FDA-RFQ-CDRH-2023-118641 DIDSR2023-33705 - Glass Pathology Slides of Cancer.docx

Request for Quotations: FDA-RFQ-CDRH-2023-118641 DIDSR2023-33705-Glass Pathology Slides of Cancer.

Part-A (b) Continuation pages 1 – General- NOTICE OF COMBINED SYNOPSIS/SOLICITATION This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotes are being requested and a written solicitation will not be issued.

Solicitation Number # FDA-RFQ-CDRH-2023-118641, is issued as a Request for Quotations (RFQ). The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 20223-02. This is a solicitation for commercial items in accordance with the procedures of FAR Part 12–Acquisition of Commercial Items. This requirement is being solicited under full and open competition, using the Simplified Acquisition Procedures per FAR Subpart 13.5.

The U. S. Food & Drug Administration, (FDA) Office of Acquisition and Grants Services (OAGS) has a requirement to procure a CDRH-2023-118641 DIDSR2023-33705 - Glass Pathology Slides of Cancer, under solicitation FDA-RFQ-CDRH-2023-118641-DIDSR2023-33705.

2 - Contract Type The Government intends to award a Firm Fixed-Price (FFP) Purchase Order to procure the requested items/system/services.

The associated NAICS Code is: 334516-Analytical Laboratory Instrument Manufacturing. Offerors must have an active registration in www.SAM.gov, with completed representations and certifications, by the close date of the solicitation.

3.1. Background/Statement of Need

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

The Office of Science and Engineering Laboratories (OSEL) supports the CDRH’s mission of protecting and promoting public health. The OSEL undertakes the highest quality science to provide their customers with the best methods, tools and expertise to:

The Division of Imaging, Diagnostics, and Software Reliability (DIDSR) within CDRH’s OSEL, develops methods for evaluating the image quality of emerging imaging systems; develops methods for characterizing new medical image display devices; evaluates the dose reduction potential of new image reconstruction methods and assesses the performance of Artificial Intelligence and Machine Learning algorithms. The technical disciplines of the Division’s staff include physics, electrical and biomedical engineering, mathematics and statistics, computer science, and medical radiology.

3.2. Purpose

FDA seeks to purchase Glass Pathology Slides of Cancer. This project is an OSEL approved project in the Digital Pathology program. It is also embedded within the Pathology Innovation Collaborative Community, which has FDA participation:-https://www.fda.gov/about-fda/cdrh-strategic-priorities-and-updates/collaborative-communities-addressing-health-care-challenges-together.

3.3. Objective

This procurement supports research to create datasets of pathologist annotations, digital pathology images, and glass pathology slides that can be used to validate digital pathology imaging devices, display devices, artificial intelligence and machine learning models, and other components and issues involved in interpreting medical images. To be clear, annotations in this context are a recording of pathologist interpretations and measurements. The research creates and explores data-collection methods and tools, study designs, and statistical analysis methods and software. This procurement serves the mission of CDRH by studying and demystifying regulatory issues related to creating a validation dataset based on evaluations from clinicians. The demonstrative research and the methods, tools, and software will generate transparent regulatory science that will streamline the medical device review process and accelerate patient access to the digital pathology emerging technologies.

3.4 - Description/Specifications, salient characteristics and Statement of Work At a minimum, the requested system shall have the technical/salient/functional, operational characteristics and specifications here below described:

4. Conditions: Note* that:

4.1. The Contractor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement. The Contractor shall demonstrate how the requested items or services, “MEET” or “DO NO MEET” the salient/functional characteristics and specifications listed here-below. The Contractor shall annotate each salient/functional characteristics and specifications with the following: Meets (if it meets the specification) or Does not meet (if it fails to meet the specification).

4.2. Grey market or refurbished products will not be accepted.

4.3. The Vendor shall indicate if non-domestic items are included in the quote.

4.4. The Vendor shall provide all, of the items/services listed or none.

4.5. The Vendor shall meet all technical/salient/functional, operational characteristics and specifications listed, and if not the manufacturer, shall be able to provide the required service with OEM certified technicians and parts or show proof that they are an authorized third party re seller/provider.

V. Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

5. Minimum Specifications and Salient Characteristics. Technical Specifications.

5.1. Specifications/Salient characteristics

The requested system/items/services, shall at a minimum, meet all the technical/salient/functional, operational characteristics and specifications here-in, below listed.

The required features of this requirement are:

System Requirements and Deliverables:

Refer to Table 1 for instructions for preparing slides and metadata.

5.2. Other Considerations:

i. The cost to ship slides to the FDA should be included in the cost for each LIN.

ii. Warranty and Service: ONE-year warranty, against defects in workmanship and component failure. A full 1-year manufacturer warranty shall be included. The entire system shall be warranted for parts and labor for twelve (12) months from date of acceptance.

5.3. Tasks/Deliverable Items/ Deliverable Schedule and Performance Requirements. To meet the purpose and objective of this requirement, the Vendor shall meet the established timelines to provide the below Deliverables. The Vendor shall be responsible for delivery and installation of the instrument to the FDA facility designated herein.

5.3.1. Specific Tasks

Project Milestones/Completion Dates (Estimates and as applicable)

5.3.2. Table of Deliverables

Table 1. Instructions for preparing slides and metadata

Table 2: Primary Metadata

Male

Asian Black or African American Native Hawaiian or Other Pacific Islander White

Not Hispanic or Latino

IA

IB

IIA

IIB

IIIA

IIIB

IIIC

IV

Table 3: Secondary Metadata

Tumor size (cm)

Size of tumor in image as measured in centimeters

- CT or Mammogram prior to surgery around time of biopsy Number

TNM stage

Lobular Tubular Cribriform Mucinous Micropapillary Apocrine Metaplastic Adenoid cystic Other

II (moderately differentiated) III (poorly differentiated)

Mitosis (/10HPF)

2 (7–12 mitosis/2 mm2) 3 (13 mitosis or more/2 mm2)

Nuclear grade

2 (moderate increase in size and variability) 3 (marked variation)

2 (Moderate degree, 10-75%) 3 (Little or none, <10%)

BRCA mutation

BRCA2

Negative N/A (Test not performed)

N/A (Stain not performed)

Ki-67 intensity

2+ (Moderate positive staining) 3+ (Strong positive staining) N/A (Stain not performed)

Number

5.3.2. Delivery:

The work is to take place at the contractor’s site.

The glass pathology slides and metadata shall be provided within 120 days from contract award date.

The performance period may be extended to permit the collection of additional glass pathology slides.

Listing of all documents filed for each IRB. Copies of each signed document in a folder for quarterly review by FDA POC.

Slides and metadata. Metadata must be plain text digital data in a .csv format (comma separated value).

Monthly report indicating the number of cases identified, the slides pulled or prepared. Reports must be digital. Reports generated directly from the data using R markdown are preferred.

An aggregated running summary of the monthly reports Point of Contact (POC)

FDA/CDRH/OSEL/DIDSR

Attention: TBD Building W062, Room 4104 10903 New Hampshire Ave Silver Spring, MD 20993-0002

Contracting Officer Representative (COR) Attention: TBD Acquisition Program Specialist Division of Acquisition Services (DAS) Office of Management (OM) Center for Devices and Radiological Health (CDRH) U.S. Food and Drug Administration

6.1. Contractor Facility Access: Contractor staff, belongings, and their vehicles are subject to search when they arrive at the FDA facility.

6.2. SECURITY CONSIDERATIONS

Government will provide escort of Contractor’s staff. The company engineer shall not be provided access to any material that involves Non-Public positions and involves the lowest degree of adverse impact on the efficiency of the Agency.

7. Period of Performance and Shipment Destination/Place of Performance

7.1.1. The period of performance shall be one year of 12 months, including a one-year warranty.

7.1.2. The Period of Performance shall be as follows:

The glass pathology slides and metadata must be provided within 120 days from contract award date. The performance period may be extended to permit the collection of additional glass pathology slides.

The work is to take place at the contractor’s site. Vendor shall not require access to Sensitive Information.

7.2. Packing, Marking, Delivery and Shipping

The Contractor shall deliver the items and quantities ordered, all or none. All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor’s name. All required materials shall be delivered in immediate new, usable and acceptable condition, at the U. S. Food and Drug Administration (FDA) facility/address listed below:

Point of Contact (POC)

FDA/CDRH/OSEL/DIDSR

Attention: TBD Building W062, Room 4104 10903 New Hampshire Ave Silver Spring, MD 20903-0002

Contracting Officer Representative (COR) Attention: TBD Acquisition Program Specialist Division of Acquisition Services (DAS) Office of Management (OM) Center for Devices and Radiological Health (CDRH) U.S. Food and Drug Administration

The delivery or services shall be during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM, Eastern, excluding holidays.

The FDA’s TPOC will approve all tasks and deliverables. The delivery or services shall be performed during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM Eastern, excluding holidays.

The TPOC will be responsible for determining the acceptance of the work that is completed. The Vendor shall contact the TPOC by email or phone to schedule delivery. Deliveries shall be coordinated with the TPOC prior to shipment. No deliveries will be accepted without prior authorization from the TPOC.

INSPECTION AND ACCEPTANCE

The Project Officer or their designee that initiated the tasking or designated manager has the authority to accept or reject services. The acceptance of service and satisfactory work performance required herein shall be based upon the timeliness, accuracy and suitability of the service. The specific services and schedule for service shall be as agreed upon and documented.

The Government will accept goods, reports and services only if they conform to all terms and conditions of this order. The Government will provide written notification of acceptance or rejection within ten (10) business days of receiving the delivery.

The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within thirty (30) days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR or technical POC of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

i. Delivery and Marking All deliverables shall be marked as follows:

(a) Name and address of the Contractor,

(b) Contract Number

(c) Description of item contained therein; and

(d) Consignee’s name and address.

(e) Each delivery location may provide specific delivery instructions.

(f) Travel and expenses shall be covered by the Contractor.

ii. Payment of Postage and Fees All postage and fees related to distribution of deliverable including forms, reports, etc., shall be paid by the Contractor.

8.1. Contracting Officer’s Technical Point of Contact (TPOC)

The TPOC is responsible for the acceptance of the items or services requested.

8.2. Technical Direction

A. Performance of the work under the resultant contract shall be subject to the technical direction of the TPOC. The term "technical direction" is defined to include the following:

i). Technical directions to the Contractor which shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual scope of work, ii). Providing information to the Contractor for assistance in the interpretation of specifications, or technical portions of the work description, and iii). Reviewing and, where required by the contract, approving of technical reports, specifications, and technical information to be delivered by the Contractor to the Government under the requirement.

B. Technical direction shall be within the general scope of work stated in the contract. The TPOC does not have the authority to, and may not, issue any technical direction which (1) constitutes an assignment of additional work outside the general scope of the contract; (2) constitutes a change as defined in the contract clause entitled "Changes, FAR 52.212 – 4 (c)." (3) in any manner causes an increase or decrease in the total contract price; or (4) changes any of the expressed terms, conditions, or specifications of the contract.

C. All technical directions shall be issued in writing by the TPOC or shall be confirmed by him/her in writing within five (5) working days.

D. The Contractor shall proceed promptly with the performance of technical directions duly issued by the TPOC in the manner prescribed by this clause and within his/her authority under the provisions of this clause.

E. If, in the opinion of the Contractor, any instruction or direction issued by the TPOC is within one of the categories as defined in B. (1) through B. (4) above, the Contractor shall not proceed but shall notify the Contracting Officer, in writing, within five (5) working days after the receipt of any such instruction or direction and shall request the Contracting Officer to modify the Contract accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor, in writing, that, in his/her opinion, the technical directions are within the scope of this clause and do not constitute a change under the "Changes" clause of the contract. The Contractor shall thereupon proceed immediately with the direction given. Any failure of the parties to agree upon the nature of the instruction or direction, or upon the contract action to be taken with respect thereto, shall be subject to the provisions of the contract clause entitled "Disputes."

8.3. Contracting Officer’s Authority

The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of the statement of work. In the event the Contractor effects any changes at the direction of any person other than the CO or the TPOC the changes shall be considered to have been made without authority and no adjustment shall be made in the contract price to cover any increase in costs incurred as a result thereof. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract and modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds.

The Contracting Officer is the only person with authority to act as agent of the Government under the Contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of the Contract; or (5) otherwise change any terms and conditions of the Contract.

Part-B Contract Clauses

1. FAR 52.212-4 - Contract Terms and Conditions – Commercial – Items (Dec 2022).

2. FAR 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 these addresses: https://www.acquisition.gov/browse/index/far; https://www.acquisition.gov/hhsar

Health and Human Services Acquisition Regulation (HHSAR) Clauses can be viewed in full text at: http://www.hhs.gov/policies/hhsar/subpart352.html#Subpart352.1- InstructionsforUsingProvisionsandClauses

3. FAR 52.217-8 - Option to Extend Services. (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor any time before the contract expires.

4. FDA Security and Privacy (NA)

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following:

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

ii. 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 FDA 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.

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with FDA policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

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. Note to the Requiring Activity Representative: Complete the following section using the information obtained from the Information Security and Privacy Certification Checklist.

ii. Categorize all information owned and/or collected/managed on behalf of FDA and information systems that store, process, and/or transmit FDA information 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. Based on information provided by the System/Data Owner, ISSO, privacy representative, or other POC, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

Confidentiality: [ ] Low [ ] Moderate [ ] High

Integrity: [ ] Low [ ] Moderate [ ] High

Availability: [ ] Low [ ] Moderate [ ] High

Overall Impact Level: [ ] Low [ ] Moderate [ ] High

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of FDA regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s). This includes notifying the FDA Cybersecurity and Infrastructure Operations Coordination Center (CIOCC) within one (1) hour of discovery/detection in the event of a cybersecurity or privacy incident.

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the 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 Protection (IS2P) policy, by contacting the CO/COR or emailing your ISSO.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable FDA privacy policies and complete all the requirements below: Note to the Requiring Activity Representative: Complete this section using the information obtained from the Information Security and Privacy Certification Checklist. This information may be included after award in the event it is not yet available at the time of acquisition.

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (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.

ii. Based on information provided by the ISSO, System/Data Owner, or other security or privacy representative, it has been determined that this solicitation/contract involves: [ ] No PII [ ] PII

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not a full Privacy Impact Assessment (PIA) needs to be completed. If the results of the PTA show that a full PIA is needed, the Contractor must support the agency 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).

The Contractor must support the agency in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/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.

e. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI 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. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

i. Marked appropriately;

ii. Disclosed to authorized personnel on a Need-To-Know basis;

iii. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for 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

iv. Returned to FDA control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

f. 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) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

g. Government Furnished Equipment (GFE) for Foreign Travel. FDA personnel are prohibited from taking GFE when participating in personal, unofficial travel to foreign countries. FDA personnel are strictly prohibited from teleworking using GFE in foreign countries. FDA personnel must also request loaner GFE from the FDA Foreign Travel

h. 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 must be used only for the purpose of carrying out the provisions of this contract and must 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 must ensure that all work performed by its employees and subcontractors must 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 must 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 must be protected in accordance with HHS and FDA policies. Unauthorized disclosure of information will be subject to the HHS and FDA sanction policies and/or governed by the following laws and regulations:

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

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

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

i. Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol must comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

j. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115-232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR 52.204.25. The contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

k. 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 must 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, HTTPS is not required, but it is highly recommended. Consult the HHS Policy for Internet and Email Security for additional information.

program for official travel to any foreign country. Please see the FDA IS2P, Appendix T Government Furnished Equipment for Foreign Travel.

l. Contract Documentation. The Contractor must use provided templates, policies, forms, and other agency documents to comply with contract deliverables as appropriate. Note to the Requiring Activity Representative: See Appendix C for baseline deliverables. Do NOT include in procurement documentation.

m. Standard for Encryption. The Contractor (and/or any subcontractor) must:

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

ii. 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 an encryption solution that is validated with current FIPS 140 validation certificates from the NIST CMVP.

iii. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices 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).

iv. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificates from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR.

v. 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 http://csrc.nist.gov/publications/. Encryption keys must be provided to the COR upon request and at the conclusion of the contract.

n. Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the FDA non-disclosure agreement (3398 Form)], as applicable. Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition. Note to the Requiring Activity Representative: See Appendix D for the FDA Contractor Non-Disclosure Agreement. Do NOT include in procurement documentation.

2. Training Requirements

a. Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract must complete the applicable FDA information security awareness, privacy, and records management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees must complete FDA information security awareness, privacy, and records management training at least annually, during the life of this contract. All provided training must be compliant with HHS training policies.

b. 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.

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

3. Rules of Behavior

a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, HHS Rules of Behavior for Privileged Users, and FDA policies and standards.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Agency 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 above.

4. Incident Response

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/FDA CIOCC /Incident Response Team 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. In accordance with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable

Information (PII), an incident is "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" and a privacy breach is "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." For additional information on the HHS breach response process, please see the FDA IS2P Appendix F: Incident Response and the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

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

i. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with current FIPS 140 validation certificates from the NIST CMVP.

ii. 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 must send FDA approved notifications to affected individuals as directed by FDA’s SOP.

iii. Report all suspected and confirmed information security and privacy incidents and breaches to the FDA CIOCC, COR, CO, FDA SOP (or his or her designee), and other stakeholders, including breaches 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, 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, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

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

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

Encrypt sensitive information in attachments to email, media, etc.

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

v. 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 on demand.

5. 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 (e.g. tier 1, 2, or 4): ____________. Note to the Requiring Activity Representative: The Requiring Activity Representative, in conjunction with Personnel Security, must use the OPM Position Sensitivity Designation automated tool (https://www.opm.gov/investigations/) to determine the sensitivity designation for background investigations. After making those determinations, include all applicable position sensitivity designations.

6. Homeland Security Presidential Directive (HSPD)-12 The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2. Note to the Requiring Activity Representative: For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-12

7. Roster. The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to the COR and/or CO per the COR or CO’s direction. Any revisions to the roster as a result of staffing changes must 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 must provide a position description and the Government will determine the appropriate suitability level.

8. Contract Initiation and Expiration

a. General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor must follow the 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 and in accordance with the HHS Contract Closeout Guide (2012).

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) must provide all required documentation in accordance with SMGs published by FDA’s…