75N95021R00018_Combined_synopsis.pdf

RFP 75N95021R00018

COMBINED SYNOPSIS / SOLICITATION

COMPETITIVE

Title: Biomedical Data Translator User Interface Development

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is conducted under the authority of 42 U.S.C. 287(a).

(ii) The solicitation number is 75N95021R00018 and the solicitation is issued as a request for proposal (RFP).

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures;

FAR Subpart 13.5— Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-06 dated July 12, 2021.

(iv) The associated NAICS code is 541511 Custom Computer Programming Services, and the small business size standard is $30 million. No set aside restrictions apply.

(v) Schedule of Services:

This is anticipated to be a time and materials contract.

(vi) Background:

The purpose of this requirement is to work with NCATS to develop a user interface for the Biomedical Data Translator. The contractor will work with NCATS and parts of the Translator development consortium (currently fifteen different teams from within and outside the Government) to develop a user interface for biomedical researchers to interact with Translator. The development of a user interface poses several distinct design challenges for the developer, including but not limited to:

• presentation of multiple complex knowledge graph “answers” in response to a single query;

• establishing confidence in the ability of Translator to address the user’s question by providing provenance of the knowledge returned to the user;

• capturing the collection and history of user decisions used to formulate, iterate, filter and merge results as they develop their query; and

• gathering feedback from the user.

Substantial background information is available at Sam.Gov Contract Opportunities, including:

• Audio-only Presentation, “Biomedical Data Translator Overview (Audio Only)”, https://youtu.be/Tx4VIMAuKnQ.

• Video Presentation, “Biomedical Data Translator Architecture and Workflow”, https://youtu.be/-rKngxwtHX4.

• Translator User Interface Materials (PDF portfolio – 7 items):

o “Translator and UI Background” o “18F Discovery Research,” GSA 18F o “Biomedical Data Translator Architecture and Workflow,” slide deck presented in the video presentation.

o Four Example Use Cases:

“Pain Points for Pain Meds – Introduction” “Pain Points for Pain Meds – Detailed” “Explaining Finasteride’s Use to Treat Hair Loss: A Translator Use

Case” “Finding Genes with Any Connection to IL-6”

• Extensive background on the Biomedical Data Translator:

o https://ncats.nih.gov/translator

(vii) Delivery is in accordance with the attached Schedule, f.o.b. destination, at:

The National Center for Advancing Translational Sciences (NCATS) Drug Development Partnership Programs Office of the Director 9800 Medical Center Drive, Bldg B-371 Rockville, MD 20850

The period of performance will be one year from the date of award, with two option periods of one year each. Award is anticipated on or before September 1, 2021.

(viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition and is incorporated by reference. Additional instructions are contained in the Schedule, Section L. This solicitation requires delivery of proposals as stated in Attachment 1, "Packaging and Delivery of Proposals for Use with the NIH Electronic Contract Proposal Submission (eCPS) Website." If your proposal is not received by the contracting officer or her designee at the place and time specified for the Office of Acquisitions, then it will be considered late and handled in accordance with https://youtu.be/Tx4VIMAuKnQ https://youtu.be/-rKngxwtHX4 https://ncats.nih.gov/translator subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors – Competitive Acquisition," located in Section L.1. of this solicitation.

(ix) Evaluation factors are provided in the Schedule, Section M. All factors will be evaluated in accordance with the Solicitation.

(x) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with offers. Additional representations apply; see Schedule Section K.

(xi) The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition, and is incorporated by reference. Additional terms and conditions are included in the Schedule.

(xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items, applies to this acquisition. Clauses applicable to this acquisition have been incorporated into the Schedule by reference or in full text.

(xiii) Additional requirements and terms and conditions determined by the contracting officer to be necessary for this acquisition are included in the Schedule and attachments. In the event of a conflict or inconsistency between FAR clauses 52.212-1, 52.212-4, 52.212-5, and the Schedule, the Schedule shall take precedence.

(xiv) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement.

(xv) The Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

Proposals must reference solicitation number 75N95021R00018 and be submitted through the NIH Electronic Contract Proposal Submission website in accordance with Attachment 1, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website." Proposals must be submitted no later than 11:00 a.m. Eastern time on Monday, August 16, 2021. Offers will be valid for 120 days unless a different period is specified by the offeror on the attachment entitled, "Proposal Summary and Data Record,” NIH 2043.

Questions may be submitted by email to the contract specialist no later than 11:00 a.m.

Eastern time on Tuesday, August 3 2021. INCLUDE THE SOLICITATION NUMBER IN

THE SUBJECT LINE OF THE EMAIL TO ENSURE IT IS APPROPRIATELY

IDENTIFIED. The Government will provide answers on or about Friday, August 6, 2021.

http://www.sam.gov/

Direct questions by email to Stuart Kern, Contract Specialist, stuart.kern@nih.gov.

mailto:stuart.kern@nih.gov

RFP TABLE OF CONTENTS

Contents

RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II – CONTRACT CLAUSES SECTION I - CONTRACT CLAUSES

ARTICLE I.1. GENERAL CLAUSES FOR A TIME AND MATERIAL OR A LABOR HOUR CONTRACT

ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES

ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES

ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

ARTICLE I.5. SERVICE CONTRACT LABOR STANDARDS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

c. BUSINESS PROPOSAL INSTRUCTIONS

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. TECHNICAL EVALUATION FACTORS

5. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY - SECTION

508 59

6. PAST PERFORMANCE FACTOR

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN

CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO

THIS SOLICITATION. ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE

IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND

GENERAL INFORMATION APPLICABLE TO THE CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS

CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT

REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT

OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL

PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION

PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED

CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY

INFORMATION TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT

CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of this requirement is to provide NCATS with support services for the development of a user interface for the Biomedical Data Translator.

ARTICLE B.2. Time and Materials - Ceiling Price

This is a Time and Materials contract as contemplated by FAR 16.601.

The Contractor shall provide a base quantity of up to TBD hours (maximum) under this contract.

The ceiling price for the base period of the contract will be $ TBD . The sum of all costs for all work performed during the base period shall not exceed the ceiling price.

If the Government exercises is option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the ceiling price for the option quantities will be as specified below. The sum of all costs for all work performed for each option quantity shall not exceed the ceiling price for that option quantity.

Period of

Performa nce

Ceiling Hours

Ceiling Price ($)

Base Quantity TBD TBD $TBD Option Quantity TBD TBD $TBD Option Quantity TBD TBD $TBD

The Contractor shall notify the Government at least thirty (30) days in advance if it anticipates that the work performed under this contract will reach the ceiling.

The ceiling price does not constitute a commitment, implied or otherwise, that the Government will expend the entire amount indicated above.

ARTICLE B.3. Labor Hour Rate

The Contractor shall be paid a fixed hourly rate for each labor category specified below.

Labor Category Hourly Rate ($)

See Section L of this RFP for an estimate of effort.

a. For invoices, compensation shall be computing by multiplying the appropriate hourly rate prescribed in this contract by the number of direct hours performed.

b. The hourly rates include all costs, including but not limited to applicable taxes, duties, wages, indirect costs, general and administrative costs, and profit.

c. The hourly rate will be calculated in tenth-of-an-hour increments for each full six minutes.

d. Hourly rates shall apply to a forty (40) hour work week. Overtime will not be required.

ARTICLE B.4. Material Costs

a. The Contractor shall be paid for the actual costs for purchase of materials as required by the Statement of Work. See Section L of this RFP for an estimate of material costs.

b. The Contractor may also include material handling costs as a part of the material costs. The material handling costs shall include only costs clearly excluded from the labor-hour rate. Material handling costs may include all appropriate indirect costs allocated to direct materials in accordance with the Contractor’s usual accounting procedures consistent with FAR Part 31. In no event shall the final amount reimbursable for material handling costs exceed a ceiling of % of material costs.

ARTICLE B.5. ADVANCE UNDERSTANDINGS

1. Intellectual Property

The Government will require unlimited rights in any data produced in the performance of this contract in accordance with FAR 52.227-14, Rights in Data – General (May 2014).

All software and other tools used for this entirety of the Translator program must be open source and publicly available. All software created during the project period must be made publicly available through program-directed source code repositories. The NIH expects and supports the timely release and sharing of final research data, software and tools that support the publication of these data from NIH-supported programs for use by other researchers. NCATS expects that this project will be intensely collaborative among research partners and NIH staff, and that the unrestricted exchange of source code and software tools written as part of this program will be essential to a successful outcome.

2. Contracting Officer’s Authorization

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated TBD, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports shall be submitted in electronic format.

All reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

a. Technical Progress Reports

1. Twice-Monthly Performance Report

The Contractor shall document the efforts performed in the completion of each task in a detailed twice monthly report and presentation. The report shall include the content identified in the SOW any additional information that NCATS deems necessary. The report shall include the following items and any additional information that NCATS deems necessary:

a. Individual project status to include objectives met, work completed, and work outstanding;

b. Weekly resource challenges;

c. Issues and obstacles impeding progress and recommended solutions;

d. Status of deliverables/milestones;

e. Status and plan for activities relating to Very Important Persons (VIPs) and critical service tickets;

f. Resource planning/status;

g. Topics or issues identified by the COR.

2. Weekly Support Report

Due each Monday, the Contractor shall provide a status update on all active, pending, and recently completed tasks for all equipment support activities.

3. Monthly Support Report

Within fifteen (15) days following the end of each month, the Contractor shall deliver a report that describes all of the equipment support activities conducted during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

4. Weekly Programming Report

Due each Monday, the Contractor shall provide a status update on all active, pending, and recently http://www.hhs.gov/web/508/index.html completed tasks for all software development activities.

5. Monthly Programming Report

Within fifteen (15) days following the end of each month, the Contractor shall deliver a report that describes all of the software development activities conducted during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

6. Monthly Budget and Labor Summary

Within fifteen (15) days following the end of each month, the Contractor shall provide a report summarizing the labor hours and budget expended per labor category for each month.

7. Technical Documentation

On an ongoing basis, the contractor shall document the systems, software, and procedures supported or developed during the contract and as requested by the Government.

8. Incident and Breach Report

The Contractor shall report all incidents, to include but not limited to unintended disclosures of information, as soon as possible but no later than one hour after the incident is discovered.

9. Final Management Plan

The Contractor shall finalize their Draft Management Plan (required with proposal submission) within fifteen (15) days following the effective date of the contract. The Final Management Plan shall reflect any changes, additions, or revisions to the Draft Management Plan as required by NCATS.

10. Final Transition-In Plan

The Contractor shall finalize their Draft Transition-In Plan (required with proposal submission) within three

(3) days following the Contract Kick-Off Meeting. The Final Transition-In Plan shall reflect any changes, additions, or revisions to the Draft Transition Plan as required by NCATS.

11. Transition-Out Plan

The Contractor shall develop a Draft Transition-Out Plan that shall facilitate the accomplishment of a seamless transition from the incumbent to an incoming contractor/Government personnel at the expiration of the contract. The contractor shall provide the COR with the Draft Transition-Out Plan no later than ninety (90) days prior to the expiration of the contract. The Contractor shall identify how it will coordinate with the incoming contractor and/or Government personnel to transfer knowledge regarding the following:

• Program and project management processes;

• Points-of-contact (includes Key Stakeholders);

• Location of technical, program, and project management documentation and software tools;

• Status of ongoing technical initiatives;

• Appropriate contractor to contractor coordination to ensure a seamless transition;

• Transition of Key Personnel;

• Identifying schedules and milestones;

• Identifying actions required of the Government;

• Establish and maintain effective communication with the incoming contractor/Government personnel for the period of the transition via weekly status meetings.

The Draft Transition-Out Plan shall include:

• Coordination with Government representatives;

• Review, evaluation, and transition of current support services;

• Transition of historic data to new contractor systems;

• Transfer of hardware warranties and software licenses (if applicable);

• Transfer of all necessary business and/or technical documentation;

• Orientation phase and program to introduce Government personnel, programs, and users to the contractor's team, tools, methodologies, and business processes;

• Disposition of contractor-purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc.;

• Transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and GFE inventory management assistance;

• Personnel out-processing procedures, turn-in of all Government keys and ID/access cards;

• Upon receipt of Government approval of the Draft Transition-Out Plan, the Contractor shall execute the Final Transition-Out Plan.

12. Draft Final Report

At least thirty (30) days prior to contract expiration, the Contractor shall provide a report comprehensively describing the work performed and results obtained for the entire contract period of performance.

13. Final Report

On or before contract expiration, the Contractor shall provide a final report comprehensively describing the work performed and results obtained for the entire contract period of performance. This report shall incorporate and address comments on the Draft Final Report that will be provided by the COR.

b. Other Reports/Deliverables

1. Source Code and Object Code

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

2. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

a. Information Security Plan

An Information Security Plan consistent with Article H.6 shall be submitted to the Contracting Officer within 30 days following the effective date of any task order and updated annually on the anniversary date of the contract.

b. Roster of Employees Requiring Suitability Investigations

The Roster of Positions Requiring Suitability Investigations required by Article H.6 shall be submitted to the Contracting Officer and the COR along with the offeror's proposal.

c. Contractor Non-Disclosure Agreement

Contractor Non-Disclosure Agreements required by Article H.6 shall be submitted to the Contracting Officer and COR prior to performing any work under this contract.

d. Security Awareness, Privacy, and Records Training

Training records required by Article H.6. shall be submitted to the Contracting Officer and the COR prior to performing any work under a task order.

e. Rules of Behavior

Training records required by Article H.6 shall be submitted to the Contracting Officer and the COR prior to performing any work under this contract.

f. Incident Response

The Contractor shall report any incidents subject to Article H.6 within 24 hours of the occurrence.

g. Sanitization

The Contractor shall provide certification related to sanitization of records as required by Article H.6 to the Contracting Officer and COR upon the expiration of this contract.

h. Notification of Employee Departure

The Contractor shall notify the Contracting Officer, COR, and system Information Systems Security Officer (ISSO) within 15 days before an employee stops working under this contract.

i. Employee Separation Checklist

The NIH Contractor Employee Separation Checklist required by Article H.6 shall be submitted to the Contracting Officer and COR within two days of an employee's exit from the contract.

3. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/ contracting/technology/vendors.html under "Vendor Information and Documents."

http://www.hhs.gov/web/508/contracting/technology/vendors.html http://www.hhs.gov/web/508/contracting/technology/vendors.html

SECTION D - 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.

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the NCATS Contracting Officer’s Representative (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Center for Advancing Translational Sciences (NCATS) Drug Development Partnership Programs Office of the Director 9800 Medical Center Drive, Bldg B-371 Rockville, MD 20850

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-6, Inspection Time-and Material and Labor Hour (May 2001). Alternate I (April 1984) is not applicable to this contract.

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from [one year from the date of award].

If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Period 1 – [one year]

Option Period 2 – [one year]

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b.

DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract.

Item Description Delivery to

Delivery Schedule

(1) Twice-Monthly Performance Report COR Due the 1st and 15th of each month

(2) Weekly Support Report COR Due each Monday

(3) Monthly Support Report COR Due the15th of each month

(4) Weekly Programming Report COR Due each Monday

(5) Monthly Programming Report COR Due the 15th of each month

(6) Monthly Budget and Labor Report COR Due the 15th of each month

(7) Technical Documentation COR Upon request/as developed

(8) Incident and Breach Report CO, COR

As needed

(9) Final Management Plan CO, COR

Within 15 calendar days following the effective date of the contract

(10) Final Transition-In Plan CO, COR

Within 3 calendar days following contract kick-off meeting

Item Description Delivery to

Delivery Schedule

(11) Transition-Out Plan CO, COR

At least 90 calendar days prior to contract expiration

(12) Draft Final Report CO, COR

At least 30 calendar days prior to contract expiration

(13) Final Report CO, COR

On or before contract expiration

(14) Source Code and Object Code COR On or before contract expiration

(15) IT Security Plan CO, COR

Within 30 days following the effective date of the contract and updated annually

(16) Roster of Employees Requiring Suitability Investigations

CO,

COR

Due with Proposal, and as needed.

(17) Contractor Non-Disclosure Agreements CO, COR

Prior to performing any work under the contract.

(18) Security Awareness, Privacy, and Records Training

CO,

COR

Prior to performing any work under the contract

(19) Rules of Behavior CO, COR

Prior to performing any work under the contract

(20) Incident Response IRT, CO, COR

ISSO

Within 24 hours of occurrence

(21) Sanitization CO, COR

At expiration of contract

(22) Notification of Employee Departure CO, COR

ISSO

15 days before departure

(23) Employee Separation Checklist CO, COR

Within 2 days of employee's exit from the contract

(24) Annual Section 508 Report CO, COR

Upon anniversary of award

Note:

CO: Contracting Officer COR: Contracting Officer's Representative IRT: Incident Response Team, irt@nih.gov

ISSO:

Information Systems Security Officer

b. The above items shall be addressed and delivered to:

Addressee Deliverable Item No mailto:irt@nih.gov

Contracting Officer: TBD 8- 13; 15- 24

Contracting Officer's Representative: TBD

1- 24

Incident Response Team:

irt@nih.gov

Information Systems Security Officer: TBD

20, 22

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is not applicable to this contract.

https://www.acquisition.gov/?q=browsefar

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

[to be specified prior to award]

The COR 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.

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 statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are 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 Contracting Officer 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’ 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 Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

ARTICLE G.3. INVOICE SUBMISSION

a. Invoice Instructions for NCATS Time-and-Materials Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor shall submit invoice to the National Institutes of Health (NIH)/Office of Financial

Management (OFM) via email at invoicing@nih.gov with a copy to the approving official, as directed below. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment in Section J of this contract. The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer's Representative:

Approving Official: Contracting Officer

Name: TBD Email: TBD

Contracting Officer's Representative

Name: TBD Email: TBD

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@incontactemail.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https:// ofm.od.nih.gov/Pages/Customer-Service.aspx.

Note: The OFM Customer Service is open Eastern Standard Time Monday - Friday from 8:30 a.m.

to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is

NIDA_INV_NCATS.

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract.

[Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

c. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract.

[Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any https://ofm.od.nih.gov/Pages/Home.aspx https://ofm.od.nih.gov/Pages/Home.aspx https://ofm.od.nih.gov/Pages/Home.aspx mailto:invoicing@nih.gov https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files mailto:ofm_customer_service@incontactemail.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx https://ofm.od.nih.gov/Pages/Customer-Service.aspx existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer. Note: The Contractor shall not include TIN if it is a Social Security Number.

d. Invoice Matching Option. This contract requires a two-way match.

e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

f. The Contract Title is:

Biomedical Translator User Interface Development

g. Contract Line Items as follows:

Line Item # Line Item Description

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-

6088.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-

70, Salary Rate Limitation in SECTION I of the above referenced contract."

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (December 2013)

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

c. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

(End of Clause)

ARTICLE G.5. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," which can be found at:

http://oamp.od.nih.gov/sites/default/ files/appendix_q_hhs_contracting_guide.pdf.

ARTICLE G.6. ON-SITE CONTRACTOR ACCESS TO GOVERNMENT PROPERTY

The Contractor shall be held responsible for Government Property, regardless of dollar value, when:

• The contract requires contractor personnel to be located on a Government site or installation;

• The property utilized by contractor personnel is incidental to the place of performance; and,

• The property used by the contractor remains accountable to the Government

Responsibility includes physical presence, proper use and handling, normal maintenance, and reporting loss, damage, or destruction.

Responsibility for government property shared by two or more contractors or located in space shared by two or more contractors shall be determined and documented by the contractors involved. In cases where the parties cannot reach agreement on shared responsibility, the matter will be referred to the NIH Property Officer for resolution.

ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually as follows on or before the anniversary of the award date.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

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 Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf http://www.cpars.gov/

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

ARTICLE H.2. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE H.3. OMB CLEARANCE

In accordance with HHSAR 352.211-3, Paperwork Reduction Act, the Contractor shall not proceed with surveys or interviews until such time as Office of Management and Budget (OMB) Clearance for conducting interviews has been obtained by the Contracting Officer's Representative (COR) and the Contracting Officer has issued written approval to proceed.

ARTICLE H.4. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

ARTICLE H.5. GUN CONTROL

The Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.

ARTICLE H.6. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-9, Option to Extend the Term of the Contract set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and the ceiling price of the contract will be increased as set forth in the OPTION PRICES Article in SECTION B of this contract.

ARTICLE H.7. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. The Small Business Subcontracting Plan, dated TBD, is attached hereto and made a part of this

2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages- Subcontracting Plan."

b. Subcontracting Reports

The Contractor shall submit the following Subcontracting reports electronically via the "electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov.

1. Individual Subcontract Reports (ISR)

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

• April 30th

• October 30th

• Expiration Date of Contract

2. Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

• October 30th

For both the Individual and Summary Subcontract Reports, the Contracting Officer shall be included as a contact for notification purposes.

ARTICLE H.8. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT

PROCUREMENTS

ARTICLE H.8.1. INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

c. Baseline Security Requirements

1. Applicability- The requirements herein apply whether the entire contract or order (hereafter "contract"), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

2. Safeguarding Information and Information Systems- In accordance with the Federal Information

Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

• Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

http://www.esrs.gov/

• Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

d. Comply with the Privacy Act requirements.

3. Information Security Categorization- In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Contractor Non-Disclosure Agreement and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [ ] Low [X] Moderate [ ] High Integrity: [ ] Low [X] Moderate [ ] High Availability: [X] Low [ ] Moderate [ ] High Overall Risk Level: [ ] Low [X] Moderate [ ] High

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[X] No PII [ ] Yes PII

Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, "PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother's maiden name, biometric records, etc.

Confidentiality Impact Level has been determined to be:

[X] Low [ ] Moderate [ ] High

4. Controlled Unclassified Information (CUI)- CUI is defined as "information that laws, regulations, or

Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R.

2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed.

Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

mailto:fisma@hhs.gov

a. Marked appropriately;

b. Disclosed to authorized personnel on a…