Sol_75N91024R00009.pdf

75N91024R00009

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 185

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

H

G

F

E

D

C

B

A

SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 3304 (a) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

11/26/2024 X

NCI-EXEC

National Institutes of Health National Cancer Institute Bethesda, MD 20892-7511

1400 ES 01/06/2025

ANTOINETTE C ROBINSON +12 23

antoinette.robinson@nih.g ov402-7658

X

X

X

X

X

X

X

X

X

X

X

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PAGE(S)

KARINA A. PETERSON

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (REV. 6/2014)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____0_________ calendar days (60 calendar days unless a different period is inserted

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 185

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75N91024R00009

(A) (B) (C) (D) (E) (F)

Period of Performance: 09/16/2025 to 09/15/2030

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

SOLCITATION

SECTION A – SOLICITATION/CONTRACT FORM

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

2. Request for Proposal (RFP) Number:

75N91024R00009

3. Issue Date:

November 26, 2024

4. Set Aside:

[X] No [ ] Yes See Part IV Section L

5. Title: Biomedical Data Computing Support Services

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 31 Center Dr., 11A35P Bethesda, MD 20892

7. SUBMIT OFFERS TO:

See ATTACHMENT 1 -, "Packaging and Delivery of Proposals for Use with the NIH eCPS website”.

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 Proposals (eCPS)," until 2:00PM local time on January 6, 2025. Offers will be valid for 120 days unless a different period is specified by the offeror on Attachment 14 entitled, "Proposal Summary NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF PROPOSALS (eCPS)." 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 OF THIS

SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) at the time of offer submission and 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: Antoinette Robinson

PHONE: 240-276-5823

e-MAIL: antoinette.robinson@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Questions related to this RFP shall be made in writing and submitted to the Contract Specialist, Antoinette Robinson, at antoinette.robinson@nih.gov no later than 2:00PM EST on December 10, 2024, with the subject line RFP 75N91024R00009.

Secondary Point of Contact Michael Welsh, Contracting Officer Office of Acquisitions, National Cancer Institute welshmi@mail.nih.gov https://www.sam.gov/SAM/ mailto:antoinette.robinson@nih.gov mailto:welshmi@mail.nih.gov

Table of Contents

Part I – THE SCHEDULE

SECTION B

SECTION C

SECTION D

SECTION E

SECTION F

SECTION G

SECTION H

Part II – CONTRACT CLAUSES

SECTION I

Part III – LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J

Part IV – REPRESENTATIONS AND INSTRUCTIONS

SECTION K

SECTION L

SECTION M

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 National Institutes of Health (NIH) National Cancer Institute (NCI) Division of Cancer Epidemiology and Genetics (DCEG) conducts broad-based, high quality, high impact research to uncover the causes of cancer and the means of its prevention.

DCEG maintains a national and international perspective, giving priority to emergent issues identified through epidemiologic, clinical, and laboratory observations, as well as to public health concerns identified by the NCI, Congress, regulatory agencies, and other appropriate bodies. The Division develops research resources and strategic partnerships in molecular epidemiology across NCI, NIH, and the global research community.

The goal of this acquisition is to identify biomedical data computing services in support of the ongoing research programs conducted in DCEG and other divisions of the NCI. DCEG programs include domestic and international studies with diverse study designs in epidemiology and genetics research including prospective cohort studies, case-control studies, family studies, and randomized clinical trials. These studies span several geographic areas (potentially in any continent), are of varying size and complexity, and include dense, high-dimensional data on exposures, endpoints, clinical information, and biomarkers from molecular technologies.

ARTICLE B.2. PRICES/COSTS

a. This is a Multiple Award Indefinite Quantity contract as contemplated by FAR 16.504. The

Contractor shall be reimbursed by the Government in an amount not less than a total of $3,000 (minimum) nor more than a total of $147,000,000 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract period 09/16/2025 through 09/15/2030, with one 5-year option from 09/16/2030 through 09/15/2035.

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

d. Ordering procedures are described in The TASK ORDER PROCEDURE Article in SECTION G of this contract.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

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

ARTICLE B.4. ADVANCE UNDERSTANDINGS

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

This is a parent indefinite delivery award. HHSAR 352.232-71 applies to all task/delivery orders issued under this award.

ARTICLE B.5. RAMP-ON

The Contracting Officer will periodically review the total number of Contractors under this Multiple Award IDIQ contract to ensure adequate competition for task orders throughout the period of performance. Over time, the total number of Contractors may fluctuate for various reasons including but not limited to: advancement in the biomedical data computing services and changes in technology and market conditions.

If the Contracting Officer determines that it is in the best interest of the Government to open the Multiple Award IDIQ contract to new Contractors, the Contracting Officer has the discretion to announce an open season at any time during the effective period of the base contract but no earlier than one year from date of award.

The Contracting Officer will announce this open season by publishing a notice on www.SAM.gov. The open season will be subject to applicable federal procurement laws and guidance at the time the open season is announced. The Open Season announcement will provide an estimate of the number of new awards that the Contracting Officer intends to make. Under the Open Season, the Contracting Officer will issue a solicitation. Any offeror meeting the eligibility requirements identified in the new "ramp on" solicitation may submit a proposal in response to the solicitation.

However, the Contracting Officer has the discretion to award more or fewer contracts than the number anticipated in the solicitation depending upon the quality of the offers received.

Any resulting contracts awarded under this provision will not exceed the remaining period of performance of the existing Multiple Award IDIQ contract. Any Contractor receiving a contract under this open season will be eligible to compete on future task orders with the same rights and obligations of any other Contractor.

http://www.sam.gov./

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 October 1, 2024, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. STATEMENT OF WORK – PRIVACY ACT

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.3. 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.

Each email submission shall contain only one deliverable. If the attached files for the deliverable exceed 50MB, the contractor shall divide the deliverable into files of 50MB 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_ Task Order Number_ Vendor'sName_Deliverable Description_Due Date.

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

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

Checklists to ensure appropriate formatting can be found at HHS Section 508 Accessibility Checklists. Document or document-type specific testing shall serve in lieu of the Section 508 Annual Report for Vendors, which is located at https://www.itic.org/policy/accessibility/vpat. In addition, we refer the offerors to the mailto:ncibrancheinvoices@mail.nih.gov http://www.hhs.gov/web/508/index.html http://www.itic.org/policy/accessibility/vpat following two GSA Section 508 pages for guidance on developing electronic documents for accessibility and Section 508-conformance:

GSA Section508.gov. Best Practices. https://www.section508.gov/best-practices GSA Section508.gov. Create Accessible Electronic Documents https://www.section508.gov/content/buiId/createaccessible-documents

The offeror shall use the relevant or respective checklist as a Section 508 report for each document it submits per filetype (e.g., Microsoft Word, Microsoft Excel, PDF, etc.)

at the end of the year, in lieu of the Section 508 Annual Report for Vendors.

Deliverables required for Task Orders may include:

A. 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 Task Order award.

1. Monthly Task Order Progress Reports

Reports should include status updates of all projects within the period-of-performance, as well as the corresponding costs related to those tasks. Data elements that may be required include, but are not limited to, project codes, descriptions of services rendered, requestor name, hours billed for each activity, and total amount. Monthly reports are not due when the Annual Report is due.

2. Annual Task Order Progress Report

Shall include a summary of the monthly task order progress reports.

3. Final Task Order Report

Report shall include the work performed and the results obtained for the entire task order period of performance. The report shall be in sufficient detail to describe comprehensively the results achieved.

4. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

http://www.section508.gov/best-practices http://www.section508.gov/content/bui

5. and 6. Transition In Plan

In the event of a new contractor, the Contractor shall ensure the orderly, efficient, and safe transition of all contract activities and materials within three (3) months of the inception of the contract.

a. Draft Transition In Plan The Contractor shall deliver to the COR a Draft Initial Transition In Plan within fourteen (14) calendar days of the contract effective date.

b. Final Transition In Plan The Contractor shall deliver to the COR a Final Initial Transition Plan no later than two (2) weeks after receipt of COR comments.

7. and 8. Transition Out Plan

When the contract ends, the Contractor shall ensure the orderly, efficient, and smooth transition of all contract and materials.

a. Draft Transition Out Plan

A Draft Final Transition Out Plan shall be submitted to the COR and Contracting Officer five (5) months prior to the completion date of the contract.

b. Final Transition Out Plan A Final Transition Out Plan shall be submitted to the COR and Contracting Officer no later than three (3) months prior to the completion date of the contract.

B. OTHER REPORTS/DELIVERABLES

9. Kick-Off Meeting Presentation

a. Deliver a Power Point presentation providing a corporate overview with organizational structure and points of contact.

b. Within the same presentation, or as an addendum, provide a summary of capabilities, including a menu of services offered. Summary should include labor categories required and corresponding rates for each service as applicable to each of the Task Areas, as well as a description of the infrastructure and methods for data retention and documentation.

10. Source Code and Object Code

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

11. Documentation

Includes methods, coding and version control for analytic services rendered.

ARTICLE C.4. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS (C002.04.04)

INFORMATION AND/OR PHYSICAL SECURITY

A. Assessment and Authorization (A&A)- A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) must work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within three (3) months after contract award. The Contractor must conduct the A&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

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

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

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

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

D. Security Assessment Plan/Report (SAP/SAR) - due 30 days after the contract award. The security assessment must be conducted by the assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and NIH policies. The assessor will document the assessment results in the SAR.

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

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

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

F. Plan of Actions and Milestones (POA&M) - due 30 days after contract award. The

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

• Critical within 30 days;

• High within 60 days;

• Medium within 1 year; and

• Low within 1 year.

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

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

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

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

I. POSITION SENSITIVITY DESIGNATIONS

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

https://pdt.nbis.mil/ .

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

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

[ ] Tier 5SR: Reinvestigation.

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

[ ] Tier 4SR: Reinvestigation.

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

[ ] Tier 3SR: Reinvestigation.

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

[X ] Tier 2SR: Reinvestigation.

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

J. 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.

https://ors.od.nih.gov/ser/dpsac/administrators/onboarding-new-staff/Pages/position-designation-tool.aspx https://ors.od.nih.gov/ser/dpsac/administrators/onboarding-new-staff/Pages/position-designation-tool.aspx https://pdt.nbis.mil/ 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

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

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

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

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

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

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

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

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

K. 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/ https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/HHS-Closeout-Directive-2018.pdf https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/HHS-Closeout-Directive-2018.pdf https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/HHS-Closeout-Directive-2018.pdf https://www.hhs.gov/sites/default/files/eplc-policy-dec-2016.pdf https://www.hhs.gov/sites/default/files/eplc-policy-dec-2016.pdf https://ocio.nih.gov/PM/Pages/EPLC.aspx https://ocio.nih.gov/PM/Pages/EPLC.aspx 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 Contractor (and/ or any subcontractors) must return all government information and IT resources ( i.e., government information in non- government- owned systems, media, and backup systems) acquired during the term of this contract to the CO and/ or COR. Additionally, the Contractor must provide a certification that all government information has been 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. The Contractor ( and/or any subcontractor) must perform and document the actions identified in the NIH Contractor Employee Separation Checklist https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf when an employee terminates work under this contract within 2 days of the employee's exit from the contract. All documentation must be made available to the CO and/ or COR upon request.

g. Contractor Non- Disclosure Agreement (NDA)- Each Contractor ( and/ or any subcontractor) employee having access to non- public government information under this contract shall complete the NIH non- disclosure agreement: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA must be submitted to the Contracting Officer ( CO) and/ or CO Representative ( COR) prior to performing any work under this acquisition.

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

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

i. At any tier handling or accessing information, consent to and allow the Government, or an independent third party working at the Government's direction, without notice at any time during a weekday during regular business hours contractor local time, to access contractor and subcontractor installations, facilities, infrastructure, data centers, equipment (including but not limited to all servers, computing devices, and portable media), operations, documentation (whether in electronic, paper, or other forms), databases, and personnel which are used in performance of the contract. The Government includes but is not limited to the U.S. Department of Justice, U.S. Government Accountability Office, and the HHS Office of the Inspector General (OIG). The purpose of the access is to facilitate performance inspections and reviews, security and compliance audits, and law enforcement investigations. For security audits, the audit may include but not be limited to such items as https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf 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.

ARTICLE C.5. INVENTION REPORTING REQUIREMENT (C003.00.00)

All reports and documentation required by FAR Clause 52.227-11, Patent Rights- Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The first annual utilization report shall be due on or before TBD with each task order. Thereafter, reports shall be due on or before the TBD Calendar day following the reporting period. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following email address:

Contracting Officer Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive Bethesda, Maryland 20892-9705 ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov

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

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of lnteragency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected.

Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov ), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

http://www.iedison.gov/

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.

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, the Contracting Officer’s Representative for each task order is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Cancer Institute Division of Cancer Epidemiology and Genetics 9609 Medical Center Drive Bethesda, MD 20892-9765

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 52.246-7, Inspection of Research and Development - Fixed Price (August 1996)

FAR Clause 52.246-8, Inspection of Research and Development - Cost- Reimbursement (May 2001)

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from 09/16/2025 through 09/15/2030.

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 09/16/2030 – 09/15/2035

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 electronically as identified at the Task Order Level, 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 Delivery Schedule

Technical Progress Reports

(1) Monthly Task Order Progress Reports Defined at Task Order Level

(2) Annual Task Order Progress Reports Defined at Task Order Level

(3) Final Task Order Report Defined at Task Order Level

(4) Summary of Salient Results Defined at Task Order Level

(5) Draft Transition In Plan Defined at Task Order Level

(6) Final Transition In Plan Defined at Task Order Level

(7) Draft Transition Out Plan Defined at Task Order Level

(8) Final Transition Out Plan Defined at Task Order Level

Other Reports/Deliverables

(9) Kick-Off Meeting Presentation Defined at Task Order Level

(10) Source Code and Object Code Defined at Task Order Level

(11) Documentation Defined at Task Order Level

Item Description Delivery Schedule

Information and Physical Security Deliverables

(12) A&A Package Deliverables Defined at Task Order Level

(13) Systems Security Plan (SSP) Defined at Task Order Level

(14) Security Assessment Plan/Report (SAP/SAR) Defined at Task Order Level

(15) Independent Assessment Defined at Task Order Level

(16) Plan of Action & Milestones (POA&M) Defined at Task Order Level

(17) Contingency Plan and Contingency Plan Test

Defined at Task Order Level

(18) E-Authentication Questionnaire Defined at Task Order Level

(19) Roster of Employees Requiring Suitability Investigations

Defined at Task Order Level

(20) System Documentation Defined at Task Order Level

(21) Sanitization of Government Files and Information

Defined at Task Order Level

(22) Notification of Departing Employee Defined at Task Order Level

(23) Contractor Responsibilities Upon Physical Completion of the Contract

Defined at Task Order Level

(24) Contractor Employee Separation Checklist Defined at Task Order Level

(25) Contractor Non-Disclosure Agreement

(NDA)

Defined at Task Order Level

(26) Vulnerability Scanning Report Defined at Task Order Level

(27) Government Access for Security Assessment

Defined at Task Order Level

Additional Reporting

(28) Invention Reporting Requirement to Include the Annual Utilization Report and Final Invention Statement

Defined at Task Order Level

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

Addressee Deliver To: Quantity

Contracting Officer’s Representative (COR) ncibrancheinvoices@mail.nih.gov 1-28 Contracting Officer (CO) ncibrancheinvoices@mail.nih.gov 1-28

ARTICLE F.3. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide direct labor Hours as provided in each task order. The labor hours exclude vacation, holiday, and sick leave. These labor hours exclude subcontractor labors. The specification for how the labor hours will be expended will be determined at the award of each task order.

b. The Contractor shall have satisfied the requirement herein if not less than 80% nor more than 120 % of the total direct Labor Hours as specified within each task order. These terms and conditions do not supersede the requirements of either the “Limitation of Cost” or “Limitation of Funds” clause.

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

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEB 1998).

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989).

52.242-15, Stop Work Order (August 1989) - Alternate I (April 1984) is not applicable to this contract.

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

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

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

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

[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.