RFP 75N91022R00023 Final w Attachments.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:

75N91022R00023

3. Issue Date:

09/27/2022

4. Set Aside:

[ ] No

[X] Yes See Part IV Section L

5. Title : Clinical Data Management for the National Cancer Institute (NCI) Center for Cancer Research (CCR)

6. ISSUED BY:

Office of Acquisitions National Cancer Institutes National Institutes of Health 9609 Medical Center Drive 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 eastern time on 10/28/2022. 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." 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 https://www.sam.gov/SAM/.

11. FOR INFORMATION CALL: Lydia Castro-Perigo

PHONE: 240-276-6911

e-MAIL: lydia.perigo@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The cut off date for questions is 4 pm EST on 10/07/22. Questions shall be submitted via email to: lydia.perigo@nih.gov Please provide the specific paragraph reference (Section/Sub-section numbers from the solicitation)

Pooja Rathore Contracting Officer Office of Acquisitions, NCI pooja.rathore@nih.gov https://www.sam.gov/SAM/

RFP Number : 75N91022R00023

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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. LEVEL OF EFFORT

g. COMMITMENT OF PUBLIC FUNDS

h. COMMUNICATIONS PRIOR TO CONTRACT AWARD

i. RELEASE OF INFORMATION

j. PREPARATION COSTS

k. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

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9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

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. Obtaining and Disseminating Biomedical Research Resources

5. Section 508 accessibility standards for HHS Web Site Content and Communications Materials

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

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, Small Business Specialist, at:

natasha.boyce@hhs.gov .

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 Washington Metropolitan Area District Office

Address 409 3rd St SW, Floor 2

Washington, DC 20416

Cognizant SBA Business Opportunity Specialist's Name Pamela Mannion

Phone 202-205-8800

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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 purpose of this contract is to provide comprehensive site data management support to the CCR intramural clinical trials program. This includes all standardized data management functions for NCI CCR Clinical Trials and Studies, professional development and training of contract staff on performing data abstraction and data entry into the CCR's centralized research databases, multiple databases of various pharmaceutical sponsors (whose clinical trials are conducted at the NCI CCR), and CCR legacy systems. Data management also includes user acceptance testing of the systems as required by the Government, as well as ensuring high quality of data using standard operating procedures as required by Good Clinical Data Management Practices.

ARTICLE B.2. ESTIMATED COST - OPTION

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

b. The fixed fee for the Base Period of this contract is $ TBD . 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 $ TBD .

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

IC Option-Base Period

Option Period 1

IC Option-Option Period 1

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option Period 2

IC Option-Option Period 2

Option Period 3

IC Option-Option Period 3

Option Period 4

IC Option-Option Period 4

GRAND TOTAL

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 $ TBD .

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

Funded Estimated Cost ($)

Funded Fixed Fee ($) (as appropriate)

Funded Estimated Cost Plus Fee ($) (as appropriate)

Base Period IC Option-Base Period

Option Period 1 IC Option-Option Period 1

Option Period 2 IC Option-Option Period 2

Option Period 3 IC Option-Option Period 3

Option Period 4 IC Option-Option Period 4 Total Base and All Options [Total] [Total] [Total]

*To be inserted after negotiation

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

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.

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.

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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.

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. 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 09/27/2022, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

b. The Privacy Act System of Records Number is 09-25-0200 and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer Representative (COR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports and other documents required herein shall be submitted in electronic format via email as attachment to the following NCI Branch E Distribution mailbox: ncibrancheinvoices@mail.nih.gov.

Note: Each email submission shall contain only one deliverable. If the attached files for the deliverables exceed 50 MB, the contractor shall divide the deliverables into files of 50 MB each. All deliverables should be limited to five file attachments or less. We understand that in some cases more than five attachments will be necessary. The subject line of the email should read as follows:

Deliverable_Contract Number_Vendor's Name_Deliverable Description_Due Date

All electronic files submitted shall be conformant with Section 508 of the Rehabilitation Act of 1973.

The applicable Section 508 Standards can be found at Electronic Documents.

HHS’s website for Section 508 can be found at Accessibility @ HHS | HHS.gov (https://www.hhs.gov/web/ section-508/index.html). This site includes information about formatting documents for Section 508 conformance, which can be found at Accessibility Training Resources | HHS.gov (https://www.hhs.gov/web/section-508/os-training-resources/index.html).

Checklists for Section 508-Conformance Reports for electronic documents, files, videos, etc., based on HHS’s Accessibility Compliance Checklists | HHS.gov. These Accessibility Compliance Checklists shall be submitted for all reports, files, or other documents submitted as part of this contract. Note that one representative Section 508 Conformance Report per file type shall suffice – that is, one Microsoft Word checklist shall represent all Word files submitted under this contact, one Microsoft PowerPoint checklist shall represent all PowerPoint files submitted under this contact, one Adobe PDF checklist shall represent all PDF files submitted under this contact, etc.

In addition, we refer the Contractor to the following GSA Section 508 page for guidance on developing electronic documents for accessibility and Section 508-conformance: GSA Section508.gov. Create Accessible Digital Products | Section508.gov (https://www.section508.gov/create/). The Contractor may use the respective GSA Section508 checklist (in Microsoft Word format) as a Section 508 report for each document it submits per file type (e.g., Microsoft Word, Microsoft Excel, PDF, etc.) in lieu of HHS’s Checklists in Microsoft Office Excel format.

Given that there are no other Information and Communication Technology (ICT) products or services being delivered under this contract or Statement of Work, no Voluntary Product Accessibility Template (VPAT) or Accessibility Conformance Report (ACR) is necessary.

In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following gin the manner stated below and in accordance with the deliverables article of this contract.

https://www.section508.gov/sample-procurement/electronic-documents https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/os-training-resources/index.html https://www.hhs.gov/web/section-508/os-training-resources/index.html https://www.hhs.gov/web/section-508/os-training-resources/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/sites/default/files/hhs-508-word-checklist.xlsx https://www.hhs.gov/sites/default/files/hhs-508-powerpoint-checklist.xlsx https://www.hhs.gov/sites/default/files/hhs-508-pdf-checklist.xlsx https://www.section508.gov/create/ https://www.section508.gov/create/ https://www.section508.gov/create/ https://www.itic.org/policy/accessibility/vpat https://www.section508.gov/buy/request-accessibility-information/ https://www.section508.gov/buy/request-accessibility-information/

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a. Technical Reporting Requirements

1. Bi-weekly Project Status Report (PSR)

This report shall address the status of data entry, data abstraction, data quality and submission to study sponsors according to the requirements of each sponsor. These reports shall also provide an assessment of data backlog and progress and interventions to minimize backlogs, in addition to a summary of findings from Site Monitoring Visits (SMV) and audits and status of responses to queries and clarifications. Reports due 1st and 3rd week of the month to be presented at the Steering Committee meeting.

2. Ad Hoc Reports

These reports shall be submitted upon the request of the Contracting Officer’s Representative (COR). The types of reports shall include, but not be limited to; real-time progress, cost, schedule, Quality Assurance Standard Status Report, Administrative Protocol Statistical Report, Project Management Report and Process Improvements.

3. Standard Operating Procedures (SOPs)

Contractor shall develop SOPs for all activities performed under the following work areas: Information Technology (IT), QA/QC, and Multi-institute Study Support. Initial draft SOPs shall be provided to the COR with 30 days of start of contract. Contractor shall update SOPs as procedures change. Updated versions of SOPs shall be provided to COR within 14 calendar days of change in procedure.

4. Semiannual Reports

This report shall include the status of data management services, data quality updates, and summary of errors identified in audit reports. The report should include both accomplishments and challenges experienced by the Contractor and a summary of financial status, including but not limited to a summary of costs versus projects, and overall workload parameters within reporting period. The report should also include any changes with key personnel and if any organizational changes made if applicable. The Semiannual Report shall be due six (6) months after the award of the contract and every six (6) months thereafter. This report shall not be due for the period in which the Annual and Final Report are due.

5. Annual Reports

This report shall include a summation of previously submitted reports, including the work performed and results obtained during the preceding 12-month period. The Annual Report shall be due annually on the anniversary date of contract award.

6. Final Report

This report documents and summarizes the results of the entire contract. This report shall be in sufficient detail to explain comprehensively the results achieved in performance of the contract statement of work as stated herein. A summary listing of the items and quantities delivered to the Government under this contract shall be included in this report. A draft copy of the Final Report shall be due one month prior to the expiration date of the contract. The final copy of the Final Report shall be due 15 days prior to the expiration date of the contract.

7. Plan for Transition-In and Transition-Out

a. Upon receipt of comments from the COR on the Draft Transition-In plan submitted as part of the proposal, the Contractor shall submit a final Transition-In plan to the COR within 7 days of contract award for formalization. This plan shall describe the Contractor's approach to organizing a seamless transition and maintaining ongoing work, including any capture of the incumbent staff and hiring of new qualified staff, compiling a strong management team, transition of authority, duties, activities. and equipment. The Transition-In plan shall outline potential transition-in related risks and corresponding mitigation measures.

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b. Draft Transition-Out plan shall be submitted six months prior to the end of the contract. The plan shall clearly describe transition of authority, duties, activities, equipment and function for the services to a new contracted awarded to perform these services. The COR shall provide comments within 30 days of receipt and the final plan shall be submitted 30 days prior to the expiration date of the contract.

b. Other Reports and Deliverables

HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

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). To determine the designation, the Position Designation Tool (PDT) discussion is found at: https:// www.ors.od.nih.gov/ser/dpsac/resources/Pages/investigation-requirements-for-your-position.aspx and the link to access the tool is found at: https://pdt.nbis.mil/

The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Tier 5: Critical Sensitive and Special Sensitive National Security, including Top Secret, SCI, and "Q" access eligibility.

[ ] Tier 5SR: Reinvestigation.

[ ] Tier 4: High Risk Public Trust (HRPT).

[ ] Tier 4SR: Reinvestigation.

[ ] Tier 3: Non-Critical Sensitive, National Security, including Secret and "L" access eligibility.

[ ] Tier 3SR: Reinvestigation.

[ x ] Tier 2S with Subject Interview: Moderate Risk Public Trust (MRPT).

[ ] Tier 2SR: Reinvestigation.

[ x ] Tier 1: Low Risk, Non-Sensitive, including HSPD-12 Credentialing.

B. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

1. Roster-

The Contractor (and/or any subcontractor) must 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 must 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 must 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://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

a. If the Contractor is filling a new position, the Contractor must 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.

https://www.ors.od.nih.gov/ser/dpsac/resources/Pages/investigation-requirements-for-your-position.aspx https://www.ors.od.nih.gov/ser/dpsac/resources/Pages/investigation-requirements-for-your-position.aspx https://pdt.nbis.mil/ https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

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

c. The Contractor must 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.

d. All contractor and subcontractor employees must 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.

e. 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 must ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

f. 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).

g. The Contractor must 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).

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

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

C. CONTRACT INITIATION AND EXPIRATION

1. General Security Requirements - The Contractor (and/or any subcontractor) must 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 must follow the HHS EPLC framework and methodology or and in accordance with the HHS Contract Closeout Directive (2018) located at: https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/HHS-Closeout- Directive-2018.pdf . HHS EA requirements located at: https://www.hhs.gov/sites/default/files/eplc-policy-dec-2016.pdf and NIH EA requirements are located at: https://ocio.nih.gov/PM/Pages/EPLC.aspx .

2. System Documentation - Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, 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) must 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. Contractor Responsibilities Upon Physical Completion of the Contract- The Contractor ( and/ or any subcontractors) must 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 must provide a certification that all government information has been https://ocio.nih.gov/PM/Pages/EPLC.aspx

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5. Notification- The Contractor (and/or any subcontractors) shall notify the CO and/or COR and system ISSO within 15 days before an employee stops working under this contract.

6. Employee Separation Checklist- The Contractor ( and/or any subcontractor) must 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 must be made available to the CO and/ or COR upon request.

7. 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 must be submitted to the Contracting Officer ( CO) and/ or CO Representative ( COR) prior to performing any work under this acquisition.

8. Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) must afford the Government access to the Contractor's facilities, installations, operations, documentation, information systems, and personnel used in performance of this contract to the extent required to carry out a program of security assessment ( to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the confidentiality, integrity, and availability of federal data or to the protection of information systems operated on behalf of HHS, including but are not limited to:

i. At any tier handling or accessing information, consent to and allow the Government, or an independent third party working at the Government's direction, without notice at any time during a weekday during regular business hours contractor local time, to access contractor and subcontractor installations, facilities, infrastructure, data centers, equipment (including but not limited to all servers, computing devices, and portable media), operations, documentation (whether in electronic, paper, or other forms), databases, and personnel which are used in performance of the contract. The Government includes but is not limited to the U.S. Department of Justice, U.S. Government Accountability Office, and the HHS Office of the Inspector General (OIG). The purpose of the access is to facilitate performance inspections and reviews, security and compliance audits, and law enforcement investigations. For security audits, the audit may include but not be limited to such items as buffer overflows, open ports, unnecessary services, lack of user input filtering, cross site scripting vulnerabilities, SQL injection vulnerabilities, and any other known vulnerabilities.

ii. At any tier handling or accessing protected information, fully cooperate with all audits, inspections, investigations, forensic analysis, or other reviews or requirements needed to carry out requirements presented in applicable law or policy. Beyond providing access, full cooperation also includes, but is not limited to, disclosure to investigators of information sufficient to identify the nature and extent of any criminal or fraudulent activity and the individuals responsible for that activity. It includes timely and complete production of requested data, metadata, information, and records relevant to any inspection, audit, investigation, or review, and making employees of the contractor available for interview by inspectors, auditors, and investigators upon request. Full cooperation also includes allowing the Government to make reproductions or copies of information and equipment, including, if necessary, collecting a machine or system image capture.

iii. Segregate Government protected information and metadata on the handling of Government protected information from other information. Commingling of information is prohibited. Inspectors, auditors, and investigators will not be precluded from having access to the sought information if sought information is commingled with other information.

iv. Cooperate with inspections, audits, investigations, and reviews.

9. 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.

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

c. Inspection and acceptance will be performed at:

National Institute of Health National Cancer Institute Center for Cancer Research

BLDG. 10, RM 10C101

10 Center Drive Bethesda, MD 20892

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 January 15, 2023 through January 14, 2024.

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 Period of Performance Option Period 1 January 15, 2024 – January 14, 2025 Option Period 2 January 15, 2025 – January 14, 2026 Option Period 3 January 15, 2026 – January 14, 2027

Option Period 4

January 15, 2027 – January 14, 2028

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 Deliver to Due Date a.1 Bi-weekly PSR COR or approved designees 1st and 3rd week of the month or as requested by COR or approved designees a.2 Ad Hoc Reports COR or approved designees As requested by COR or approved designees a.3 SOPs COR or approved designees Initial SOPs due within 30 days of start of contract. Revisions due within 14 calendar days of change in procedures.

a.4 Semiannual Reports ncibrancheinvoices@mail.nih.gov and COR Six months after the effective date of the award and every six months, thereafter. Not due in period when Annual and/ or Final Report is due.

a.5 Annual Reports ncibrancheinvoices@mail.nih.gov and COR Annually on the anniversary date of the effective date of the contract award a.6 Final Report ncibrancheinvoices@mail.nih.gov and COR Due 15 days before the completion date of the contract a.7.a Final Transition-In Plan ncibrancheinvoices@mail.nih.gov and COR 7 business days after the effective date of contract award a.7.b Transition-Out Plan ncibrancheinvoices@mail.nih.gov and COR Draft Transition-Out plan is due 6 months prior to expiration date of the contract and final plan is due mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov

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Item Description Deliver to Due Date 30 days before the expiration date of the contract

a. 8 Section 508 conformance checklists ncibrancheinvoices@mail.nih.gov and COR Due annually at the end of the base and each option period b.B.1 Roster of Employees Requiring Suitability Investigations ncibrancheinvoices@mail.nih.gov and COR 14 calendar days after effective date of the contract award and then seven (7) calendar days of staffing changes impacting the roster.

C.1-4 Contract Initiation and Expiration Requirements

COR and as requested to the Office of NCI

CISSO

As requested by COR and/or Office of the NCI CISSO

C.5 Notification COR and as requested to the Office of NCI

CISSO

within 15 days before an employee stops working under this contract

C.6 Employee Separation Checklist ncibrancheinvoices@mail.nih.gov and COR Shall be completed within 2 days of employees exit from the contract. Documentation shall be provided upon request.

C.7 Contractor - Employee Non- Disclosure Agreement(s) ncibrancheinvoices@mail.nih.gov and COR Prior to performing any work on the contract.

C.8 Government Access for Security Assessment

COR and as requested to the Office of NCI

CISSO

As requested by the COR and/or Office of the NCI CISSO

C.9 Training Records COR Provide COR and/or CO within 30 days after contract award and annually therefore or upon request.

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 Exclude vacation, holiday, and sick leave. These labor Hours Exclude/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

Base Period Option Period 1 Option Period 2 Option Period 3 Option Period 4 Base and Term Options

TBD TBD TBD TBD TBD

Increased Capacity Options

TBD TBD TBD TBD TBD

Totals TBD TBD TBD TBD TBD mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov

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b. The Contractor shall have satisfied the requirement herein if not less than 85% 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 (FEB 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:

TBD at the time of 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)-4 for 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. The Contractor shall submit invoices electronically via the Department of Treasury’s Invoice Processing Platform (IPP) or successor system in accordance with HHSAR 352.232-71 and a copy to the Approving Official as directed below.

The electronic copy of the invoice shall be transmitted as an attachment via email to the Approving Official at the email address listed below in one of the following formats: Word or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

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

Approving Official: Contracting Officer

Name- TBD Email Address- TBD

Contracting Officer Representative

Name- TBD Email Address- TBD

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

Note: The OFM Customer Service is open Eastern Standard Time Monday - Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

One courtesy copy of the original invoice shall be submitted electronically as follows:

The Central Point of Distribution:

NCI OA Branch E - ncibrancheinvoices@mail.nih.gov

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 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. Note: The Contractor shall not include TIN if it is a Social Security Number.

c. Unique Entity Identifier (UEI). The UEI 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, 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.

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

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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:

Clinical Data Management for the National Cancer Institute (NCI) Center for Cancer Research (CCR)

g. Contract Line Items as follows:

Line Item # Line Item Description

TBD TBD

b. 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 (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…