RFP_75N91023R00001_FINAL_w_attachments.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority:

2. Request for Proposal (RFP) Number: 75N91023R00001

3. Issue Date:

January 30, 2023

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Centralized Chemopreventive Agent Repository and Chemistry Support Services

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive Room 1E620, MS 9705 Rockville, Maryland 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 4:00 PM local time on February 28, 2023. 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: PAULA WILKISON, CONTRACTING OFFICER

PHONE: (240) 276-7386

e-MAIL: paula.wilkison@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Submit all questions in writing to the Contracting Officer at paula.wilkison@nih.gov no later than 12:00 PM EST on 02/08/2023.

Questions received will be consolidated and the responses posted on www.sam.gov as an amendment to the RFP.

Paula Wilkison Contracting Officer Office of Acquisitions NIH - National Cancer Institute

RFP Number : 75N91023R00001

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. COMMITMENT OF PUBLIC FUNDS

e. COMMUNICATIONS PRIOR TO CONTRACT AWARD

f. RELEASE OF INFORMATION

g. PREPARATION COSTS

h. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. ROTC Access and Federal Military Recruiting on Campus

12. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

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13. Past Performance Information

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

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. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. TECHNICAL EVALUATION FACTORS

5. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

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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 requirement is to continue a well-established Repository program within the Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI). The successful Contractor shall maintain a centralized source of agents and development services necessary to support chemoprevention studies for effective medical interventions in the prevention or reduction of cancer. The repository provides important logistic organization for the acquisition, tracking, storage, maintenance, testing, quality control, and distribution of investigational agents.

ARTICLE B.2. PRICES/COSTS

a. This is an Indefinite-Quantity-Indefinite-Delivery (IDIQ) contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $1,000 (minimum) nor more than a total of $49,990,000 (maximum) for successful performance of this contract.

b. The costs set forth in the ARTICLE will cover the contract period 07/01/2023 through 06/30/2028.

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

d. Ordering procedures are described in the TASK ORDER PROCEDURE Article in SECTION G 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.

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. DESCRIPTION-STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated December 1, 2022, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format via email as attachments to the following designated NCI Branch Distribution Mailbox: ncibranchbinvoices@mail.nih.gov.

Each email submission shall contain only one deliverable. If the attached file for the deliverable exceeds 50 MB, the Contractor shall divide the deliverable into files of 50 MB each. All deliverables shall be limited to five file attachments or less.

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

Deliverable_Contract Number_Task Order Number_Vendor's Name_Deliverable Description_Due Date

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html and at: https://www.section508.gov/create/ documents, "Create Accessible Documents."

a. Technical Progress Reports

In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit regularly recurring Technical Progress Reports. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined within each individual Task Order. Reports shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract and with the requirements of Task Orders issued here under. [Note: Beginning May 25, 2008, the Contractor shall include, in any technical progress report submitted, the applicable PubMed Central (PMC) or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

1. Weekly Task Order Electronic Reports – to include the status of all on-going projects, including procurement, receiving, and shipping.

2. Monthly Task Order Progress Reports - A Monthly Task Order Progress Report is not required for the period when a Quarterly Task Order Progress Report is due. The report shall include but is not limited to:

a. Summary of progress in the past month for each SOW area

b. Summary of meeting and teleconferences

c. Repository, investigator, and clinical site inventories of drugs/agents/materials

d. All shipping activities

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e. Spreadsheet summary of agent name, protocol number, investigator, study title, supplier, study allocation, and remaining inventory of agents

f. Analytical laboratory summary

g. Discussion of current or potential problem areas

h. Suggestions for solutions to problems and operational improvements

i. Discussion of progress, accomplishments, and plans for future work

3. Quarterly Task Order Progress Reports - A Quarterly Task Order Progress Report is not required for the period when an Annual Task Order Progress Report is due. The report shall include but is not limited to:

a. Summary of progress in the past quarter for each SOW area

b. Discussion of current or potential problem areas

c. Suggestions for solutions to problems and operational improvements

d. Discussion of progress, accomplishments, and plans for future work

e. Corrective actions that describe problems and deviations from specifications, along with appropriate follow-up actions taken to remediate and correct discrepancies.

4. Annual Task Order Progress Reports - shall submit an Annual Task Order Progress Report to include a summary of the results for the period covered. This report shall include but is not limited to:

a. Summary of progress in the past year for each SOW area

b. Report of annual physical inventory of materials and any problems between the electronic and physical inventories

c. Summarize internal and external audit findings

d. An Annual Site Visit report (due 30 days following site visit)

e. Discussion of current or potential problem areas

f. Suggestions for solutions to problems and operational improvements

g. Report on select Agents or Toxins and/or Highly Pathogenic agents (see below)

h. Section 508 Annual Report

i. Discussion of progress, accomplishments, and plans for future work the Annual Progress Report is not required for the month that the Final Report is due.

5. Project/Inventory/ Package System Report

Project System Report - The Contractor shall provide a report which shall consist of written summaries of the high points undertaken during the project. The Report shall have a beginning target date, intermediate milestones, and a final disposition of the project. Tools such as Gantt charts, milestone development, important features and other project descriptions. It shall be provided to the COR as requested.

Inventory System Report - The Contractor shall provide a completed itemization of the entire repository inventory. This report shall include quantities, manufacturers, expiration date, and most recent testing. It shall be provided to the COR as requested.

Package Tracking System Report shall be utilized to ensure that all materials are delivered only to the intended recipient. In addition, complete logistic tracking for disposition of all materials. It shall be provided to the COR as requested.

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6. Draft Final Task Order Progress Report - The Contractor shall provide a Draft Task Order Final Report 60 calendar days prior to the expiration date of the task order. The COR will review the draft report and provide the Contractor with comments within 15 calendar days after receipt. The Task Order Final Report shall be corrected by the Contractor, if necessary and the final version delivered as specified.

7. Final Task Order Progress Report - The Final Task Order Progress Report is to include a summation of the work performed and results obtained for the entire task order period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Task Order Progress Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The content and format shall be specified by the COR. This shall include but is not limited to:

a. Progress in the performance of the task order in accordance with each item of the Statement of Work.

b. A discussion of any problems the Contractor had in maintaining an effective operating program.

c. Any other points specifically requested by the Contracting Officer's Representative (COR) or which the Contractor feels are of interest.

A final report shall be due on or before the expiration or completion date of the task order.

8. Summary of Salient Results per Task Order

The Contractor shall prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the task order. This report is due on or before the expiration or completion date of the task order.

b. Other Reports/Deliverables

9. Service Contract Reporting

In accordance with FAR clause 52.204-15, Service Contract Reporting Requirements for Indefinite Delivery Contracts (Jan 2014), the Contractor shall enter and submit the following Service Contract Report data elements into http://www.sam.gov, with a copy to the Contracting Officer annually, by October 31st for services performed under this contract during the preceding Government fiscal year (October 1 – September 30). SCR data elements:

a. Contract Number

b. The total dollar amount invoiced for services performed during the previous Government fiscal year under the contract.

c. Total number of Contractor direct labor hours expended on the services performed during the previous Government fiscal year.

d. Data reported by first-tier subcontractors that have provided services under this contract, as applicable.

e. First-tier Subcontract number (including subcontractor name and UEI number)

f. The number of first-tier subcontractor direct-labor hours expended on the services performed during the previous Government fiscal year.

10. Section 508 Annual Report

The Contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of the Task Order. The Section 508 Report Template and Instructions for completing the report are available at: https:// www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc

11. Disaster Recovery Plan

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The Contractor shall develop and submit a draft Disaster Recovery Plan for review and approval by the COR Due 30 calendar days after Task Order award.

12. Invention Disclosure Report

13. Annual Utilization Report

14. Final Invention Statement

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 COR. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the COR on the expiration date of the Task Order.

15. Security Assessment and Authorization Package

Contractor shall provide the components of the Security Assessment and Authorization Package (SA&A), as described in Section H:

a. FIPS-199

b. E-Auth (if applicable)

c. PTA/PIA (if applicable)

d. Business Impact Analysis

e. SSP

f. SAR

g. POA&M

h. Authorization Letter

i. CP and CPT Report

j. Interconnection/Data Use Agreements (if applicable)

k. Configuration Management Plan (if applicable)

l. Configuration Baseline

16. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under each Task Order who will develop, access, or host and/or maintain a Federal information system(s). The roster shall be submitted prior to performing work.

17. Report of New and Departing Employees

The Contractor shall notify the Contracting Officer’s Representative (COR) and the Contracting Officer (CO) due five (5) working days of staffing changes for positions that require suitability determinations as follows:

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

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

18. Contractor-Employee Non-Disclosure Agreements

The Contractor shall complete and submit a signed and witnessed “Commitment to Protect Non-Public Information – Contractor Agreement” form for each Contractor and subcontractor employee who may have access to non-public Departmental information under this Task Order. This form is located at: Https:// ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf.

19. Vulnerability Scanning Reports

The Contractor shall report the results of the required monthly special vulnerability scans due 10 calendar days following the end of each reporting period. This report may be included as part of the Monthly Progress Report.

If not included in the Monthly Progress Report, the Contractor shall submit it under separate cover. Reference subparagraph E.5. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H

20. System Review Analysis and Performance Metric Standards

The Contractor shall assess the standing system for baseline performance capability and propose metric indicators for reporting that demonstrate operational maintenance success. The Contractor shall submit the analysis due 30 calendar days after Task Order award.

21. Management of Sensitive Information Plan

The Contractor shall develop and submit a draft plan for management of sensitive information due 30 calendar days after Task Order award.

22. Report on Status of Minimum Background Investigation Clearances (HSPD-12 Security Requirements)

The Contractor shall perform and report on the status of background investigations in accordance with Homeland Security Presidential Directive 12. The Contractor shall provide monthly updates on background investigations as part of the Monthly IT Status Report Requirement.

23. Monthly IT Status Report Requirement

The Contractor shall submit IT Status Reports in accordance with HHS Office of the Chief Information Officer (OCIO) Enterprise Performance Life Cycle (EPLC) Policy Adherence. See http://www.hhs.gov/ocio/ policy/2008-0004.001.html.

24. Configuration Management Plan

The Contractor shall provide documentation of the existing system configuration and any alterations to it. The documentation shall include a plan for revisions and upgrades to its baseline functionality and structure as an artifact document if any software is to be developed for the Task Order period. The Contractor shall submit the plan due 30 days after Task Order award.

25. Data Collection Plan

The Contractor shall develop and submit a Data Collection Plan in accordance with HHSAR 352.224-70 Privacy Act due 30 days after Task Order award.

26. Source Code and Object Code

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

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27. Standard of Encryption

Verification that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2

28. Training Records

The Contractor shall provide a copy of training records for all mandatory training.

29. Rules of Behavior

Contractor shall submit signed Rules of Behavior for all employees.

30. Incident Report

The Contractor shall submit an Incident Report as incidents or breaches occur.

31. Incident and Breach Response Plan

The Contractor shall submit an Incident and Breach Response Plan, if requested.

32. Certification of Sanitization

Certification of Sanitization of Government and Government Activity Related Files, Information, and Devices.

See Appendix G of NIST SP 800-88 for sample form.

33. Final Data Set, Cleaned and Locked

The Contractor shall develop and submit a Data Collection Plan as part of the Program Management Plan. Data sets distributed under this policy shall remove data with personal identifiers and other variables that might enable individual participants to be identified, such as outliers, dates, and study sites. The Final Data Set cleaned and locked shall be delivered to the NCI COR, or designee, upon Task Order expiration.

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

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 clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

FAR Clause 52.246-2, Inspection of Supplies - Fixed Price (August 1996).

FAR Clause 52.246-3, Inspection of Supplies - Cost-Reimbursement (May 2001).

FAR Clause 52.246-4, Inspection of Services - Fixed Price (August 1996).

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

The period of performance of this contract shall be from 07/01/2023 through 06/30/2028.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Description Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract are required to be delivered in electronic format to the designated NCI Branch Distribution Mailbox:

ncibranchbinvoices@mail.nih.gov and in accordance with and by the date(s) specified below and to any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract. The subject line of the email shall read as follows: Contract Number_Task Order Number_Deliverable Number_Deliverable Description. Each email submission shall contain only one deliverable. If the attached file for the deliverable exceeds 50MB, the Contractor shall divide the deliverable into files of 50MB each. All deliverables shall be limited to five (5) file attachments or less.

b. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

c. Deliverables Chart

Deliverable Number Deliverable Name Deliver to: DUE DATE

Project Management Deliverables

1 Weekly Task Order Electronic Reports

COR, CO Due on Friday of each week

2 Monthly Task Order Progress Reports

COR, CO Due within 15 calendar days following the first full month of the task order and monthly thereafter. A Monthly Task Order Progress Report is not required for the period when a Quarterly Task Order Progress Report is due.

3 Quarterly Task Order Progress Reports

COR, CO Due within 15 calendar days following the 1st full quarter (3-months period) of the task order.

A Quarterly Task Order Progress Report is not required for the period when an Annual Task Order Progress Report is due.

4 Annual Task Order Progress Reports

COR, CO Due within 15 calendar days following completion

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Deliverable Number Deliverable Name Deliver to: DUE DATE of each year of the task order.

5 Project/Inventory/ Package System Report

COR, CO As requested by COR

6 Draft Final Task Order Progress Report

COR, CO Due 60 calendar days prior to the Task Order expiration date

7 Final Task Order Progress Report

COR, CO Due on or before the expiration or completion date of the Task Order

8 Summary of Salient Results per Task Order

COR, CO Due on or before the expiration or completion date of the Task Order

Task Order Management Deliverables

9 Service Contract Act Reporting

CO, Report in www.sam.gov

Due October 31 of each year of Task Order performance

10 Section 508 Annual Report COR, CO Annually on the anniversary of Task Order award

11 Disaster Recovery Plan COR, CO Due 30 calendar days after Task Order award

12 Invention Disclosure Report

CO, OPERA Due the date of Task Order expiration

13 Annual Utilization report CO, OPERA Annually on the anniversary of Task Order award

14 Final Invention Statement CO, OPERA Due the date of Task Order expiration

Information System Deliverables

15 SA&A Package

1. FIPS-199

2. E-Auth (if applicable)

3. PTA/PIA (if applicable)

4. Business Impact Analysis

5. SSP

6. SAR

7. POA&M

8. Authorization Letter

9. CP and CPT Report

COR, CO 1. 30 days after award

2. 30 days after award

3. 30 days after award (drafted)

4. 30 days after award (drafted)

5. 90 days after award, update annually thereafter.

6. 120 days after award

7. Prior to production release and ATO letter signing

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Deliverable Number Deliverable Name Deliver to: DUE DATE

10. Interconnection/ Data Use Agreements (if applicable)

11. Configuration Management Plan (if applicable)

12. Configuration Baseline

8. Prior to production release and ATO letter signing

9. 120 days after award, update annually thereafter.

10. 60 days after award

11. 60 days after award

12. 60 days after award

16 Roster of Employees Requiring Suitability Investigations

COR, CO Prior to performing work

17 Report of New and Departing Employees

COR, CO Due 5 working days after staff changes that require suitability investigations

18 Contractor-Employee Non- Disclosure Agreements

COR, CO Prior to having access to any non-public information

19 Vulnerability Scanning Reports

COR Due monthly, 10 calendar days following the end of each task order reporting period

20 System Review Analysis and Performance Metric Standards

COR Due 30 calendar days after Task Order award

21 Management of Sensitive Information Plan

COR Due 30 calendar days after Task Order award

22 Report on Status of Minimum Background Investigation Clearances (HSPD-12 Security Requirements)

COR To be provided with Monthly IT Status Reports

23 Monthly IT Status Report COR Due monthly, 10 calendar days following the end of each task order reporting period

24 Configuration Management Plan

COR Due 30 calendar days after Task Order award.

25 Data Collection Plan COR Due 30 calendar days after Task Order award.

26 Source Code and Object Code

COR Due on the Task Order expiration date

27 Standard of Encryption COR Within 15 days of validation under the Cryptographic Module Validation Program

28 Training Records COR No later than 30 days after i of Task Order and annually thereafter

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Deliverable Number Deliverable Name Deliver to: DUE DATE

29 Rules of Behavior COR Initiation of Task Order and annually thereafter

30 Incident Report COR As soon as possible and without unreasonable delay, and no later than 1 hour of discovery

31 Incident and Breach Response Plan

COR No later than 30 days after Task Order award

32 Certification of Sanitization COR Not later than 2 weeks prior to contract expiration, or as directed by the NCI

33 Final Data Set, cleaned and locked

COR Due on the Task Order expiration date

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

Addressee Delivery To: Deliverable Item Number Contracting Officer’s Representative

(COR)

ncibranchbinvoices@mail.nih.gov all

Contracting Officer ncibranchbinvoices@mail.nih.gov all

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.

52.242-17, Government Delay of Work (April 1984).

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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:

To be specified prior to award. Additional CORs may be specified at the individual Task Order Level.

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, if appointed, 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

To be determined

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 the Contractor 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.

c. Evaluation and Award of Task Order Proposals

The Government will evaluate the Task Order proposal against the requirements of the TORFP. Specifically, the technical evaluation factors, cost/price, past performance and any other factors specifically identified in the TORFP will be used for evaluation of the proposal. In addition, the TORFP will identify the basis for selecting the 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 the evaluation, the Contracting Officer will issue a task order to the Contractor.

ARTICLE G.4. INVOICE SUBMISSION - COST REIMBURSEMENT

a. Invoice Submission/Contract Financing Request, NIH(RC)-1for NIH Cost-Reimbursement Type Task Orders is attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a “proper invoice” pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor shall submit invoice to the National Institutes of Health (NIH)/Office of Financial Management (OFM) via email at invoicing@nih.gov with a copy to the approving official, as directed below. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors , which is included as an attachment in Section

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

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

Approving Official: Contracting Officer

Name- Paula Wilkison Email Address- paula.wilkison@nih.gov

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 B - ncibranchbinvoices@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. If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer. Note: The Contractor shall not include TIN if it is a Social Security Number.

c. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Universal Numbering System (DUNS) number. The UEI number must identify the Contractor identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer. Note: The Contractor shall not include TIN if it is a Social Security Number.

d. Invoice Matching Option. This contract requires a two-way match.

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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:

Centralized Chemopreventive Agent Repository and Chemistry Support Services

g. Contract Line Items as follows:

Line Item # Line Item Description

To be determined

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

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

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

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

ARTICLE G.5. INVOICE SUBMISSION - FIXED PRICE

a. Invoice Instructions for NIH Fixed-Price Type Contracts, NIH(RC)-2, are attached and made part of this contract.

The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor shall submit invoice to the National Institutes of Health (NIH)/Office of Financial Management (OFM) via email at invoicing@nih.gov with a copy to the approving official, as directed below. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment in Section J of this contract. The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

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

Approving Official: Contracting Officer

Name- Paula Wilkison Email Address- paula.wilkison@nih.gov

Contracting Officer Representative

Name- TBD Email Address- TBD

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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 B - ncibranchbinvoices@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. If the Contractor has neither a TIN, Unique Entity Identifier (UEI, or VIN, contact the Contracting Officer.

c. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid UEI number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. If the Contractor has neither a TIN, UEI , or VIN, contact the Contracting Officer. Note: The Contractor shall not include TIN if it is a Social Security Number.

d. Invoice Matching Option. This contract requires a two-way match.

e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

f. The Contract Title is:

Centralized Chemopreventive Agent Repository and Chemistry Support Services

g. Contract Line Items as follows:

To be determined

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

ARTICLE G.6. 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.7. INDIRECT COST RATES

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

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

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer. Go to the Indirect Cost Submission web page: https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission for electronic copies of the Branch's information package documents.

ARTICLE G.8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually as follows on TBD.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement.