75D301-20-Q-72495.pdf

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

THIS RFQ IS X IS NOT A SMALL BUSINESS SET-ASIDE.

PAGE OF PAGES

1 25

1. REQUEST NO.

75D301-20-Q-72495

2. DATE ISSUED

08/28/2020

3. REQUISITION/PURCHASE REQUEST NO.

00HCVLBG-2020-47524

4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta GA 303414004

6. DELIVERY BY (Date)

5b. FOR INFORMATION CALL (No collect calls)

NAME TELEPHONE NUMBER

AREA CODE NUMBER

Sheenum Gupta (404) 498-3891 x

8. TO: 9. DESTINATION

a. NAME b. COMPANY a. NAME OF CONSIGNEE

c. STREET ADDRESS b. STREET ADDRESS

c. CITY

d. CITY e. STATE f. ZIP CODE d. STATE e. ZIP CODE

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON OR BEFORE CLOSE OF BUSINESS (Date)

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services.

Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

QUESTIONS DUE: 08/31/2020 3:00PM EST

QUOTES DUE: 09/04/2020 1:00PM EST

PLEASE QUOTE EQUIVALENT

ALL VENDORS MUST BE REGISTERED IN SAM.GOV TO

BID.

DUNS #_________________________________

PRICE FIRM FOR _________DAYS

IF ABOVE ITEMS ARE ON FEDERAL SUPPLY SCHEDULE,

PLEASE INDICATE THE CONTRACT

NUMBER__________________

CDC Contract Spec: Sheenum Gupta

E-mail: pyx9@cdc.gov

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS

b. 20 CALENDAR DAYS

c. 30 CALENDAR DAYS

d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations are are not attached.

13. NAME AND ADDRESS OF QUOTER 14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

15. DATE OF

QUOTATION

a. NAME OF QUOTER

b. STREET ADDRESS 16. SIGNER

a. NAME (Type or print) b. TELEPHONE

c. COUNTY AREA CODE

d. CITY e. STATE f. ZIP CODE c. TITLE (Type or print) NUMBER

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 18 (REV. 6-95)

Previous edition not usable Prescribed by GSA FAR (48 CFR) 53.215-1(a)

7. DELIVERY

FOB

DESTINATION

OTHER

(See Schedule) mailto:pyx9@cdc.gov

75D301-20-Q-72495

SUPPLIES OR SERVICES AND PRICES/COST

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Automated Monitoring System

Devices, peripherals, and installation of automated monitoring system that will record temperature, humidity, and CO2 levels in MDB laboratories and notify laboratory staff when required levels are out of range.

Period of Performance: September 21, 2020 – September 20, 2021

1 Each

STATEMENT OF WORK/DESCRIPTION

Title: Automated Equipment Monitoring - Mycotics Diseases Branch/DFWED/NCEZID

Period of Performance: September 21, 2020 – September 20, 2021

SECTION 1 – BACKGROUND AND NEED

The Centers for Disease Control and Prevention (CDC) works 24/7 to protect America from health, safety and security threats, both foreign and in the U.S. Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights diseases and supports communities and citizens to do the same. CDC’s Mycotics Disease Branch works to determine the burden of fungal infections, respond to outbreaks, and to address public health problems related to fungal infections.

In order for MDB to achieve their mission, state-of-the-art laboratory equipment must be in working order and compliant with either the Clinical Laboratory Improvement Amendments (CLIA) regulations or with the

International Standards Organization (ISO) requirements. These regulations and standards require monitoring of temperature and humidity in all laboratory areas where quality assurance materials and other samples are manufactured, stored, and/or tested. Accurate recordings are essential to ensure the quality of the materials being used and stored in the laboratory. Historically, monitoring and recording temperature, humidity, and CO2 in all required areas was done manually and over half of our equipment inventory requires at least daily monitoring. This process is inaccurate, impractical and cost prohibitive. The lack of automated notifications when levels are out of range could lead to severe damage to our collection full of invaluable, well-characterized specimens from around the world. CDC laboratories have an urgent need for a robust automated temperature, humidity, and CO2 monitoring and notification system.

SECTION 2 – PURPOSE

This requirement is to obtain an automated monitoring and notification system that will record temperature, humidity, and CO2 levels in MDB laboratories and notify laboratory staff when required levels are out of range.

SECTION 3 – SCOPE OF WORK

The vendor will provide and install a comprehensive monitoring system (blutooth enabled with digital download capabilities) to record temperature, humidity, and CO2 levels in necessary laboratory areas, including open laboratory rooms, refrigerators, freezers, and incubators. The monitoring system will include a network of temperature transmitters, laboratory receivers, and software to collect data (centralized via either cloud or server) and generate graphs and reports; remote access and notification capabilities; and door sensors to indicate when equipment is opened, closed, or left ajar.

The vendor will provide all necessary software and hardware, covering monitored equipment, rooms, and doors. The system must be scalable to allow future expansion.

The vendor must provide training to laboratory staff on how to access and use temperature monitoring effectively as well as what to do in the case of an issue with the monitoring system.

The vendor must be ISO 17025 compliant to perform required calibration/recalibration; perform installation qualification (IQ) and operational qualification (OQ) following laboratory protocol; and provide documentation on all installation and calibration activities.

SECTION 4 - TECHNICAL REQUIREMENTS

Temperature mapping the areas where laboratories store products ensures the products are kept at the correct condition which is essential for safety and compliance. This requirement includes purchase of equipment, warrantied for one (1) year, installation, software set up and monitoring.

a. Equipment must meet the following specifications

1. NIST traceable sensors (Temperature range -200 to 300C

2. Minimum of 0.1C resolution out of specification reporting with the ability to electronically review and/or approve reports

3. Ability to document corrections/corrective action with electronic signature

4. Single-server 21 CFR part 11/CLIA/ISO compliant system

5. Server and SQL instance that supports virtualization using VMWare ESC Hypervisor

6. Active Directory or LDAP Domain Authentication

7. Ability to create user groups and at least 3 permission levels

8. Text/email alerts

9. Secure and auditable logs of all system activity, recording user and action with date/time

10. 900Mhz Zigbee IEEE 802.15.4 Wireless Transmitters

11. Transmitter battery-life of at least 12 months, based on minimum two readings per hour

12. Minimum 14 days data buffering when power or connection to server fails

13. Replacing batteries does not erase logged data

14. Door status sensor and 2 analog sensor inputs on each transmitter

15. LCD temp/humidity/CO2 display on transmitter modules

16. Audible and visual alarms

17. 900Mhz Zigbee IEEE 802.15.4 Wireless Receivers with Gigabit Ethernet network ports

18. Self-healing, redundant MESH network topology that auto-recovers from receiver failures

19. User-friendly web-based client GUI (no client application required)

20. Graphs of monitored readings

21. Table, List and Map views of monitored resources

b. Warranty /Monitoring /Support

1. One (1) year equipment warranty

2. Perform installation qualification (IQ) and operational qualification (OQ)

3. Unlimited phone, fax, e-mail and website operational support for up to two MDB points-of-contact.

4. Remote support must be available 24 hours per day, 7 days per week. Local 8/5 tech support (local support technician proximal to campus)

5. Onsite support must be available 8 hours per day, 5 days per week, excluding federal holidays.

6. Remote 24/7 tech support (for support during emergency response activities)

7. Users’ phone calls must be returned within four (4) business hours if not handled immediately; and

8. Provide support for all equipment in ATTACHMENT A: Equipment list.

9. Provide NIST traceable calibration services by an ISO 17025 certified vendor.

10. Provide application server software /firmware updates in a timely manner and without additional cost.

11. Provide a HHS Product Accessibility Template (HHS PAT) for every software release or upgrade (for

Section 508 compliance) after system installation.

SECTION 5 – REPORTING SCHEDULE

The contractor shall provide announcements of product updates through customer service bulletins and announcements or directly to MDB points of Contact.

SECTION 6 – DELIVERY SCHEDULE

The delivery schedule for equipment installation shall be between four (4) and eight (8) weeks from the date of award.

Equipment shall be under warranty for a period of twelve (12) months beginning the day after installation and qualifications are completed.

The system may be expanded and/or additional systems /components may be acquired in the future. Expansion will be determined as needed and funded through issuance of a contract modification.

SECTION 7 – OTHER REQUIREMENTS

a. Safety (as applicable for each laboratory): As required by the Occupational Safety and Health

Administration’s (OSHA) Bloodborne Pathogens Program (BBP), Standard 29 CFR 1910.1030, CDC’s Exposure

Control Plan (ECP) is in place to inform employees about appropriate control measures necessary to eliminate or minimize exposure to human blood and other potentially infectious materials.

1. CDC requires contractors that may be exposed to these hazards comply with the requirements listed in the BBP ECP.

2. All mechanical or electrical systems that must be deactivated prior to service shall be deactivated by whatever disconnect or shut-off means are provided. Each deactivated system shall be properly "tagged-out" to prevent accidental reactivation. The CDC Environmental, Safety and Health Compliance (ESHCO) will furnish "tag-out" procedures and tags. The government shall be responsible for performing surface decontamination of equipment; removing the contents of equipment and ensuring the equipment is biologically safe before making it available to the contractor service representative for service or repair.

b. Security: Information Security Continuous Monitoring - Upon the government issuance of an Authority to Operate (ATO), the vendor owned/operated systems that input, store, process, output, and/or transmit government information, shall meet or exceed the information security continuous monitoring (ISCM) requirements in accordance with FISMA and NIST SP 800-137, Information Security Continuous Monitoring (ISCM) for Federal

Information Systems and Organizations, and HHS IS2P. The following are the minimum requirements for ISCM:

1. Annual Assessment/Pen Test - Assess the system security and privacy controls (or ensure an assessment is conducted) at least annually to determine the implemented security and privacy controls are operating as intended and producing the desired results (may involve penetration testing conducted by the agency or independent third-party.) Review relevant SA&A documentation (SSP, POA&M, Contingency Plan, etc.).

2. Asset Management - Using any available Security Content Automation Protocol (SCAP)-compliant automated tools for active/passive scans, provide an inventory of all information technology (IT) assets for hardware and software, (computers, servers, routers, databases, operating systems, etc.) that are processing HHS-owned information/data. It is anticipated that this inventory information will be required to be produced at least annually or to comply with CDC/ATSDR change management requirements. IT asset inventory information shall include IP address, machine name, operating system level, security patch level, and SCAP- compliant format information. The contractor shall maintain a capability to provide an inventory of 100% of its IT assets using SCAP-compliant automated tools.

3. Configuration Management - Use available SCAP-compliant automated tools, per NIST IR 7511, for authenticated scans to provide visibility into the security configuration compliance status of all IT assets, (computers, servers, routers, databases, operating systems, application, etc.) that store and process government information. Compliance will be measured using IT assets and standard HHS and government configuration baselines. The contractor shall maintain a capability to provide security configuration compliance information for

100% of its IT assets using SCAP-compliant automated tools.

4. Vulnerability Management - Use SCAP-compliant automated tools for authenticated scans to scan information system(s) and detect any security vulnerabilities in all assets (computers, servers, routers, Web applications, databases, operating systems, etc.) that store and process government information. Contractors shall actively manage system vulnerabilities using automated tools and technologies where practicable and in accordance with HHS policy. Automated tools shall be compliant with NIST-specified SCAP standards for vulnerability identification and management. The contractor shall maintain a capability to provide security vulnerability scanning information for 100% of IT assets using SCAP-compliant automated tools and report to the agency at least monthly.

5. Patching and Vulnerability Remediation - Install vendor released security patches and remediate critical and high vulnerabilities in systems processing government information in an expedited manner, within vendor and agency specified timeframes.

6. Secure Coding - Follow secure coding best practice requirements, as directed by United States

Computer Emergency Readiness Team (US- CERT) specified standards and the Open Web Application Security

Project (OWASP), that will limit system software vulnerability exploits.

7. Boundary Protection - The contractor shall ensure that government information, other than unrestricted information, being transmitted from federal government entities to external entities is routed through a Trusted

Internet Connection (TIC).

8. End of Life Compliance. The Contractor (and/or any subcontractor) must use Commercial off the Shelf

(COTS) software or other software that is supported by the manufacturer. In addition, the COTS/other software need to be within one major version of the current version; deviation from this requirement will only be allowed via the

HHS waiver process (approved by HHS CISO). The contractor shall retire and/or upgrade all software/systems that have reached end-of-life in accordance with HHS End-of-Life Operating Systems, Software, and Applications

Policy.

c. Special Considerations: The vendor shall employ a formal tracking system to identify and track customer issues reported to them. The tracking system shall include a critical evaluation of the reported issues, proposed resolutions for each issue, an estimated timeline for release of updates to correct each issue, and documentation of product quality assurance activities related to validation of software fixes and enhancements. The vendor must maintain a timeline of planned future product releases to include estimated timelines and specific issues addressed as part of the expected product release, and make such timelines available on request.

SECTION 8 – GOVERNMENT FURNISHED MATERIALS

CDC will not furnish any property. The server is hosted in a consolidated virtual environment provided by CDC.

The vendor shall ensure that all IT equipment (e.g., laptops, desktops, servers, routers, mobile devices, peripheral devices, etc.) used to process information on behalf of CDC are deployed and operated in accordance with approved security configurations and meet the following minimum requirements:

a. Encrypt equipment and sensitive information stored and/or processed by such equipment in accordance with HHS and FIPS 140-2 encryption standards.

b. Configure laptops and desktops in accordance with the latest applicable United States Government

Configuration Baseline (USGCB), and HHS Minimum Security Configuration Standards;

c. Maintain the latest operating system patch release and anti-virus software definitions;

d. Validate the configuration settings after hardware and software installation, operation, maintenance, update, and patching and ensure changes in hardware and software do not alter the approved configuration settings;

e. Automate configuration settings and configuration management in accordance with HHS security policies, including but not limited to:

1. Configuring its systems to allow for periodic HHS vulnerability and security configuration assessment scanning; and

2. Using Security Content Automation Protocol (SCAP)-validated tools with USGCB Scanner capabilities to scan its systems at least on a monthly basis and report the results of these scans to the CO and/or COR, Project Officer, and any other applicable designated POC.

SECTION 9- QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Requirement Milestone Standard Incentive /Disincentive

Installation Between 4 and 8 weeks from contract award

No deviations from the standard allowed on-time payment /delayed payment

IQ, OQ Within 30- days of installation on- time payment /delayed payment

SECTION 10- DELIVERABELS

Deliverable Due Date

Roster Within 30 days of the effective date of the contract

Contract Employee Non- Disclosure Agreement

(NDA)

At contract award and Prior to performing work

Assist in the completion of a PTA/PIA form As required by the COR.

Copy of training records for mandatory training At contract award and annually thereafter

Signed ROB for all employees At contract award and annually thereafter

Incident Report (as incidents or breaches occur) As soon as possible and no later than 1 hour of discovery

Incident and Breach Response Plan Upon request from government

List of Personnel with roles and responsibilities Within 30 days before an employee begins working

Onboarding documents, equipment and badge At contract award and Prior to performing work

Off-boarding documents, equipment and badge Within 30 days after CDC final acceptance of work or at termination

Form or deliverables required by OpDiv. At contract expiration.

SA&A Package; SSP; SAR; POA&M; Authorization

Letter; CP and CPT Report; E-Auth; PTA/PIA (if applicable); Interconnection /Data Use Agreements ;

Configuration Management Plan and Baseline

Due within 6 months of system go live date.

SECTION 11– TRAVEL

Travel may be required for installation of temperature monitoring system and training of laboratory staff. Contractor will be responsible for all associated travel costs.

SECTION 12 – INSPECTION AND ACCEPTANCE CRITERIA

The CDC COR and/or designee will monitor the contractor's performance and shall be responsible for documenting acceptance or rejection of contractor services with five (5) business days of services being rendered. If inspection and written (e-mail) notice of rejection has not been provided to the contractor with ten (10) business days of service, such services will be determined acceptable.

CDC Clauses

1. Contract Communications/Correspondence (Jul 1999)

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

(End of Clause)

2. Contracting Officer (Jul 1999)

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States

Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

3. CDC0_G008 Contracting Officer’s Representative (COR) (Jul 2017)

Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract.

As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof.

In the event that the Contractor believes full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer, immediately or as soon as possible, in a letter or e-mail separate of any required report(s). No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government COR is not authorized to change any of the terms and conditions of this contract. Contract changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the COR delegation memorandum upon request.

4. CDC0_G018 Payment by Electronic Funds Transfer (Feb 2018)

(a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer –System for Award Management, in

Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In the case that EFT information is not within the System of Award Management, FAR 52.232-34 requires mandatory submission of Contractor’s EFT information directly to the office designated in this contract to receive that information (hereafter: “designated office”); see below. The contractor shall submit the EFT information within the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the

Contracting Officer or the CDC Office of Financial Resources at 678-475-4510.

(c) In cases where the contractor has previously provided such information, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

(d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention

Office of Financial Resources (OFR)

P.O. Box 15580

Atlanta, GA 30333

Or – Fax copy to: 404-638-5342

5. CDCAG001 – – Invoice Submission (Jul 2017)

(a) The Contractor shall submit the original contract invoice/voucher to the address shown below:

The Centers for Disease Control and Prevention Office of Financial Resources (OFR) P.O. Box 15580 Atlanta, GA

30333

Or – The Contractor may submit the original invoice via facsimile or email:

Fax: 404-638-5324

Email: FMOAPINV@CDC.GOV

NOTE: Submit to only one (1) of the above locations.

(b) The contractor shall submit 2 copies of the invoice to the cognizant contracting office previously identified in this contract. These invoice copies shall be addressed to the attention of the Contracting Officer.

Financial Management Office (FMO): Email: FMOAPINV@CDC.GOV

(c) The Contractor is ___, is not _X_ required to submit a copy of each invoice directly to the Contracting Officer’s

Representative (COR) concurrently with submission to the Contracting Officer.

(d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Office of Financial Resources is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(e) The Contractor shall include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Task Order Number, if Appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information in (c)(1).

(13) DUNS + 4 Number

(14) Electronic funds transfer (EFT) banking information

6. CDC37.0001 Non-Personal Services (Jun 2020)

(a) Personal services shall not be performed under this contract. Although the Government may provide sporadic or occasional instructions within the scope of the contract, the Contractor is responsible for control and supervision of its employees. If the Contractor (including its employees) believes any Government action or communication has been given that would create a personal services relationship between the Government and any

Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

(b) The contractor shall comply with, and ensure their employees and subcontractors comply with, CDC

Policy titled "Contractor Identification and Safeguarding of Non-Public Information". No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. The contractor is limited to performing the services identified in the contract statement of work and shall not interpret any communication with anyone as a permissible change in contract scope or as authorization to perform work not described in the contract. All contract changes will be incorporated by a modification signed by the Contracting Officer.

(c) The Contractor shall ensure that all of its employees and subcontractor employees working on this contract are informed of the terms and conditions herein. The Contractor agrees that this is a non-personal services contract; and that for all the purposes of the contract, the Contractor is not, nor shall it hold itself out to be an agent or partner of, or joint venture with, the Government. The Contractor shall notify its employees that they shall neither supervise nor accept supervision from Government employees. The substance of the terms herein shall be included in all subcontracts at any tier.

(d) The terms and conditions above do not limit the Government's rights under other terms of the contract, including those related to the Government's right to inspect and accept or reject the services performed under this contract.

Special Contract Requirements

1. Information Security and/or Physical Access Security

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) employee 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 HHS network or operated by the Contractor on behalf of HHS 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.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS 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 HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

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, CISO, 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: [] Low [X] Moderate [ ] High

Availability: [X] Low [ ] Moderate [ ] High

Overall Risk Level: [] Low [X] Moderate [ ] High

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

[X] No PII [ ] Yes PII

4) Personally Identifiable Information (PII). Per the Office of Management and Budget (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 [ ] 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 32 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 HHS 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.

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.

7) Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS 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 HHS 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

[CDC] policies. Unauthorized disclosure of information will be subject to the HHS/[CDC] 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).

8) 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).

9) 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.

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

Document Deliverable Title/Description Due Date

Roster Roster By effective date of this contract

Contractor Employee Non-

Disclosure Agreement (NDA)

Contractor Employee Non-

Disclosure Agreement (NDA)

Prior to performing any work on behalf of HHS

Privacy Threshold Analysis (PTA)/

Privacy Impact Assessment (PIA)

Assist in the completion of a

PTA/PIA form

In conjunction with contract award

Training Records

Copy of training records for all mandatory training

In conjunction with contract award and annually thereafter or upon request

Rules of Behavior Signed ROB for all employees Initiation of contract and at least annually thereafter

Incident Response Incident Report ( as incidents or breaches occur)

As soon as possible and without reasonable delay and no later than 1 hour of discovery

Incident Response Incident and Breach Response Plan Upon request from government

Personnel Security Responsibilities List of Personnel with defined roles and responsibilities

Prior to performing any work on behalf of HHS

Personnel Security Responsibilities Onboarding documentation when beginning contract

Prior to performing any work on behalf of HHS

Background Investigation Onboarding documentation when beginning contract

Prior to performing any work on behalf of HHS

Certification of Sanitization of

Government and Government

Activity- Related Files, Information, and Devices

Form or deliverables required by

CDC

At contract expiration

Contract Initiation and Expiration If the procurement involves a system or cloud service, additional

At contract expiration documentation will be required, such as Disposition/Decommission Plan

11) 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. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and CDC-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 have been validated under the Cryptographic Module Validation

Program to confirm compliance 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 shall be provided to CDC Office of Chief Information Security Officer (OCISO).

12) 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 CDC non-disclosure agreement, as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or

CO Representative (COR) prior to performing any work under this acquisition.

13) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the CDC

Senior Official for Privacy (SOP) or designee with conducting a PTA for the information system and/or information handled under this contract in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the

Privacy Provisions of the E-Government Act of 2002.

a. The Contractor shall assist the CDC SOP or designee in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the CDC SOP that a review is required based on a major change to the system (e.g., new uses of information collected, changes to the way information is shared or disclosed and for what purpose, or when new types of PII are collected that could introduce new or increased privacy risks), whichever comes first.

B. Training

1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/CDC 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 CDC Security Awareness Training (SAT), Privacy, and Records

Management training at least annually, during the life of this contract. All provided training shall be compliant with

HHS training policies.

2) 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 (RBT) within 60 days of assuming their new responsibilities. Thereafter, they shall complete RBT at least annually in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security

Responsibilities Memorandum.

All HHS employees and contractors with SSR who have not completed the required training within the mandated timeframes shall have their user accounts disabled until they have met their RBT requirement.

3) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS 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.

C. Rules of Behavior

1) 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.

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department 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 CDC 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.

D. Incident Response

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 Federal Information Security Modernization Act (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.

OMB Memorandum M-17-12, “Preparing for and Responding to a Breach of Personally Identifiable Information”

(03 January 2017) states:

Definition of an Incident:

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.

Definition of a Breach:

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.

It further adds:

A breach is not limited to an occurrence where a person other than an authorized user potentially accesses PII by means of a network intrusion, a targeted attack that exploits website vulnerabilities, or an attack executed through an email message or attachment. A breach may also include the loss or theft of physical documents that include PII and portable electronic storage media that store PII, the inadvertent disclosure of PII on a public website, or an oral disclosure of PII to a person who is not authorized to receive that information. It may also include an authorized user accessing PII 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”.

Contracts with entities that collect, maintain, use, or operate Federal information or information systems on behalf of

CDC shall include the following requirements:

1) The contractor shall cooperate with and exchange information with CDC officials, as deemed necessary by the CDC Breach Response Team, to report and manage a suspected or confirmed breach.

2) All contractors and subcontractors shall properly encrypt PII in accordance with OMB Circular A-130 and other applicable policies, including CDC-specific policies, and comply with HHS-specific policies for protecting PII. To this end, all contractors and subcontractors shall protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

3) All contractors and subcontractors shall participate in regular training on how to identify and report a breach.

4) All contractors and subcontractors shall report a suspected or confirmed breach in any medium as soon as possible and no later than 1 hour of discovery, consistent with applicable CDC IT acquisitions guidance, HHS/CDC and incident management policy, and United States Computer Emergency Readiness Team

(US-CERT) notification guidelines. To this end, the Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center

(CSIRC) or CDC Computer Incident Response Team (CSIRT) within 24 hours via email at csirt@cdc.gov or telephone at 866-655-2245, whether the response is positive or negative.

5) All contractors and subcontractors shall be able to determine what Federal information was or could have been accessed and by whom, construct a timeline of user activity, determine methods and techniques used to access

Federal information, and identify the initial attack vector.

6) All contractors and subcontractors shall allow for an inspection, investigation, forensic analysis, and any other action necessary to ensure compliance with HHS/CDC Policy and the HHS/CDC Breach Response Plan and to assist with responding to a breach.

7) Cloud service providers shall use guidance provided in the FedRAMP Incident Communications Procedures when deciding when to report directly to US-CERT first or notify CDC first.

8) Identify roles and responsibilities, in accordance with HHS/CDC Breach Response Policy and the HHS/CDC

Breach Response Plan. To this end, the Contractor shall NOT notify affected individuals unless and until so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, all notifications must be pre-approved by the appropriate CDC officials, consistent with HHS/CDC

Breach Response Plan, and the Contractor shall then send CDC- approved notifications to affected individuals; and,

9) Acknowledge that CDC will not interpret report of a breach, by itself, as conclusive evidence that the contractor or its subcontractor failed to provide adequate safeguards for PII.

E. 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).

F. 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.

For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-

12)

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…