RFP_75N95022R00054_and_Attachments_AMENDMENT_02.pdf

REQUEST FOR PROPOSAL (RFP) NUMBER 75N95022R00054

Project Title: “NCATS Clinical and Translational Science Awards (CTSA) Program: Coordination, Communication and Operations Support (CCOS)”

ISSUED BY:

Mark McNally Contract Specialist National Institutes of Health National Institute on Drug Abuse Office of Acquisition NCATS Section

Email: mark.mcnally@nih.gov Phone: (301) 827-5869

Rieka Plugge Contracting Officer National Institutes of Health National Institute on Drug Abuse Office of Acquisition NCATS Section

E-mail: rieka.plugge@nih.gov Phone: (301) 827-7515

ISSUE DATE: June 3, 2022

PROPOSAL DUE: July 5, 2022, by 05:00 P.M (Eastern Daylight Time)

The National Institute on Drug Abuse (NIDA) Office of Acquisition (OA) on behalf of the National Center for Advancing Translational Sciences (NCATS) invites you to submit a proposal in response to the requirements of this RFP No.

75N95022R00054 for “NCATS Clinical and Translational Science Awards (CTSA) Program: Coordination, Communication and Operations Support (CCOS).”

This Request for Proposal is prepared in accordance with the Uniform Contract Format prescribed for Government Wide application by the Federal Acquisition Regulation (FAR). The Uniform Contract Format is both a Request for Proposal and a contract award document. The resulting contract will consist of Parts I, II, III of the Uniform Contract Format.

The Government expects to award a cost-reimbursement, term (level-of-effort) contract for a one (1) year base period with four (4) one-year option periods. Future year funding will be dependent on the previous year’s performance and funding availability. The initial performance period will start on or around August 25, 2022. Responses must include technical and pricing proposals for the entire project and include separate pricing for each individual option.

This acquisition will not be set aside for small businesses. Because this acquisition will not be set aside, and because the maximum will exceed $750,000, the RFP will require non-small business Offerors to submit a small business subcontracting plan with their business proposal. The North American

Industry Classification System (NAICS) Code applicable to this requirement is 541990.

Particularly direct your attention to Part IV, which contains instructions, provisions, and evaluation factors for the submission and review of proposals.

The balance of Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Review these parts as to the effects on performance capability and technical and cost considerations in the development of your proposal. However, you do not fill in blanks or otherwise complete portions of Parts I, II, and III which otherwise appear to require the insertion of data. The Government will complete those Parts prior to contract award. NIDA OA tailors Parts I, II, and III to the final negotiation (if negotiations are conducted) and will modify, as necessary, for the type of contractor organization, cost and/or fee arrangement, and other elements as negotiated prior to award.

Officials authorized to bind your organization must digitally sign the technical and business proposals.

Section C of the RFP addresses the “Description/Specification/Work Statement.”

Section J of the RFP addresses the “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.

Section L of the RFP addresses “Instructions, Conditions, and Notices to Offerors”

Section M of the RFP addresses “Evaluation Factors for Award.”

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 Mark McNally, Contract Specialist, mark.mcnally@nih.gov.

Furnish in writing (by email is acceptable) any areas of uncertainty, which, in your opinion, require clarification or correction to the Contracting Officer. Questions concerning this RFP should be directed to Mark McNally, Contract Specialist, mark.mcnally@nih.gov and copy Rieka Plugge, Contracting Officer, rieka.plugge@nih.gov. The e-mail subject line should read: “Offeror's Questions RFP No. 75N95022R00054.”

Question due date/time: June 13, 2022, by 4:00 P.M. Eastern Daylight Time.

Responses to Offeror questions shall be provided via an amendment to the RFP on or around June 17, 2022.

It is your responsibility to monitor the web page at https://sam.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 L.1.a., “Instructions to Offerors—Competitive Acquisition,” 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.

Your proposal must provide a contact name and telephone number, your organization name, and complete mailing address. Furthermore, FAR Provision 52.204-7, System for Award Management (SAM), which is applicable to this solicitation, requires that an Offeror be registered in SAM when submitting an offer or quotation, and continue to be registered until time of 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), you must include the Unique Entity Identifier (UEI) Number for your organization in your offer.

This 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 contract award for this requirement is contingent on the availability of funds (see FAR 52.232-18, Availability of Funds – April 1984).

The RFP shall take precedence if any of the content in this letter is contradictory.

The NCATS appreciates your interest in this RFP and looks forward to receipt of your proposal. Requests for any information concerning this RFP should be directed to the Contract Specialist and Contracting Officer. Discussions with any other individuals should not occur.

Regards, Mark McNally, Contract Specialist NCATS Section, Contracts Branch Blue Office of Acquisition, NIDA, NIH

Rieka Plugge, Contracting Officer NCATS Section, Contracts Branch Blue Office of Acquisition, NIDA, NIH

Mark E. Mcnally -S Digitally signed by Mark E.

Mcnally -S Date: 2022.06.03 15:03:46 -04'00'

Rieka N. Plugge -S Digitally signed by Rieka N.

Plugge -S Date: 2022.06.03 15:55:42 -04'00'

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: 6303180

2. Request for Proposal (RFP)

Number: 75N95022R00054

3. Issue Date: June 3, 2022 4. Set Aside:

[X] No [ ] Yes See Part IV Section L

5. Title : NCATS Clinical and Translational Science Awards (CTSA) Program: Coordination, Communication and Operations Support (CCOS)

6. ISSUED BY:

National Institutes of Health National Institute on Drug Abuse Office of Acquisition c/o 3WFN MSC 6012 301 N. Stonestreet Ave Bethesda, Maryland 20892

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 the Proposal," until 05:00 pm local time on July 5, 2022. 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 THE PROPOSAL." 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 ECPS WEBSITE AT THE 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) when submitting an offer or quotation, and shall continue to be registered until time of award, during performance, and through final payment of any contract resulting from this solicitation. Offerors must access the System for Award Management (SAM) at https://www.sam.gov/.

11. FOR INFORMATION CALL: Mark McNally, Contract Specialist

PHONE: 301-827-5869

E-MAIL: mark.mcnally@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Rieka Plugge Contracting Officer NCATS Section, Contracts Branch Blue Office of Acquisition, NIDA, NIH https://www.sam.gov/ mailto:mark.mcnally@nih.gov

RFP Number : 75N95022R00054

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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

TECHNICAL PROPOSAL 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. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

k. AVAILABILITY OF THE "FEDERAL ADP AND TELECOMMUNICATIONS STANDARDS INDEX."

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. Standards for Privacy of Individually Identifiable Health Information

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10. Privacy Act – Treatment of Proposal Information

11. ROTC Access and Federal Military Recruiting on Campus

12. Certification Regarding Tax Matters

13. 52.203-98 Prohibition on Contracting with Entities

14. Past Performance Information

15. Electronic and Information Technology Accessibility Notice

16. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Section 508 Accessibility Standards for HHS Web Site Content

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Data Other than Certified Cost or Pricing Data

4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. HUBZone Small Business Concerns

8. Total Compensation Plan

9. Other Administrative Data

10. Qualifications of the Offeror

11. Subcontractors

12. Proposer's Annual Financial Report

13. 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. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

6. SUBCONTRACTING PROGRAM EVALUATION CRITERIA

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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.

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SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The National Center for Advancing Translational Sciences (NCATS) Clinical and Translational Science Awards (CTSA) Program is one component of the NCATS Strategic Plan to advance clinical and translational science (CTS); it is designed to develop and implement innovative solutions that will improve the efficiency, quality, and impact of the process for turning observations in the laboratory, clinic, and community into interventions that improve individual and public health. The CTSA Program is a national consortium of medical research institutions, called ‘hubs’, that collaborate locally and regionally to catalyze innovation in training, research tools and processes to improve the translational research process; it includes other CTSA Program initiatives as well. As one of the largest NIH clinical and translational science programs and an exemplar for team science, NCATS envisions the CTSA Program progressing towards a standards-based, interoperable network in a cloud environment.

The purpose of this contract will be to provide the NCATS with coordination, communication and operations support to create and promote effective collaboration among CTSA Consortium participants. Anticipated activities may include implementing innovative approaches to the collection, analysis, use and dissemination of various types of data to assess the impact of the CTSA Program; fostering effective communication to support CTSA Program activities; and strengthening collaboration and team science among the participants and stakeholders. The contractor shall work closely with the CTSA Program hubs, centers, external partners, stakeholders, and NIH staff in order to accomplish these goals.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

ARTICLE B.3. ESTIMATED COST PLUS FIXED FEE - OPTION

a. The estimated cost of the Base Period of this contract is $ .

b. The fixed fee for the Base Period of this contract is $ . The fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ .

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period (Contract Year 1)

Option Period One (1) (Contract Year 2) Option Period Two (2) (Contract Year 3) Option Period Three (3) (Contract Year 4) Option Period Four (4) (Contract Year 5) Total [Base Period and Option(s)]

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ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs requiring consent under FAR 52.244-2; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.4. 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.

NIH is using a phased transition approach from the NIH Office of Financial Management (OFM) Electronic Invoice Submission instructions to the Department of Treasury’s Invoice Processing Platform (IPP). This award will transition to IPP in the future. The Contractor/Vendor shall use the attached NIH OFM Electronic Invoice Submission Instructions until the contractor/vendor is notified of its transition to IPP.

All IPP invoices must contain a Unique Entity Identifier (UEI) which is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

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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, 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 electronic format.

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 and at: https://www.section508.gov/create/ documents, "Create Accessible Documents."

a. Technical Progress Reports

1. Website Development and Milestones

A website that not only communicates consortium activities, but will be used to intake information from the hubs, manage registrations, and other consortium activities in a bi-directional way. As the website is developed, we expect milestones to be completed to meet our designated timeline.

2. CTSA Groups’ Meetings and Minutes

There are a number of consortium groups that meet bi-weekly, monthly, bi-monthly, quarterly, annually, and it is expected that these meetings will be run by the contractor and minutes will be posted online in a timely fashion and reported to the COR according to the reporting requirements.

3. Newsletter

A monthly newsletter reporting out important activities from the consortium and NCATS. This is a cross-cutting newsletter that includes all of the consortium.

4. Biannual Program Meeting Plans

There are two program meetings hosted each year, and the meeting planning begins after the other ends, or before. The contractor is expected to manage these meeting planning and be actively engaged in the planning process.

5. Social Media Strategy

A strategy for how the contractor will use social media to share CTSA Program stories, highlights, and activities to keep the public and the consortium engaged, and measure uptake of strategies.

6. Technical Writing and Manuscript Coordination Support Activities

Any publication support to working groups, or other consortium groups should be reported according to the schedule above.

7. Survey Strategy and Design http://www.hhs.gov/web/508/index.html https://www.section508.gov/create/documents https://www.section508.gov/create/documents

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The contractor will be asked to collect information from the consortium ad hoc and an experienced survey designer is expected to be available to provide a strategy for needed support for the most succinct survey to prevent multiple surveys or unnecessarily long surveys.

8. Database of Educational Offering Across the Consortium

Maintenance of the educational offerings the CTSA Program has built and offers to consortium or the public.

9. Plan for Consortium Data for Impact Strategy and Analysis

Plan for data collection, data analysis, results, and reporting of consortium wide activities and information to evaluate impact from publicly available and other sources.

10. Consortium Data for Impact Strategy and Analysis Report

Data collection, data analysis, results, and reporting of consortium wide activities and information to evaluate impact from publicly available and other sources (e.g., RePORTER, surveys, Clinical Trials.gov).

11. Survey Results and Storage

Survey results are expected to be returned to the those surveyed and the results stored for NCATS and CTSA Program future planning.

12. Report of Discussion Forum Activity

Discussion forums are a primary way the consortium uses asynchronous communication. A report on the DF activity is expected according to the schedule above.

13. Ad Hoc Meetings/Workshop Plan

The consortium activities vary and sometimes ad hoc groups come up to solve a roadblock or workshops are hosted. The contractor shall host and engage in the planning of these activities with a report to the COR as above.

14. Meeting Report

A report of the bi-annual meetings is expected as above.

15. Other Consortium-wide Activities Report

The CTSA Program is a cross-cutting, dynamic program and in order to stay aware of activities as they go on, the contractor is expected to be report on activities of interest to NCATS.

16. Monthly Progress Report

The Monthly Progress Report shall include a description of the activities 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. The report is due on or before the 15th of the month following each reporting period.

The report must also include the following sections:

a. Introduction: A section covering the purpose and scope of the contract effort.

b. Progress report: A section describing overall progress for each task or segment of work listed in the

Statement of Work on which effort was expended during the reporting period.

c. Personnel changes: A section covering any changes in personnel.

d. Problems and solutions: A section describing technical or performance problems encountered and corrective action taken. An explanation of any differences between planned and actual progress

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As part of the monthly report, the following stand-alone reports shall also be submitted when applicable:

e. Proposed revisions to the Project Management Plan

f. Proposed Web Portal posting

g. Proposed Consortium information for transfer to the public domain

h. Proposed CTSA Program Surveys

i. Proposed CTSA Program Newsletter publications topics (not a draft)

j. Proposed revisions to the Transition Plan

k. Summary of meetings, collaborations, and other communications supported

l. Updates to database of educational offerings across the consortium

m. Any Technical Writing Support provided

n. Report of manuscript coordination activities

o. Consortium Data collection and analysis Reports

p. Report of stories collated

q. Social media summary

r. Updates to website

A Monthly Progress Report shall not be due when the Annual Progress Report is due.

17. Annual Progress Report

On or before the anniversary date of the contract, the Contractor shall submit an Annual Progress Report.

This report includes a summation of the results of the entire contract work for the period covered. This report shall include all of the sections provided in the Monthly Progress Report, an additional section to summarize all work conducted during the reporting period, and a section to address the anticipated work plan and budget for the coming year. An Annual Progress Report will not be required for the period when the Final Report is due.

18. Final Report

On or before the expiration date of the contract, the Contractor shall submit a comprehensive Final Report.

This report is to include a summation of the work performed and the results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. A draft of this report is due sixty (60) days prior to the Final Report.

b. Other Reports/Deliverables

1. Roster of Employees Requiring Suitability Investigations

This deliverable is described under paragraph E of the SECTION H ARTICLE titled INFORMATION SECURITYAND/OR PHYSICAL ACCESS SECURITY. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at:

https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Suitability%20Roster%202021%20Revised.xlsx

2. Contractor Non- Disclosure Agreement (NDA)

This deliverable is described under paragraph A.6. of the SECTION H ARTICLE titled INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY. An electronic template is available for contractor use at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf

3. Signed Rules of Behavior for All Employees https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Suitability%20Roster%202021%20Revised.xlsx https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Suitability%20Roster%202021%20Revised.xlsx https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf

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This deliverable is described under paragraph B. of the SECTION H ARTICLE titled INFORMATION

SECURITY AND/OR PHYSICAL ACCESS SECURITY.

4. Disposition Plan

This deliverable is described under paragraph A. of the SECTION H ARTICLE titled CLOUD SERVICES.

5. Asset Inventory/Management Report

Using any available Security Content Automation Protocol (SCAP)-compliant automated tools for active/passive scans, provide an inventory of all information technology (IT) assets for hardware and software, (computers, servers, routers, databases, operating systems, etc.) that are processing HHS-owned information/data. It is anticipated that this inventory information will be required to be produced at least 60 days after contract award. IT asset inventory information must include IP address, machine name, operating system level, security patch level, and SCAP-compliant format information. The Contractor must maintain a capability to provide an inventory of 100% of its IT assets using SCAP-compliant automated tools.

This deliverable is described under paragraph C. of the SECTION H ARTICLE titled CLOUD SERVICES.

6. Assessment and Authorization (A&A) Package

This deliverable is described under paragraph B. of the SECTION H ARTICLE titled CLOUD SERVICES.

For all acquired cloud services, the A&A package must contain the following documentation: FIPS-199, Standards for Security Categorization; and Interconnection Security Agreement / Data Use Agreements (if applicable).

7. Incident Response Report (as incidents or breaches occur)

This deliverable is described under paragraph C. of the SECTION H ARTICLE titled INFORMATION

SECURITY AND/OR PHYSICAL ACCESS SECURITY.

8. Vulnerability Scanning Reports

This deliverable is described under paragraph C. of the SECTION H ARTICLE titled CLOUD SERVICE.

9. Computer software, including the source code

This deliverable is described under the SECTION H ARTICLE titled INFORMATION TECHNOLOGY

APPLICATION DESIGN, DEVELOPMENT, OR SUPPORT.

10. Section 508 Annual Report

The Contractor must 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:

https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc

11. Service Contract Reporting Requirements

The Contractor shall report on services performed as required by FAR Clause 52.204-14, Service Contract Reporting Requirements.

https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc

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12. Subcontract Reporting

The Contractor shall submit Individual Subcontract Reports and Summary Subcontract Reports as required by the SUBCONTRACTING PROVISIONS Article in SECTION H of this contract and the DELIVERIES Article in SECTION F of this contract.

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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.

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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, is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institutes of Health National Center for Advancing Translational Sciences 6701 Democracy Boulevard Bethesda, MD 20817

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

The Government reserves the right to an Inspection period of calendar days, unless a different time period is stated when (the Record of Call/elsewhere in the contract). The receiving report, completed and signed by the appropriate official, constitutes acceptance and shall be acknowledged to the payment office (OFM).

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 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The anticipated period of performance of this contract shall be from August 2022 through August 2023.

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

Option Option Period Option Period One (1) (Contract Year 2) August 2023 to August 2024 Option Period Two (2) (Contract Year 3) August 2024 to August 2025 Option Period Three (3) (Contract Year 4) August 2025 to August 2026 Option Period Four (4) (Contract Year 5) August 2026 to August 2027

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Description 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:

Technical Progress Reports Item Description Quantity Delivery Schedule

(1) Website Development and Milestones

Link and electronic copy of metrics via email to

COR

Within 5 days after the end of each quarter

(2) CTSA Groups’ Meetings and Minutes

Link emailed to COR Within 48 hours after each meeting

(3) Newsletter Electronic copy via email to COR

First Thursday after the end of each month.

(4) Biannual Program Meeting Plans Electronic copy via email to COR

Within 5 days after the end of each month

(5) Social Media Strategy Electronic copy via email to COR

Within 90 days after contract award

(6) Technical Writing and Manuscript Coordination Support Activities

Electronic copy via email to COR

Within 5 days after the end of each quarter

(7) Survey Strategy and Design Electronic copy via email to COR

Within 90 days after contract award and for each survey 10 days prior to survey release

(8) Database of Educational Offering Across the Consortium

Electronic copy via email to COR

Within 5 days after the end of each quarter

(9) Plan for Consortium Data for Impact Strategy and Analysis

Electronic copy via email to COR

Within 90 days of contract award, and annually on award anniversary date

(10) Consortium Data for Impact Strategy and Analysis Report

Electronic copy via email to COR

Within 5 days after the end of each quarter

(11) Survey Results and Storage Electronic copy via email to COR

Within 10 days prior to survey results being posted

(12) Report of Discussion Forum Activity

Electronic copy via email to COR

Within 5 days after the end of each quarter

(13) Ad Hoc Meetings/Workshop Plan Electronic copy via email to COR

Within 90 days of contract award and annually on award anniversary date

(14) Meeting Report Electronic copy via email to COR

Within 30 days after each meeting

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(15) Other Consortium-wide Activities Report

Electronic copy via email to COR

Within 90 days of contract award and updated quarterly

(16) Monthly Progress Report Electronic copy via email to COR and CO

Within 5 days after the end of each reporting period

(17) Annual Progress Report Electronic copy via email to COR and CO

Annually within 5 days after award anniversary date

(18) Final Report Electronic copy via email to COR and CO

Due by contract expiration date

Other Reports/Deliverables Item Description Quantity Delivery Schedule

(1) Roster of Employees Requiring Suitability Investigations

Electronic copy via email to COR and CO

Within 30 days of the effective date of this contract

(2) Contractor Non- Disclosure Agreement (NDA)

Electronic copy via email to COR and CO

Prior to performance of any work under the contract

(3) Signed Rules of Behavior for All Employees

Electronic copy via email to COR and CO

Within 30 days after contract award and annually thereafter

(4) Disposition Plan Electronic copy via email to COR and CO

At least 2 weeks prior to contract expiration

(5) Asset Inventory/Management Report

Electronic copy via email to COR and CO

Within 90 days after contract award

(6) Assessment and Authorization (A&A) Package

Electronic copy via email to COR and CO

Within 90 days after contract award

(7) Incident Response Report Electronic copy via email to COR and CO

As soon as possible and without reasonable delay and no later than 1 hour of discovery

(8) Vulnerability Scanning Reports Electronic copy via email to COR and CO

Monthly, within 10 days following the end of each month

(9) Computer software, including the source code

Electronic copy via email to COR and CO

Prior to performance of work under the contract

(10) Section 508 Annual Report Electronic copy via email to COR and CO

Annually on the award anniversary date

(11) Service Contract Reporting Requirements

Electronically to sam.gov

Annually on October 31

(12) Subcontract Reporting Electronically to eSRS.gov

Semi-annually by April 30 and October 30 each year

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

Addressee Deliverable Item No.

Contracting Officer’s Representative Name:_____ Email Address:_____

Technical Progress Reports 1-18 Other Reports/Deliverables 1-10

Contracting Officer Name:_____ Email Address:_____

Technical Progress Reports 16-18 Other Reports/Deliverables 1-12

ARTICLE F.3. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide _______ direct labor hours. The labor hours exclude vacation, holiday, and sick leave. These labor hours include subcontractor labor hours. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

Labor Hours Labor Category Year 1 Year 2 Year 3 Year 4 Year 5

Professional Other Professional Support Totals

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b. The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

c. In the event fewer hours than the minimum specified number of direct labor hours in the total categories are used by the Contractor in accomplishing the prescribed work and the Government has not invoked its rights under FAR Clause 52.249-6, TERMINATION (Cost-Reimbursement) incorporated in this contract, these parties agree that the fee will be adjusted based solely upon the quantity of hours by which the number of direct labor hours furnished is less than the number of direct labor hours specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

ARTICLE F.4. 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 applicable to this contract.

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

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SECTION G - CONTRACT ADMINISTRATION DATA

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

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

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/CONTRACT FINANCING REQUEST

a. Invoice Submission/Contract Financing Request, NIH(RC)-1for NIH Cost-Reimbursement Type 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 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

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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 Representative:

Approving Official: Contracting Officer

Name- Email Address-

Contracting Officer Representative

Name- Email Address-

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, Unique Entity Identifier (UEI), or VIN, contact the Contracting Officer.

c. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI 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 UEI 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 existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, 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: NCATS Clinical and Translational Science Awards (CTSA) Program:

Coordination, Communication and Operations Support (CCOS)

g. Contract Line Items as follows:

Line Item # Line Item Description 1 Base Period: NCATS Clinical and Translational Science Awards

(CTSA) Program: Coordination, Communication and Operations Support (CCOS)

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.

mailto:OFM%20Customer%20Service mailto:ofm_customer_service@incontactemail.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx

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ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (Nov 2021)

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. Go to the Indirect Cost Submission web page: https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission for electronic copies of the Branch's information package documents.

ARTICLE G.6. 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 on the contract anniversary 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,…