RFQ.pdf

Schedule B

Contract Type

The contract type is Firm-Fixed-Price

Pricing Schedule

Year Product Subscription Length Users Unit Price Total Price Base Period

Subscription to UpToDate or equal application

12-months 106 $ $

Option Period 1

Subscription to UpToDate or equal application

12-months NTE

Option Period 2

Subscription to UpToDate or equal application

12-months NTE

Total $

Statement of Work Center for Biologics Evaluation and Research (CBER)

Evidence-Base Clinical Decision Support (UpToDate or equal) Subscription Version 3.29.17

1. 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 above 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 in their day-to-day practices.

2. Objective

The objective is to procure a 12-month subscription to UpToDate or equivalent – an online evidence-based clinical decision support resource for CBER’s Medical Officers.

3. Technical Requirements:

The Contractor shall provide online subscription 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 10,000 clinical topics/articles 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.

• 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).

• 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 graphics search feature that allows subscribers to search a library of high-quality graphics (i.e., pictures, tables, illustrations, graphs, videos, and diagrams).

• Accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Shall be able to provide subscribers CME/CE/CPD credit by using the time they already spent researching clinical questions toward continuing professional development requirements.

• 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 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.

4. Deliverable The Contractor shall provide

Year Product Subscription Length

Users

Base Period Subscription to UpToDate or equal application

12-months 106 users

Option Period 1 Subscription to UpToDate or equal application

12-months NTE 120 users

Option Period 2 Subscription to UpToDate or equal application

12-months NTE 120 users

The Government reserves the right to exercise partial options in option periods 1 and 2. In the event that the Government requires fewer than 120 users, 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 agreed upon unit pricing in Schedule B. The Government will pay the agreed upon unit price for the number of users required in that year.

5. Inspection and Acceptance The FDA Contracting Officer’s Representative (COR) will perform inspection and acceptance of the subscription to be provided under this contract. The COR will log on and inspect the functionality of the subscription provided by the Contractor within 10 days of submission. The Contractor shall implement necessary changes within 10 business days from the day of rejection or change notification.

6. Period of Performance

The Government anticipates a one (1) year base period with two (2), 12-month option periods as follows:

Base: 05/01/2017 – 04/30/2018 Option 1: 05/01/2018 – 04/30/2019 Option 2: 05/01/2019 – 04/30/2020

7. Section 508 Compliance

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 or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

The following Section 508 sections apply:

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

1194.41 – Information, Documentation, and Support

8. Government Points of Contact http://www.access-board.gov/ http://www.acquisition.gov/ http://www.section508.gov/

Contract Specialist (CS):

Jennifer Benisek 5630 Fishers Lane Room 2088 FHA-500 Rockville, Maryland 20857-0001 Jennifer.Benisek@fda.hhs.gov 240-402-7532

Contracting Officer (CO):

Steven Chang 5630 Fishers Lane Room 2021 FHA-500 Rockville, Maryland 20857-0001 Tzeleong.Chang@fda.hhs.gov 240-402-7527

Contracting Officer’s Representative (COR):

To be determined at award

a. The COR may be changed at any time by the Government without prior notice to the Contractor by a unilateral modification to the Contract.

b. The responsibilities and limitations of the COR are as follows:

(1) The COR is responsible for the technical aspects of the project and serves as technical liaison with the Contractor. The COR is also responsible for the final inspection and acceptance of all reports, and such other responsibilities as may be specified in the contract.

(2) The COR is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the Contract price, terms or conditions. Any Contractor request for changes shall be referred to the Contracting Officer directly or through the COR. No such changes shall be made without the expressed prior authorization of the Contracting Officer (CO). The CO may designate assistant or alternate CORs to act for the COR by naming such assistant/alternate(s) in writing and transmitting a copy of such designation to the Contractor.

9. Provisions and Clauses

9.1. 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.

mailto:Jennifer.Benisek@fda.hhs.gov mailto:Tzeleong.Chang@fda.hhs.gov http://farsite.hill.af.mil/reghtml/regs/other/hhsar/352.htm#P517_108793 http://farsite.hill.af.mil/reghtml/regs/other/hhsar/352.htm#P529_112287 http://www.hhs.gov/web/508 http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards 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

9.2. 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 2017)

(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, 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).

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/Far/02.htm#P10_603

___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5)

_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]

_X__ (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 (15 U.S.C. 657a).

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

___ (13) [Reserved]

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

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

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

644).

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

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

___ (16) 52.219-8, Utilization of Small Business Concerns (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—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 (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 (Oct 2016) (E.O. 13126).

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

_X__ (28) 52.222-26, Equal Opportunity (Sep 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).

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

_X__ (33) (i) 52.222-50, Combating Trafficking in Persons (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). (E. O. 12989).

___ (35) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (Oct 2016).

Note to paragraph (b)(35): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, DoD, GSA, and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

___ (36) 52.222-60, Paycheck Transparency (Executive Order 13673) (Oct 2016).

___ (37) (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.)

___ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693).

___ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

___ (40) (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.

___ (41) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

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

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

___ (43) (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__ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

___ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

___ (46) 52.223-21, Foams (Jun 2016) (E.O. 13696).

___ (47) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

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

___ (48) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

_X__ (49) (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.

___ (50) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19 U.S.C.

3301 note).

_X__ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (52) 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).

___ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (55) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).

___ (56) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.

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

_X__ (57) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (58) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (59) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (60) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (61) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C.

637(d)(12)).

___ (62) (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:

___ (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) (E.O.

13658).

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

13706).

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

___ (11) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).

___ (12) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 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 (1) of FAR clause 52.222-17.

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

(vi) 52.222-26, Equal Opportunity (Sep 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) (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C.

chapter 78 and E.O. 13627).

(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O.

13627).

(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) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (Oct 2016) (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

Note to paragraph (e)(1)(xvii): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, DoD, GSA, and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

(xviii) 52.222-60, Paycheck Transparency (Executive Order 13673) (Oct 2016).

(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.

(xxi) 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).

(xxii) 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.

(xxiii) 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.

52.217-5 Evaluation of Options (JULY 1990)

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2017_2.html#wp1078150 for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

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 within any time period before contract expiration. 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.

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

(a) The Government may extend the term of this contract by written notice to the Contractor within any period before contract expiration provided that the Government gives the Contractor a preliminary written notice of its intent to extend within any period before contract expiration. 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 3 years.

9.3. 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)

10. 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 inciprotated into this order as an attachment and the FAR and HHSAR Clauses incorporated into this order, the FAR or HHSAR Clauses shall take precedence.

11. Three-way Invoice Instruction To be provided at award.

12. Instructions to Offerors

The Quoter shall use and complete the Pricing Schedule in Schedule B. An incomplete quotation or pricing with omission will be considered unacceptable.

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 2PM Eastern Time on 13 April 2017. Any questions must be addressed to Jennifer Benisek, Jennifer.Benisek@fda.hhs.gov no later than 2PM Eastern Time on 03 April 2017.

Primary Point of Contact:

Jennifer Benisek Jennifer.Benisek@fda.hhs.gov Phone: 240-402-7532

13. 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.

http://www.sam.gov/ mailto:Jennifer.Benisek@fda.hhs.gov mailto:Jacqueline.Warren@fda.hhs.gov