NCATS_RFP_Research_Support_Services_(RFP_No._N02TR-17-4002).pdf

OMB #0990-0115

REQUEST FOR PROPOSALS (RFP) No. N02TR-17-4002

Project Title: “Research Services Section Support”

Issued by:

Jeffrey Schmidt, Contracting Officer Office of Acquisitions NCATS Section, NINDS Contract Management Branch, NIH 6001 Executive Blvd Room 3287, MSC 9531 Bethesda, MD 20892-9534

Point of Contact: Jeffrey Schmidt, Contracting Officer E-mail: schmidtjr@mail.nih.gov Phone: (301) 402-1488

ISSUE DATE: July 3, 2017

DATE DUE: August 2, 2017, by 3:00 P.M (local time)

The National Center for Advancing Translational Sciences (NCATS), NIH, invites you to submit a proposal in response to RFP No. N02TR-17-4002. NCATS seeks to award a contract to an organization with the capabilities to provide services to support the day-to-day scientific, technical, research, and automation requirements of the Robotic Services Laboratories of NCATS. The services will be in the areas of laboratory management and support; laboratory automation and equipment support; automation research services; scientific project and program management; cheminformatics, bioinformatics, computational chemistry and biology; scientific systems programming and research data management; scientific cloud computing services and engineering support; and scientific research support.

THIS ACQUISITION IS ISSUED AS A WOMAN-OWNED SMALL BUSINESS SET-ASIDE

whereby only woman-owned small businesses will be eligible for contract award. Please reference Article I.3., FAR Clause 52.219-30, “Notice of Set-Aside for, or Sole Source Award to, Woman-Owned Small Business Concerns Eligible Under the Woman-Owned Small Business Program (December 2015)” for further details.

The North American Industry Classification System (NAICS) code for this this requirement is 541990. The small business size standard is $15,000,000.

If your organization is a Woman-Owned Small Business, please see the guidance from the SBA at https://www.sba.gov/contracting/government-contracting-programs/women-owned-small-businesses/what-you-need-know-if-you-are-women-owned-small-business. These instructions provide detailed requirements for you to follow prior to submitting an offer.

mailto:schmidtjr@mail.nih.gov https://www.sba.gov/contracting/government-contracting-programs/women-owned-small-businesses/what-you-need-know-if-you-are-women-owned-small-business https://www.sba.gov/contracting/government-contracting-programs/women-owned-small-businesses/what-you-need-know-if-you-are-women-owned-small-business

Offerors are advised to pay particular attention to Section L of the RFP entitled “Instructions, Conditions, and Notices to Offerors” and Section C entitled “Description/Specification/Work Statement.” For this solicitation, offerors are required to submit a staffing plan, a draft management plan, and a draft transition plan, among other requirements. Section L also includes estimates of labor categories/effort and materials requirements.

Proposals will be evaluated pursuant to Section M entitled “Evaluation Factors for Award.”

Additionally, offerors are advised to review the list of attachments in Section J entitled “List of Attachments.” This list identifies the attachments that need to be completed and submitted with your proposal, as well as attachments that are included for informational purposes only. Some of the attachments listed in Section J supplement the Instructions in Section L of the main RFP document, so it is important to refer to both Section L and the applicable attachments in Section J when preparing your proposal. The list of attachments in Section J also provides links to fillable forms for many of the attachments that need to be completed and submitted with your proposal.

If you intend to submit a proposal in response to this solicitation, please send a “Proposal Intent Response Sheet,” RFP Section J, Attachment 2, to Jeffrey Schmidt, schmidtjr@mail.nih.gov. This allows us to anticipate the resources needed to properly evaluate all responses to this RFP.

You must furnish in writing (email is acceptable) any areas of uncertainty, which, in your opinion, require clarification or correction to the Contracting Officer. You must submit your questions on or before July 17, 2017.

It is your responsibility to monitor the web page at http://www.FedBizOpps.gov/ for any amendments that might be issued under this RFP. A separate notice of RFP amendments, if any, to individual sources, will not be made.

Proposals are to be delivered electronically via the NIH electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Please reference Attachment 1, listed in Section J, entitled “Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website” for instructions and further details. Please note that you must create an account in the NIH electronic Contract Proposal Submission (eCPS) system/website in order to submit a proposal and it may take up to there (3) business days to establish a new account. Please apply for a new account early to allow enough time for the registration process.

Please review Section A.8 and 9, and Section L.1, “Instructions to Offerors,” subparagraph (c)(3), addressing late proposals, so that you will be fully aware of the time requirements for submitting your proposal. It is your responsibility to ensure that your proposal is delivered by the due date and time to the NIH electronic Contract Proposal Submission (eCPS) website as required in the RFP.

mailto:schmidtjr@mail.nih.gov http://www.fedbizopps.gov/ https://ecps.nih.gov/

Your proposal must be prepared in the format prescribed in the RFP. Please be sure that all documents which you are required to complete and sign (e.g., Representations and Certifications, NIH Form 2043 “Proposal Summary and Data Record”, etc.) are submitted with your proposal (again, please review the list of attachments included in Section J which will indicate which attachments need to be completed and submitted with your proposal, and whether to include them with your Technical Proposal or Business Proposal).

Your proposal must provide a contact name and telephone number, your company name, and complete mailing address. Furthermore, FAR Provision 52.204-7, System for Award Management (SAM), which is applicable to this solicitation, requires that a prospective awardee be registered in the SAM database prior to award, during performance, and through final payment of any contract resulting from this solicitation. In addition to providing your organization’s Tax Identification Number (TIN), FAR Provision 52.204-6, Data Universal Numbering System (DUNS) Number, requires you to submit a DUNS number for your company along with your offer. Contact information for Dun and Bradstreet is provided in the FAR provision at 52.204-6. Please include this information on the first page of your business proposal.

The RFP does not commit the Government to pay the costs for the preparation and submission of a proposal.

The Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds in connection with this acquisition. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

Any questions concerning this RFP should be directed to Jeffrey Schmidt, Contracting Officer, schmidtjr@mail.nih.gov, 301-402-1488, or Stuart Kern, Contract Specialist, stuart.kern@nih.gov, 301-402-3334.

Regards, Jeffrey R. Schmidt, Contracting Officer Office of Acquisitions, NCATS/NINDS/NIH mailto:schmidtjr@mail.nih.gov mailto:stuart.kern@nih.gov

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: 42 U.S.C. 287(a)

2. Request for Proposal (RFP) Number:

N02TR-17-4002

3. Issue Date:

July 3, 2017

4. Set Aside:

[ ] No

[X] Yes See Part IV Section L

5. Title: Research Services Section Support

6. ISSUED BY:

National Center for Advancing Translational Sciences NINDS R&D Contracts Management Branch, NIDA, NIH Neurosciences Center 6001 Executive Blvd, Suite 3287, MSC 9531 Bethesda, MD 20892-9531

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," until 3:00 p.m. local time on Wednesday, August 2, 2017. 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.

9. 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 proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) at http://www.sam.gov prior to award of a contract.

11. FOR INFORMATION CALL: Stuart Kern, Contract Specialist

PHONE: 301-402-3334

e-MAIL: stuart.kern@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Jeffrey Schmidt Contracting Officer

NINDS R&D CMB, NIDA, NIH

http://www.sam.gov

RFP Number : N02TR-17-4002

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

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

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL 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

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NOTICE OF SMALL BUSINESS SET-ASIDE

c. NAICS CODE AND SIZE STANDARD

d. TYPE OF CONTRACT AND NUMBER OF AWARDS

e. ESTIMATE OF EFFORT

f. ESTIMATE OF MATERIAL COSTS

g. COMMITMENT OF PUBLIC FUNDS

h. COMMUNICATIONS PRIOR TO CONTRACT AWARD

i. RELEASE OF INFORMATION

j. PREPARATION COSTS

k. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

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11. Certification of Filing and Payment of Taxes

12. Past Performance Information

13. Information and Physical Access Security

14. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Salary Rate Limitation

5. Total Compensation Plan

6. Other Administrative Data

7. Qualifications of the Offeror

8. Subcontractors

9. Proposer's Annual Financial Report

10. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. TECHNICAL EVALUATION FACTORS

5. PAST PERFORMANCE FACTOR

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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 Contractor shall provide services to support the day-to-day scientific, technical, research, and automation requirements of the Robotic Services Laboratories of the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH). The services will be in the following areas:

• Laboratory Management and Support

• Laboratory automation and equipment support

• Automation research services

• Scientific project and program management

• Cheminformatics, Bioinformatics, Computational Chemistry and Biology

• Scientific Systems Programming and Research Data Management

• Scientific Cloud computing services and Engineering support

• Scientific research support

ARTICLE B.2. TIME AND MATERIALS CEILING PRICE – OPTION

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

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

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

Period of Performance Ceiling Price ($)

Base Period - Contract Year 1 9/1/2017 - 8/31/2018

Option Period 1 - Contract Year 2 9/1/2018 - 8/31/2019

Option Period 2 - Contract Year 3 9/1/2019 - 8/31/2020

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d. 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.

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

ARTICLE B.3. LABOR HOUR RATE

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

Labor Category Hourly Rate ($) Base Period

Hourly Rate ($) Option Period 1

Hourly Rate ($) Option Period 2

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

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

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

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

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

ARTICLE B.4. MATERIAL COSTS AND MATERIAL HANDLING 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

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

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Government, as needed to perform the Statement of Work, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in accordance with the DELIVERIES ARTICLE in SECTION F of this contract.

All electronic 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:

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

• Weekly resource challenges;

• Issues and obstacles impeding progress and recommended solutions;

• Status of deliverables/milestones;

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

• Resource planning/status;

• 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 completed tasks for all software development activities.

http://www.hhs.gov/web/508/index.html

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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 Plan (required with proposal submission) within three (3) days following the Contract Kick-Off Meeting. The Final Transition 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;

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• 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

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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. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. (Reference subparagraph A.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Security Plan (IT-SP)

The Contractor shall submit the IT-SP within thirty (30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

c. IT Risk Assessment (IT-RA)

The Contractor shall submit the IT-RA within thirty (30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy.

The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

d. FIPS 199 Assessment

The Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

(Reference subparagraph D.c.3. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract.

e. IT Security Certification and Accreditation (IT-SC&A)

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The Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within three (3) months after contract award.

The Contractor shall perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid.

(Reference subparagraph D.c.4. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

f. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five calendar days of staffing changes for positions that require suitability determinations as follows:

a. New Employees who have or will have access to HHS Information systems or data: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

b. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

(Reference subparagraph E.2.a-c. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

g. Contractor - Employee Non-Disclosure Agreement(s) The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information

- Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is attached at SECTION J, and is also located at: https://ocio.nih.gov/aboutus/ publicinfosecurity/acquisition/Documents/Nondisclosure.pdf.

(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

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.

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b. For the purpose of this SECTION, the NCATS Contracting Officer's Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Center for Advancing Translational Sciences, NIH Division of Pre-Clinical Innovation 9800 Medical Center Drive Rockville, MD 20850

Acceptance of work, materials, services, and reports may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within thirty 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 9/1/2017 through 8/31/2018.

b. 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 Option Period Option Period 1 9/1/2018 - 8/31/2019 Option Period 2 9/1/2019 - 8/31/2020

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 Method Delivery Schedule

(1) Twice-Monthly

Performance Report electronically to COR Due the 1st and 15th of each month

(2) Weekly Support Report electronically to COR Due each Monday

(3) Monthly Support Report electronically to COR Due the 15th of each month

(4) Weekly Programming

Report electronically to COR Due each Monday

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

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Item Description Delivery Method Delivery Schedule

(6) Monthly Budget and Labor

Summary electronically to COR Due the 15th of each month

(7) Technical Documentation electronically to COR Upon request/as developed

(8) Incident and Breach Report electronically to CO and

COR

as needed

(9) Final Management Plan electronically to CO and

COR

Within 15 calendar days following the effective date of the contract

(10) Final Transition-In Plan electronically to CO and

COR

Within 3 calendar days following Contract Kick-Off Meeting

(11) Transition-Out Plan electronically to CO and

COR

At least 90 calendar days prior to contract expiration

(12) Draft Final Report electronically to CO and

COR

At least 30 calendar days prior to contract expiration

(13) Final Report electronically to CO and

COR

On or before contract expiration

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

(15) Roster of Employees Requiring Suitability Investigations electronically to CO and

COR

within 14 calendar days following the effective date of the contract

(16) IT Security Plan electronically to CO and

COR

within 30 calendar days following the effective date of the contract and updated annually on the anniversary date of the contract

(17) IT Risk Assessment electronically to CO and

COR

within 30 calendar days following the effective date of the contract and updated annually on the anniversary date of the contract

(18) FIPS 199 Assessment electronically to CO and

COR

within 30 calendar days following the effective date of the contract

(19) IT Security Certification and Accreditation electronically to CO and

COR

within 3 months following the effective date of the contract and updated annually on the anniversary date of the contract

(20) Reporting of New and Departing Employees electronically to CO and

COR

within 5 calendar days of staffing changes

(21) Contract-Employee Non- Disclosure Agreements electronically to CO and

COR

prior to performance of any work under the contract

b. The above items shall be delivered electronically to:

Addressee Deliverable Item No.

Contracting Officer email: schmidtjr@mail.nih.gov; stuart.kern@nih.gov

8 - 13; 15 - 21

Contracting Officer's Representative email: TBD

1 - 21

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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.

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:

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

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Name Title

ARTICLE G.3. INVOICE/FINANCING REQUEST SUBMISSION

a. Invoice/Financing Request 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. Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

a. The original invoice shall be submitted to the following designated billing office:

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

b. One copy of the invoice shall be submitted to the following approving official:

NCATS Contracting Officer NINDS R&D Contracts Management Branch NIDA Office of Acquisitions 6001 Executive Blvd, Room 3287, MSC 9531 Bethesda, MD 20892-9531

E-mail: schmidtjr@mail.nih.gov; stuart.kern@nih.gov

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.

[Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

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 Invoices

NCATS CMB .

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. 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

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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. If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

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:

Research Services Section Support

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.

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. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer.

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ARTICLE G.6. 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.7. 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.8. 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 in the first quarter of the Government's fiscal year following each full year of performance.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted fourteen (14) 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

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.

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

- 17 -

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. 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.4. GUN CONTROL

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

ARTICLE H.5. CERTIFICATION OF FILING AND PAYMENT OF TAXES

The Contractor must be in compliance with Section 518 of the Consolidated Appropriations Act of FY 2014.

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.4 of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options 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.

ARTICLE H.7. INFORMATION AND PHYSICAL ACCESS SECURITY

A. HHS-Controlled Facilities and Information Systems Security

a. To perform the work specified herein, Contractor personnel are expected to have routine (1) physical access to an HHS-controlled facility; (2) physical access to an HHS-controlled information system; (3) access to sensitive HHS data or information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

b. To gain routine physical access to an HHS-controlled information system, and/or access to sensitive data or information, the Contractor and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; Office of Management and Budget Memorandum (M-05-24); and Federal Information Processing Standards Publication (FIPS PUB) Number 201; and with the personal identity verification and investigations procedures contained in the following documents:

1. HHS-OCIO Information Systems Security and Privacy Policy ( http://www.hhs.gov/ocio/policy/ #Security)

2. HHS HSPD-12 Policy Document, v. 2.0 ( http://www.whitehouse.gov/sites/default/files/omb/assets/ omb/memoranda/fy2005/m05-24.pdf)

3. Information regarding background checks/badges ( http://idbadge.nih.gov/background/index.asp) http://www.hhs.gov/ocio/policy/#Security http://www.hhs.gov/ocio/policy/#Security http://www.whitehouse.gov/sites/default/files/omb/assets/omb/memoranda/fy2005/m05-24.pdf http://www.whitehouse.gov/sites/default/files/omb/assets/omb/memoranda/fy2005/m05-24.pdf…