FDA-20-RFQ-1223463 - UptoDate or equal.pdf
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- FDA-20-RFQ-1223463
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FDA-20-RFQ-1223463 Page 1 of 18 Evidence-based Clinical Decision Subscription (UpToDate or equal)
Offeror Name DUNS
PART 1 – GENERAL INFORMATION
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 and 13.1, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The Government contemplates issuing a firm fixed-price purchase order resulting from this solicitation. This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2020-04, effective January 15, 2020.
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
Contract Type: Firm fixed-price purchase order
Pricing Table:
Line Item
Description Annual Price per user (unit price)
Qty (Users)
Total Annual Price
Subscription to UpToDate or equal – Base Year May 1, 2020 – April 30, 2021
$ 130 $
2a Subscription to UpToDate or equal – Option Year 1 May 1, 2021 – April 30, 2022
$ 130 $
2b Option for Additional Users $
NTE 10
additional
3a Subscription to UpToDate or equal – Option Year 2 May 1, 2022 – April 30, 2023
$ 130 $
3b Option for Additional Users $
NTE 20
additional
4a Subscription to UpToDate or equal – Option Year 3 May 1, 2023 – April 30, 2024
$ 130 $
4b Option for Additional Users $
NTE 30
additional
TOTAL $
FDA-20-RFQ-1223463 Page 2 of 18
In accordance with FAR 52.217-6, the Government reserves the right to exercise increased quantities in option periods 1, 2 and 3 at the per user rate specified. In the event that the Government requires fewer than maximum users listed in the table above, the Government will inform the Contractor of the number of users prior to exercising the option via the Notice of Intent to Exercise Option. The Contractor shall price the option using the unit pricing in the table above. The Government will pay the agreed upon unit price for the number of users required in that year.
PART 3 – DESCRIPTION OF REQUIREMENTS
Background The Center for Biologics Evaluation and Research’s (CBER) mission is to regulate biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
In order to meet its mission, CBER’s Medical Officers (MOs) review an unlimited number of adverse event reports and analyze various types of data to answer biologics safety questions and concerns.
When an adverse event is received, MOs need access to knowledge provided by leading medical specialists. Typically, CBER MOs need to obtain background rates of diseases in multiple populations, risk factors for disease occurrence, and classification schemes for syndromes, diagnostic options, and the latest treatments. This information forms the foundation for the interpretation of adverse events, and it is constantly changing as the volume of published medical information increases exponentially.
Currently, CBER maintains a subscription to UpToDate, an online resource that brings the most current scientific and medical information together in a rapidly accessible and integrated format. The current subscription allows MOs to log on to UpToDate 24 hours a day to look up and verify medical information. The subscription service uses topic reviews that are referenced back to the original journal articles, which were written by physicians and peer-reviewed by other physicians. The service is designed to assist medical professionals to keep up with the latest advances in medicine in their day-to-day practices.
Objective and Scope The objective is to procure 12-month subscription, with three (3) option years to UpToDate – an online evidence-based clinical decision support resource for CBER’s Medical Officers.
The scope of this contract is to provide CBER MOs access to an online evidence-based clinical decision support resource that brings the most current scientific and medical information together in a rapidly accessible and integrated format.
Technical Requirements
FDA-20-RFQ-1223463 Page 3 of 18
This requirement is being solicited in accordance with FAR 52.211-6, Brand Name or Equal. Equivalent specifications that differ from the requirements shall be justified by the proposing vendor. The Contractor shall provide an online subscription equivalent to UpToDate with the following capabilities:
• Clinical knowledge resource with scientific studies published in high-quality peer-reviewed journals demonstrating an impact on patient safety, reduced hospital complications, improved hospital efficiency, and improved medical knowledge acquisition.
• Accessible anytime from any Internet browser on a desktop or laptop computer, tablet, or mobile device with a personal username and password.
• The database shall have at least 11,000 clinical topics in twenty-five (25) or more specialties that are evidence-based and are updated using comprehensive review of peer-reviewed journals, clinical databases, and other resources whenever important new information is published and or as new evidence becomes available. The need for access to a wide variety of clinical topics is crucial to FDA MOs’ decision making and learning.
• Subscription shall provide graded recommendations that include the latest evidence and clinical experiences of leading physician authors and editors (i.e., strong (Grade 1) or weak (Grade 2) according to the balance between benefits, risk, burden, and costs, and the degree of confidence in estimates of benefits, risks, and burden).
• The application shall allow the clinician to search and navigate in multiple languages.
• The application shall have a feedback feature that will allow subscribers to submit questions and comments/suggestions to the editors.
• The application shall have medical calculators that will allow subscribers to enter the values in commonly used formulas to obtain numerical data (i.e., calculators to estimate the severity of a condition based upon the presence or absence of major risk factors).
• The subscription shall present the subscribers with synthesized content; one-stop shopping for a clear and concise answer. The application shall not offer an aggregation of many information resources such as textbooks or journal articles; leaving the subscribers to choose among them.
• The application shall have Infographics search feature that allows subscribers to search a library of high-quality graphics (i.e., pictures, tables, illustrations, graphs, videos, and diagrams).
• The subscription shall provide access to a fully integrated drug references/database that provides more in-depth analysis of drug-drug, drug-herb, and herb-herb interactions, drug adverse effects, warnings, and precautions, and current FDA Special Alerts and major Health Canada safety communications.
• Shall be accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
• Shall be able to provide FDA MO subscribers with CME/CE/CPD credits using the time spent researching clinical questions with the application toward continuing professional development requirements at no extra cost and/or additional testing.
FDA-20-RFQ-1223463 Page 4 of 18
• Shall be able to provide FDA/CBER the ability to be able to manage access rights for their group of users. Subscription shall include an online console where a subscriber manager can activate and deactivate individual users for access. If one of the users were to leave CBER, their access shall be able to be deactivated and transitioned to the new hire in that position. FDA/CBER should also have access to usage and utilization reports showing the aggregate use, along with the last login date for each user.
Deliverables
Year Deliverable Subscription Length Users Base Period 05/01/2020 – 04/30/2021
Subscription to UpToDate or equal
12-months 130 users
Option Period 1 05/01/2021 – 04/30/2022
Subscription to UpToDate or equal
12-months 130 users;
option for up to 140 users
Option Period 2 05/01/2022 – 04/30/2023
Subscription to UpToDate or equal
12-months 130 users;
option for up to 150 users
Option Period 3 05/01/2023 – 04/30/2024
Subscription to UpToDate or equal
12-months 130 users;
option for up to 160 users
PART 4 - PACKAGING, MARKING and SHIPPING All 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 at the delivery location. 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 30 days of receipt of the deliverable(s). If a rejection is issued, the Contractor shall correct any deficiencies within five (5) business days from the time the Government notifies the Contractor of any rejected deliverables. 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.
PART 6 – DELIVERIES OR PERFORMANCE
Deliveries and Place of Performance
FDA-20-RFQ-1223463 Page 5 of 18
Satisfactory performance of this contract shall be deemed to occur upon completion of services described above and/or upon acceptance by the Contracting Officer or the Technical Representative of these products and services. Any deliveries required by the contractor shall be made F.O.B. destination.
Unless otherwise directed, the required subscription shall be provided online.
Period of Performance The anticipated period of performance for this contract is as follows:
Base Year: May 1, 2020 – April 30, 2021 Option Year 1: May 1, 2021 – April 30, 2022 Option Year 2: May 1, 2022 – April 30, 2023 Option Year 3: May 1, 2023 – April 30, 2024
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):
Robin Goon 4041 Powder Mill Road Beltsville, MD 20705 Robin.Goon@fda.hhs.gov 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:
The Contractor shall submit an annual invoice for the fixed-price annual subscription amount.
FDA Three-Way Match Invoicing Procedures:
A. The contractor shall submit all invoices to:
FDA-20-RFQ-1223463 Page 6 of 18
U.S. FOOD AND DRUG ADMINISTRATION
Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor
MAIL HUB 2145
Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov
*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.
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;
mailto:FDAVendorPaymentsTeam@fda.hhs.gov
FDA-20-RFQ-1223463 Page 7 of 18
(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 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/
(End of clause)
FAR 52.204-13 – System for Award Management Maintenance (Oct 2018) FAR 52.204-18 – Commercial and Government Entity Code Maintenance (Jul 2016) FAR 52.212-4 – Contract Terms and Conditions – Commercial Items (Oct 2018) FAR 52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013) FAR 52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)
FAR 52.217-6 – Option for Increased Quantity (Mar 1989) The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor any time mailto:ERIC@fda.hhs.gov https://acquisition.gov/far/
FDA-20-RFQ-1223463 Page 8 of 18 prior to the expiration of the contract. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.
(End of clause)
FAR 52.217-9 – Option to Extend the Term of the Contract (Mar 2000)
(a) The Government may extend the term of this contract at any time prior to the expiration of the contract; provided that the Government gives the Contractor a preliminary notice of its intent to extend at least 3 days before the contract expires. The preliminary notice does not commit the Government to an extension.
(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.
(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed four (4) years.
(End of Clause)
52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items (Jan 2020)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).
(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).
(6) 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)).
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#unique_252523041 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
FDA-20-RFQ-1223463 Page 9 of 18
__ (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).
__ (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 (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 (Oct 2019) (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)).
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 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1064243 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1062590 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#i1062651 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057314 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057314 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057352 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057352 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057393 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057419 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057419 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057419 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-8 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_219-9 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057715 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057730 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057758 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057823 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057874
FDA-20-RFQ-1223463 Page 10 of 18
__ (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 2020) (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.
_X_ (29) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).
__ (ii) Alternate I (July 2014) of 52.222-35.
_X_ (30) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).
__ (ii) Alternate I (July 2014) of 52.222-36.
_X_ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).
__ (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). (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).
https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057902 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1057947 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055332 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055664 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055713 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055793 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055793 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056230 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056230 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056250 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section793&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056250 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056265 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056304 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056535 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056535 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1056753 https://www.acquisition.gov/content/part-22-application-labor-laws-government-acquisitions#i1095479 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053138 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053138 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053180 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053196 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053207 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053207 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053232 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053232 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053246
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__ (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. 552 a).
__ (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 (Oct 2019) (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)(13)).
__ (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.
https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053274 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053274 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053316 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_223_20 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#id1668D08086F https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_224_3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i52_224_3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053372 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053446 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 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#i1053446 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053446 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053446 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1053648 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section2501&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section3301&num=0&edition=prelim https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1054249 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1054921 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#i1055038 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1055048 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1050508 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#i1050540 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#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 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
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(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).
__ (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.
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(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) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 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.
(vi) 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.
(vii) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(viii) 52.222-26, Equal Opportunity (Sept 2015) (E.O.11246).
(ix) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C.4212).
(x) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).
(xi) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C.4212)
(xii) 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.
(xiii) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).
(xiv) (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 and E.O 13627).
(xv) 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).
(xvi) 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).
(xvii) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).
(xviii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(xix) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).
(xx) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate I (Jan 2017) of 52.224-3.
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