75N91024R00005 final 122023.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 92-918 as amended

2. Request for Proposal (RFP) Number: 75N91024R00005

3. Issue Date:12/20/2023 4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Epidemiology and Prevention of Infections and Related Diseases

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive, MSC 9705 Rockville, Maryland 20850-9705

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 3:00PM local time on February 12, 2024. 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 https://www.sam.gov/SAM/.

11. FOR INFORMATION CALL: Michele Brown

PHONE: 240-620-0556

e-MAIL: brownmiche@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Requests for clarification, additional information, or correction must be made in writing to the contract specialist at brownmiche@nih.gov on or before 1:00 PM EST January 12, 2024 with the subject line RFP 75N91024R00005.

Kari Peterson, Contracting Officer Office of Acquisitions kari.peterson@nih.gov https://www.sam.gov/SAM/

RFP Number : 75N91024R00005

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

ADDITIONAL TECHNICAL PROPOSAL ATTACHMENTS

ADDITIONAL BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. COMMITMENT OF PUBLIC FUNDS

e. PROMOTING EFFICIENT SPENDING

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

j. LATE PROPOSALS AND REVISIONS

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. Evaluation of Proposals

6. Potential Award Without Discussions

7. Use of the Metric System of Measurement

8. Standards for Privacy of Individually Identifiable Health Information

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

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12. Past Performance Information

13. HHS Security and Privacy Language 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. Human Subjects

5. Enhancing Reproducibility through Rigor and Transparency

6. Obtaining and Disseminating Biomedical Research Resources

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. HUBZone Small Business Concerns

7. Total Compensation Plan

8. Other Administrative Data

9. Qualifications of the Offeror

10. Subcontractors

11. Proposer's Annual Financial Report

12. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. HUMAN SUBJECT EVALUATION

4. EVALUATION OF OPTIONS

5. TECHNICAL EVALUATION FACTORS

6. EVAL OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY SECTION 508

7. PAST PERFORMANCE FACTOR

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PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The objective is to build a comprehensive body of evidence evaluating HPV vaccine protection for adolescents and adults with the ultimate goal to make huge advances towards controlling cervical cancer globally in the next decade.

Secondary goals are to study the epidemiology and prevention of infections and related diseases of public health importance using the infrastructure and methodology developed within the HPV vaccination framework.

The Contractor shall be the liaison, prepare study materials and forms, train staff, follow-up with study participants, conduct screenings, provide a diagnosis and treatment procedures for cervical disease, enter and maintain data, collect biospecimens and data, store specimens, ship biological specimens, conduct sample testing, and provide study monitoring. In addition, the Contractor shall enroll and follow, if required, participants in new studies of HPV infection and related diseases of importance to public health.

ARTICLE B.2. PRICES/COSTS

a. This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $2,000 (minimum) nor more than a total of $49,000,000 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract period July 1, 2024 through June 30, 2034.

c. The Government will issue Task Orders based on the work described in SECTION C of this contract.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

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

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ARTICLE B.4. ADVANCE UNDERSTANDINGS

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

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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 11/09/2023, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

b. Privacy Act System of Records Number 09-25-0200 is applicable to this contract 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's Representative (COR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports shall be submitted electronically.

508 Compliance:

These reports 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: https://www.hhs.gov/web/section-508/index.html and at: https://www.section508.gov/create/documents , "Create Accessible Documents."

Checklists for Section 508-Conformance reporting for electronic documents, files, videos, etc., based on Section 508, are available at HHS’s Accessibility Compliance Checklists. Should the deliverable type not have an applicable checklist, please notify the CO. These HHS 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 per deliverable shall suffice – that is, one Microsoft Word checklist shall represent all Word files submitted, one Microsoft PowerPoint checklist shall represent all PowerPoint files submitted, one Adobe PDF checklist shall represent all PDF files submitted, etc. per deliverable.

Submission:

All reports required herein shall be submitted in an electronic format via email to the NCI COR and as an attachment to the following email address: ncibrancheinvoices@mail.nih.gov

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

Deliverable_Contract Number_Vendor’s Name_Deliverable Description_Due Date.

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 attachments or less.

Task Order Reports and Deliverables:

The frequency and specific content of these reports and deliverables will be determined within each individual Task Order. Reports and deliverables shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract and with the requirements of Task Orders issued.

The Contractor shall include, in any technical progress report submitted, the applicable PubMed Central (PMC) or National Institutes of Health (NIH) Manuscript Submission reference number when citing publications that arise from its NIH funded research.

The Contractor shall deliver the following items:

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a. Scientific Reports

1. Monthly or Quarterly Task Order(s) Progress Reports

The Contractor shall provide Task Order Progress Reports that summarizes all Task Order activities, these reports shall be broken out for each task area as outlined in the Statement of Work. Reports shall be tailored by task area and include: 1) Summary of progress; 2) Summary of tasks that have been completed and the completion date;

3) Summary of tasks yet to be completed, whether or not these projects are on schedule, and discussion of any problems encountered in the collection, handling, or processing of data, including resolution of each problem; 4) Suggestions for modification of the project plan; and 5) Copies of the shipping list/manifest of all biologic specimens delivered to the repository in Maryland, laboratories or individuals.

This report is due on or before the 15th calendar day following each reporting period.

2. Annual Task Order Progress Reports (Draft Annual and Annual)

The Annual Task Order Progress Report shall include a summation of the results of the work performed for the entire period covered. The period covered shall be twelve (12) months from the start date of the Task Order period of performance. A Quarterly Report shall not be submitted when an Annual Report is due.

The Contractor shall provide the Contracting Officer (CO) and the Contracting Officer’s Representative (COR) with 1 copy of the Draft Annual Progress Report in accordance with the DELIVERIES Article in SECTION F of this Contract thirty (30) calendar days prior to the end of the current Task Order period of performance. The COR will review the Draft Annual Task Order Progress Report and provide the Contractor with comments within fourteen (14) calendar days after receipt.

The Draft Annual Progress Report shall be corrected by the Contractor, if necessary, and the final version of the Annual Task Order Progress Report shall be delivered as specified in the Deliveries Article of Section F.

3. Final Task Order Reports

The Final Task Order Report shall include a summation of the work performed and the results obtained for the entire Task Order period of performance. This report shall be in sufficient detail to comprehensively describe the results achieved. Neither a Quarterly or Annual Report shall be submitted when a Final Report is due.

The Contractor shall provide the CO and the COR with 1 copy of the Draft Task Order Report thirty (30) calendar days prior to the end of the Task Order period of performance. The COR will review the Draft Final Task Order Report and provide the Contractor with comments within 14 calendar days after receipt. The Final Task Order Report shall be corrected by the Contractor, if necessary, and the final version delivered on or before the last day of the period of performance of the Task Order.

b. Other Reports/Deliverables

4. Emergency Response Reports

The Contractor shall submit a written report to the COR within 3 days of any incident to include details regarding the cause of the incident, steps taken to address the immediate needs, and recommendations for further actions needed to avoid similar incidents in the future.

5. Specimen Damage Reports

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The Contractor shall submit a written report to the COR within 7 calendar days of the incident that describes the specimens and studies affected, a description of the finding, and any follow-up action taken or needed.

6. Biological Specimens

The Contractor shall package and ship biological specimens at the proper temperatures to the designated place as instructed by the COR.

7. Biological Specimen Testing Failures

The Contractor shall submit a written report to the COR within 7 calendar days of failures for sample testing, describe the incident, and studies affected, a description of the finding, and any follow-up action taken or needed.

8. Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations (when appropriate) for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, "Cumulative Inclusion Enrollment Report," which is set forth in SECTION J of this contract. The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report. If the clinical study(s) involves US and non-US sites, the US sites and non-US sites should be reported on separate Cumulative Inclusion Enrollment Reports.

In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October 2001 applies. If this contract is for Phase III clinical trials, see II.B of these guidelines. The Guidelines may be found at the following website: https://grants.nih.gov/policy/inclusion/women-and-minorities.htm.

For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes. This includes designing the study in a manner that potential differences, as appropriate, by sex/gender and/or racial/ethnic groups in the clinical trial protocol could be conducted. Also, provide a description of any analyses by sex/gender, race, and/or ethnicity, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/gender, race and/or ethnicity.

9. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in [Electronic/Hard Copy] format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94. 45 CFR Part 94 is available at: https://www.ecfr.gov/ current/title-45/part-94.

See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.

(Reference the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

c. INFORMATION AND/OR PHYSICAL SECURITY

10. Assessment and Authorization (A&A)

A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any

- 9 -subcontractor) must work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within three (3) months after contract award. The Contractor must conduct the A&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, Contracting Officer Representative must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

NIH acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

11. A&A Package Deliverables

The Contractor (and/or any subcontractor) must provide an A&A package within 30 days of contract award to the CO and/or COR. The following A&A deliverables are required to complete the A&A package.

12. System Security Plan (SSP)

Due within 30 days after contract award. The SSP must comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and NIH policies and other guidance. The SSP must be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The SSP must provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor must update the SSP at least annually thereafter.

13. Security Assessment Plan/Report (SAP/SAR)

Due 30 days after the contract award. The security assessment must be conducted by the assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and NIH policies. The assessor will document the assessment results in the SAR.

The NIH should determine which security control baseline applies and then make a determination on the appropriateness/necessity of obtaining an independent assessment. Assessments of controls can be performed by Contractor, government, or third parties, with third party verification considered the strongest. If independent assessment is required, include statement below.

Thereafter, the Contractor, in coordination with the NIH shall conduct/assist in the assessment of the security controls and update the SAR at least annually.

14. Independent Assessment

Due 90 days after the contract award. The Contractor (and/or subcontractor) must have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party must review and analyze the Security Authorization package, and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor must address all "high" deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M).

15. Plan of Actions and Milestones (POA&M)

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Due 30 days after contract award. The POA&M must be documented consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. All findings/weaknesses must be documented in the POA&M and remediated/ mitigated from the date the weaknesses are formally identified and documented by the timelines below:

• Critical within 30 days;

• High within 60 days;

• Medium within 1 year; and

• Low within 1 year.

The NIH will determine the risk rating of vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the SAR, must be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, NIH may require designated POAM weaknesses to be remediated before an ATO is issued. Thereafter, the POA&M must be updated at least quarterly.

16. Contingency Plan and Contingency Plan Test

Due 60 days after contract award. The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and NIH policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, must test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed. Thereafter, the Contractor must update and test the Contingency Plan at least annually.

17. E-Authentication Questionnaire

The contractor (and/or any subcontractor) must collaborate with government personnel to ensure that an E- Authentication Threshold Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary. System documentation developed for a system using E-auth TA/E-auth RA methods must follow OMB 04-04 and NIST SP 800-63, Rev. 2, Electronic Authentication Guidelines.

Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS policies.

18. 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://ors.od.nih.gov/ser/ dpsac/administrators/onboarding-new-staff/Pages/position-designation-tool.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:

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

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

19. 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

- 11 -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

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.

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.

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.

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.

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.

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).

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).

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

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.

20. Notification of Departing Employees

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

21. Contractor 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.

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22. 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.

23. Vulnerability Scanning Reports

The Contractor must report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report must be submitted under a separate cover on monthly basis.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer NationalInstitutesofHealth NationalCancerInstituteOfficeofAcquisition 9609MedicalCenterDriveRoom1E608 Rockville, MD 20850

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

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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, TBD is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Cancer Institute

9609 Medical Center Drive

Rockville, Md 20852

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 52.246-9, Inspection of Research and Development (Short Form) (April 1984)

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from July 1, 2024 through June 30, 2034.

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

Item Report Frequency

1 Monthly or Quarterly Task Order(s)Progress Reports

The contractor shall submit the monthly or quarterly report on or before the 15th of each month following each reporting period

2 Annual Task Order Progress Reports The draft report is due 30 days prior to the end of the period of performance with the final version of the annual progress report due on the last day of the period of performance

3 Final Task Order Reports The draft final task order report is due thirty (30) calendar days prior to the end of the task order period of performance.

The final task order report shall be delivered before the last day of the period of performance of the task order

4 Emergency Response Reports The contractor shall submit a written report to the cor within 3 days of any incident

5 Specimen Damage Reports The contractor shall submit a written report to the cor within 7 calendar days of the incident

6 Biological Specimens As instructed by the cor

7 Biological Specimen Testing Failures The contractor shall submit a written report to the cor within 7 calendar days of failures for sample testing

8 Annual Technical Progress Report for Clinical Research Study Populations

The report is due annually and at the conclusion of each study

9 Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, responsible prospective contractors

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Item Report Frequency including, but not limited to, the new FCOI report, annual FCOI report, revised FCOI report, and the mitigation report, shall be submitted to the contracting officer in electronic format

10 Assessment and Authorization (A&A) Due within 3 months of contract award

11 A&A Package Deliverables Due within 30 days of contract award

12 System Security Plan (SSP) Due within 30 days after contract award

13 Security Assessment Plan/Report

(SAP/SAR)

Due 30 days after the contract award

14 Independent Assessment Due 90 days after the contract award

15 Plan of Actions and Milestones

(POA&M)

Due 30 days after contract award

16 Contingency Plan and Contingency Plan Test

Due 60 days after contract award

17 E-Authentication Questionnaire As requested by the government

18 Position Sensitivity Designations As requested by the government

19 Roster Roster must be submitted within fourteen (14) calendar days after the effective date of this contract

20 Notification of Departing Employees The contractor/subcontractor must notify the co and/or cor and system ISSO within fifteen days before an employee stops working under this contract.

21 Contractor Employee Separation Checklist

Due within 2 days of an employee’s exit from the contract

22 Contractor Non-Disclosure Agreement

(NDA)

Prior to performing any work under this acquisition

23 Vulnerability Scanning Reports Monthly special vulnerability scans due no later than 10 days following the end of each reporting period

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

Addressee Deliverable Item No. Distribution

Contracting Officer's Representative

(COR)

1-23 NCI BranchEInvoices@mail.nih.gov

Contracting Officer (CO) Office of Acquisition (OA) National Cancer Institute (NCI)

1-23 NCI BranchEinvoices@mail.nih.gov

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ARTICLE F.3. 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 REPRESENTATIVE (COR)

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

TBD

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 alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.

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

The Government may unilaterally change its COR designation.

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

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

(End of clause).

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

Name Title

ARTICLE G.3. TASK ORDER PROCEDURE

This contract provides for the issuance of Task Orders on a negotiated basis as follows:

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed

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Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

No other costs are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer.

b. Requesting Task Order Proposals.

The Contracting Officer or a designated individual may solicit responses to requirements from Contractors within a technical area covered by a task order requirement in writing. A Task Order Request for Proposals (TORFP) will be prepared and issued for each task order requirement.

Generally, the Task Order Request for Proposal (TORFP) will include but is not limited to the following:

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

All contract clauses contained this contract shall be incorporated in the TORFP and the resultant task order.

If conflicts exist between the contract clauses and the information outlined in the task order, the contract language takes precedence over the information in the task order.

Contractors are not required to propose on all TORFPs. Those eligible Contractors that decide not to submit a proposal shall advise the Contracting Officer, in writing, of their intention not to submit a proposal on or before the closing date and time established in the TORFP. An election not to propose on a given TORFP will not negatively affect or prohibit a Contractor from competing on future TORFPs. However, it may affect the Contractor's eligibility for continuations or extensions of the resultant Task Order.

c. Evaluation and Award of Task Order Proposals

The Government will evaluate the Task Order proposals against the requirements of the TORFP.

Specifically, the technical evaluation factors, cost/price, past performance and any other factor specifically identified in the TORFP will be used for evaluation of each proposal. In addition, the TORFP will identify the basis for selecting a Contractor for award. Generally, technical factors will be significantly more important than cost or price. However, each TORFP will specify how the award decision will be made.

Upon completion of evaluations, the Contracting Officer will issue a task order to the Contractor.

The Contracting Officer will notify the Contractor(s) of the selection decision in writing.

ARTICLE G.4. INVOICE SUBMISSION

1. Until the Contractor has transitioned to IPP as specified on the OALM IPP website, the Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment in Section J of this contract. The invoice submitted to the NIH/OFM must be transmitted as an attachment via email to the address https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files

- 20 -listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF).

The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

The Contractor must submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer 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@mail-cmp.niceincontact.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

Invoices shall be submitted in accordance with Electronic Invoicing Instructions for NIH Contractors/ Vendors, which is included as an attachment in Section J of this contract.

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 mailto:ofm_customer_service@mail-cmp.niceincontact.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx mailto:ncibrancheinvoices@mail.nih.gov

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(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 is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid UEI number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [ Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.

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:

Epidemiology and Prevention of Infections and Related Diseases Task Order Title - TBD

g. Contract Line Items as follows:

Line Item # Line Item Description

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

ARTICLE G.5. 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.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15.