REQUEST FOR QUOTE

Fast Healthcare Interoperability Resources

(FHIR) Server

RFQ-2026- 75F40126Q00368

The Request for Quote (RFQ) FDA- is being conducted in accordance with the NASA SEWP V Indefinite Delivery / Indefinite Quantity (IDIQ) Contracts. This RFQ is for Fast Healthcare Interoperability Resources (FHIR) Server. This will be a single Firm Fixed Price (FFP) award with a one-year period of performance and will be solicited as a Total Small Business set-aside under NAICS code 541519 on a brand name and equal basis.

The Government is in no way obligated to make an award, nor to pay any costs incurred by the Contractor in preparing and submitting its quote.

1. Statement of Need _______________________________________________________________

The Food and Drug Administration (FDA) / Center for Biologics Evaluation and Research (CBER) / requires enterprise FHIR server that can provide a secure and scalable repository for storing and sharing healthcare data. The FHIR server should be operation-ready and fully configured with minimal configuration steps to be performed by the end user. The security, backups, and management of the FHIR server should be maintained by the offeror.

Background:

Starting in FY 2018, the FDA Center for Biologics Evaluation and Research (CBER) created the Sentinel Biologic Effectiveness and Safety Innovative Methods (BEST IM) program to support CBER’s postmarket surveillance responsibilities. BEST aims to encourage the development and validation of innovative methods to provide the FDA, CBER, Office of Biostatistics and Pharmacovigilance (OBPV) with an enhanced safety monitoring and evaluation system, which includes enhanced AE detection, validation and reporting, and build capabilities to conduct active surveillance studies to ensure the safety and effectiveness of the CBER-regulated products portfolio. BEST led multi-workstream efforts to achieve its strategic objectives aiming to provide enhanced safety monitoring capabilities and to validate the accuracy of mined safety and effectiveness phenotypes among patients using CBER-regulated products to support future automated or semi-automated patient chart review.

Throughout the years, the BEST program developed, tested, and established the following:

1. A library of multi-tier computable phenotypes (includes 3 levels of phenotypes ranging from simple (diagnosis codes-based) to complex (including structured and unstructured data from EHRs)) to identify and extract Biologics exposure/AE data from EHRs via FHIR or OMOP , and recommend evidence to the chart review tool (CRT), which was developed by BEST IM as well.

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2. A Chart Review Tool (CRT) that interfaces with a HAPI FHIR server to extract, load, and display EHRs data for review, assessment, and validation (by a clinician) of clinical cases defined by one of the BEST IM phenotypes.

3. Mappings of EHRs data to corresponding fields in Individual Case Safety Reports (ICSR) accepted by FDA, such as the International Council for Harmonization (ICH) E2B format and VAERS reports formats (https://vaers.hhs.gov/uploadFile/index.jsp).

4. Algorithms to extract required information from the validated cases, auto ICSRs, and made ready, in XML and PDF format, for submission to FDA electronic submission gateway (ESG) upon the approval of the reporting provider.

5. A case management application (CMA), a modified and HIPAA compliant version of the CRT, to operationalize the POC platform and enable the conduct of a pilot with few eHX participants.

6. The Survey of Health and Patient Experience (SHAPE) platform, which includes 3 components:

the SHAPE Admin for study coordinators to build and deploy surveys, and downloaded responses;

SHAPE API to allow integration of the SHAPE platform with other systems; and SHAPE app, a patient facing app available on iOS (apple devices), Google Play Store (android devices) and as a web progressive app for PC users.

7. A proof of concept (POC) platform, using synthetic data, to validate AE reports using the HL7® FHIR® standard and technology via eHealth Exchange (eHX) as the largest health information exchange (HIE) network in the US.

8. Established the BEST Exchange Pilot (2022-2023) in collaboration with eHX, as the first nationwide FHIR-based AEs validation and detection system.

As BEST IM Platform continues to mature, CBER has moved its deployment and operation from Amazon Web Services (AWS) to CBER’s High-performance Integrated Virtual Environment (HIVE) (https://hive.fda.gov). As BEST IM transitions to an operational environment, CBER desires increased participation from eHX pa, and assessment and evaluation of the data gathered. CBER has identified the need to incorporate FHIR server technology into the existing platform. The FHIR sever is a critical part of the BEST IM platform and it provides the platform with the following:

a. The FHIR server and its associated repository, is a critical component of our system because it is the backbone of the Platform (interacting with all the services of the Platform).

b. It plays a crucial role in interfacing with the other systems utilizing the FHIR standards and technology.

c. It provides a stable environment, and the technically supported software (FHIR Server) is required to support our Platform in the operational (production) phase.

d. Integration with other services and applications, e.g. OMOP-on-FHIR, to utilize some of the tools developed by the open-source community for our research and exploratory efforts.

e. The FHIR sever will allow the BEST IM Platform to have the necessary scalability to onboard various organizations, like regional and state health information exchanges, pharmacies, registries, etc., To achieve such scalability, we must have the ability and flexibility to interact with diverse systems that might have different technical abilities, or at different modernization stages, i.e. don’t have FHIR capabilities, yet. This support is available in few commercial applications, such as IRIS for Health, which has been

P a g e 3 | 31 implemented, tested, used for a long period of time. Alternatively, building this support, designing and creating our own solution would be prohibitively costly and time. Leveraging, one of these integrated FHIR servers, and its built-in functionalities will enable the BEST IM Platform to interact and communicate with disparate systems to and provides a timely solution to this issue.

2. Supplies or Services and Price/Cost__________________________________________________

Quote should include Optional Line Items – Additional quantities, listed in table below:

CLIN Item Quantity

19.1 Server NVIDIA DGX H100 with 8 GPUs

19.2 PDU 1U rack mounted for DGX (PDUH32HV19)

3. Technical Requirement____________________________________________________________

The Contractor shall provide a commercial grade FHIR server to enable the enhancement and expansion of the capabilities of the BEST IM platform in the next, operational, phase which shall meet or exceed the following salient characteristics for the FHIR server:

FHIR Server System Solution Requirements:

The solution should support:

• The latest HL7 / FHIR version, including the United States Core Data for Interoperability

(USCDI), and

• Open API-based definitions for all FHIR resources

• A developer portal for understanding and testing FHIR APIs, preferably, using a user interface-based tool, for example, Swagger-UI front-end, to allow easy access to all FHIR API configuration parameters and documentation

• Full lifecycle FHIR API management

• Multiple methods of authentication, including an API Key and several Identity Providers

(iDPs) using OpenID Connect

Item No

Description Qty Unit Price

001 FHIR Server (HL7) 1 12 months

(optio nal)

Technical Support Services for Enterprise FHIR rver

1 12 months

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• Built-in support for OAuth 2.0 using the Cognito authorization server, including intuitive methods to select custom FHIR scopes

• Support for multiple external OAuth 2.0 servers (OKTA, Ping, Google Identity, Azure AD)

• Logging of important FHIR request/send data activities

• Support of large volume FHIR requests and message to operate in emergency situations

• Have the capability to integrate with other tools and applications, especially, open-source tools developed by the scientific community, e.g. OMOP common data model, SMART-on- FHIR applications, SQL-on-FHIR, etc.

• Have the capability to store and use data from the Internet of Medical Things (IoMT), registries, electronic health records, research databases, and other sources.

• Contractor quotes shall demonstrate compatibility and interoperability with these existing hardware systems that are listed below and their existing management tools.

If an alternate configuration is proposed, the Contractor shall attest that the alternate solution is compatible with the HIVE system (see attached Salient Characteristics). Compatibility for this RFQ means that there will be no communication, performance, or maintainability issues in the interconnection of solutions with different configurations and that the solution will allow for seamless (no application change) interoperation including active/passive or active/active processing. In addition, the Contractor shall provide examples of actual implementations where their proposed alternative solution has been successfully implemented.

Optional Line Item 002: Technical Support Services for Enterprise FHIR Server

• Technical support shall cover configuration assistance, software updates (security patches and minor updates), performance optimization, and troubleshooting issues/bugs during the 12 months period of performance. Support level includes basic support during regular business hours (Monday-Friday, 8:30am-5:00pm EST), conducted remotely via email and online meeting platform (e.g. Microsoft Teams). Contractor shall acknowledge support requests within 48 hours and provide resolution timeline. All support staff must execute a Business Associate Agreement (BAA) compliant with HIPAA requirements prior to accessing any healthcare data.

• Contractor shall provide a clear escalation path for critical issues that impact system availability or data integrity. Escalation procedures shall include:

1. Initial escalation to senior technical staff within 4 business hours for issues preventing normal system operations

2. Management escalation within 8 business hours for unresolved critical issues

3. Executive-level escalation within 48 hours for issues affecting patient safety or regulatory compliance

Critical issues shall be defined as any server bugs resulting in malfunction preventing access to or proper receipt of patient data.

• Contractor shall provide detailed monthly reports documenting all support activities performed.

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5. Delivery Locations ________________________________________________________________ Administration will be managed within the FDA Headquarters offices located at:

Food & Drug Administration CBER 10903 New Hampshire Ave.

Building 75, Room G632 Silver Spring MD 20993-0002

Any contractor travel costs related to the fulfillment of this maintenance requirement cost shall not be reimbursable.

6. Period of performance_________________________________________________________ The Period of Performance for this order is twelve (12) months. The Contractor shall deliver requested product within 30 days of award.

7. Contract Type_____________________________________________________________________ This order is a firm-fixed-price order.

8. Conformance with Applicable Laws, Regulations, Policies, and Standards__________________ Contractor Compliance

The Contractor shall be responsible for knowledge of, and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov/. HHS documents are found at: http://www.hhs.gov/oirm/

Section 508 Standard Compliance Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this order must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.section508.gov/. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/provisions.htm

Special Notice and Agreement Regarding Software EULA/TOS

Computer software and services are often subject to license agreements, referred to as End User License Agreements (EULA), Terms of Service (TOS), or other similar legal instruments or agreements. Many http://www.cio.gov/ http://www.hhs.gov/oirm/ http://www.section508.gov/ http://www.access-board.gov/sec508/provisions.htm

P a g e 6 | 31 of these agreements contain indemnification clauses that are inconsistent with Federal law and unenforceable, but which could create a violation of the Anti-Deficiency Act (31 U.S.C. 1341) if agreed to by the Government.

Therefore, by submitting a quotation the all offeror shall agree that the inclusion of any Limitation of Liability, Indemnification, and any other clauses that conflict with Federal law or regulation in any EULA or TOS are NULL AND VOID. The offeror agrees that any EULA/TOS clauses conflicting with Federal law or regulation and are not agreed to by the Government if included with the submission of a quotation. Additionally, by submission of the quotation the offeror shall agree to the inclusion of FAR 52.232-39 Unenforceability of Unauthorized Obligations in any resulting contract or order, if awarded.

9. Security and Privacy Requirement______________________________________________________

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter

“contract”), or portion thereof, includes either or both of the following:

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

a. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission.

In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

3) Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

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

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

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

b. Provide security for any Contractor systems, and information contained therein, connected to an FDA network or operated by the Contractor on behalf of FDA regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party. This includes notifying the

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FDA Systems Management Center (SMC) within one (1) hour of discovery/detection in the event of an information security incident.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS/FDA Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the FDA Information Security Program security requirements, outlined in the FDA Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing your ISSO.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

4) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

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

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

[x] No PII [ ] Yes PII

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

PII Confidentiality Impact Level has been determined to be: [x] Low [ ] Moderate [ ] High

5) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or

Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI.

32 C.F.R. 2002.4(aa). As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re- using, and disposing of the

P a g e 8 | 31 information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. returned to FDA control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization and the FDA IS2P Appendix T:

Sanitization of Computer-Related Storage Media.

6) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any FDA records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and FDA policies. Unauthorized disclosure of information will be subject to the HHS/FDA sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

7) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB

Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

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8) Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

9) Contract Documentation. The Contractor shall use FDA-provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

10) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee under this contract shall complete the FDA non-disclosure agreement (3398 Form, RFP Attachment D), as applicable. A copy of each signed and witnessed NDA shall be submitted to the CO and/or COR prior to performing any work under this acquisition.

11) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed.

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist procuring activity representative, program office and the FDA SOP or designee with completing a PIA for the system or information after completion of the PTA and in accordance with HHS and FDA policy and OMB M- 03-22, Guidance for Implementing the Privacy Provisions of the E- Government Act of 2002. The PTA/PIA must be completed and approved prior to active use and/or collection or processing of PII and is a prerequisite to agency issuance of an authorization to operate (ATO).

b. The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee in reviewing and updating the PIA at least every three years throughout the Enterprise Performance Life Cycle (EPLC) /information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

A. POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract: [See the FDA Security Article, entitled Contractor Personnel Security Clearance Standards and Residency Requirements for the Position Risk Designation Tier(s) (i.e., 1, 2, and/or 4”) that apply to this award.]

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12) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR as soon as it is known that an employee will stop working under this contract.

13) 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 non-government-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 FDA policies.

14) The Contractor (and/or any subcontractor) shall coordinate with the COR via email, copying the

Contract Specialist, to ensure that the appropriate person performs and documents the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm as soon as it is known that an employee will terminate work under this contract within days of the employee’s exit from the contract. All documentation shall be made available to the CO and/or COR upon request. Contractor shall work with COR to access eDepart system.

B. RECORDS AND MANAGEMENT AND RETENTION

The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 - Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/FDA policies and shall not dispose of any records unless authorized by HHS/FDA.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/FDA policies.

C. FDA PERSONNEL SECURITY CLEARANCE REQUIREMENTS.

Contractor Personnel Security Clearance Standards and Residency Requirements (October 2017)

1. BACKGROUND - The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that Contractor employees (including subcontractors) who will be working in DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, must undergo a background investigation that results in a favorable determination.

Contractor employees who will work in DHHS-owned or leased space for less than thirty (30) days are considered visitors and are exempted from background investigation requirements; and therefore, will not be issued a Personal Identity Verification (PIV) Card. These contractor employees go through visitor screening each day and must be escorted at all time while in DHHS- owned or leased space.

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2. GENERAL - The Contractor must submit the following items to the Contracting Officer’s Representative (COR), within five (5) business days of commencement of work under this contract:

• A roster of contractor employee names, identifying Key Personnel and Tier designation(s);

• Confirmation all individual employee security information has been submitted properly; and

• "Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in the roster.

Pursuant to HSPD-12, the Contractor must advise its prospective employees about the security and background requirements stated herein.

For any individual who does not obtain a favorable background investigation he/she must cease work on the contract immediately.

If a Contractor employee changes job responsibilities under this contract, the Contractor must notify the COR, and the Government will make a determination whether an additional security clearance is required.

In the event there are any proposed personnel changes in the Contractor’s staffing roster previously submitted to the COR, the Contractor must submit an updated roster to the COR, along with a brief explanation for the change. In turn, the COR will initiate the procedures stated herein to ensure any new contractor employees obtain a PIV card in a timely manner – prior to that individual commencing work under the contract.

Note: If the proposed personnel change is for a position designated Key Personnel under the contract, a complete justification – along with a resume or curriculum vitae – must be submitted to the Contracting Officer and COR for review and approval. If approved, the Contracting Officer will execute a Contract Modification prior to that individual commencing work under the contract.

3. BACKGROUND INVESTIGATIONS - With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the Contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor.

Employees who hold or have previously held a Government security clearance must advise the FDA Personnel Security Staff of the details of such clearance.

Note: Background investigations will be conducted by the Office of Personnel Management (OPM)

4. CONTRACT RISK DESIGNATION(S) - Contractor employees who will be in DHHS-owned or leased space for thirty (30) days or more must be able to obtain and shall obtain a PIV card pursuant to Homeland Security Presidential Directive-12 (HSPD-12) in order to access to DHHS-owned or leased property without an escort. (See Section 6 for details on the PIV Card process) However, in the event that work must commence before a security screening can be completed, contractor employees will be considered

P a g e 12 | 31 visitors, as described above, and allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing system (e-Qip) system. The FDA Personnel Security Specialist will provide access to the e-Qip as well as guidance as to which forms will be required. The forms required vary with the position risk designations for the contract.

All standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) to initiate background investigations. The assigned FDA Personnel Security Specialist will resolve with the contractor employee any issues arising out of inaccurate or incomplete forms.

The Risk Designation(s) for this contract is/are Tier(s):

Tier(s) 1.

There are three (3) potential position risk designations, which are:

• Non-Sensitive Low Risk (Tier 1) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by the FDA Personnel Security Specialist are required for Non-Sensitive Low Risk Positions.

• Sensitive Moderate Risk (Tier 2) or Sensitive High Risk (Tier 4) - Public Trust Positions - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs.

In order to access the e-QIP system, Contractor employees must provide the appropriate FDA Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. This information will be provided on the e-Qip form that will be electronically sent to the employee. The FDA Personnel Security Specialist will use this information to enter each Contractor employee into the e-QIP system.

Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the background investigation.

A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed.

Furthermore, any such noncompliance may detrimentally impact Contractor performance, Contractor performance evaluations, rights and remedies available at law and equity retained by the Government.

5. PERSONAL IDENTITY VERIFICATION (PIV) CARDS - All PIV Cards (and any other type of Government-issued Access Card) shall remain the property of the Federal Government. At any time, if a Contractor employee is terminated or otherwise ceases work under the contract, or no longer requires a PIV Card for contract performance purposes, the Contractor must collect the individual’s PIV card and immediately notify FDA Personnel Security Staff in writing, with copies to the respective COR and Contracting Officer. The Contractor must immediately return the PIV Card(s) to the COR.

Because PIV Cards, like other Government-issued Access Cards are Government property, Contractors and Contractor Employees are hereby placed on notice that any abuse, destruction, defacement, P a g e 13 | 31 unauthorized transfer or withholding (i.e., failure to return to the Government) may be punishable to the greatest extent at law.

Unauthorized possession of a PIV Card, or any other type of Government-issued Access Card, and/or willfully allowing any other person to have or to use your Access Card, is prohibited and can be criminally prosecuted under 18 U.S.C. §§ 499 and 70I, which prohibit photographing or otherwise reproducing or possessing HHS identification cards in an unauthorized manner, under penalty of fine, imprisonment, or both. Wrongdoers may also be held financially responsible for any/all civil and equitable remedies – to include, but not limited to, damages for any pecuniary loss suffered by the Government as a result of any of the above-listed actions or failure to act.

6. PIV CARD PROCESS - The COR will sponsor Contractor employees on the Form HHS 745 and HHS Smart Card Management System (SCMS) for the purpose of obtaining an FDA PIV Card. In order to obtain a PIV card, a Contractor employee must receive a favorable FBI fingerprint return and complete required security forms. The FDA Personnel Security Specialist will provide the Contractor employee(s) direction for scheduling fingerprinting appointments at the FDA location or other approved location.

During a fingerprint appointment, each contractor employee must present two (2) forms of identification in order to receive his or her PIV Card. One form of identification must be a government-issued photo identification document. Acceptable forms of identification are listed in

Appendix A, provided below. An individual who receives an unfavorable report may appeal that finding by submitting a written request to the FDA Personnel Security Specialist.

Required background investigations may include, but are not limited to:

• Review of prior Government/military personnel records;

• Review of FBI records and fingerprint files;

• Searches of credit bureaus;

• Personal interviews; and

• Written inquiries covering the subject's background.

7. RESIDENCY REQUIREMENTS FOR FOREIGN NATIONALS - Under the requirements for Homeland Security Presidential Directive-12 (HSPD-12), OPM can complete a background investigation only for persons who have resided in the U.S. for a total of at least three (3) of the past five (5). The residency requirements apply only to foreign nationals. If any prospective foreign national contractor/subcontractor employee does not meet the residency requirements, he/she cannot qualify for a PIV Card under HSPD-12.

8. NON-PUBLIC DATA PROTECTION - The Contractor must protect the privacy of all information reported by or about Contractor employees and protect against unauthorized disclosure.

*Upon a favorable fingerprint return, the Contractor will be notified to return to the Badging and

Credentialing Office for their building pass.

*Food and Drug Administration Badging and Credentialing Office

8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m., Eastern Time

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10903 New Hampshire Avenue Building 32, Room 1205 Silver Spring, MD 20993

No appointment necessary Telephone: (301) 796-4000

10. Inspection and Acceptance________________________________________________________ The COR/designee shall review all Reporting Requirements/Deliverables in accordance with specifications and standards identified in the task order. The acceptance of equipment and satisfactory work performance, required herein, shall be based upon the timeliness, accuracy, quality of the deliverables.

The COR/designee shall perform inspection and acceptance of materials and services. Inspection and acceptance shall be performed at 10903 New Hampshire Ave, Silver Spring, MD 20993-0002 (FDA Campus). FDA shall have 10 days for inspection and acceptance, after which the deliverable will be deemed, accepted. The Contractor shall have 5 business days to fix the deliverable if FDA deems it unacceptable.

11. Contract Administration______________________________________________________________

Contracting Officer (CO):

TBD

Email:

Contracting Officer’s Representative (COR): (To be entered at time of award)

TBD

Email:

Contract Specialist (CS):

Allison Meads Email: Allison.Meads@fda.hhs.gov

10. Contracting Officer’s Authority________________________________________________________ The Contracting Officer (CO) 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 RFQ;

(2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this award. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the award. The Government will not reimburse the Contractor for any work not authorized by the Contracting Officer, including work outside the scope of the award.

The Contracting Officer’s Representative (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 contract and any other technical

P a g e 15 | 31 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.

13. IPP Invoicing Instructions_____________________________________________________________

(a) All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

(b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov.

(c) The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment.

The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

(1) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. or phone (866) 973- 3131. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

(2) The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

(3) If your company is already registered to use IPP, you will not be required to re-register.

(4) If the Contractors unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

(d)Invoices that include time and materials, or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and

(2) substantiate material costs incurred (when applicable).

(e)Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

(1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred. -Direct Labor-include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category.

-Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirect)-show rate, base and total amount; -Consultants (if applicable)-include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant.

-Travel-include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed; -Subcontractors (if applicable)-include, for each subcontractor, the same data as required for the Prime Contractor.

mailto:IPPCustomerSupport@fiscal.treasury.gov

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-Other Direct Costs-include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and-Fee– amountasallowableinaccordancewiththeScheduleandFAR52.216-8ifapplicable.

(f) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following: invoice number, amount, & date submitted-corresponding payment amount &date received -totalamountofallpaymentsreceivedtodateunderthesubjectcontractororder-and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

(g) Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

(h) If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

(i) Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

(j) The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

(k) Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827- ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received.

When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

14. Payment terms_____________________________________________________________________ Payment terms Net 30 days after government acceptance of the supply item/service. Payments shall not be made more frequently than monthly in arrears. Advance payments will not be made.

15. FAR / HHSAR Clauses_______________________________________________________________ FAR 52.252-2 – Clauses Incorporated by Reference (Feb 1998) This purchase order incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Also, the following FAR and HHSAR provisions and clauses, incorporated by reference, apply to this acquisition and can be obtained in full text at: https://www.acquisition.gov/far/ and http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR Clauses https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

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52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) 52.204–23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab or Other Covered Entities (Jul 2018) 52.204-25 Prohibition on Contracting For Certain Telecommunications And Video Surveillance Services or Equipment (Aug 2020) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payment to Small Business Subcontractors (Dec 2013)

FAR Provision

52.211-6: Brand Name or Equal (Aug 1999)

HHSAR Clauses 352.232-71 Electronic Submission of Payment Requests [(APR 2026) (RFO DEVIATION)]

(a) Definitions. As used in this clause – Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements in FAR 32.905(b), and the applicable payment clause included in this contract.

(b) Submission instructions. Except as provided in paragraph (c) of this clause, the Contractor must submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c)Alternate submission procedures. The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing.

(d) Submission of alternate payment procedures authorization. If alternate payment procedures are authorized, the Contractor must include a copy of the Contracting Officer's written authorization with each payment request.

(End of clause)

352.239-71 Security Requirements For Information Technology Resources (Feb 2024) (Deviation)

(l) Definitions. As used in this clause— Information technology has the same meaning in FAR 2.101.

Information and communication technology (ICT) also means information technology (see FAR 2.101 for definitions).

Information system security plan means a formal document that provides an overview of the…