75F40126Q00383_final.docx

75F40126Q00383 - 3D Imaging Microscope System This is a combined synopsis/solicitation for commercial product prepared in accordance with the format in Federal Acquisition Regulation (FAR), Revolution FAR Overhaul (RFO) Part 12.2, as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2026-1, 3/13/2026.

This announcement constitutes the only solicitation and a separate solicitation will not be issued. The solicitation number is 75F40126Q00383. This solicitation is issued as a Request for Quotes (RFQ).

The associated North American Industry Classification System (NAICS) code for this acquisition is 334519: OTHER MEASURING AND CONTROLLING DEVICE MANUFACTURING; the applicable Small Business Size Standard is 600 employees. This requirement is solicited for full and open competition. This requirement is being solicited as an open market. Prospective offerors are responsible for downloading the solicitation and amendments from SAM.gov. The Government reserves the right to award a contract without discussion if the Contracting Officer determines that the initial offer provides the best value and discussions are not necessary.

The U.S. Food and Drug Administration (FDA) is requesting a quote for a Bruker Alicona InfiniteFocus G6 (IFM G6) optical 3D measurement system. This non-contact, optical 3D imaging and measurement system will be used by NFCC's Trace Examination Section (TES) for surface profilometry and difference analysis measurements, including tablet debossing, punch face embossing, surface abrasion, pit measurements, corroded surface analysis, and pharmaceutical packaging topography and print profiling. The system must expand analytical throughput to meet increasing demand for forensic 3D image analysis from law enforcement stakeholders.

Interested Quoters shall submit any questions concerning the RFQ at the earliest time possible to enable the Government to respond. Questions shall be submitted directly by email to Pamela.Lee@fda.hhs.gov. No phone calls. Questions not received by the question submission deadline of: September 10, 2026, 2026, at 3:00 PM ET may not be considered.

The deadline for receipt of offers for this requirement is: September 14, 2026, at 3:00 PM ET. Quote submissions must be submitted by email only to Pamela Lee at: Pamela.Lee@fda.hhs.gov. Subject line of the email should be titled: “Quote Submission: “75F40126Q00383 - 3D Imaging Microscope System”.

Part 1.0: Quotation Submission Instructions

1.1 Quoters shall submit a firm-fixed price quote, including details of all prices supporting the required deliverables.

1.2 The quoter shall complete the pricing chart below. Pricing shall include all applicable fees including FOB destination shipping and handling. Any charges presented after contract will not be considered.

1.3 Quotes shall clearly reference the RFQ, date of offer, company proposing and point of contact.

1.4 Quote shall be valid for at least 60 days after close of RFQ.

1.6 Quoters shall include in the quote:

· a point of contact (name, telephone number, and email address),

· proposed firm-fixed-prices,

· business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.),

· Unique Entity ID (UEI) number,

· certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current.

Quoters shall ensure the RFQ number is visible in the header of the email transmission of their quote.

1.7 Award Criteria:

Quotations that do not respond to all requirements in the solicitation may be considered non-responsive without further evaluation nor consideration. The Government reserves the right to award without discussions. The Government contemplates award of a Firm-Fixed-Price Purchase Order resulting from this solicitation to the responsible Quoter whose quote conforming to the solicitation will be most advantageous to the Government and whose quote is the Lowest Priced Technically Acceptable (LPTA).

1.8 52.252.-1 Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

Provisions Number Title

(End of provision)

1.8.1 Authorized Deviations in Provisions (Nov 2020)

(a) The use in this solicitation of any Federal Acquisition Regulation (48 CFR Chapter 1) provision with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the provision.

(b) The use in this solicitation of any ______________ [insert regulation name](48 CFR Chapter______) provision with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of provision)

Part 2: Schedule of Products (all shipping and handling shall be included in the price)

Item #

Total:

Part 3: Statement of Work (SOW) 3D Imaging Microscope System

BACKGROUND

The National Forensic Chemistry Center (NFCC) requires an additional InfiniteFocus Microscope (IFM) system to expand analytical throughput to meet increasing demand for forensic 3D image analysis from stakeholders in law enforcement.

The IFM system is a non-contact, optical, 3D imaging and measurement system used by NFCC's Trace Examination Section (TES) for surface profilometry and difference analysis measurements, including tablet debossing, punch face embossing, surface abrasion, pit measurements, corroded surface analysis, and pharmaceutical packaging topography and print profiling. Over the past 17 years NFCC has used these systems to amass detailed 3D images of hundreds of forensic samples.

Increasing demand for forensic 3D image analysis in support of counterfeit pharmaceutical investigations has begun to exceed the capabilities of the single instrument currently in use for this type of analysis. These investigations increasingly involve large numbers of individual items to be analyzed, necessitating automated, high-throughput methods of image capture and analysis. Additional analysts have been trained to perform the analysis, but an additional instrument is required to meet growing stakeholder demand.

Additionally, system software upgrades included with a new system are expected to reduce data analysis time, increase cases processed per month for analysts, and achieve accuracy in automated matching. These upgrades will yield long-term benefits, including improved forensic capabilities, operational efficiency, strategic advantages, financial benefits, and future-proofing. Specifically, they will enhance accuracy and reliability, reduce costs, increase throughput, and ensure scalability and adaptability to future technologies.

The IFM system is crucial for meeting growing demand for the NFCC's forensic 3D image analysis capabilities, supporting stakeholder efforts to combat counterfeit pharmaceuticals and illicit drugs.

PURPOSE

The U.S. Food and Drug Administration (FDA), in support of the National Forensic Chemistry Center (NFCC), requires a Bruker Alicona IFM System which meets the following requirements:

SCOPE

I. Minimum Performance Requirements/Salient Characteristics Salient Characteristics The contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this statement of work, including the hardware system requirements which are the minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the NFCC prior to purchase.

1.0 General Requirement

The National Forensic Chemistry Center (NFCC) requires a Bruker Alicona InfiniteFocus G6 (IFM G6) optical 3D measurement system. This non-contact, optical 3D imaging and measurement system will be used by NFCC's Trace Examination Section (TES) for surface profilometry and difference analysis measurements, including tablet debossing, punch face embossing, surface abrasion, pit measurements, corroded surface analysis, and pharmaceutical packaging topography and print profiling. The system must expand analytical throughput to meet increasing demand for forensic 3D image analysis from law enforcement stakeholders.

2.0 Core Technology and Measurement Principle

2.1 The system shall be based on the principle of Focus Variation Microscopy (FVM), utilizing Bruker Alicona's proprietary Focus Variation algorithms to reconstruct high-resolution 3D surfaces.

2.2 The system must include advanced illumination technology (e.g., ring light, coaxial light) to enable accurate measurement of surfaces with steep angles, up to and exceeding 85 degrees.

2.3 The system must be capable of measuring both form and surface roughness parameters in a single measurement, with all data being co-registered.

2.4 The system must have the ability to measure highly reflective materials without surface treatment. The system must be capable of acquiring accurate 3D topographic data on reflective and specular materials without requiring surface alteration that could compromise the integrity of forensic samples.

2.5 The system must have the capability to capture true-color optical data co-registered with 3D topography. This capability supports surface characterization, documentation, and interpretation of coating or material variations. Many profilometry systems such as systems that use laser or tip technologies do not provide integrated true-color 3D datasets.

3.0 Performance Specifications

3.1 Resolution:

· Vertical resolution of 10 nm or better

· Capable of measuring minimum areal surface roughness (Sa) of 0.015 µm or better

3.2 Positioning Volume: Minimum positioning volume of 200 mm (X) × 200 mm (Y) × 180 mm (Z) to accommodate a wide range of sample sizes.

3.3 Objective lens compatibility: The system must include at a minimum 5x and 10x objective lenses to maintain consistency in data capture with existing datasets.

4.0 Hardware Requirements

4.1 The system shall include all necessary hardware components for a complete IFM G6 installation.

4.2 Minimum Computer Requirements:

· Operating System: Windows 11 64-bit

· GPU (graphics card): NVIDIA required

· RAM: 16 GB minimum

· Hard Disk: 1 TB minimum

5.0 Software Requirements and Data Compatibility

5.1 Critical Requirement: Backward Compatibility with Historical NFCC Data This is a mandatory, non-negotiable requirement. The IFM G6 system's software and native data formats must provide seamless backward compatibility with data generated from the NFCC's existing Bruker Alicona InfiniteFocus G5 system and the NFCC’s extensive digital library of historical forensic 3D datasets.

5.1.1 Native Compatibility with Proprietary Formats: The software must provide full, native read/write/search support for Bruker Alicona proprietary 3D dataset formats (e.g., .al3d, .met, and associated metadata). The system must interact directly with the IFM G5's existing sensor calibrations and optical encoders without requiring data conversion.

5.1.2 Unified Analysis Environment: The system must allow for the loading, storage, analysis, and direct quantitative comparison of historical datasets from the G5 system alongside newly acquired G6 data within a single, unified software environment. This capability is critical to ensure:

· Continuity of long-term forensic investigations and trend analysis

· Preservation of historical quality assurance data

· Metrological traceability across system generations

· The ability to compare evidence collected at different time periods using different system generations

5.1.3 Technical Continuity and Data Integrity: The current NFCC digital library consists of close to a terabyte of high-resolution 3D measurements acquired on the G5 system. The G6 software must guarantee that 3D point cloud data, difference analysis measurements, and surface difference measurement calculations remain consistent with the original G5 acquisition parameters. Only the original equipment manufacturer's (OEM) software can ensure non-destructive access to this historical data while maintaining metrological traceability.

5.1.4 Proprietary Interoperability: The IFM systems use specific Focus Variation algorithms unique to the Alicona architecture. The G6 software must be able to parse the specific headers and metadata layers from G5 datasets to enable full searchability and comparison capabilities across both historical and new data.

5.2 Advanced Data Management and Searchability

5.2.1 High-Volume Library Indexing (terabyte-scale): The software must be capable of indexing and querying the NFCC's terabyte-sized digital library of 3D datasets, including all historical G5 data.

5.2.2 Search-in-Place Capabilities: Users must be able to query historical NFCC datasets based on metadata (date, operator, difference analysis measurements, roughness parameters, or batch ID) without having to load individual massive files into active memory.

5.2.3 Non-Destructive Data Integrity: The software must utilize a read-only indexing protocol when accessing the current NFCC digital library. Search, upload, or transfer processes must not alter the original timestamp, file structure, or metrological traceability of existing 3D datasets.

5.2.4 Seamless Dataset Ingestion and Expansion: The platform must allow for seamless background uploading or cataloging of all current NFCC in-house datasets (including G5 data) while simultaneously allowing users to add new G6 measurements to the database in real-time.

5.3 Software Licenses

5.3.1 The software license(s) must include measurement, analytical, and automation software (if separate).

5.3.2 All software upgrades and updates must be included for the duration of the maintenance period.

5.4 Automation and Integration

5.4.1 The system software shall support the creation of user-independent, automated measurement routines that can be initiated with a single button press or via a barcode scanner.

5.4.2 The system must support CAD-based measurement planning, allowing operators to define measurement points and strategies directly on digital models.

5.4.3 The system must provide advanced programming interfaces (e.g., .NET remoting interface or LabVIEW framework) for integration into custom automated workflows.

5.5 Data Output and Connectivity

5.5.1 The system must be capable of exporting full 3D point cloud and mesh datasets in industry-standard formats (e.g., STL, PLY, XYZ) for use in third-party CAD, CAM, and analysis software.

5.5.2 The system must provide options for connecting to and exchanging data with higher-level enterprise systems, such as Quality Management (QM) and Enterprise Resource Planning (ERP) systems.

6.0 Metrological Traceability and Verification

6.1 The system's measurements for both form and roughness must be traceable to recognized metrology standards.

6.2 The vendor must provide documentation and traceable calibration artifacts to verify system performance according to international standards, including EN ISO 25178 (for areal surface texture) and EN ISO 10360 (for CMM verification).

7.0 Training, Support, and Documentation

7.1 Installation and Training:

· The system shall be installed with all necessary files required for installation and start-up

· Installation and operational training shall be included and provided within 30 days of delivery

· Training must enable operators to independently operate the system

7.2 Support:

· Annual phone and online remote support must be included

· Annual maintenance costs for additional licenses purchased during the contract term shall be prorated from the date of purchase to the date of contract renewal

7.3 Documentation:

· Complete system manuals must be provided

8.0 Summary of Mandatory Differentiating Capabilities

To be considered compliant, the proposed Bruker Alicona InfiniteFocus G6 system must include the following critical capabilities:

1. Core technology based on advanced Focus Variation Microscopy

2. Ability to measure steep angles exceeding 85 degrees

3. Demonstrable backward compatibility for data comparison with the NFCC's existing InfiniteFocus G5 system – This includes native support for G5 proprietary data formats, seamless integration of historical and new datasets, and preservation of metrological traceability across system generations

4. OEM software that guarantees non-destructive indexing and searchability of the existing terabyte-scale NFCC digital library

Justification for OEM-Specific Requirement:

The requirement for the Bruker Alicona InfiniteFocus G6 with OEM software is justified by the critical need to maintain backward compatibility with the NFCC's substantial investment in historical forensic data. Only the original equipment manufacturer's upgraded software can guarantee non-destructive indexing of existing G5 datasets while ensuring seamless, real-time integration with both G5 and G6 hardware. Failure to utilize OEM software would result in loss of metrological traceability and require a costly, high-risk migration of the entire NFCC digital library of 3D datasets, potentially compromising ongoing and future forensic investigations.

Deliverables

Shipping Destination Any required shipping documentation to the following laboratory:

US Food & Drug Administration National Forensic Chemistry Center 6751 Steger Dr.

Cincinnati, OH 45237 POC Name: TBD

Period of Performance/Place of Performance The equipment will be purchased so the Period of Performance runs from the date of contract award through the end of the Original Equipment Manufacturer’s (OEM) warranty period (minimum one year).

Equipment to be delivered no later than 30 days after contract award.

2.3 Interpretations of Modifications

No oral or written statement of any person and no written statement of anyone other than the CO shall modify or otherwise affect the terms and conditions of this contract. Requests for interpretations, modifications or changes must be made in writing to the CO. The technical point of contact can only respond to technical matters that do not result in a change of scope to this contract.

2.4 Security and Privacy

A. Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

a. 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.

b. 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.

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

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.

3) 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: [ ] Low [X] Moderate [ ] High Integrity: [ ] Low [X] Moderate [ ] High Availability: [X] Low [ ] Moderate [ ] High Overall Risk Level: [ ] Low [X ] 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:

[ ] No PII [ X] 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:

[ ] Low [X] Moderate [ ] High The Privacy Act does not apply.

4) 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 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.

5) 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).

6) 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).

7) 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.

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

9) Standard for Encryption. The Contractor (and/or any subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. All devices (i.e.: desktops, laptops, mobile devices, etc.) that store, transmit, or process non-public FDA information should utilize FDA-provided or FDA information security authorized devices that meet HHS and FDA-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use are compliant with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the COR.

e. Use the Key Management system on the HHS Personal Identification Verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys (PIV card) shall be provided to the COR upon request and at the conclusion of the contract. Upon completion of contract, contractor ensures that COR is able to access and read any encrypted data.

10) 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 FDA non-disclosure agreement (3398 Form), 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.

1.1.1.1 Training

12) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable FDA Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete FDA Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS and FDA training policies.

13) Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS and FDA policy and FDA Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Standard Operating Procedures (SOP).

14) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS and FDA policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

1.1.1.2 Rules of Behavior

15) The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior.

16) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior (ROB) before accessing HHS and FDA data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual FDA Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines.

1.1.1.3 Incident Response

The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/FDA SMC /Incident Response Team (IRT) teams within 24 hours, whether the response is positive or negative.

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies.” The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by FISMA as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII.”

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

17) Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

18) NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send FDA approved notifications to affected individuals as directed by FDA’s SOP.

19) Report all suspected and confirmed information security and privacy incidents and breaches to the FDA Systems Management Center, COR, CO, and other stakeholders, (Recommend adding the FDA Senior Official for Privacy with contact information and either defining or deleting “other stakeholders.”) including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour of discovery/detection, and consistent with the applicable FDA and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

a. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

b. not include any sensitive information in the subject or body of any reporting e-mail; and

c. encrypt sensitive information in attachments to email, media, etc.

20) Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information and HHS and FDA incident response policies when handling PII breaches.

21) Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation demand.

1.1.1.4 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.]

1.1.1.5 Homeland Security Presidential Directive (HSPD)-12

The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

Roster. 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 and any revisions to the roster as a result of staffing changes shall be submitted to the COR and/or CO per the COR or CO’s direction. Any revisions to the roster as a result of staffing changes shall be submitted within a timeline as directed by the COR and/or CO. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.

1.1.1.6 Contract Initiation and Expiration

22) 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 FDA EPLC framework and methodology in accordance with the FDA EPLC Project documentation, located here: http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePages/v2/EPLCHome.aspx HHS EA requirements may be located here: https://www.hhs.gov/about/agencies/asa/ocio/index.html

23) 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 system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

24) 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 FDA OAGS SMGs 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 and FDA IS2P Appendix T: Sanitization of Computer-Related Storage Media

25) 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.

26) 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.

27) 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.

1.1.1.7 Records 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.

Part 4: Contract Clauses

4.1 52.252-2 Clauses Incorporated By Reference (Feb 1998) This contract 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 full text of a clause may be accessed electronically at this/these address(es):

Clauses Number Title