75N91020R00042 - RFP.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 92-218 as Amended

2. Request for Proposal (RFP) Number:

75N91020R00042

3. Issue Date:

10/9/2020

4. Set Aside:

[ ] No

[X] Yes See Part IV Section L

5. Title : Support of Cancer Therapeutics Evaluation Program's Protocol Information Office (PIO)

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive Room 1E606, MSC 9705 Rockville, MD 20850

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," 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 3:00 pm local time on November 9, 2020. 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 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) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Chris Shih

PHONE: 240-276-7451

e-MAIL: chris.shih@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The cutoff date for questions is October 19, 2020 at Noon EST.The page limit for Technical Proposals is 35 pages. Please see "Additional Technical Proposal Instructions" in Section L.

Jame Chang Contracting Officer Office of Acquisitions http://www.sam.gov

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1. Requisition or other Purchase Authority: Public Law 92-218 as Amended jame.chang@nih.gov

RFP Number : 75N91020R00042

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RFP TABLE OF CONTENTS

NOTICE TO OFFERORS

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. NOTICE OF SMALL BUSINESS SET-ASIDE

c. NOTICE OF 8(a) COMPETITIVE SET-ASIDE

d. NAICS CODE AND SIZE STANDARD

e. TYPE OF CONTRACT AND NUMBER OF AWARDS

f. PERFORMANCE BASED ACQUISITION

g. LEVEL OF EFFORT

h. COMMITMENT OF PUBLIC FUNDS

i. COMMUNICATIONS PRIOR TO CONTRACT AWARD

j. RELEASE OF INFORMATION

k. PREPARATION COSTS

l. 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

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8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. Certification of Filing and Payment of Taxes

12. Past Performance Information

13. HHS SECURITY AND PRIVACY LANGUGAGE FOR INFORMATION AND IT

PROCUREMENTS

14. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

15. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Additional Technical Proposal Instructions

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. Total Compensation Plan

7. Other Administrative Data

8. Qualifications of the Offeror

9. Subcontractors

10. Proposer's Annual Financial Report

11. Travel Costs/Travel Policy

12. Additional Business Proposal Instructions

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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NOTICE TO OFFERORS

This solicitation is being processed under a Partnership Agreement (PA) between the Department of Health and Human Services (HHS) and the Small Business Administration (SBA), under which the SBA has delegated to HHS, authority to enter into 8(a) contracts directly with eligible 8(a) firms. The PA implements innovative and effective methodology designed to streamline the acquisition process for awards under the 8(a) program. The National Cancer Institute is a designated pilot agency under the PA.

Any solicitation and subsequent awards processed under the referenced PA, National Cancer Institute will make the award directly to the 8(a) firm. SBA will not be a signatory to the award resulting from this solicitation. SBA will, however, retain responsibility for 8(a) certification, administer other eligibility related issues under the 8(a) program, and be available to 8(a) firms for counseling and assistance.

If you have any questions pertaining to this PA, please contact Natasha Boyce (Natasha.Boyce@hhs.gov/202-640-8118) .

HHS/SBA PA (OCTOBER 23, 2012 until amended)

Servicing Small Business Administration Field Office

To facilitate communications, it is requested that the 8(a) participant submitting this offer/bid provide the following information regarding the firm's cognizant servicing Small Business Administration (SBA) office.

Servicing SBA Office

Address

Cognizant SBA Business Opportunity Specialist's Name

Phone

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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 Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), plans, assesses and coordinates all aspects of cancer treatment clinical trials. CTEP develops new pharmacological and biological agents for the treatment of cancers. CTEP's responsibilities for developing, designing, conducting and managing ethical clinical trials requires the collection, assimilation, storage, analysis and communication of this clinical data within and outside of CTEP.

The purpose of this contract is to support the PIO by coordinating all administrative aspects related to clinical trial document review, in order to ensure that quality protocols are developed in the most expeditious and efficient manner possible.

* Utilize various database and document tracking/reviewing applications to electronically track a protocol throughout its lifecycle.

* Support protocol related material and support meetings.

* Assist CTEP with the tracking of Operational Efficiency Working Group (OEWG) timelines.

* Store electronic materials and document Standard Operating Procedures (SOP).

ARTICLE B.2. ESTIMATED COST - AWARD 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 shown in the chart below:

e. If the Award Option(s) is/are earned pursuant to the AWARD OPTION QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) 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:

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period: 6/1/2021 – 5/31/2022

Option Period: 6/1/2022 –5/31/2023

Award Option Period 1: 6/1/2023 – 5/31/2024

Period 2: 6/1/2024 – 5/31/2025

Period 3: 6/1/2025 – 5/31/2026

Total [Base Period and Award Term(s)]

ARTICLE B.3. ESTIMATED COST - INCREMENTALLY FUNDED CONTRACT

a. The total estimated cost to the Government for full performance of this contract, including all allowable direct and indirect costs, is $ .

b. The following represents the schedule* by which the Government expects to allot funds to this contract:

CLIN, Task, Number, or Description

Start Date of Period or Increment of

Performance

End Date of

Period or Increment of Performance

Estimated Cost ($)

Fee ($) (as appropriate)

Estimated Cost Plus Fee ($) (as appropriate)

[Total] [Total] [Total]

*To be inserted after negotiation

c. Total funds currently obligated and available for payment under this contract are $ .

d. The Contracting Officer may issue unilateral modifications to obligate additional funds to the contract and make related changes to paragraphs b. and/or c., above.

e. Until this contract is fully funded, the requirements of the clause at FAR 52.232-22, Limitation of Funds, shall govern. Once the contract is fully funded, the requirements of the clause at FAR 52.232-20, Limitation of Cost, shall govern.

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f. Payment of fee 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.

The 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.

ARTICLE B.4. 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; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

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.

1. Indirect Rate Ceiling - The Government reserves the right to negotiate a ceiling rate for all Indirect Rates proposed.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. DESCRIPTION-STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated October 9, 2020, 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 via email as attachments to the following designatedNCI Branch Distribution Mailbox: ncibranchbinvoices@mail.nih.gov. Each email submission shall contain only one deliverable. If the attached file for the deliverable exceeds 50 MB, the Contractor shall divide the deliverable into files of 50 MB each. All deliverables shall be limited to five file attachments or less.

The subject line of the email and file attachment name shall read as follows:

Deliverable_Contract Number_Vendor's Name_Deliverable Description_Due Date

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. Reports/Deliverables

1. Monthly Technical Progress Report:

The Contractor shall prepare a monthly progress report that describes the work performed and results obtained for that period by sub-project (protocols, LOIs, Concepts, training, Scientific Writing, etc.). The report shall include the monthly and cumulative hours and dollars spent. Projected estimates for each column shall be provided for comparison. Monthly and cumulative grand totals for the entire project shall also be provided.

Hourly and dollar variance for the entire project shall be provided. Projected project and sub-project end dates shall be provided based on dollars and hours. The first report shall cover the period consisting of the first full month of this Contract. Thereafter, reports shall be due on or before the 15th calendar day following each monthly reporting period. The Monthly Progress Report shall not be required when the Annual Technical Report is due.

2. Annual Technical Progress Report:

The Contractor shall prepare an Annual Technical Progress Report that provides a summation of the work performed and results obtained by sub-project (protocols, LOIs, Concepts, training, Scientific Writing, etc.) for the entire year. The report shall include the annual cumulative hours and dollars spent. Projected estimates for each column shall be provided for comparison. Cumulative grand totals for the entire project to date shall also be provided. Hourly and dollar variance for the entire project to date shall be provided. Projected project and sub-project end dates shall be provided based on dollars and hours.

3. Final Technical Progress Report:

To include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the work conducted. A final report shall be submitted on or before the last day of the Contract performance period.

4. Standard Operating Procedures The Contractor shall have in place a set of Standard Operating Procedures (SOPs) to describe the process for completing the tasks required by the SOW. The COR will be provided the opportunity to review and comment on the SOPs before the procedures are implemented. The SOPs shall be developed within 90 calendar days mailto:ncibranchbinvoices@mail.nih.gov http://www.hhs.gov/web/508/index.html

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5. Scheduled reports and special queries of CTEP-ESYS The Contractor shall provide any scheduled reports and conduct special queries of CTEP-ESYS, as directed by the COR. Scheduled reports will include reports required for the evaluation of the QASP. Regular scheduled reports are reports that can be generated by the Contractor through the CTEP-ESYS. The Contractor shall work with the COR to determine the need for any additional scheduled reports to be generated, based upon CTEP business needs.

6. Presentations that communicate processes or results on activities to CTEP leadership The Contractor shall provide presentations that communicate processes or results on activities to CTEP leadership. The Contractor shall first give the presentation to the COR for review. The Contractor shall then deliver the presentations, as directed by the COR.

7. Reports to Document the Quality Assurance Plan (QASP) The Contractor shall develop a Quality Assurance (QA) plan that addresses all of the items that performance will be measured on in the Quality Assurance Surveillance Plan (QASP). The QA plan may address other business processes or areas that fall outside the scope of the QASP. The QA plan will provide a process to address and resolve any area of performance that falls beneath stated acceptable levels. The Contractor shall have the opportunity to research and prepare a response for the reconsideration of the assessment of a QASP measure.

8. Surveys to measure satisfaction of CTEP personnel (including CTEP contractors) with PIO services The Contractor shall conduct one satisfaction survey annually to measure the satisfaction of CTEP personnel (including CTEP contractors) with PIO services. The COR shall have the opportunity to review the survey tool prior to distribution. The Contractor shall collect, analyze and report the findings of the survey to the COR within one month following the completion of the survey.

9. Surveys to measure satisfaction of CTEP personnel (including CTEP contractors) with PIO services The Contractor shall conduct one satisfaction survey annually to measure the satisfaction of customers outside of CTEP personnel with PIO services. The COR shall have the opportunity to review the survey tool prior to distribution. The Contractor shall collect, analyze and report the findings of the survey to the COR within one month following the completion of the survey.

10. Training Programs The Contractor shall conduct a minimum of four (4) training programs annually. The programs shall be delivered to CTEP personnel, CTEP contractors or submitters and submitter personnel who interact with CTEP, as directed by the COR. The Contractor shall measure the effectiveness of the programs (see the QASP for additional information on this aspect).

11. Phase-In Transition Plan Within 5 business days of award, the draft phase-in transition plan will be revised, if necessary, and the draft Phase-in Transition Plan will become the Final Phase-in Transition Plan upon approval of the COR. The Final Phase-in Transition Plan shall be followed to ensure an orderly, secure, efficient, and expedient transition of all contract activities. Concerns anticipated or encountered shall be immediately communicated to the COR and an approved resolution pursued.

12. Phase-out Transition Plan The Contractor shall, within 90 days before the completion of the contract, submit a plan for the transfer of all materials stored by the Contractor to the successor Contractor. This plan shall include a quality assurance element that provides for determination that all files and data have been completely and accurately transferred to the successor Contractor. This plan shall be reviewed and approved by the COR.

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13. Training Records The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

14. Section 508 Annual Report (VPAT)

The Contractor shall submit an annual VPAT in accordance with the schedule set forth by the Contracting Officer(CO)/Contracting Officer's Representative (COR). The VPAT and Instructions for completing the report areavailable at: https://www.itic.org/policy/accessibility/vpat. The applicable VPAT is the VPAT 2.3 REV 508 (April 2019).

INFORMATION AND/OR PHYSICAL SECURITY

A. POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI).

[X] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[ ] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

1. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

Roster-

a. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within fourteen (14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within seven (7) calendar days of the change.

The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx.

b. If the Contractor is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

c. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

d. The Contractor shall notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations.

https://www.itic.org/policy/accessibility/vpat https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx

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e. All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed.

f. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14. Accordingly, the Contractor shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

g. Typically, the Government investigates personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s).

h. The Contractor shall include language similar to this "HHS Controlled Facilities and Information Systems Security" language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

i. The Contractor shall direct inquiries, including requests for forms and assistance, to the Contracting Officer or designee.

j. Within 7 calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the Contractor shall return all identification badges to the Contracting Officer or designee.

B. CONTRACT INITIATION AND EXPIRATION

1. General Security Requirements- The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology or and in accordance with the HHS Contract Closeout Guide (2012).

HHS EA requirements may be located here: https://www.hhs.gov/ocio/ea/documents/proplans.html

2. System Documentation- Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

3. Sanitization of Government Files and Information- As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation in accordance with the NIH Media Sanitization and Disposal Policy to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

4. Notification- The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO within fifteen days before an employee stops working under this contract.

5. Contractor Responsibilities Upon Physical Completion of the Contract- The contractor (and/ or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/ or NIH policies.

https://www.hhs.gov/ocio/ea/documents/proplans.html

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6. The Contractor (and/or any subcontractor) shall perform and document the actions identified in the NIH Contractor Employee Separation Checklist https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/ Documents/Emp-sep-checklist.pdf when an employee terminates work under this contract within 2 days of the employee's exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

C. Contractor Non-Disclosure Agreement (NDA)- Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

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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, Contracting Officer Representative (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

The National Cancer Institute National Institutes of Health 9609 Medical Center Drive Rockville, MD 20850-9705

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

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

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

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from June 1, 2021 through May 31, 2022.

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

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 Delivered to Due Date 1 MonthlyTechnical Progress

Report

COR;

Contracting Officer

On or before the 15th calendar day following each monthly reporting period.

2 Annual Technical Progress Report

COR;

Contracting Officer

Within 30 days after the anniversary date of the contract.

3 Final Technical Progress Report

COR;

Contracting Officer

On or before the last day of the contract performance period.

4 Standard Operating Procedures (SOPs)

COR Within 90 calendar days following the effective date of the contract and updated whenever business procedures are modified or as directed by the COR.

To be reviewed annually by Contractor.

5 Scheduled reports and special queries of CTEP-

ESYS

COR As directed by the COR.

6 Presentations that communicate processes or results on activities to CTEP leadership

COR As directed by the COR.

7 Reports to document the

QASP

COR Semi-annually within 15 days of the end of each six month period

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Item Description Delivered to Due Date 8 Surveys to measure satisfaction of CTEP personnel (including CTEP contractors) with PIO services

COR Annually, on or before the anniversary date of each contract year.

9 Surveys to measure satisfaction of customers PIO serves outside of CTEP personnel

COR Annually, on or before the anniversary date of each contract year.

10 Training Programs COR Provided Quarterly to the COR within 7 days of each 3 month period.

11 Phase-In Transition Plan COR; Contracting Officer Within 5 business days of the contract start date.

12 Phase-out Transition Plan COR; Contracting Officer Ninety (90) days prior to the contract end date

13 Training Records COR; Contracting Officer 30 days after contract award and annually thereafter or upon request

14 VPAT COR; Contracting Officer Annually, on or before the anniversary date of each contract year.

The above items shall be addressed and delivered to ncibrancheinvoices@mail.nih.gov. The following addressees are provided for general correspondence and to be copied on email for deliverables as noted below.

Addressee Deliverable Item # Quantity COR – TBD 1-14 1 Electronic Copy CS – TBD 1-3, 11-14 1 Electronic Copy

ARTICLE F.3. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide TBD direct labor Hours . The labor Hours Include vacation, and holiday. 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

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.

mailto:ncibrancheinvoices@mail.nih.gov

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

To be specified prior to award

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

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

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of Clause)

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

Name Title

TBD TBD

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-4for 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.

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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. Invoices shall be submitted electronically following the attachment entitled, "Instructions for Submitting Electronic Invoices via Email to the NIH Office of Financial Management (OFM) ," in SECTION J, unless or until such time as the Contractor is directed by the Contracting Officer to switch to hard copy invoice submission. If the Contractor is directed by the Contracting Officer to switch to hard copy invoice submission, see sub paragraph c., below

b. In addition, one courtesy copy of the original invoice shall be submitted electronically as follows:

1. The Contractor shall scan the original payment request (invoice) in Adobe Portable Document Format (PDF) along with the necessary supporting documentation as one single attachment.

2. Save the single attachment (scanned invoice along with any supporting documentation) in the following format: YourVendorName_Invoice number (e.g., if you are submitting Invoice 123456, save the single attachment as "Ash Stevens_Invoice 123456") [Note: Please do not use special characters such as (#, $, %,*, &, !) when saving your attachment. Only the underscore symbol (_) is permitted.]

3. Transmit the saved single attachment via e-mail to the appropriate branch's Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NCI OA Branch E - ncibrancheinvoices@mail.nih.gov . Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contract Number_ Contract Title_ Contractor's Name_ unique Invoice number

(e.g, HHSN2612XXXXXC_Clinical Genetics Support_Ash Stevens_Invoice 12345) [Note:

The original payment request must still be submitted in hard copy and mailed to the designated billing office listed in subparagraph a, above, to meet the requirements of a "proper invoice." Also, The Contractor must certify on the payment request that the electronic courtesy copy is a duplicate of the original invoice mailed to NIH's Office of Financial Management.]

c. If the Contractor is directed by the Contracting Officer to switch to hard copy invoice submission:

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

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 National Cancer Institute .

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

- 21 -number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

c. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [ Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] 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:

Operation & Support of the CTEP Protocol and Information Office (PIO)

g. Contract Line Items as follows:

Line Item # Line Item Description

TBD TBD

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract.

For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (December 2013)

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

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

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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.

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.

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.

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

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

b. Electronic Access to Contractor Performance Evaluations

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

http://www.cpars.gov http://www.cpars.gov

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

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

ARTICLE H.2. ACKNOWLEDGEMENT OF FEDERAL FUNDING

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