FDA-SOL-RFP-1215412.pdf

Number # FDA-SOL-RFP-1215412: IDIQ Contract for Implementation of SHIELD-Harmonized Laboratory Data Standards in 6 Active Healthcare Institutions.

PART I

SECTION A – REQUEST FOR PROPOSAL SOLICITATION

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2019-05.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED.

SECTION B – Services and Prices

B.1. General

The requirement is being solicited as 100% full and open competition for Implementation of SHIELD-Harmonized Laboratory Data Standards in 6 Active Healthcare Institutions.

B.2. Contract Type –Fixed Price

Multiple Awards, Indefinite Delivery, Indefinite Quantity (IDIQ), task order oriented contracts.

Maximum of 6 awards will be contemplated under this RFP. The Contractor(s) shall provide services in accordance with the individual Statement of Work as the designated contract type.

This NAICS Code for the solicitation is 622110 General Medical and Surgical Hospitals

B.3. Funding

Funds for the services provided will be obligated via individual Task Order in a respective IDIQ Basic Contract. The Contractor shall only be paid for effort that has been authorized by the Government and performed in accordance with the contract specifications.

B.3.1 Contract Ceiling

The Government shall pay the Contractor the fixed price of $1,000.00 as the guaranteed minimum amount for the life of the contract, which shall be incorporated as part of the first task order. The amount can only be claimed at the end of the contract period if the Contractor does not receive any Task Orders under the IDIQ contract. The maximum value of the individual contracts shall not exceed $4,000,000.00.

B.3.2 Task Orders

Individual Task Orders shall be issued as requirements occur. Task Orders shall specify work to be performed and reflect the rates of the proposed tests in effect when the Task Order is issued The Contractor shall perform all services in accordance with the task order performance work statement/specifications, which shall be included in the Task Order. All Task Orders shall be fixed price. The period of performance of a Task Order may extend one year after the IDIQ contract’s expiration date.

B.4. Rates

The Contractor’s fully-loaded labor rates for all personnel included in Table B.4.1 shall apply for the period of performance of the contract, as requested. These rates shall be used by the Contractor as the ceiling labor rates when submitting price proposals in response to requests for task orders and change orders issued under the contract.

B.4.1. Schedule of Hourly Fully Burdened Rates

The firm fixed price for providing the services for the contract period is: $__________ The firm fixed price per month is described below:

September 30, 2019 through September 29,2021 24 Annual amounts:_____

SECTION C: DESCRIPTION/SPECIFICATIONS/WORK STATEMENT ARE ALL

UNDER ATTACHMENT 1 OF THIS RFP

SECTION D - DELIVERIES OR PERFORMANCE PERIOD

D.1. Performance Period

This contract provides for an initial Period of Performance of two (2) years.

D.2 Place of Performance

The required services shall be performed at the Contractor’s facility.

Labor Category Maximum number of hours

Year 1 Year 2

Project Manager $ $

Field Supervisor $ $

D.3. Reports/Deliverables/Scheduled Items

The Contractor shall submit the following reports/deliverables:

(Unless otherwise noted, calendar days apply)

TASK: Implementation Pilots in FHIR or HL7 V2 (all work conducted in parallel)

Year 1, Year 2

Task Timeline Justification Deliverable

1 LIVD: Data Governance and Interoperability Knowledge Base Team

1.1 Identify ~100 lab test

codes to use in trial across and associated answer sets

1 month Time price for data governance and information knowledge base team – estimated 200 hours

Provide list of ~100 appropriate codes for SHIELD review

1.2 Obtain LOINC mappings

in LIVD from authoritative source with SHIELD help

2 months Bi-weekly update at SHIELD meeting

1.3 Compare healthcare

institution’s LOINC data dictionary mappings to those from the authoritative source

3 months Present findings from comparison to SHIELD.

1.4 Ensure the proper

LOINC code is used for these tests

Provide list of final codes with rationale as to why they were or were not accurate to

SHIELD.

1.5 Develop a plan to test the

sending and reception of the codes in a test environment

Provide plan for SHIELD review

1.6 Move work to a

production environment after a successful test

~100 IVD descriptive code sets in production environment; report to

SHIELD

2 LIVD: LIS or Registry Database Team

2.1 Compare the LOINC

mappings provided by authoritative source

2 months Time costs for LIS or Registry Team – estimated 140 hours

Present findings from comparison to SHIELD.

Update LIS (e.g., Sunquest) with correct mappings if needed

Present challenges and successes with update to

SHIELD.

3 LIVD: EHR Vendor

3.1 Interface with healthcare

institution

2 months Time costs for EHR – estimated 80 hours

Update progress at bi-weekly SHIELD meeting

Creation of aliases in the alias tables for the mapping of LOINC codes transmitted to the EHR for both retrieval and storage of the LOINC codes transmitted to it from the lab

Present alias challenges and code transmission challenges to SHIELD.

4 LAW Implementation

4.1 Project management 1 month Based on time price Update at bi-weekly SHIELD meeting

4.2 Building interface

between device and LIS

3 months Based on time price Present challenges of builds to SHIELD

4.3 Testing transmission

from device to LIS

2 months Based on time price Present challenges of transmission to

SHIELD

5 FHIR and HL7 V2 Query Applications

5.1 Project Management, Requirements, Testing

4 months Based on time price Functional applications for systems leveraging FHIR or HL7 V2 that can associate LOINC codes with ICD and

5.2 FHIR or HL7 V2 App

Development

Based on time price

5.3 FHIR or HL7 V2 Server

Implementation

Based on time price CPT codes

Implementation Total ~5 months See above See above

Implementation and System Evaluation for 1 Active Healthcare Insitutions Total

18 months See above See above

D.4. Delivery Instructions for Reports

Reports shall be submitted electronically to: Contracting Officer Representative (COR) and Sarah Hussain, Contract Specialist at the following addresses, unless otherwise specified:

One copy to the COR or other program center/office designee, clearly marked “courtesy copy only”:

U.S. Food and Drug Administration Attention: COR

DMD/OIR/CDRH

10903 New Hampshire Avenue Silver Spring, MD 20993 and

Food and Drug Administration Attn.: Sarah Hussain, Contract Specialist Facilities Support Branch, DAP 4041 Powder Mill Road Beltsville, MD 20705 Sarah.Hussain@fda.hhs.gov

D.5. Notice of Delays

The Contractor shall provide written notification to the Contracting Officer of any actual or potential situation that threatens to delay the timely performance of work under this contract.

The notification shall include all relevant information and shall be made immediately upon the Contractor having knowledge of the actual or potential situation that may delay this contract.

D.6. On-Site Coordinators

The Contractor shall contact the FDA's onsite technical representative (to be designated under separate correspondence where applicable) to arrange for the scheduling of work.

mailto:Sarah.Hussain@fda.hhs.gov

SECTION E - CONTRACT ADMINISTRATION DATA

E.1. Role of Government Personnel and Responsibility for Contract Administration

The COR and/or Contracting Officer (CO) is responsible for the acceptance of work.

Technical Direction

A. Performance of the work under this contract shall be subject to the technical direction of the

COR. The term "technical direction" is defined to include the following:

1.Technical directions to the Contractor which shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual scope of work;

2. Providing information to the Contractor for assistance in the interpretation of drawings, specifications, or technical portions of the work description; and

3. Review and, where required by the contract, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the contract.

B. Technical direction must be within the general scope of work stated in the contract. The COR does not have the authority to, and may not, issue any technical direction which (1) constitutes an assignment of additional work outside the general scope of the contract; (2) constitutes a change as defined in the contract clause entitled "Changes," (3) in any manner causes an increase or decrease in the total contract price; or (4) changes any of the expressed terms, conditions, or specifications of the contract.

C. All technical directions shall be issued in writing by the COR or shall be confirmed by him/her in writing within five (5) working days.

D. The Contractor shall proceed promptly with the performance of technical directions duly issued by the COR in the manner prescribed by this clause and within his/her authority under the provisions of this clause.

E. If, in the opinion of the Contractor, any instruction or direction issued by the COR is within one of the categories as defined in B. (1) through B. (4) above, the Contractor shall not proceed but shall notify the Contracting Officer, in writing, within five (5) working days after the receipt of any such instruction or direction and shall request the Contracting Officer to modify the contract accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor, in writing, that, in his/her opinion, the technical directions are within the scope of this clause and do not constitute a change under the "Changes" clause of the contract. The Contractor shall thereupon proceed immediately with the direction given. Any failure of the parties to agree upon the nature of the instruction or direction, or upon the contract action to be taken with respect thereto, shall be subject to the provisions of the contract clause entitled "Disputes."

The following COR will represent the Government for the purpose of this contract:

COR: TBD

U.S. Food and Drug Administration

DMD/OIR/CDRH

10903 New Hampshire Avenue Silver Spring, MD 20993

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.

E.2. Post Award Evaluation of Contractor Performance

a. Contract Performance Evaluations

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration. FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations.

CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm.

FDA will register the contractor in CPARS upon receipt of the name and email address of two

(2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 30 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3 year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm. There is no fee for registration or use of the

CPARS.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Past Performance Information Retrieval System (PPIRS)

Contractors may obtain access to PPIRS through the System for Award Management process. To obtain access, a Contractor must enter a Marketing Partner Identification Number (MPIN) in their profile in the System for Award Management (http://www.SAM.gov/). This can then be used to access the report(s) in PPIRS related to your company. If they are already registered in SAM, Contractors will be asked for their DUNS number and Transaction Partner Identification Number (TPIN) when they update their Contractor profile to include the past performance point of contact and MPIN. Contractors should ensure that they know their DUNS number and TPIN number in order to update contact information in their SAM profile. To access information in PPIRS, the Contractor should log in using his/her DUNS and MPIN number.

The Contractor may also log into PPIRS through the following website address:

http://www.ppirs.gov/

E.3. Key Personnel

The key personnel specified in the contract is considered to be essential to work performance. At least 30 days prior to the Contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the CO and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the Contractor is terminated for cause or separates from the Contractor voluntarily with less than thirty days http://www.sam.gov/ http://www.ppirs.gov/ notice, the Contractor shall provide the maximum notice practicable under the circumstances.

The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the CO. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

E.4. ORDERING PROCESSES AND PROCEDURES

E.4.1. Ordering services under this contract shall be accomplished by the issuance of written Individual Task Orders specifying the types of services being ordered.

E.4.2. Authorized Users. Only the Food and Drug Administration, Office of Acquisitions & Grant Services CO’s are authorized as ordering officials to place Task Orders under this contract.

E.5. TASK ORDER PROCESSING

All IDIQ Task Orders issued hereunder are subject to the terms and conditions of this contract.

The contract shall control in the event of conflict with any Task Order. The general process for individual task orders is as follows:

a) The FDA will prepare a statement of work in accordance with the technical requirements. The SOW will include, at a minimum, the following elements:

1. Description of work in terms of the purpose or objectives of the work to be performed.

2. Description of how the work performance is assessed relative to objectives, goals, and outcomes.

3. Period and place of performance

4. Reporting requirements and Deliverables.

b) Individual Task orders shall only be issued by the OAGS CO.

c) The Contractor shall prepare and submit responses addressing all areas of the requirement.

The Contractor shall submit the response within 2 weeks or as specified in the individual TO and adhere to the ceiling rates established in the contract. No separate payment will be made to the Contractor for the price to prepare, submit, or negotiate a response.

d) The Government shall evaluate each response for technical acceptability and price reasonableness.

SECTION F - SPECIAL CONTRACT REQUIREMENTS

F.1. Payments to Contractors

Payment shall be based on invoicing for services completed, on a monthly basis.

52.242-5 – Payments to Small Business Subcontractors (Jan 2017)

(a) Definitions. As used in this clause--

“Reduced payment” means a payment that is for less than the amount agreed upon in a subcontract in accordance with its terms and conditions, for supplies and services for which the Government has paid the prime contractor.

“Untimely payment” means a payment that is more than 90 days past due under the terms and conditions of a subcontract, for supplies and services for which the Government has paid the prime contractor.

(b) Notice. The Contractor shall notify the Contracting Officer, in writing, not later than 14 days after--

(1) A small business subcontractor was entitled to payment under the terms and conditions of the subcontract; and

(2) The Contractor--

(i) Made a reduced or untimely payment to the small business subcontractor; or

(ii) Failed to make a payment, which is now untimely.

(c) Content of notice. The Contractor shall include the reason(s) for making the reduced or untimely payment in any notice required under paragraph (b) of this clause.

F-2. Required Insurance

The clause 52.228-5, Insurance-Work on a Government Installation, in Section C, is supplemented to require the following minimum amount of insurance:

A. Worker’s Compensation and Employer’s Liability. Contractors are required to comply with applicable Federal and State workers’ compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer’s liability section of the insurance policy, except when contract operations are so commingled with a Contractor’s commercial operations that it would not be practical to require coverage. Employer’s liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers’ compensation to be written by private carriers.

F.3. General Operating Conditions

Observance of Legal Holidays.

The Government hereby provides “notice” and the Contractor hereby acknowledges “receipt” that Government personnel observe the listed days as holidays:

Martin Luther King, Jr’s Birthday President Day

Memorial Day Independence Day

Labor Day Columbus Day

Veterans Day Thanksgiving Day

Christmas Day New Year’s Day

Any other day designated by Federal Statue

Any other day designated by Executive Order

Any other day designated by President’s Proclamation

When any such day falls on a Saturday, the preceding Friday is observed; when any such day falls on a Sunday, the following Monday is observed. Contractor employees performing duties for the Food and Drug Administration are not automatically relieved from duty by virtue of the fact that the Government employees are dismissed or given the day off.

Observance of such days by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, estimated cost, or fee(s), if any, except as set forth in the contract. Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on the holidays set forth above. The Contractor shall not charge any holiday as direct charge to the contract. In the event Contractor personnel work during a holiday observed by the Contractor other than those above, no form of holiday or other premium compensation will be reimbursed as either a direct or indirect cost. However, this does not preclude reimbursement for authorized overtime work.”

In the event the FDA grants administrative leave to its Government employees at the site, on-site Contractor personnel shall also be dismissed if the site is being closed. In each instance when the site is closed to Contractor personnel as a result of inclement weather, potentially hazardous conditions, explosions, or other special circumstances, the Contractor shall direct its staff as necessary to take actions such as reporting to its own site(s) or taking appropriate leave consistent with its policies. The cost of salaries and wages to the Contractor for the period of any such site closure shall be a reimbursable item of direct cost under the contract for employees whose regular time is normally a direct charge if they continue to perform on contract work;

otherwise, the costs are reimbursable as indirect costs in accordance with the Contractor's established accounting policy.”

F.4. Safety and Accident Prevention

1. Contractors working at FDA facilities shall be responsible for compliance with all applicable safety regulations and standards issued under the provisions of the Williams/Steiger Occupational Safety and Health Activities (OSHA) and other applicable regulations issued by state, county, or local authorities. Any deviations from the OSHA regulations will require a variance from the OSHA authorities prior to initiating the change.

2. Contractors shall safeguard the work site and perform all operations in such manner as to insure that their employees, Government personnel, and others who may gain access to the site will not be endangered.

3. The Prime Contractor shall be responsible for the enforcement of these safety rules by its subcontractors. Questions concerning safety shall be submitted to the COR for clarification by the Safety Office. The Safety Office has the authority at any time to enter a site, in conjunction with the COR or Site Manager, after first contacting the Project Manager, for the purpose of conducting a safety survey.

4. A contractor working on FDA Property is required to promptly report any accident suffered by its employees to the COR who will in turn notify the Safety Office.

F.5. Government-furnished Information/Reference Materials.

Any reference materials such as manuals, test data, drawings, articles, and study reports, available to the contractor in preparation of their task order proposals shall be provided at the procurement phase of the specific task orders. It will specify whether that information requires additional controls to monitor access and distribution (e.g., technical specifications, building designs). Copies can be made of the material that is requested, but no original information would be taken from the reading room.

PART II

SECTION G - CONTRACT CLAUSES

FAR 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 these addresses:

www.acquisition.gov/far/index.html and http://www.hhs.gov/policies/hhsar/subpart301-1.html.

http://www.acquisition.gov/far/index.html http://www.hhs.gov/policies/hhsar/subpart301-1.html

FAR Clause Title Date 52.203-3 Gratuities (Apr 1984) 52.245-1 Government Property (Jan 2017) 52.228-5 Insurance--Work on a Government Installation (Jan 1997)

(Jan 1997)

52.227-14 Rights in Data-General (May 2014) HHSAR Title Date 352.211-3 Paperwork Reduction Act. Dec, 2015

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations

Dec, 2015

352.227-14 Rights in Data—Exceptional Circumstances. Sept 2014

352.239-74 Electronic Information and Technology Accessibility Notice. Dec 2015

52.212-4 - Contract – Terms and Conditions – Commercial – Items (Oct 2018)

52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items. (May 2019)

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

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and

Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

(4) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(5) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

___ (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).

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

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

_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).

_X__ (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).

_X_ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

___ (10) [Reserved]

___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

___ (ii) Alternate I (Nov 2011) of 52.219-3.

___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

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

___ (13) [Reserved]

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

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

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

644).

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

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

_X_ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C.

637(d)(2) and (3)).

_X__ (17) (i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637 (d)(4)).

___ (ii) Alternate I (Nov 2016) of 52.219-9.

___ (iii) Alternate II (Nov 2016) of 52.219-9.

___ (iv) Alternate III (Nov 2016) of 52.219-9.

___ (v) Alternate IV (Aug 2018) of 52.219-9.

___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

___ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

___ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set- Aside (Nov 2011) (15 U.S.C. 657f).

_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

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

637(m)).

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

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

_X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).

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

_X_ (28) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

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

_X_ (29) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

___ (ii) Alternate I (July 2014) of 52.222-35.

_X_ (30) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

___ (ii) Alternate I (July 2014) of 52.222-36.

_X_ (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 (JAN 2019)

(22 U.S.C. chapter 78 and E.O. 13627).

___ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627).

___ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA- Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693).

___ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

___ (38) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514

___ (ii) Alternate I (Oct 2015) of 52.223-13.

___ (39) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

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

___ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (41) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-16.

_X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

___ (43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

___ (44) 52.223-21, Foams (Jun 2016) (E.O. 13696).

_X_ (45) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

___ (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 2018) (19 U.S.C. 2501, et seq., 19 U.S.C.

3301 note).

_X_ (49) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

___ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).

___ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.

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

_X_ (55) 52.232-33, Payment by Electronic Funds Transfer--System for Award Management (Oct 2018) (31 U.S.C. 3332).

___ (56) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C.

637(d)(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.

(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).

_X__ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C.206 and 41 U.S.C. chapter 67).

___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-- Requirements (May 2014) (41 U.S.C. chapter 67).

___ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67).

___ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O.

13658).

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

13706).

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

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Jan 2019) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and

Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C.

637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(v) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495).

Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

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

(vii) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

(viii) 52.222-35, Equal Opportunity for Veterans (Oct 2019) (38 U.S.C. 4212).

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

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

(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (Aug 2018), (41 U.S.C. chapter 67).

(xiii) (A) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C.

chapter 78 and E.O. 13627).

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

13627).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)

(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67)

(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).

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

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

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

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

(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations.

(May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph

(e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

FAR 52.216-18 - Ordering (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from date of award through the expiration date.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

FAR 52.216-19 - Order Limitations (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount less than $1,000.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor -

(1) Any order for a single item in excess of $1,000,000

(2) Any order for a combination of items in excess of $1,000,000; or

(3) A series of orders from the same ordering office within thirty (30) days that together call for quantities exceeding the limitation in subparagraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216- 21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within five (5)days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

FAR 52.216-22 - Indefinite Quantity (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided that the Contractor shall not be required to make any deliveries under this contract after the fifth year.

FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 1 day prior to expiration of the base contract or any option period that is in existence.

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 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR or Technical Point of Contact (TPOC). The COR/TPOC is (insert name and email address.)

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.