Solicitation.pdf

RFP NIH-OD-26-000008

Table of Contents

NOTICE TO OFFERORS

PART I – THE SCHEDULE

SECTION A – SOLICITATION

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

ARTICLE B.2. OPTION PRICES

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. WORK STATEMENT

ARTICLE C.2. REPORTING REQUIREMENTS

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

ARTICLE F.2. DELIVERIES

SECTION G - CONTRACT ADMINISTRATION DATA

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

ARTICLE G.1. CONTRACTING OFFICER (CO)

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

ARTICLE G.4. GOVERNMENT PROPERTY

ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. PRIVACY ACT, HHSAR 352.224-70 (December 2015)

ARTICLE H.2. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT

PROCUREMENTS

ARTICLE H.3. ACCESS TO NATIONAL INSTITUTES OF HEALTH (NIH) ELECTRONIC MAIL

ARTICLE H.4. CONTRACTOR'S USE OF LIBRARY RESOURCES AT NIH

ARTICLE H.5. CONFIDENTIALITY OF INFORMATION

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF

OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

SECTION M - EVALUATION FACTORS FOR AWARD

NOTICE TO OFFERORS

This solicitation is being processed under a Partnership Agreement (PA) between the Department of Health and Human Services (HHS) and the Small Business Administration (SBA), under which the SBA has delegated to HHS, authority to enter into 8(a) contracts directly with eligible 8(a) firms. The PA implements innovative and effective methodology designed to streamline the acquisition process for awards under the 8(a) program. The National Institutes of Health is a designated pilot agency under the PA.

Any solicitation and subsequent awards processed under the referenced PA, National Institutes of Health will make the award directly to the 8(a) firm. SBA will not be a signatory to the award resulting from this solicitation. SBA will, however, retain responsibility for 8(a) certification, administer other eligibility related issues under the 8(a) program, and be available to 8(a) firms for counseling and assistance.

If you have any questions pertaining to this PA, please contact Susan A. Nsangou, Contracting Officer.

To facilitate communications, it is requested that the 8(a) participant submitting this offer/bid provide the following information regarding the firm's cognizant servicing Small Business Administration (SBA) office.

U.S. SMALL BUSINESS ADMINISTRATION

Washington Metropolitan Area District Office 409 3rd St., SW, Floor 2 Washington, DC 20416 202-205-8800 Cognizant SBA Business Opportunity Specialist: Anthony G. Clayborne II Anthony.ClayborneII@sba.gov mailto:Anthony.ClayborneII@sba.gov

PART I – THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION, HEREIN CONTAINS

IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS

SOLICITATION.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS

CONTRACTUALINFORMATION 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.

SECTION A – SOLICITATION

This RFP does not commit the Government to pay any cost incurred in the submission of quotes or make necessary studies or designs for the preparation thereof, nor to procure or contract for the articles or services. It is also brought to your attention that the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed procurement. Any other commitment, either explicit or implied, is invalid.

In addition to the clauses/provisions of this RFP, the resultant Contract shall include any clauses/provisions required by Public Law, Executive Order, or Acquisition Regulations in effect at the time of execution of the award.

Responses to this RFP are not to be considered an offer that can be accepted by the Government to form a binding matter. The actual Contract is considered the offer by the Government to the Contractor and the Contractor's written acceptance of the order, or the commencement of performance under the order, is the Contractor's indication of their acceptance of the offer.

THE GOVERNMENT RESERVES THE RIGHT TO MAKE AN AWARD WITHOUT FURTHER

DISCUSSIONS OF THE QUOTES RECEIVED. THEREFORE, IT IS IMPORTANT THAT YOUR

QUOTE BE SUBMITTED INITIALLY ON THE MOST FAVORABLE TERMS FROM BOTH THE

TECHNICAL AND COSTS STANDPOINTS.

The Schedule Contractor shall direct all communications to the attention of the Contracting Officer.

All documents and deliverables described in this RFP and amendments or modifications shall be submitted in a professional manner and on the Prime Contractor's letterhead.

All Contract Administration matters will be handled by the following:

CONTRACTOR: TBD at the time of BPA Issuance

GOVERNMENT: National Institutes of Health (NIH) Office of the Director (OD) OALM-OLAO Hospital and Laboratory Division Medical & Patient Care (MPC) 6701 Rockledge Dr, Floor 5 Bethesda, MD 20817\

SOLICITATIONS:

The question and answering period for this solicitation concludes on April 30, 2026 at 12:00 P.M. (EST). All questions pertaining to this RFP shall be submitted in writing via email to the Point(s) of Contact listed below. No telephone calls will be accepted. Any questions received after the aforementioned date and time may not be answered.

Proposals are due no later than May 8, 2026 at 12:00 P.M. (EST). The Point of Contact(s) for this acquisition are:

NAME: Susan Nsangou TITLE: Contracting Officer (Branch Chief) ADDRESS: National Institutes of Health (NIH) Office of the Director (OD)

OALM-OLAO Hospital and Laboratory Division Medical & Patient Care (MPC) 6701 Rockledge Dr, Floor 5 Bethesda, MD 20817

EMAIL: susan.nsangou@nih.gov

NAME: Chris Ryssa Nix TITLE: Contract Specialist ADDRESS: National Institutes of Health (NIH) Office of the Director (OD)

OALM-OLAO Hospital and Laboratory Division Medical & Patient Care (MPC) 6701 Rockledge Dr, 538-N

EMAIL: ryssa.nix@nih.gov

ACKNOWLEDGEMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NUMBER DATE

MISSING PAGES: It is the responsibility of the Offeror to examine this solicitation to verify that he or she has received all pages. In addition, in compiling this package, some pages may have been duplicated. If the Offeror feels that pages are missing or duplicated, the Offeror is encouraged to contact the Contracting Officer via email.

NOTICE TO PROSPECTIVE CONTRACTOR(S): Prospective awardees MUST be registered in the System for Award Management (SAM) at http://www.sam.gov, PRIOR TO AWARD and through final payment.

ADDITIONAL INFORMATION FOR OFFERORS:

•Contract Type: Labor Hours IDIQ

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This contract is to provide on a long-term (not temporary) basis administrative medical support services at the NIH Clinical Center. The potential Contractor(s) for this acquisition will be required to provide administrative support personnel over the life of the proposed contract, one (1) base year and two (2) option periods. Services required will be performed in a clinical research hospital setting.

ARTICLE B.2. OPTION PRICES

a. Unless the Government exercises its option pursuant to the option clause referenced in

PART II - CONTRACT CLAUSES, this contract consists only of the Base Period specified in the Statement of Work (SOW) as defined in SECTIONS C and F, for the price set forth on the table below.

b. Pursuant to FAR Clause 52.217-9 set forth in PART II - CONTRACT CLAUSES of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Period(s) specified in the SOW as defined in

SECTIONS C and F of this contract. If the Government exercises this/these option(s), notice must be given before the expiration date of the contract.

c. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. WORK STATEMENT

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 SOW, attached hereto and made a part of this Solicitation.

PLEASE SEE ATTACHMENT 1: Combined Statement of Work (SOW)

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format.

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."

The Contractor is responsible for the reports and documentation as stated on the SOW, attached hereto and made a part of this Solicitation.

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

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.

http://www.hhs.gov/web/508/index.html

SECTION E - INSPECTION AND ACCEPTANCE

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

b. Inspection and acceptance will be performed at:

NIH Clinical Center 9000 Rockville Pike Building 10 Bethesda, MD 20892

c. Invoices are due by the 10th of each calendar month.

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: 52.246-6 Inspection-Time-and-Material and Labor-Hour.

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

Period Dates

Base 06/01/2026 – 05/31/2028 Option 1 (if exercised) 06/01/2027 – 05/31/2029 Option 2 (if exercised) 06/01/2028 – 05/31/2030

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the SOW and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative.

SECTION G - CONTRACT ADMINISTRATION DATA

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

The Contracting Officer's Representative (COR) representing the Government for the purpose of this contract will 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) https://www.acquisition.gov/far/52.246-6 performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Government may unilaterally change its COR.

ARTICLE G.1. CONTRACTING OFFICER (CO)

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

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015) The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder: Program Manager to be determined at award

ARTICLE G.4. GOVERNMENT PROPERTY

Any equipment, property, or facilities furnished by the government or any contractor-acquired property must be specified in the contract. Contracting Officers are responsible to ensure that the contract consistent with the policies and procedures of FAR Part 45 for providing government property to contractors, contractors' use and management of government property, and reporting, redistributing, and disposing of contractor inventory.

Contractors are responsible and liable for government property in their possession pursuant to FAR 52.245-1 and 52.245-2, as applicable. In the case that the Government- Furnished Equipment (GFE) or Government-Furnished Information (GFI) are not provided to the contractor by the specified date, the contractor will immediately notify the Contracting Officer. Upon conclusion of the contract, the contractor shall return the GFE or GFI to the government as specified in the task order or as directed in writing by the Contracting Officer.

The services of the Medical Support Assistants are provided on site at the NIH Clinical Center. The Government will provide office space, computers, desks, chairs and general office supplies.

ARTICLE G.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 on anniversary dates.

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

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

b. Electronic Access to Contractor Performance Evaluations

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

SECTION H - SPECIAL CONTRACT REQUIREMENTS

It is anticipated that one or two awards will be made from this solicitation and that the award will be made on/about May 29, 2026.

It is anticipated that the award from this solicitation will be labor hours.

https://www.cpars.gov/cparsweb/home

ARTICLE H.1. PRIVACY ACT, HHSAR 352.224-70 (December 2015)

ARTICLE H.2. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION

AND IT PROCUREMENTS

ARTICLE H.2.1. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT

PROCUREMENTS INFORMATION AND/OR PHYSICAL SECURITY

A. Security Assessment and Authorization (SA&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) shall 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 shall conduct the SA&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. SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an SA&A package within 30 days of contract award to the CO and/or COR.

The following SA&A deliverables are required to complete the SA&A package.

System Security Plan (SSP) - due within 30 days after contract award. The SSP shall 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 shall 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 shall provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or https://www.acquisition.gov/hhsar/352.224-70-privacy-act.

planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP at least annually thereafter.

Security Assessment Plan/Report (SAP/SAR) - due 30 days after the contract award. The security assessment shall 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.

Independent Assessment - due 90 days after the contract award. The Contractor (and/or subcontractor) shall have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party shall 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 shall 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).

POA&M - due 30 days after contract award. The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. All high-risk weaknesses must be mitigated within 30 days and all medium weaknesses must be mitigated within 60 days from the date the weaknesses are formally identified and documented. 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, shall 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 shall be updated at least quarterly.

C. 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, shall 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 shall update and test the Contingency Plan at least annually.

E-Authentication Questionnaire - The contractor (and/or any subcontractor) shall 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 shall 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.

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

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI).

[ ] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[X] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

a. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12 Roster-

i. The Contractor (and/or any subcontractor) shall 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 shall 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 shall 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://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documen ts/SuitabilityRoster_10-15-12.xlsx.

ii. If the Contractor is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable

iii. Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

iv. 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.

v. The Contractor shall 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.

vi. All contractor and subcontractor employees shall 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.

vii. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-

14. Accordingly, the Contractor shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

viii. 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).

ix. The Contractor shall 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).

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

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

E. CONTRACT INITIATION AND EXPIRATION

a. General Security Requirements- The Contractor (and/or any subcontractor) shall 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 shall follow the HHS EPLC framework and methodology or and in accordance with the HHS Contract Closeout Guide (2012).HHS EA requirements may be located here:

https://www.hhs.gov/ocio/ea/documents/proplans.html

b. System Documentation- Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide https://www.hhs.gov/ocio/ea/documents/proplans.html 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) shall 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) shall 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) shall return all government information and IT resources (i.e., government information in nongovernment-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall 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) shall perform and document the actions identified in the NIH Contractor Employee Separation Checklist Employee Separation Checklist (nih.gov) when an employee terminates work under this contract within 2 days of the employee's exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

F. 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/Nondisclos ure.pdf , as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

G. Vulnerability Scanning Reports The Contractor shall 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 shall be submitted under a separate cover on monthly basis.

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf#search=employee%20separation

H. Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) shall 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:

a. 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.

b. 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.

c. 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.

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

ARTICLE H.3. ACCESS TO NATIONAL INSTITUTES OF HEALTH (NIH)

ELECTRONIC MAIL

All Contractor staff that have access to and use of NIH electronic mail (e-mail) must identify themselves as contractors on all outgoing e-mail messages, including those that are sent in reply or are forwarded to another user. To best comply with this requirement, the Contractor staff shall set up an e-mail signature ("AutoSignature") or an electronic business card ("V-card") on each Contractor employee's computer system and/or Personal Digital Assistant (PDA) that will automatically display "Contractor" in the signature area of all e-mails sent.

ARTICLE H.4. CONTRACTOR'S USE OF LIBRARY RESOURCES AT NIH

The Contractor is authorized to use library resources at NIH in the same manner as NIH staff. The Contractor's approved use of these resources is limited to performing the requirements of this contract. The Contractor shall not use library resources at NIH in a manner that exceeds the Fair Use limitations codified in 17 U.S.C. sec. 107 of the Copyright Act. Contractors shall not share access to library resources at NIH with, perform searches for, or provide results to, non-NIH users, i.e. collaborators at other universities or research centers.

ARTICLE H.5. CONFIDENTIALITY OF INFORMATION

a. Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

b. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause.

c. If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.

d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.

e. Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.

f. Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials.

g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.

The following information is covered by this article: All medical and clinical information

PART II - CONTRACT CLAUSES

• 52.216-18 Ordering.

• 52.216-19 Order Limitations.

• 52.216-21 Requirements.

• 52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services.

• 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services.

• 52.217-8 Option to Extend Services.

• 52.217-9 Option to Extend the Term of the Contract.

• 52.232-34 Payment by Electronic Funds Transfer-Other than System for Award Management.

• 52.252-2 Clauses Incorporated by Reference.

https://www.acquisition.gov/far/52.216-18 https://www.acquisition.gov/far/52.216-19 https://www.acquisition.gov/far/52.216-21 https://www.acquisition.gov/far/52.212-4 https://www.acquisition.gov/far/52.212-4 https://www.acquisition.gov/far/52.212-5 https://www.acquisition.gov/far/52.212-5 https://www.acquisition.gov/far/52.217-8 https://www.acquisition.gov/far/52.217-9 https://www.acquisition.gov/far/52.232-34 https://www.acquisition.gov/far/52.232-34 https://www.acquisition.gov/far/52.252-2

• 52.242-15 Stop-Work Order.

• 52.242-17 Government Delay of Work.

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER

ATTACHMENTS

ATTACHMENT 1: Combined Statement of Work

ATTACHMENT 2: Evaluation Criteria

ATTACHMENT 3: Pricing Worksheet

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS

OF OFFERORS

IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST:

Go to the System for Award Management (SAM) and complete and include as part of your proposal the Representations and Certifications.

52.204-19 Incorporation by Reference of Representations and Certifications.

SECTION L - INSTRUCTIONS, CONDITIONS, AND

NOTICES TO OFFERORS

NOTICE OF 8(a) COMPETITIVE SET-ASIDE

Offers are solicited only from small business concerns expressly certified by the Small Business Administration (SBA) for participation in the SBA's 8(a) Program. Bids or proposals received from others will be considered nonresponsive.

52.212-1 Instructions to Offerors—Commercial Products and Commercial Services.

GENERAL INSTRUCTIONS

The proposal instructions are designed to provide general guidance for preparing proposals as well as providing specific instructions on proposal organization, format, and content.

Responders must include all documents and information requested and should be submitted in accordance with the instructions. The responder is cautioned to follow the https://www.acquisition.gov/far/52.242-15 https://www.acquisition.gov/far/52.242-17 https://www.acquisition.gov/far/52.204-19 https://www.acquisition.gov/far/52.212-1 instructions carefully, as the Government reserves the right to make an award based on initial proposals received without discussion of such proposal.

Responders must submit a proposal that is self-sufficient and responds directly to the requirements of the SOW. The proposal should be clear, concise, and include adequate detail for effective evaluation. The proposal must not simply rephrase or restate the Government's requirements but rather provide convincing rationale to address how the responder intends to meet the requirements. The proposal must contain sufficient information to enable the Government to fully evaluate and determine the responder’s capability to comply with the requirements. The Government will evaluate proposals based on the information presented in the responder's submission. Responder must submit with their proposal a list of names and telephone numbers of persons authorized to conduct discussions/negotiations.

The responder must provide its proposal with a cover sheet that contains the company’s name, address and telephone number, name and title of the person authorized to sign, RFP number as indicated in this solicitation, and the original date of proposal.

• Vendors shall include separate technical and business proposals.

• The technical proposal should be divided in 2 parts: Task 1 and Task 2.

• Errors or omissions may affect your rating or consideration.

SUBMITTAL OF QUOTES/PROPOSALS:

The solicitation close date for this RFQ is May 8, 2026 at 12:00 P.M. (EST). All responses are due by the aforementioned date and time. Late or incomplete responses will not be considered.

The response must be submitted in 2 formats below. Failure to submit both formats is considered an incomplete submission and will not be reviewed by the government.

1. Electronically via email to Ryssa.nix@nih.gov. Subject of the email must include the vendor name and RFP NIH-OD-26-000008.

2. Mail a printed copy of the technical proposals (Tasks 1 and 2) in a 3-ring binder to the address below. Hand deliveries will not be accepted. Technical proposals for Task 1 and Task 2 must be separated and clearly marked.

Chris Ryssa Nix National Institutes of Health (NIH) 6701 Rockledge Dr, Floor 5, 538-N mailto:Ryssa.nix@nih.gov

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

a. Evaluation of Proposals

The Government will evaluate proposals in accordance with the factors set forth in FAR 52.212-2.

b. Privacy Act - Treatment of Proposal Information The Privacy Act of 1974 (P.L. 93-579) requires that a Federal agency advise each individual whom it asks to supply information, the authority which authorizes the solicitation, whether disclosure is voluntary or mandatory, the principal purpose or purposes for which the information is intended to be used, the uses outside the agency which may be made of the information, and the effects on the individual, if any, of not providing all or any part of the requested information.

The NIH is requesting the information called for in this SOLICITATION pursuant to the authority provided by Sec. 301(a)(7) of the Public Health Service Act, as amended, and P.L. 92-218, as amended.

Providing the information requested is entirely voluntary. The collection of this information is for the purpose of conducting an accurate, fair, and adequate review prior to a discussion as to whether to award a contract.

Failure to provide any or all of the requested information may result in a less than adequate review.

In addition, the Privacy Act of 1974 (P.L. 93-579, Section 7) requires that the following information be provided when individuals are requested to disclose their social security number.

Provision of the social security number is voluntary. Social security numbers are requested for the purpose of accurate and efficient identification, referral, review and management of NIH contracting programs. Authority for requesting this information is provided by Section 301 and Title IV of the PHS Act, as amended.

The information provided by you may be routinely disclosed for the following purposes:

• to the cognizant audit agency and the Government Accountability Office for auditing.

• to the Department of Justice as required for litigation.

• to respond to congressional inquiries.

• to qualified experts, not within the definition of Department employees, for opinions as a part of the review process.

c. 52.252-1 Solicitation Provisions Incorporated by Reference.

d. Technical Proposal Instructions Your technical approach should be in as much detail as you consider necessary to fully explain your proposed technical approach or method. The technical proposal should reflect a clear understanding of the nature of the work being undertaken. The technical proposal must include information on how the project is to be organized, staffed, and managed. Information should be provided to demonstrate your understanding and management of the requirements outlined in the Statement of Work. Proposals which merely offer to conduct a program in accordance with the requirements of the Government's scope of work will not be eligible for award. The Offeror must submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the project objectives. Use as many subparagraphs, appropriately titled, as needed to clearly outline your firm's capability to provide administrative support services consistent in scope and scale with those described in the Statement of Work. Proposals which merely restate the requirements of the Government's scope of work will not be eligible for award.

The technical discussion included in the technical proposal must address the Factors detailed in ATTACHMENT 2: Evaluation Criteria.

Technical proposals for Task 1 and Task 2 must be separated and clearly marked.

e. Business Proposal Instructions Offerors must include ATTACHMENT 3: Pricing Worksheet in the business proposal.

NAICS CODE AND SIZE STANDARD

Note: The following information is to be used by the offeror in preparing its Representations and Certifications.

The North American Industry Classification System (NAICS) code for this acquisition is 561110.

The small business size standard is $7.5 Million.

https://www.acquisition.gov/far/52.252-1

COMMUNICATIONS PRIOR TO CONTRACT AWARD

Offerors shall direct all communications to the attention of the Contract Specialist or Contracting Officer. Communications with other officials may compromise the competitiveness of this acquisition and result in cancellation of the requirement.

PREPARATION COSTS

This RFP does not commit the Government to pay for the preparation and submission of a proposal.

52.233-2 Service of Protest.

SECTION M - EVALUATION FACTORS FOR AWARD

52.212-2 Evaluation—Commercial Products and Commercial Services.

The acceptability of the technical portion of each contract proposal will be evaluated by a technical review panel. The panel will evaluate each proposal in strict conformity with the evaluation factors of the RFP, utilizing points ratings and written critiques.

SEE ATTACHMENT 2: Evaluation Criteria https://www.acquisition.gov/far/52.233-2 https://www.acquisition.gov/far/52.212-2