Sol_75N92025R00010 w_attachments.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

NIDCR

Bethesda, MD 20892-7511 Craniofacial Research National Institute of Dental and National Institutes of Health

NIH/NIDCR CODE 16. ADMINISTERED BYCODE

X

X

X

541715

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORNHLBI

REQUEST FOR

PROPOSAL

(RFP)

INVITATION

FOR BID (IFB)

10. THIS ACQUISITION ISCODE

REQUEST FOR

QUOTE (RFQ)

14. METHOD OF SOLICITATION

13b. RATING

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

SMALL BUSINESS

02/10/2025 1500 ES

12/12/2024

+1 301 827 7528NATALIE BRUNING

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75N92025R00010

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 168 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

NIH/NIDCR

15. DELIVER TO

Bethesda, MD 20892-7511 Institute National Heart, Lung, and Blood

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

1,000

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

BLOCK IS MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

8(A)

National Institutes of Health

WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Note to Offerors:

For detailed information on the Request for Information and Pre-Solicitation Notice, please refer to Pre-Solicitation Number 75N92025R0314.

Pre-Proposal Conference information can be found on page 93 of this Solicitation.

Offerors must be registered in the System for Award Management (SAM) prior to award of a

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

DATED

TARA C. KNOX

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT: REFERENCE

X X

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 11/2021) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

contract. Offerors must access CCR through the

System for Award Management at https://sam.gov/

FOR INFORMATION CONTACT: Natalie Bruning at natalie.bruning@nih.gov

Submit all technical and business questions via email to natalie.bruning@nih.gov. The due date for receipt of questions is January 3, 2025.

Period of Performance: 09/30/2025 to 09/29/2026

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

168 2 of

SECTION B - Supplies or Services/Prices

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

2. PRICES/COSTS

3. ESTIMATED COST - OPTION

4. PROVISIONS APPLICABLE TO DIRECT COSTS

5. ADVANCE UNDERSTANDINGS

SECTION C - Description/Specifications

1. REPORTING REQUIREMENTS

SECTION D - Packaging and Marking SECTION E - Inspection and Acceptance SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

2. DELIVERIES

SECTION G - Contract Administration Data

1. CONTRACTING OFFICER REPRESENTATIVE (COR)

2. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

3. INDIRECT COST RATES

4. ON-SITE CONTRACTOR ACCESS TO GOVERNMENT PROPERTY

5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

6. FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. (MAR 2023)...23

7. HHSAR 352.237-75 Key Personnel. (DEC 2015)

SECTION H - Special Contract Requirements

1. HUMAN SUBJECTS

2. CERTIFICATE OF CONFIDENTIALITY

3. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

5. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

6. OMB CLEARANCE

7. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

8. GUN CONTROL

9. OPTION PROVISION

10. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

11. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF

INTEREST

12. PUBLICATION AND PUBLICITY

13. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

14. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

15. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD

16. HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice. (DEC 2015)

SECTION I - Contract Clauses

1. 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (DEVIATION)(Apr 2024)

2. Authorized Substitutions ADD 52.215-23

3. Authorized Substitutions REMOVE 52.219-9, 52.219-16

4. Authorized Substitutions REMOVE 52.232-25 *A1

5. Authorized Substitutions ADD 52.249-6 *A2

6. Authorized Substitutions ADD 52.249-6 *A5

15. FAR 52.203-13 Contractor Code of Business Ethics and Conduct. (NOV 2021)

16. FAR 52.203-14 Display of Hotline Poster(s). (NOV 2021)

24. FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems. (NOV 2021)

25. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021)

27. FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation. (OCT 2020)

28. FAR 52.204-29 Federal Acquisition Supply Chain Security Act Orders-Representation and Disclosures. (DEC 2023)

31. FAR 52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters. (OCT 2018)

46. FAR 52.217-8 Option To Extend Services. (NOV 1999)

47. FAR 52.217-9 Option To Extend the Term of the Contract. (MAR 2000)

65. FAR 52.222-62 Paid Sick Leave Under Executive Order 13706. (JAN 2022)

117. FAR 52.252-2 Clauses Incorporated by Reference. (FEB 1998)

123. HHSAR 352.231-70 Salary Rate Limitation. (DEC 2015)

125. HHSAR 352.237-74 Non-Discrimination in Service Delivery. (DEC 2015)

SECTION J - List of Documents, Exhibits and Other Attachments SECTION K - Representations, Certifications, and Other Statements of Bidders SECTION L - Instructions,Conditions, and Notices to Bidders SECTION M - Evaluation Factors for Award

1. M.1 EVALUATION FACTORS FOR AWARD

SECTION B - Supplies or Services/Prices

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

To provide comprehensive clinical research management, oversight and operations support for clinical research supported by the National Institute of Dental and Craniofacial Research (NIDCR) extramural and intramural research divisions. The contract will provide the NIDCR staff with systems and tools to assist in the effective oversight and administration of its clinical research program. In addition, it will provide adjunct expertise and resources to assure sound and efficient clinical study documentation, clinical site monitoring, data and safety monitoring, data management support, statistical support, and regulatory compliance.

2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

3. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is to be negotiated.

b. The fixed fee for the Base Period of this contract is to be negotiated. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

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

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

Estimated Cost ($)

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period: 9/30/2025 - 9/29/2026 To Be Negotiated

To Be Negotiated

To Be Negotiated

Option Period 1: 9/30/2026 - 9/29/2027 Option Period 2: 9/30/2027 - 9/29/2028 Option Period 3: 9/30/2028 - 9/29/2029 Option Period 4: 9/30/2029 - 9/29/2030

To Be Negotiated

To Be Negotiated

To Be Negotiated

Total Base Period and Options To Be Negotiated

To Be Negotiated

To Be Negotiated

4. PROVISIONS APPLICABLE TO DIRECT COSTS

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

12) Printing costs; and 13) Research Funding.

5. ADVANCE UNDERSTANDINGS

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

SECTION C - Description/Specifications

STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated 11/6/24 , attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

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).

1. REPORTING REQUIREMENTS

All reports shall be submitted electronically.

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."

4. 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 its NIH funded research.]

[ ] Monthly

[ ] Quarterly

[X] Semi-Annually

[X] Annually

[ ] Annually (with a requirement for a Draft Annual Report)

[ ] Final - Upon final completion of the contract

[X] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

5. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94. 45 CFR Part 94 is available at:

https://www.ecfr.gov/current/title-45/part-94.

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

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

b. 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.

HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

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.

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

[ ] Tier 2SR: Reinvestigation.

[ ] 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.

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 that the cost of the additional investigation(s).

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

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

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/ 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 buffer overflows, open ports, unnecessary services, lack of user input filtering, cross site scripting vulnerabilities, SQL injection vulnerabilities, and any other known vulnerabilities.

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

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

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

d. Section 508 Annual Report

The Contractor must submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at:

https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual _report.doc.

SECTION D - Packaging and Marking

A. 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

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.

1. For the purpose of this SECTION, TBD is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institutes of Health National Heart, Lung, and Blood Institute Office of Acquisitions Rockledge One , Suite 510 6705 Rockledge Drive Bethesda, Maryland 20892

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 52.246-4, Inspection of Services - Fixed Price.

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

SECTION F - Deliveries or Performance

1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from 9/30/2025 through 9/29/2026.

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 One (1) 9/30/2026 - 9/29/2027 Two (2) 9/30/2027 - 9/29/2028 Three (3) 9/30/2028 - 9/29/2029 Four (4) 9/30/2029 - 9/29/2030

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 in Attachment 6: Deliverables and as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b.

Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES

(APRIL 1984).

b. Deliveries shall be submitted through FedConnect.net

3. FAR 52.242-17 Government Delay of Work. (APR 1984)

SECTION G - Contract Administration Data

1. CONTRACTING OFFICER REPRESENTATIVE (COR)

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

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

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

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule;

(4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

2. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT

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

b. One copy of the invoice shall be submitted to the following approving official:

Contract Specialist Office of Acquisitions National Heart, Lung, and Blood Institute 6701 Rockledge Drive Room 6105 Rockledge II MSC Bethesda, Maryland 20892- 7902

E-mail: To be Determined

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. 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. [Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

Central Point of Distribution: nhlbicontractsbranchA@mail.nih.gov

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. [Note:

The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

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

mailto:nhlbicontractsbranchA@mail.nih.gov

f. The Contract Title is: Clinical Research Operations and Management (CROMS)

g. Contract Line Items as follows:

Line Item # Line Item Description

TBD TBD

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

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

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

a. The Contractor must submit invoices to the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy of the invoice to the approving official, as directed below.

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

Official: Contracting Officer

Name- TBD Email Address- TBD

Contracting Officer Representative

Name- TBD Email Address- TBD

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

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

3. INDIRECT COST RATES

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

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

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

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

4. ON-SITE CONTRACTOR ACCESS TO GOVERNMENT PROPERTY

The Contractor shall be held responsible for Government Property, regardless of dollar value, when:

• The contract requires Contractor personnel to be located on a Government site or installation;

• The property utilized by Contractor personnel is incidental to the place of performance; and,

• The property used by the Contractor remains accountable to the Government.

Responsibility includes physical presence, proper use and handling, normal maintenance, and reporting loss, damage or destruction.

Responsibility for government property shared by two or more Contractors or located in space shared by two or more Contractors, shall be determined and documented by the contractors involved. In cases where the parties cannot reach agreement on shared responsibility, the matter will be referred to the NIH Property Officer for resolution.

5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

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

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted sixty 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.

a. 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. FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors.

(MAR 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 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, including 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.

(End of clause)

7. HHSAR 352.237-75 Key Personnel. (DEC 2015)

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

The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of clause)

SECTION H - Special Contract Requirements

1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

2. CERTIFICATE OF CONFIDENTIALITY

Section 2012 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions governing the authority of the Secretary of Health and Human Services (Secretary) to protect the privacy of individuals who are the subjects of research, including significant amendments to the previous statutory authority for such protections, under subsection 301(d) of the Public Health Service Act.

Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 and is within the scope of the NIH Policy for Issuing Certificate of Confidentiality (CoC) NOT-OD-17-109, the Contractor shall protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act as a term and condition of the contract. The certificate will not be issued as a separate document.

NIH considers research in which identifiable, sensitive information is collected or used, to include:

• Human subjects research as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46), including exempt research (except for human subjects' research that is determined to be exempt from all or some of the requirements of 45 CFR 46) if the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects);

• Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual;

• Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether…