RFP_NCI_IDIQ_ContractforGCCFinal.pdf

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

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

2. Request for Proposal (RFP) Number:

75N9102 R000

3. Issue Date:

, 2023

4. Set Aside:

[X] No [ ] Yes

5. Title :

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health

MD 2

7. SUBMIT OFFERS TO:

See Section 12.3, "INQUIRIES/SUBMISSION" of this Solicitation

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, " ," until 3:00 PM on

2 , 202 . 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 I ."

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/ .

FOR INFORMATION C :

PHONE: 4

MAIL: . @nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Any requests for additional information, questions and/or clarifications concerning this RFP must be submitted in writing to before 3:00 PM ET on 1, 202 with the subject line: Questions- RFP 75N9102 R000

Contracting Officer Office of Acquisitions

. @nih.gov

NCI IDIQ Contract for Genomic Characterization Support

Request for Proposal 75N91024R00001 Page 2

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-1 effective 14 November 2023. The associated North American Industrial Classification System (NAICS) code for this procurement is 541380- Testing Laboratories and Services; Size Standard if $19.0 M. This acquisition is being procured as Full and Open Competition.

Proposals for furnishing the supplies and/or services in this RFP will be received at the place specified in, and in the number of copies specified in Atachment 1, "eCPS Proposal Delivery Instruc�ons," un�l 3:00 PM Eastern Time (ET) on February 26, 2024. Offers will be valid for 120 days unless a different period is specified by the offeror on the Atachment en�tled, "Proposal Summary and Data Record, NIH 2043.”

The deadline for receipt of ques�ons is February 1, 2024 at 3:00 PM Eastern Time (ET) per the instruc�ons in Sec�on 12.3 Inquiries/Submission. Please include the RFP number in the subject line of your email with your submission.

SECTION 1 – TABLE OF CONTENTS

SECTION 1 – TABLE OF CONTENTS

SECTION 2 – SERVICES

SECTION 3 – STATEMENT OF WORK

SECTION 4 – PERFORMANCE AND REPORTS/DELIVERABLES

SECTION 5 – TASK ORDER ISSUANCE

SECTION 6 – CONTRACT ADMINISTRATION

SECTION 7 – INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

SECTION 8 – SPECIAL CONTRACT REQUIREMENTS

SECTION 9 – CLAUSES

SECTION 10 – LIST OF ATTACHMENTS

SECTION 11 – REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF

BIDDERS

SECTION 12 – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

SECTION 13 – EVALUATION FACTORS FOR AWARD

SECTION 2 – SERVICES

2.1 BRIEF DESCRIPTION OF SERVICES

The purpose of this contract is to acquire Genome Characterization Center (GCC) services consisting of large-scale, high- resolution, and comprehensive sequencing and array platforms.

The sequencing and array platforms include Whole Exome Sequencing (WES), Whole Genome Sequencing (WGS), Deep Sequencing Targeted Validation, and DNA Methylation Array; total RNA, messenger RNA (mRNA), and microRNA (miRNA); single-cell or spatial sequencing and other molecular sequencing platforms. These services are needed to acquire cancer genomics data for NCI projects.

2.2 TYPE OF CONTRACT

The contract type is a multiple award, Indefinite Delivery Indefinite Quantity (IDIQ) contract. It is anticipated that multiple awards, up to 16 across all four IDIQ Pools, will be made from this https://www.acquisition.gov/far/subpart-12.6#FAR_Subpart_12_6

Request for Proposal 75N91024R00001 Page 3 solicitation and that the awards will be made on/about 9/15/2024. It is anticipated that the awards from this solicitation will be Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts with a Period of Performance of five years. Firm Fixed price and or time and material type task orders may be issued, and funding will be obligated at the individual task order level.

2.3 SEVERABLE AND NONSEVERABLE SERVICES

The services specified in this IDIQ have been determined as severable or non-severable services.

For severable services funds are only available for use for the line item to which they are obligated. Unused funds from one period (line item) may not rollover for use in other periods.

Non-severable services are fully-funded at the time of award, and may include options for additional non-severable services.

2.4 TYPE OF ORDERS (IDIQ)

Task or Delivery Orders issued under this IDIQ shall be Firm Fixed Priced or Time and Materials.

2.5 MINIMUM GUARANTEE AND MAXIMUM CONTRACT VALUE

During the life of the IDIQ contract, the Government shall place a minimum order to cover the minimum guarantee of $2,010. This reflects the contract minimum for the entire period of performance. The contract maximum ceiling across all IDIQs, for a shared programmatic maximum ceiling of $149,974,285.

SECTION 3 – STATEMENT OF WORK

The Contractor shall furnish all of the necessary personnel, materials, services, facilities, (except as otherwise stated herein), and otherwise do all the things necessary for or incident to the performance of the work, as set forth below. The IDIQ Statement of Work (Attachment 3) dated 12/19/2023 is hereby incorporated in this Request for Proposal (RFP).

3.1 BACKGROUND

The Center for Cancer Genomics (CCG) at the National Cancer Institute (NCI) was established in 2011 with a mission to lead the NCI efforts in generating critical datasets required to catalog the genomic alterations in human tumors. CCG promotes genomic data sharing and the development of analytical tools and approaches to improve understanding of large-scale, multi-dimensional genomic data. The Government has a need to establish Genome Characterization Centers (GCC) to provide a centralized approach to conducting molecular profiling on the same cancer tissue. This will achieve the goals of optimal data integration and data comparability.

Please see the Project Background and History link for additional information.

3.2 SCOPE OF WORK

The Contractor shall provide:

The GCCs shall provide genomic sequencing or microarray pipelines to produce molecular data resources for the research community at large. These pipelines shall be conducted with validated methods using high-throughput and quality-controlled protocols. The Contractors selected shall receive analytes (such as DNA, RNA, or other types of samples) from the Biospecimen Processing Center (BPC) funded separately by NCI. The contractor(s) will run the pipelines with the received samples and generate high-quality raw sequencing and microarray data.

Request for Proposal 75N91024R00001 Page 4

The GCC contractors shall be responsible for the following tasks for all projects:

1) Receive biomaterial from Biospecimen Processing Center (BPC)

The contractors shall execute and maintain Material Transfer Agreements (MTAs) prior to receiving molecular analytes from BPC. If required locally, the contractor shall meet its local institutes' IRB requirements. The contractors shall develop Standard Operating Procedures (SOPs) for receiving and managing the biomaterial for the period of performance of the contract.

2) Operate genome characterization pipelines

Contractors shall possess and maintain the appropriate laboratory equipment and infrastructure to support the proposed pipelines for genome sequencing and array platforms. The proposed pipelines shall be able to work with molecular analytes extracted from both fresh frozen tissues and from formalin-fixed paraffin-embedded (FFPE) tissues.

The CCGs are intended as high-throughput facilities to support a large number of cases from NCI projects per year. In general, the contractor shall support pipelines with an operational capacity of at minimum 500 cases per year. The minimum operational capacity for specific platforms will be described in the individual task order SOWs.

The pipelines proposed by the contractor shall have prior validation in large-scale genomic programs such as The Cancer Genome Atlas (TCGA). Unless requested by the NCI Program Office, the contractor shall use widely adopted commercial off-the-shelf products in the proposed pipelines. There shall be sufficient studies and datasets to demonstrate the capabilities and validity of the proposed platforms. These datasets shall corroborate statistically by other validated technologies in published studies. For some projects, pipeline specifications and modifications of protocols shall be reviewed and pre-approved by the NCI’s Program Office.

Offerors shall submit proposals for the Base IDIQ Statement of Work (SOW) and for at least one pool as listed below in this section. Offerors are permitted but not required to respond to multiple pools.

Pool 1. High-throughput DNA Sequencing

Next-generation sequencing (NGS) offers ultra-high throughput, accurate, and cost-effective ways to analyze DNA samples. DNA sequencing technology produces large datasets of nucleotide sequences for entire genomes or targeted genomic regions. The sequencing results can be used in identifying cancer mutations, detecting familial cancer mutation carriers, and providing clues for effective and targeted treatments.

The Contractor shall process DNA analytes extracted from the tumor or normal tissues using approved technologies for high-throughput DNA Sequencing. Contractors shall perform genomic sequencing for provided molecular analytes. The genomic target requirements of DNA sequencing can range from targeted genes, the whole exome to the whole genome.

Pool 2. High-throughput RNA Sequencing

High-throughput RNA sequencing (RNA-seq) is a sequencing method for studying transcriptome and non-coding RNAs such as MicroRNAs (miRNAs). RNA sequencing data can be used in studies such as whole transcriptome analysis of differential gene expression and differential splicing of mRNAs.

Request for Proposal 75N91024R00001 Page 5

The Contractor shall process RNA analytes extracted from the tumor or normal tissues using approved technologies for high-throughput sequencing. Contractors shall generate RNA sequencing data for cancer transcriptome and non-coding RNA expression profiles.

Pool 3. Epigenomic Characterization with Sequencing-based Assays or Array-based Assays

Epigenomics involves the profiling and analysis of epigenetic marks across the genome.

The types of epigenomic characterization assays have expanded in recent years. The whole epigenome analysis can be carried out with array-based assays or sequencing-based assays.

The Contractor shall process biospecimens extracted from the tumor or normal tissues using approved technologies for high-throughput methylation sequencing or methylation arrays. Contractors shall generate raw methylation data for downstream analysis.

The Contractor shall process biospecimens extracted from the tumor or normal tissues using approved technologies to study chromatin accessibility across the genome.

Contractors shall generate molecular data for ATAC-seq (Assay for Transposase- Accessible Chromatin with high-throughput sequencing).

Pool 4. Single-Cell/Spatial Characterization

Single-cell/Spatial platforms have made significant advances. Different types of sequencing technologies such as DNA-seq, RNA-seq, Methylation-Seq, and ATAC-seq have been developed for single cell or spatial studies in the context of tumor microenvironment. These applications help to tackle problems such as tumor heterogeneity and cell sub-population characterization with a high resolution not available with bulk sequencing methods.

The Contractor shall process biospecimens of tumor tissues or tumor cells using approved technologies for high-throughput single-cell or spatial studies. Contractors shall generate molecular data for genomes, epigenomes, transcriptomes or other omics on the level of individual cells.

3) Improve performance of pipelines

Contractors shall describe a process to continue evaluating the proposed technology and upgrade to more advanced technologies when properly validated. In general, improvements/optimization efforts shall include, but are not limited to:

• Enhancing detection of molecular abnormalities by improving accuracy, sensitivity and/or resolution

• Increasing pipeline throughput

• Optimizing genome coverage

• Obtaining high-quality data sets from low quantity analytes

• Reducing unit costs per samples

4) Implement quality control procedures

Contractors shall propose specific quality assurance criteria and quality control procedures to ensure and monitor the data quality from characterization pipelines. Contractors shall

Request for Proposal 75N91024R00001 Page 6 monitor, identify and take steps to mitigate sources of systematic error and bias to improve experimental reproducibility.

5) Support Informatics and Data Delivery

Public sharing of data is critical to facilitate discoveries of clinical significance. Data produced by GCCs shall be transmitted into NCI Genomic Data Commons (GDC) as soon as they are validated, in general within four weeks of generation. GCCs shall submit primary data and metadata to GDC by adapting their submission process to meet the submission requirements of GDC.

Contractors shall submit a Data Sharing Plan documenting how data will be released and shared. The Data Sharing Plan must be consistent with the goals of CCG and NCI research programs, with adherence to NCI and NIH data-sharing policies (https://datascience.cancer.gov/data-sharing, https://sharing.nih.gov).

6) Conduct transition activities

The Contractor shall:

1. Prepare a transition-in plan to outline processes for the commencement of operations, including the scale-up of staffing (including key personnel) and operational resources as well as the incorporation of data, SOPs, materials, and other transition information.

2. Prepare a close-out transition plan for the end of the contract. The plan shall include mechanisms to transmit data and materials to parties designated by the Contracting Officers as contractually obligated.

7) Ramp On

As stated above, contractors may propose on one or more of the IDIQ pools below, if they can accomplish each of the unique platforms under that specific pool. NCI has elected to include a process to add new contractors to the multiple award IDIQ pools. This process is called “Ramp On.” This process can be utilized at the discretion of the Government when a task need cannot be satisfied by current contract holders. The "Ramp On" period can be announced at any time during the effective period of performance of the IDIQ base awards, but no earlier than annually from the date of the award.

A. Meetings and Communications

The Offeror shall participate in regular communications with the program office such as biweekly regular teleconferencing calls and monthly operation reports.

SECTION 4 – PERFORMANCE AND REPORTS/DELIVERABLES

4.1 PERIOD OF PERFORMANCE

4.1.1. The period of performance for this IDIQ contract shall be five (5) years from 09/15/2024

– 09/14/2029.

4.1.2. Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order.

The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make https://datascience.cancer.gov/data-sharing https://sharing.nih.gov/

Request for Proposal 75N91024R00001 Page 7 any deliveries under this contract after a period of five years following completion of the Base IDIQ contract end date.

4.2 PLACE OF PERFORMANCE

Work shall be performed at the Contractor’s facility, except for meetings/trainings as specified in the individual Task Orders (if/when applicable).

4.3 REPORTS/DELIVERABLES

All reports/deliverables required herein shall be submitted in electronic format via email as attachments to the following designated NCI Distribution Mailbox:

ncibranchcinvoices@mail.nih.gov .

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

The subject line of the email should read as follows:

Deliverable Name_Contract Number_vendor’s Name_Due Date

Note: Each email submission shall contain only one (1) deliverable. If the attached file for the deliverable exceeds 50 MB, the contractor shall divide the deliverable into 50 MB each. All deliverables should be limited to (five) file attachments or less. We understand that in some cases more than five (5) attachments may be necessary.

All data transfer of PII or sensitive information to the NCI is to be encrypted.

4.3.1 REPORTS/DELIVERABLES

4.3.1.1 Technical Progress Reports: In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation.

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 prior to contract award. Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from tis NIH funded research.

For proposal preparation purposes only, these reports will be required as follows:

- Monthly

- Quarterly

- Annually

- Final – Upon final completion of the contract (with a requirement for a Draft

Final Report)

4.3.1.2 Other Reports/Deliverables:

1. Controlled Unclassified Information (CUI) System Security Plan (SSP) - due within 60 days after contract award. The SSP shall comply with the NIST SP 800-171 Rev2, mailto:ncibranchcinvoices@mail.nih.gov https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents

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Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations https://csrc.nist.gov/publications/detail/sp/800-171/rev-2/final. The SSP shall be consistent with and detail the CUI Plan of Action template https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev- 2/final/documents/CUI-SSP-Template-final.docx. The SSP shall provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP at least annually thereafter.

2. Controlled Unclassified Information (CUI) Security Assessment Plan of Action (POA) - due 90 days after the contract award. The security assessment shall be conducted by the assessor and be consistent with NIST SP 800-171 Rev2, Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations (https://csrc.nist.gov/publications/detail/sp/800-171/rev-2/final). The Assessor will supply a plan of action report using the CUI Plan of Action template https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev- 2/final/documents/CUI-Plan-of-Action-Template-final.docx outlining failed controls from the assessment and plans for remediation.

4.3.2. INSPECTION AND ACCEPTANCE

Pursuant to FAR clause 52.212-4, all work described in Section 3 to be delivered under this contract is subject to final inspection and acceptance by an authorized representative of the Government. Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the Contracting Officer’s Representative (COR) within 30 days of receipt.

4.4 DELIVERY SCHEDULE

The submission of deliverables is set forth in the Delivery schedule below, unless otherwise agreed to by the Contracting Officer (CO).

Item Description

Delivery Schedule

(1) Monthly Progress Report Due on or before the 15th calendar day following the end of the reporting period. Monthly reports will not be due when Quarterly reports are required.

(2) Quarterly Progress Report Due 15 calendar days after the end of each reporting period, unless an annual task order report is due during the reporting period.

(3) Annual Progress Report Due annually on/before the anniversary date of the contract.

(4) Final Report Due on or before the expiration date of the contract.

https://csrc.nist.gov/publications/detail/sp/800-171/rev-2/final https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-SSP-Template-final.docx https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-SSP-Template-final.docx https://csrc.nist.gov/publications/detail/sp/800-171/rev-2/final https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-Plan-of-Action-Template-final.docx https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-Plan-of-Action-Template-final.docx

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The above items shall be addressed and delivered to:

Addressee Deliverable Item No. Quantity Contracting Officer’s Representative (COR)

Items (1) through 11 1 electronic copy

Contracting Officer (CO) Items (1) through 11 1 electronic copy NCI Branch C Invoice Inbox ncibranchcinvoices@mail.nih.gov

Items (1) through 11 1 electronic copy

SECTION 5 – TASK ORDERS ISSUANCE

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

5.1 GENERAL

Only an NCI, Office of Acquisitions, Contracting Officer may issue Task Orders against this IDIQ contract, providing the work is within the scope of the IDIQ Statement of Work, in accordance with the procedures outlined below. The Contractor shall not commence work until a fully executed Task Order has been awarded.

Task Orders under Multiple Award Indefinite Delivery Contracts

The Contractor will be required to provide services under the resultant contract only in performance of task orders and modifications to task orders signed by the Contracting Officer.

Costs not attributed to the performance of a specific task order shall not be allowed without the prior written consent of the Contracting Officer. The Contractor will commence performance upon the receipt of a Task Order signed by the Contracting Officer. Costs for the preparation of Task Order proposals shall not be reimbursed as a direct cost under the resultant contract. One or more task orders may be issued during the performance period of the resultant contract. If a contractor responds to a Task Order Request for Proposal (TORFP) and is the successful offeror, that

(5) Roster of Employees Requiring Suitability Investigations

Due within 14 calendar days after the effective date of the contract, and any revisions to the roster as a result of staffing changes shall be submitted within 7 calendar days of the change.

(6) Contractor-Employee Non-Disclosure Agreements

Due prior to performing work under the contract. New staff shall complete prior to performing work under the contract.

(7) Controlled Unclassified Information (CUI) System Security Plan (SSP)

Due 60 days after contract award.

(8) Controlled Unclassified Information (CUI) Plan of Action & Milestones (POA&M)

Due 90 days after contract award.

(9) Training Certificates from NIH IT Security Awareness Courses

Due 30 days after contract award and annually thereafter, or upon request.

(10) Rules of Behavior Due at the beginning of the base contract and at least annually thereafter.

(11) Section 508 Due annually on/before the anniversary date of the contract.

mailto:ncibranchcinvoices@mail.nih.gov

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Contractor will be required to accept and perform the task order issued by the Contracting Officer within the scope of the resultant contract. The government has no obligation to issue any task orders, beyond the minimum identified in SECTION B of the contract. In the event of any inconsistency between any task order and the contract, the contract shall control. In accordance with the Federal Acquisition Streamlining Act, the Contracting Officer will provide each Contractor a "Fair Opportunity" to be considered for each Task Order awarded in excess of $3,000, unless one of the conditions in FAR 16.505(b)(2) applies. The competition requirements in FAR Part 6, and the policies in FAR Subpart 15.3, DO NOT APPLY to the task ordering process. For each requirement under the resultant contract, the government intends to provide each Contractor a fair opportunity for consideration of a task order. The Contracting Officer shall:

1. Issue a notice of intent to award a task order for services to all resultant Contractors within a technical area covered by the task order requirement. To satisfy the requirement, the Contracting Officer will provide an email notifying all qualified Contractors of the requirement.

The email will identify how the details concerning the requirement, including a description of the work and selection criteria, will be provided, i.e. attached to the email, posted on a website. Contractors will be asked to submit a response to the notice of intent, advising the government of their intent to submit a proposal or quote;

2. Afford all Contractors, within the technical area covered by the task order requirement, who are responding to the notice, a fair opportunity to submit an offer and have that offer fairly considered;

3. Consider price and cost under each order as one of the factors in the selection decision;

4. Keep submission requirements to a minimum;

5. Consider past performance on earlier task orders under this contract to the maximum extent possible. Past performance considerations shall include, but not be limited to, the Contractor’s performance regarding completeness, accuracy, clarity, timeliness and cost control. If a Contractor has no past performance on any earlier task order, past performance will be considered through other sources, such as the Contractor’s original proposal.

In addition to the above, for all orders exceeding $5 million, the Contracting Officer will consider all requirements set forth in FAR 16.505(b)(1)(iv).

5.2 REQUESTING TASK ORDER PROPOSALS

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

Generally, the 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;

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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 in 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.

5.3 Evaluation and Award of Task Order Proposals

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

Upon completion of evaluations, the Contracting Officer will issue a task order to the Contractor whose proposal is most advantageous to the government.

The Contracting Officer will notify the IDIQ Contractors) of the selection decision in writing.

B. Fair Opportunity

1. In accordance with FAR 16.505(b)(1)(i), each awardee will be given a fair opportunity to be considered for each order issued exceeding the micro-purchase threshold issued under multiple delivery-order contracts or multiple task-order contracts, except:

i. The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

ii. Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

iii. The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

iv. It is necessary to place an order to satisfy a minimum guarantee.

2. All awardees will be given a fair opportunity to be considered in accordance with the FAR as follows:

i. For orders exceeding the micro-purchase threshold up to the simplified acquisition threshold, in accordance with FAR 16.505(b)(1)(ii);

ii. For orders exceeding the simplified acquisition threshold up to $6 Million, in accordance with 16.505(b)(1)(iii); and,

iii. For orders exceeding $6 Million, in accordance with FAR 16.505(b)(1)(iv).

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C. Commitment of Public Funds The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed procurement. Any other commitment, either explicit or implied, is invalid.

D. Communications Prior to Contract Award Offeror shall direct all communications to the attention of the Contract Specialist or Contracting Officer cited on the face page of this SOLICITATIONS. Communications with other officials may compromise the competitiveness of this acquisition and result in cancellation of the requirement.

E. Release of Information Contract selection and award information will be disclosed to offerors in accordance with regulations applicable to negotiated acquisition. Prompt written notice will be given to unsuccessful offerors as they are eliminated from the competition, and to all offerors following award.

F. Preparation Costs This RFP does not commit the Government to pay or the preparation and submission of a proposal.

G. Service of Protest (FAR 52.233-2 (Sep 2006)

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Contracting Officer Office of Acquisitions Riverside Five 8490 Progress Drive Room 4031 Frederick, MD, 21701

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

5.4 TASK ORDER INFORMATION (IDIQ)

Each task order will contain the following minimum information:

a) Date of award;

b) Contract number and task order number;

c) Total dollar amount of the task order;

d) Statement of Work, Schedule of Deliverables and any special instructions;

e) Period of performance;

f) Task Order specific clauses;

g) Task Order COR.

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The Contractor shall submit separate invoices for each task order.

SECTION 6 – CONTRACT ADMINISTRATION

6.1 CONTRACTING OFFICER’S REPRESENTATIVE (COR) AUTHORITY

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

IDIQ COR: To be completed upon award Task Order COR: To be identified at the Task Order level.

The Government may unilaterally change its COR designation.

6.1.1 The COR is responsible for: a) Monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; b) Interpreting the statement of work and any other technical performance requirements; c) Performing technical evaluations as required; d) Performing technical inspections and acceptances required by this contract;

and e) Assisting in the resolution of technical problems encountered during performance.

6.1.2 The Contracting Officer’s Representative does not have authority to issue technical direction that: a) Constitutes a change of assignment or additional work outside the specification(s)/statement of work; b) Constitutes a change as defined in the clause entitled “Changes”; c) In any manner causes an increase or decrease in the contract price, or the time required for contract performance; d) Changes any of the terms, conditions, or specification(s)/work statement of the contract; e) Interferes with the contractor's right to perform under the terms and conditions of the contract; or f) directs, supervises or otherwise controls the actions of the actions of the contractor's employees.

6.1.3 The Contracting Officer is the only person with authority to act as an agent of the Government under this contract. Only the Contracting Officer has authority to: a) direct or negotiate any changes in the statement of work; b) modify or extend the period of performance; c) change the delivery schedule; d) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; e) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements.

6.1.4 Technical direction may be oral or in writing and must be within the scope of the specification(s)/work statement. The Contracting Officer’s Representative shall confirm oral direction in writing within five working days, with a copy to the Contracting Officer.

6.1.5 The contractor shall proceed promptly with performance resulting from the technical direction issued by the Contracting Officer’s Representative unless, in the opinion of the contractor, any direction of the Contracting Officer’s Representative, or his/her designee, falls within the limitations in 6.1.2 above. In such cases, the contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government working day.

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6.1.6 Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled “Disputes.”

6.2 CONTRACT ADMINISTRATION

Notwithstanding the Contractor’s responsibility for total management during the performance of this IDIQ and Task Orders (TO) issued, the administration of the TO will require coordination between the Government and the Contractor. The following individuals will be the Government’s points of contact during the performance of the IDIQ and TO’s.

6.2.1 Government Contracting Official

All communications pertaining to contractual and/or administrative matters under the IDIQ and Task Order’s issued shall be sent to the attention of:

TBD, Contracting Officer Email: to be completed upon award

6.3 CONTRACTOR PERFORMANCE EVALUATION (S)

6.3.1 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 on the anniversary date of each task order.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

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

6.3.2 Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address: https://www.cpars.gov

6.4 INVOICE SUBMISSION AND PAYMENT PROVISIONS – COMMERCIAL (IDIQ)

https://www.cpars.gov/

Request for Proposal 75N91024R00001 Page 15

Invoice Instructions for NIH Fixed-Price Type Contracts, NIH(RC)-2 and Invoice and Payment Provisions (Vendor has transitioned to IPP), 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.

6.4.1 INVOICE REQUIREMENTS

i. The Contractor must submit invoices to the Department of Treasury's Invoice

Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below.

The Contractor must submit a copy of the electronic invoice to the following Approving Official (Contracting Officer),Contracting Officer Representative and Program email box:

a. Approving Official: Contracting Officer

Name TBD Email Address- TBD

b. Contracting Officer Representative

Name- TBD Email Address- TBD

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

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

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

NCI Central Point of Distribution: NCI OA Branch C - ncibranchcinvoices@mail.nih.gov

Invoices must be submitted in accordance with Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment to this solicitation.

The Contractor shall submit an electronic copy of the payment request to the Central Point of Distribution mailbox. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats:

MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.

ii. In addition to the requirements specified in FAR 32.905 for a proper invoice, the

Contractor must include the following information on the face page of all payment https://www.ipp.gov/ mailto:OFM%20Customer%20Service mailto:ofm_customer_service@mail-cmp.niceincontact.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx https://ofm.od.nih.gov/Pages/Customer-Service.aspx mailto:ncibranchcinvoices@mail.nih.gov https://oamp.od.nih.gov/sites/default/files/DGS/Invoicing%20Instructions%20With%20IPP%203-23.pdf https://oamp.od.nih.gov/sites/default/files/DGS/Invoicing%20Instructions%20With%20IPP%203-23.pdf

Request for Proposal 75N91024R00001 Page 16 requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is National Cancer Institute.

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract.

[Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, 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 must identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract.

[Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.

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

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

f. The Contract Title is: NCI IDIQ Contract for Genomic Characterization Support

g. Task Order Title: To be Identified at the Task Order Level.

h. Contract Line Items as follows: (will be identified at the Task Order level)

Line Item # Line Item Description

6.4.2 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS,

FAR 52.232-40 (March 2023)

a) 1. In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801, within 15 days after receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to

Request for Proposal 75N91024R00001 Page 17 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

2. The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the 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 products or commercial services.

SECTION 7 – INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

7.1 BASELINE SECURITY REQUIREMENTS

7.1.1 Applicability. The requirements herein apply whether the entire contract or order

(hereafter "contract"), or portion thereof, includes either or both of the following:

i. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have routine physical (entry) or logical (electronic) access to government information.

ii. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

7.1.2 Safeguarding Information and Information Systems- All government information and information systems must be protected in accordance with HHS/NIH policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

1. Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

2. Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

Request for Proposal 75N91024R00001 Page 18

3. Availability, which means ensuring timely and reliable access to and use of information.

ii. Categorize all information owned and/or collected/managed on behalf of

HHS/NIH and information systems that store, process, and/or transmit HHS information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II:

Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories . Based on information provided by the ISSO, CISO, OpDiv SOP, or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

Confidentiality: [ x ] Low [ ] Moderate [ ] High Integrity: [ ] Low [ x ] Moderate [ ] High Availability: [ x] Low [ ] Moderate [ ] High Overall Risk Level: [ ] Low [ x ] Moderate [ ] High

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of HHS/NIH regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s).

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the HHS/NIH Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain all applicable security and privacy policies by contacting the CO/COR or HHS/NIH security and/or privacy officials.

7.1.3 Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

7.1.4 Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable HHS/OpDiv privacy policies, and complete all the requirements below:

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (PII), is "information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother's maiden name, biometric records, etc.

ii. Based on information provided by the ISSO, system/ data owner, or other security or privacy representative, it has been determined that this solicitation/ contract involves:

http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

Request for Proposal 75N91024R00001 Page 19

[X] No PII [ ] PII

iii. The Contractor must support the agency with conducting a Privacy Threshold

Analysis (PTA) for the information system and/ or information handled under this contract to determine whether or not a full Privacy Impact Assessment (PIA) needs to be completed.

• If the results of the PTA show that a full PIA is needed, the Contractor must support the agency with completing a PIA for the system or information within 60 days after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E- Government Act of 2002.

• The Contractor must support the agency in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

7.1.5 Controlled Unclassified Information (CUI) Executive Order 13556 defines - CUI as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information."

The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term " handling " refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed.

Reg.