RFP 75N91022R00007 final.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 92.218 as amended

2. Request for Proposal (RFP) Number:

75N91022R00007

3. Issue Date:

July 15, 2022

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Storage and Distribution of Clinical Agents

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive

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 PM Eastern time on August 14, 2022. Offers will be valid for 180 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: Mesfin Alemayehu

PHONE: 2402767995

e-MAIL: mesfin.alemayehu@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The deadline for receipt of questions concerning this RFP is 4 PM EST on July 25, 2022. Please Note: Mandatory Criteria (see Section M of the RFP)

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

RFP Number : 75N91022R00007

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. 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. Evaluation of Proposals

6. Potential Award Without Discussions

7. Use of the Metric System of Measurement

8. Privacy Act - Treatment of Proposal Information

9. Selection of Offerors

10. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

11. Past Performance Information

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

13. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Obtaining and Disseminating Biomedical Research Resources

5. Instructions to Offerors-Sustainable Acquisition, HHSAR Provision 352.223-71 (December 2015). . . 74

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. MANDATORY QUALIFICATION CRITERIA

4. EVALUATION OF OPTIONS

5. TECHNICAL EVALUATION CRITERIA

6. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

7. PAST PERFORMANCE FACTOR

8. EVALUATION OF SUSTAINABLE ACQUISITION PLAN

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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 Pharmaceutical Management Branch (PMB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), is charged with providing pharmaceutical support for clinical trials sponsored and/or funded by CTEP, DCTD, NCI. The DCTD sponsors intramural and extramural research for the clinical evaluation and development of potentially effective cancer treatments. CTEP administers, coordinates, and funds these clinical trials, as well as supports other clinical research initiatives. The program fosters collaborations within the cancer research community and works extensively with the pharmaceutical and biotechnology industries. The purpose of this contract is to provide a facility and project team that is responsible for the receipt, storage, distribution and final disposition of clinical investigational agents in support of these clinical trials. The Contractor shall also maintain specialized expertise in the management, labeling and distribution of clinical supplies for double-blind placebo-controlled trials.

ARTICLE B.2. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ To Be Negotiated (TBN).

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

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

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

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period (2/1/2023 – 1/31/2024) TBN TBN TBN

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option Period 1 (2/1/2024 – 1/31/2025) TBN TBN TBN Option Period 2 (2/1/2025 – 1/31/2026) TBN TBN TBN Option Period 3 (2/1/2026 – 1/31/2027) TBN TBN TBN Option Period 4 (2/1/2027 – 1/31/2028) TBN TBN TBN Increased Capacity Base Period (12 months TBN TBN TBN Increased Capacity Option Period 1 (12 months) TBN TBN TBN Increased Capacity Option Period 2 (12 months) TBN TBN TBN Increased Capacity Option Period 3 (12 months) TBN TBN TBN Increased Capacity Option Period 4 (12 months) TBN TBN TBN Phase-in Transition (60 Days) TBN TBN TBN Phase-out Transition (90 Days) TBN TBN TBN Total (Base Period and Options) TBN TBN TBN

ARTICLE B.3. ESTIMATED COST - INCREMENTALLY FUNDED CONTRACT

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

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

CLIN, Task, Number, or Description

Start Date of Period or Increment of

Performance

End Date of

Period or Increment of Performance

Estimated Cost ($)

Fee ($) (as appropriate)

Estimated Cost Plus Fee ($) (as appropriate)

[Total] [Total] [Total]

*To be inserted after negotiation

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

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

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

f. Payment of fee shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

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The fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended.

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

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

ARTICLE B.5. ADVANCE UNDERSTANDINGS

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

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

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated July 15, 2022, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

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

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format via email as attachments to the following designated NCI Branch Distribution Mailbox: ncibrancheinvoices@mail.nih.gov Note: Hard copies of reports are no longer required and shall no longer be mailed to NCI, OA. Each email submission shall contain only one deliverable. If the attached files for the deliverables exceed 50 MB, the contractor shall divide the deliverables into files of 50 MB each. All deliverables should be limited to five file attachments or less. We understand that in some cases more than five attachments will be necessary. The subject line of the email should read as follows:

Deliverable_Contract Number_Vendor's Name_Deliverable Description_Due Date

All electronic 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."

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

Prior to acceptance, the government reserves the right to perform testing on required Information and Communication Technology (ICT) items to validate the offeror’s Section 508 conformance. If the government determines that Section 508 conformance claims provided by the offeror represent a higher level of conformance than what is actually provided to the agency, the government shall, at its option, require the offeror to remediate the item to align with the Contractor’s original Section 508 conformance claims prior to acceptance.

a. Technical Reports

1. Contract Pricing Table

The Contractor shall provide annual pricing updates for receipt, storage, shipping (supplies and freight), and final disposition of agents for each calendar year. The contract pricing table will be used by the Government for the purposes of creating cost estimates for individual studies. The initial contract pricing table shall be submitted within 3-months of contract award and then annually thereafter in the Contractor’s Annual Progress Report.

mailto:ncibrancheinvoices@mail.nih.gov http://www.hhs.gov/web/508/index.html https://www.section508.gov/create/documents https://www.section508.gov/create/documents

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2. Physical Inventory Report

Year one of the contract, Contractor shall perform a complete physical inventory of all agents stored in the repository, at the start of the contract (day 1), at the mid-point and at the end of year one. For option years - Coinciding with the option period durations of the contract, the Contractor shall perform a complete physical inventory of all agents stored in the repository, at the mid-point and end of the option period (i.e., at the end of every 6-month period if option period duration is 12-months). For option period durations of less than 12-months, the frequency of the complete physical inventory shall be agreed upon with the COR, but shall at a minimum, occur at the end of the option period. Reports shall be submitted electronically within 15 calendar days following the end of the reporting period except for the final inventory which shall be included in the Final Report on the completion date of the contract.

3. Ad Hoc Inventory Report

The Contractor shall perform, and report limited, special inventory checks as requested by the COR to resolve inventory discrepancies on an as needed basis.

4. Monthly Progress Report

This report shall include a description of the activities during the reporting period, and the activities planned for the ensuing reporting period. This report shall include a summary of all aspects of agent receipt, distribution and return/destruction agent processes. The report shall include a description of all aspects of the repository operation that were not performed satisfactorily (e.g., error/incident reports). The report shall include analysis of problems and corrective action plans implemented. The report shall include printouts from temperature and humidity monitors from all storage areas and storage units. The report shall include a detailed tracking summary for the recyclable shipping container systems reportable on a monthly basis as well as cumulative basis indicating containers received from the vendor, used, returned for refurbishment and any still outstanding in the field yet to be returned for refurbishment. A physical inventory of each agent distributed during the month shall also be conducted on a rolling basis and reported monthly to the COR in the Monthly Progress Report. All individual agent inventories performed shall be submitted with the monthly report for the month in which the agent inventory is conducted. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month. Reports shall be submitted electronically within 10 calendar days following the end of the reporting period.

5. Annual Progress Report

This report shall include a summation of previously submitted monthly reports . This report shall include a report of the complete physical inventory of all agents held in the repository and summation of any inventory discrepancies noted, if present. Reports shall be submitted electronically within 15 calendar days following the end of the last month in the reporting period.

6. Final Report

This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to comprehensively describe the results achieved. The Final Report shall include a final physical inventory of all agents and summation of any inventory discrepancies noted, if present. The Final Report shall be submitted in accordance with the deliverables of this contract. A draft Final Report shall be submitted within 15 calendar days prior to the end of the contract for review and approval by the COR and Contracting Officer. Once approved, the Final Report shall be submitted on the completion date of the contract.

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7. Phase-in Transition Plan

The Contractor shall submit the final Phase-in plan to the COR and the Contracting Officer within 5 calendar days of the contract award. The plan shall include, but not be limited to, details on the receipt of transferred of files and documents and the transfer of agent inventory and Government-furnished equipment and supplies and plans for continuity of operations

8. Phase-out Transition Plan

The Contractor shall prepare and submit a Phase-out Plan to the COR and the Contracting Officer 120 calendar days prior to the completion date of the contract. The plan shall include, but not be limited to, details on the transfer of files and documents and the transfer of agent inventory and Government-furnished equipment and supplies and plans for continuity of operations.

9. Policies, Standard Operating Procedures and Work Instructions

The Contractor shall prepare written policies and SOPs and work instructions that govern operations of the facility and activities described in this Statement of Work. The policies, SOPs and work instructions shall cover areas including, but not limited to, operational, validation, quality and safety aspects of the work.

All final policies, procedures and work instructions shall be submitted in electronic pdf format and initially submitted within 60 days of contract award. Any new or updates to existing policies, procedures or work instructions shall be submitted within 30 days of implementation.

10. Shipping Container Validation or Qualification Reports

Qualification or validation reports for each shipping container used on the Contract shall be provided to the COR within 14 days of contract award and as use of any new shipping containers are implemented.

11. Personnel Training Documents for Handling and Disposal of Hazardous, Biohazardous, and Infectious Material.

Training for all personnel for the handling and disposal of hazardous, biohazardous and infectious materials shall be documented, and documentation provided to the COR within 14 days of contract award and as training renewals occur.

12. Certifications/Permits/Licenses

Copies of all applicable facility and personnel certifications, permits, and licenses required for the performance of the contract shall be provided to the COR prior to contract award and at the time of any renewal.

b. Other Reports/Deliverables

HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

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INFORMATION AND/OR PHYSICAL SECURITY

A. POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). To determine the designation, the Position Designation Tool (PDT) discussion is found at: https://www.ors.od.nih.gov/ser/dpsac/resources/Pages/investigation-requirements-for-your-position.aspx and the link to access the tool is found at: https://pdt.nbis.mil/

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

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

[ ] Tier 5SR: Reinvestigation.

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

[ ] Tier 4SR: Reinvestigation.

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

[ ] Tier 3SR: Reinvestigation.

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

[ ] Tier 2SR: Reinvestigation.

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

B. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

Roster-

The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to the COR and/ or CO within fourteen (14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted within seven (7) calendar days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at: https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

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

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

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

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

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

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

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

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

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

C. CONTRACT INITIATION AND EXPIRATION

a. General Security Requirements- The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the Contractor must follow the HHS EPLC framework and methodology or and in accordance with the HHS Contract Closeout Directive (2018) located at: https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/HHS-Closeout- Directive-2018.pdf. HHS EA requirements located at: https://www.hhs.gov/sites/default/files/eplc-policy-dec-2016.pdf and NIH EA requirements are located at: https://ocio.nih.gov/PM/Pages/EPLC.aspx.

b. System Documentation- Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals ( specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

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

d. Notification - 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.

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

f. Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) must afford the Government access to the Contractor's facilities, installations, operations, documentation, information systems, and personnel used in performance of this https://ocio.nih.gov/PM/Pages/EPLC.aspx

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

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

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

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

D. Reporting of New and Departing Employees

The Contractor shall provide a report of all new and departing employees within 5 days of the hiring of a new employee or within 5 days of the departure of an employee.

E. Return of Identification Badges

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

F. Employee Separation Checklist

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

G. Employee Non-Disclosure Agreement

Non-Disclosure Agreements for all Contractoremployees who may have access to non-public information shall be submitted priorto performing any work under the contract.

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H. Training Records

All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/NIH Contractor Information Security Awareness, Privacy, and Records Management training course at http://irtsectraining.nih.gov/ before performing any work under this contract. Thereafter, the employees shall complete NIH Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable NIH required trainings as informed by the COR. All training shall be completed by the assigned due date.

All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum. Read further guidance about the NIH Role-based Training https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/Pages/ rolebasedtraining.aspx

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

I. VPAT

The Contractor shall submit an annual VPAT in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The VPAT and Instructions. for completing the report are available at: https://www.itic.org/policy/accessibility/vpat. The applicable VPAT version is currently VPAT 2.4 REV 508 (March 16 2022), however, the Contractor is responsible for using the latest version of the VPAT form when submitting this report.

http://irtsectraining.nih.gov/ https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/Pages/rolebasedtraining.aspx https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/Pages/rolebasedtraining.aspx https://www.itic.org/policy/accessibility/vpat

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

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SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, Contracting Officer's Representative (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

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

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

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

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

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from February 1, 2023 through January 31, 2024.

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

Option Option Period Option Period 1 02/01/2024 – 01/31/2025

Option Period 2 02/01/2025 – 01/31/2026

Option Period 3 02/01/2026 – 01/31/2027

Option Period 4 02/01/2027 – 01/31/2028

ARTICLE F.2. DELIVERIES

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

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract:

Item Description Quantity Delivery Schedule

(1) Contract Pricing Table 1 Within 3-months of contract award and then annually in the Annual Progress Report.

(2) Physical Inventory Report 1 Day 1 and within 15 calendar days following each reporting period.

(3) Ad Hoc Inventory Report 1 At the request of the COR to resolve inventory discrepancies.

(4) Monthly Progress Report 1 Within 10 calendar days following each reporting period.

(5) Annual Progress Report 1 Within 15 calendar days following each reporting period.

(6) Draft Final Report and Final Report 1 Draft due 15 calendar days before the completion date of the contract. Final due on the completion date of the contract.

(7) Final Phase-In Transition Plan 1 Within 5 days of contract award. Phase-

In Execution to be completed within 60 days following award of the contract.

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Item Description Quantity Delivery Schedule

(8) Phase-out Transition Plan 1 120 calendar days prior to completion date of contract. Phase-out execution to be completed prior to the completion date of the contract.

(9) Policies, Standard Operating Procedures and Work Instructions

1 Within 60 days of contract award and within 30 days of implementation of new or updates to existing policies, procedures or work instructions.

(10) Shipping Container Validation or Qualification Reports 1 Within 14 days of contract award and at time of use of any new containers

(11) Personnel Training Documents for Handling and Disposal of Hazardous, Biohazardous, and Infectious Material.

1 Within 14 days of contract award and at subsequent intervals described by the Contractor’s SOPs.

(12) Certifications/Permits/Licenses 1 Within 14 days of contract award and at the time of any renewal.

(13) Annual VPAT 1 Draft 30 days prior to the end of each contract year. Final report due prior to the expiration of each Base or Option Phase

(14) Roster of Employees Requiring Suitability Investigations

1 The roster is due within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 7 calendar days of the change

(15) Reporting of New and Departing Employees

1 The notification shall occur within 5 working days of staffing changes.

(16) Return of Identification Badges All Within 7 calendar days after the Government’s final acceptance of the work under this contract, or upon termination of the contract

(17) Employee Separation Checklist 1 The Contractor (and/or any subcontractor) shall perform and document the actions identified in the NIH Contractor Employee Separation Checklist when an employee terminates work under this contract within

2 days of the employee's exit from the contract. All documentation shall be made available to the CO and/or COR upon request

(18) Contractor/Employee Non-

Disclosure Agreements 1 Non-Disclosure Agreements for all Contractor employees who may have access to non-public information shall be submitted prior to performing any work under the contract.

(19) Training Records 1 A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or as training occurs or upon request.

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

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Addressee Deliverable Item No. Electronically COR Pharmaceutical Management Branch

CTEP, DCTD, NCI

9609 Medical Center Drive

Room 5W228

Rockville, MD 20850

Items (1) – (19) TBD

Contracting Officer

Office of Acquisitions

National Cancer Institute

9609 Medical Center Drive

Rockville, MD 20850

Items (1) and (2), (4) – (8), (10), (13) – (15), (17) - (19)

TBD

ARTICLE F.3. LEVEL OF EFFORT

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

Labor Category Base Period Option Period 1

Option Period 2

Option Period 3 Option Period 4

Professional 11,280 11,280 11,280 11,280 11,280 Other Professional 13,485 13,485 13,485 13,485 13,485 Support 564 564 564 564 564 Total 25,329 25,329 25,329 25,329 25,329

Option for Increased Capacity

Labor Category Base Period

Option Period 1

Option Period 2

Option Period 3

Option Period 4

Professional 1,880 1,880 1,880 1,880 1,880

Other Professional 6,110 6,110 6,110 6,110 6,110

Total 7,990 7,990 7,990 7,990 7,990

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

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

- 19 -labor Hours furnished is less than the number of direct labor Hours specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is applicable to this contract.

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

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SECTION G - CONTRACT ADMINISTRATION DATA

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

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

To be specified prior to award

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

The 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

TBD Project Manager

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

FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-4 for NIH Cost- Reimbursement Type Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

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1. The Contractor shall submit 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- TBD Email Address- TBD

Contracting Officer Representative

Name- TBD Email Address- TBD

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

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

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

The Central Point of Distribution:

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

Invoices shall be submitted in accordance with Electronic Invoicing Instructions for NIH Contractors/ Vendors.

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…