The Government intends to issue a firm fixed-price purchase order resulting from this solicitation.

Pricing Table:

Contract Line Item Number (CLIN) Description Qty Price

Base Year

- Full, standard access to dataQ®

- User accounts and access to WebConnect application

1 year $

Option Year 1

- Full, standard access to dataQ®

- User accounts and access to WebConnect application

1 year $

Option Year 2

- Full, standard access to dataQ®

- User accounts and access to WebConnect application

1 year $

Option Year 3

- Full, standard access to dataQ®

- User accounts and access to WebConnect application

1 year $

TOTAL $

PART 3 – DESCRIPTION OF REQUIREMENT

1.0 Background

The mission of the U.S. Food and Drug Administration Center for Drug Evaluation and Research (FDA/CDER) is to assure that safe and effective drugs are available to the American people. CDER promotes, protects and enhances the health of the public through drug development, evaluation and continuous safety monitoring throughout the drug life cycle. One of CDER responsibilities is to apply risk-based approaches to regulatory strategies to ensure the supply of compounded drugs is safe. Data

FDA-19-RFQ-1211449 Page 2 of 15 and data analysis are cornerstones of regulatory science. Increasing complexity of the pharmacy compounding industry requires a thorough approach to maintaining accurate data. High quality data, easily accessible through computerized systems, is an effective tool in developing a risk informed inventory of the regulated industry. We seek to ensure our data is as accurate and complete as possible in order to better understand the complexity of the compounded drug supply chain.

FDA also conducts inspections of firms that engage in compounding. In general, compounding involves the combining, mixing, or altering ingredients of a drug to create a medication tailored to the medical needs of an individual patient. Compounding, if done properly, can serve an important public health function for patients whose needs cannot be met by an FDA-approved medication. For example, a compounded drug may be appropriate for a patient who has an allergy and needs a medication to be made without a certain dye found in the FDA-approved product, or if an elderly patient or a child is unable to swallow a pill and needs a medicine in a liquid form that is not otherwise available.

Before 2012, FDA generally inspected compounders in response to reports of serious adverse events or when other issues have come to the attention of the Agency. After the fungal meningitis outbreak in 2012 in which contaminated compounded drugs caused over 60 deaths and over 750 cases of infection, FDA reexamined and became more proactive in a risk informed regulatory approach to compounding facilities.

FDA has been moving toward a proactive, risk-based approach to compliance requirements of state licensed pharmacies that compound drug products. In order to understand the complexity and impact of the growing number of drug manufacturers, including compounding pharmacies, FDA needs to ensure we have more complete information about firms that supply compounded drugs across the United States.

1.1 Objective: FDA seeks to improve the completeness and accuracy of our inventory of pharmacies which may be subject to regulation. We seek to obtain data about pharmacy establishments that includes, but is not limited to, pharmacy facility physical location, states in which licensed, copy of license for each state, license expiration dates, compounding services, establishment size, packaging capacity, open door facility, closed door facility, clinic services, etc. A current national inventory better informs our public health efforts to ensure high quality compounded drugs are available to the U.S. consumer.

2.0 Scope of Work

Access to the National Council for Prescription Drug Programs (NCPDP) dataQ® and WebConnect shall include:

(a) NCPDP user credentials to access the NCPDP dataQ® computer server at any time.

(b) The complete 12 tables of NCPDP dataQ® pharmacy record data. The data tables shall include over 79,000 pharmacy records. The records shall provide details including but not limited to, Provider Information, Parent Organization Demographics, Change of Ownership, Remit and Reconciliation Information, State License ID, and Services. The tables FDA will use the data include market analyses, supply chain distribution, research of interstate commerce, and generate updates to FDA’s information on drug compounding services, licensing, and manufacturing information. The data found in the tables include, Legal Business Name, State License ID, License Expiration Date, Copy of License, Taxonomy of NCPDP Identification and relationships, Dispenser Class Code, Provider Type, DEA Registration ID and expiration dates, Parent Organization Name, Parent Organization Address, Parent Organization ID, Old NCPDP Provider ID, Old Store information, Change of Ownership Dates, Delivery Service, Compounding Service, Drive-up Window, Walk-In Clinic, 24-Hr Emergency, Multi-Dose Compliance Packaging, Immunizations, and Closed Door Facility information.

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(c) NCPDP dataQ® implementation guides and Q&A information.

(d) User account and access to the contractor’s application WebConnect. The web application

WebConnect shall provide access to Real-Time Searchable, Live Data. Searchable by NCPDP #, NPI, DEA or also geographic searches by name, address, class, etc. Live data search results delivered via the relational database shall be viewable in the search results. FDA shall also be able to download original documents and certificates, such as, NPI confirmation letters, State License documents and DEA Certificates.

3.0 Contractor Tasks / Requirements

The Contractor shall:

• Provide full, standard access to a fixed number of CDER users (two) identified in the NCPDP dataQ® Set Up Sheet under an annual license fee. NCPDP user credentials will be issued to allow these CDER users to access the NCPDP dataQ® computer server at any time.

• Provide access to NCPDP dataQ® implementation guides and Q&A information and customer support to enable CDER users to understand dataQ data.

• Provide user accounts and access to the contractor’s application WebConnect.

• On the 1st of every month, make available a new dataQ® update in the form of a compressed file on the server for download. The monthly update file shall update the prior month’s data set. All data shall be formatted as a fixed width ASCII text file.

• The Contractor shall also provide access to dataQ® compressed file with a “rolling” 3-month of data on the computer server. The FDA shall receive access to a real-time searchable live data search engine. The contractor’s WebConnect search engine shall be available at all times the contractor servers are available.

• Provide technical support as needed to ensure that FDA is able to download the complete dataQ® pharmacy records data set for use by FDA staff. Contractor technical support shall be available Monday thru Friday 8am – 5pm EST.

4.0 Interface Coordination

The FDA will use the NCPDP issued server user credentials to download a complete database in the form of compressed dataQ® file archive. FDA shall be able to download the complete dataQ® pharmacy records data set for use by FDA staff.

FDA shall not need to download new software or computer application onto FDA systems. All data tables shall be provided in compressed ASCII text files, which can be decompressed with standard issue FDA licensed software, i.e. WinZip, and manipulated with standard issue FDA licensed software, e.g.

Microsoft Office. Original documents, such as licenses, certificates, or confirmation letters shall be received as scanned files in standard formats readable by standard software available at FDA, e.g. PDF.

5.0 Section 508 Compliance

All electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract must comply with the Section 508 accessibility standards listed in HHSAR clause 352.239-74.

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6.0 Performance Requirements

Performance Requirement

Performance Indicator

Standard Acceptable Quality Level

Surveillance Method

NCPDP

technical support

In the event of a critical event or unexpected incident, NCPDP will restore service capabilities within 24 hours

In the event of a critical event or unexpected incident, NCPDP will restore service capabilities within 48 hours

NCPDP will restore service capabilities within 48 hours of a critical or unexpected event or incident

Tracking log for instances of dataQ or WebConnect downtime

Access to dataQ database and to WebConnect

Access given Within 3 business days of contract award

Within 5 days of contract award

Success in accessing dataQ’s data and WebConnect

7.0 Deliverables

Description of Deliverable Due Date

NCPDP server user credentials to access dataQ

- NCPDP database v3.1 standard output files

- Monthly file delivery

- Implementation guides, Q&A information, and customer support

User accounts to WebConnect

User access due within 3 business days of contract award

PART 4 - PACKAGING, MARKING and SHIPPING Deliverables under this contract shall be delivered electronically to the Technical POC or specified NCPDP dataQ and WebConnect user. Any physical deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. All delivered equipment shall be newly manufactured, not used or refurbished or previously used for demonstration.

PART 5 – INSPECTION AND ACCEPTANCE

Inspection and acceptance will be performed after electronic delivery of the user account information.

The Technical Point of Contact will perform inspection and acceptance of the materials delivered.

Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer of Technical POC within 7 days of receipt of the deliverable(s). If a rejection is issued, the Contractor shall correct any deficiencies within three days from the time the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the Technical POC of the reason for the delay and provide a proposed corrective action plan within three

(3) business days.

PART 6 – DELIVERIES OR PERFORMANCE

Place of Performance Satisfactory performance of this contract shall be deemed to occur upon successful access to the required database described above and/or upon acceptance by the Contracting Officer or the Technical Representative of these products/services. The place of performance of this contract shall be offsite at the Contractor’s location. Access to dataQ and WebConnect shall be provided electronically.

FDA-19-RFQ-1211449 Page 5 of 15

Period of Performance The period of performance of this contract shall be a 12-month base period with three (3) option years.

Base Year: August 1, 2019 – July 31, 2020 Option Year 1: August 1, 2020 – July 31, 2021 Option Year 2: August 1, 2021 – July 31, 2022 Option Year 3: August 1, 2022 – July 31, 2023

PART 7 – CONTRACT ADMINISTRATION DATA

The following personnel shall represent the Government for the purpose of this contract:

Technical Representative:

To be determined upon contract award

The Technical Representative is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

Contracting Officer (CO): Contract Specialist (CS):

Gary Klaff Robin Goon 4041 Powder Mill Road 4041 Powder Mill Road Beltsville, MD 20705 Beltsville, MD 20705 Gary.Klaff@fda.hhs.gov Robin.Goon@fda.hhs.gov Tel: (240) 402-7555 Tel: (301) 348-1923

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to (1) Direct or negotiate any changes in the RFQ; (2) Modify or extend the period of performance; (3) Change the delivery schedule; (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract.

Payment Schedule:

Unless otherwise agreed to by the Technical POC, the Contractor shall submit an annual invoice for subscription access for the current period of performance.

FDA Three-Way Match Invoicing Procedures:

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

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

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 mailto:Gary.Klaff@fda.hhs.gov

FDA-19-RFQ-1211449 Page 6 of 15

FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

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

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

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

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

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

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

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

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

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in

(i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be mailto:FDAVendorPaymentsTeam@fda.hhs.gov mailto:ERIC@fda.hhs.gov

FDA-19-RFQ-1211449 Page 7 of 15 responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

PART 8 – CONTRACT PROVISIONS AND CLAUSES

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/these address(es): https://acquisition.gov/far/

52.204-13 – System for Award Management Maintenance (Oct 2018) 52.204-18 – Commercial and Government Entity Code Maintenance (Jul 2016) 52.212-4 – Contract Terms and Conditions – Commercial Items (Oct 2018) 52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

(End of clause)

FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2019)

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

(1) 52.203-19, 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) (31U.S.C.3553).

(5) 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 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).

https://acquisition.gov/far/ https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_203-19 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#id189A70O0P1N https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062680 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1048661 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1048698 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063319 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063504 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1063607 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064087 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064214

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___ (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 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 (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Aug2018) (15 U.S.C. 637(d)(4))

___ (ii) Alternate I (Jan 2017) 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 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 (Dec2015) (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 (Sept 2016) (E.O.11246).

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

___ (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.

___ (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).

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___ (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 (Jun2016) (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 (Jun2014) 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 (Jun2016) (E.O. 13693).

___ (45) (i) 52.224-3 Privacy Training (Jan2017) (5 U.S.C. 552 a).

___ (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 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 (Nov2007) (42 U.S.C. 5150).

___ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (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 (Jan2017) (41 U.S.C.4505, 10 U.S.C.2307(f)).

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_X_ (55) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) (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 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).

(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 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050674 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3332&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050705 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050789 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1049272 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552a&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_242-5 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1046560 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1046560 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1046560 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055581 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_222_41 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056410 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056443 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056463 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056685 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056732 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056818 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_222_62 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055065 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1059150 https://www.acquisition.gov/content/part-4-administrative-matters#i1122629

FDA-19-RFQ-1211449 Page 11 of 15 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) 52.204-23, 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 (May2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

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

(vii) 52.222-26, Equal Opportunity (Sept 2015) (E.O.11246).

(viii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (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 2014) (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 (Mar2015) of 52.222-50(22 U.S.C. chapter 78 and 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 (May2014) (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…