75D30124Q77701 Bio-Rad Maintenance (Open Market).doc

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

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

PAGE OF PAGES

1. REQUEST NO.

75D301-24-Q-77701

2. DATE ISSUED

04/23/2024

3. REQUISITION/PURCHASE REQUEST NO.

000HCRKD-2024-84063

4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY

Centers for Disease Control and Prevention

Chamblee Campus Building 102, MS S102-4

4770 Buford Hwy

Atlanta GA 303413717

6. DELIVERY BY (Date)

5b. FOR INFORMATION CALL (No collect calls)

c. CITY

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)

Bio-Rad Maintenance

Please provide your open market bid no later than Thursday, May 16, 2024, No later than 5:00 p.m. EST.

POP: Base Period: 7/1/2024 – 6/30/2025, Option Period 1: 7/1/2025- 6/30/2026

Option Period 2: 7/1/2026 – 6/30/2027

Option Period 3: 7/1/2027 – 6/30/2028

Option Period 4: 7/1/2028 – 6/30/2029

Contract Specialist: Gary Morgan, gmorgan1@cdc.gov 770 488 2639 This wil be a firm fixed price delivery order.

b. 20 CALENDAR DAYS

c. 30 CALENDAR DAYS

d. CALENDAR DAYS

NOTE: Additional provisions and representations

SIGN QUOTATION

15. DATE OF

QUOTATION

a. NAME OF QUOTER

c. COUNTY

AREA CODE

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 18 (REV. 6-95)

Previous edition not usable

Prescribed by GSA

FAR (48 CFR) 53.215-1(a)

Line Items

Base Period: 7/1/2024 – 6/30/2025

BASE YEAR - 7/1/2024 - 6/30/2025

C1000 Thermal Cyclers

CT032376 / RN017160

CT022972 / RF059127

CFX Real-Time PCR System

785BR15481 / CT022570

Bio-Plex 200

LX10009295402

T100 Thermal Cyclers

621BR17882

621BR31976

621BR10225

621BR10230

621BR10220

621BR17704

621BR19167

621BR23745

621BR24429

621BR23747

621BR31961

621BR31946

621BR31880

621BR37889

621BR31763

621BR51523

Custodial Account #: 91903

1 Each

Option 1 MA Option Yr. 1; 7/1/2025 – 6/30/2026

OPTION YEAR 1 - 7/1/2025 - 6/30/2026

C1000 Thermal Cyclers

CT032376 / RN017160

CT022972 / RF059127

CFX Real-Time PCR System

785BR15481 / CT022570

Bio-Plex 200

LX10009295402

T100 Thermal Cyclers

621BR17882

621BR31976

621BR10225

621BR10230

621BR10220

621BR17704

621BR19167

621BR23745

621BR24429

621BR23747

621BR31961

621BR31946

621BR31880

621BR37889

621BR31763

621BR51523

1 Each

Option 2 MA Option Yr. 2; 7/1/2026 – 6/30/2027

OPTION YEAR 2 - 7/1/2026 - 6/30/2027

C1000 Thermal Cyclers

CT032376 / RN017160

CT022972 / RF059127

Bio-Plex 200

LX10009295402

T100 Thermal Cyclers

621BR17882

621BR31976

621BR10225

621BR10230

621BR10220

621BR17704

621BR19167

621BR23745

621BR24429

621BR23747

621BR31961

621BR31946

621BR31880

621BR37889

621BR31763

621BR51523

1 Each

Option 3 MA Option Yr. 3; 7/1/2027 – 6/30/2028

OPTION YEAR 3 - 7/1/2027 - 6/30/2028

C1000 Thermal Cyclers

CT032376 / RN017160

CT022972 / RF059127

Bio-Plex 200

LX10009295402

T100 Thermal Cyclers

621BR17882

621BR31976

621BR10225

621BR10230

621BR10220

621BR17704

621BR19167

621BR23745

621BR24429

621BR23747

621BR31961

621BR31946

621BR31880

621BR37889

621BR31763

621BR51523

1 Each

Option 4 MA Option Yr. 4; 7/1/2028 – 6/30/2029

OPTION YEAR 4 - 7/1/2028 - 6/30/2029

C1000 Thermal Cyclers

CT032376 / RN017160

CT022972 / RF059127

Bio-Plex 200

LX10009295402

T100 Thermal Cyclers

621BR17882

621BR31976

621BR10225

621BR10230

621BR10220

621BR17704

621BR19167

621BR23745

621BR24429

621BR23747

621BR31961

621BR31946

621BR31880

621BR37889

621BR31763

621BR51523

1 Each

Statement of Work / Performance Work Statement Title: Ent Bio-Rad MA FY24-29 Period of performance of this entire contract is: July 01, 2024 to June 30, 2029 Base Period: July 01, 2024 to June 30, 2025 Option Period One: July 01, 2025 to June 30, 2026 Option Period Two: July 01, 2026 to June 30, 2027

Option Period Three: July 01, 2027 to June 30, 2028 Option Period Four: July 01, 2028 to June 30, 2029

BACKGROUND

The Division of Parasitic Diseases and Malaria (DPDM), Entomology Branch (EB) has multiple polymerase chain reaction (PCR) systems and a Bio-Plex 200 system that require an annual preventative and on-site maintenance contracts. These contracts guarantee equipment operates at optimum levels and prevents degradation in results. Bio-Rad Laboratories has an extensive history of providing service to the specific equipment used by EB ensuring continuity of results.

PURPOSE/OBJECTIVE

The purpose of this contract is the acquisition of a maintenance agreement contract from Bio-Rad for equipment used by DPDM/EB.

SCOPE OF WORK

Scope of work shall vary based on the equipment being covered. Replacement parts may be new or reconditioned.

· Mail-in service agreements include unlimited mail-in service repairs, including:

· Shipping

· Parts

· Labor

· DPDM/EB is entitled to a loaner instrument to support work until instrument being repaired is returned, subject to availability at time of request.

· DPDM/EB is responsible for shipping instrument in need of service to Bio-Rad Service Center.

· Bio-Rad is responsible for shipping the instrument back to DPDM/EB following service.

· Even though PC coverage is not included, it may be necessary to ship the PC with the instrument to the service center to service the instrument. In the event of PC service, re-installation of Bio-Rad software and PC re-configuration is covered by this agreement.

· Typical service repair turnaround time of 5-7 business days from the time of instrument receipt at Bio-Rad Service Center

· Full on-site service agreements offer unlimited on-site repair visits, including:

· Parts

· Labor

· Travel expenses

· In the event a PC is connected to the instrument, PC coverage is not included. For PC service, please contact the original equipment manufacturer. In the event of PC service, if required, re-installation of Bio-Rad provided software and PC re-configuration is covered by this agreement.

· Typical response time of 3-5 business days (for most locations) after Bio-Rad’s Technical Support Center receives notice of malfunction from DPDM/EB and determines an engineer dispatch is required.

· Preventative Maintenance includes defined maintenance procedures as well as:

· Perform complete system checkout to ensure continuing optimum performance.

· Replacement of wear and tear parts

· Cleaning

· Mechanical inspections

· Adjustments and lubrications

· Comprehensive list of instrument checks

TASKS TO BE PERFORMED

Base Year & Option Year 1 Task 1: Provide one-year full mail in complete support plan for PCR systems (two C1000s and sixteen T100s) on agreement

1. Unlimited repair inclusive of shipping, parts, and labor

a. Includes thermal cycler and reaction module

b. Serial Numbers include:

i. PCR systems BASE: CT032376 / RN017160

ii. PCR systems BASE: CT022972 / RF059127

iii. BASE: 621BR31976

iv. BASE: 621BR17882

v. BASE: 621BR10225

vi. BASE: 621BR10230

vii. BASE: 621BR10220

viii. BASE: 621BR17704

ix. BASE: 621BR19167

x. BASE: 621BR23745

xi. BASE: 621BR24429

xii. BASE: 621BR23747

xiii. BASE: 621BR31961

xiv. BASE: 621BR31946

xv. BASE: 621BR31880

xvi. BASE: 621BR37889

xvii. BASE: 621BR31763

xviii. BASE: 621BR51523

Task 2: Provide one-year full on-site complete support plan for Real-Time PCR system on agreement

1. Unlimited repair inclusive of travel, parts, and labor

a. Includes thermal cycler and optical reaction module

b. Computer not covered

c. Serial Numbers include:

i. Real-Time PCR system BASE: 785BR15481 / CT022570

Task 3: Provide one-year full on-site complete support plan for Bio-Plex 100/200 system on agreement

1. Unlimited repair inclusive of travel, parts, and labor

a. Computer not covered

b. Serial Numbers include:

i. Bio-Plex 100/200 system BASE: LX10009295402

Task 4: Provide report on any services or repairs performed on equipment for EB records upon completion. Bio-Rad established format of reports is sufficient.

Option Years 2-4

Task 5: Provide one-year full mail in complete support plan for PCR systems (two C1000s and sixteen T100s) on agreement

1. Unlimited repair inclusive of shipping, parts, and labor

a. Includes thermal cycler and reaction module

b. Serial Numbers include:

i. PCR systems BASE: CT032376 / RN017160

ii. PCR systems BASE: CT022972 / RF059127

iii. BASE: 621BR31976

iv. BASE: 621BR17882

v. BASE: 621BR10225

vi. BASE: 621BR10230

vii. BASE: 621BR10220

viii. BASE: 621BR17704

ix. BASE: 621BR19167

x. BASE: 621BR23745

xi. BASE: 621BR24429

xii. BASE: 621BR23747

xiii. BASE: 621BR31961

xiv. BASE: 621BR31946

xv. BASE: 621BR31880

xvi. BASE: 621BR37889

xvii. BASE: 621BR31763

xviii. BASE: 621BR51523

Task 6: Provide one-year full on-site complete support plan for Bio-Plex 100/200 system on agreement

1. Unlimited repair inclusive of travel, parts, and labor

a. Computer not covered

b. Serial Numbers include:

i. Bio-Plex 100/200 system BASE: LX10009295402

Task 7: Provide report on any services or repairs performed on equipment for EB records upon completion. Bio-Rad established format of reports is sufficient.

PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

Mail in service shall occur at Bio-Rad Service Centers.

On-site service shall occur at CDC laboratories located at 1600 Clifton Road NE, Building 23, Atlanta, GA 30329.

CONTRACT SUPPORT HOURS

All maintenance service shall be furnished between the hours of 8:30AM and 5:30PM, Monday through Friday, excluding locally observed and Bio-Rad observed holidays.

DELIVERABLES/REPORTING SCHEDULE

Bio-Rad is to provide reports on any services or repairs performed on equipment for EB records upon completion. Bio-Rad established format of reports is sufficient.

ADDITIONAL REQUIREMENTS

Information Security and Privacy Compliance Standard-1: Procurements Requiring Information Security and/or Physical Access Security

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or all of the followings. No contractor will be permitted to access or operate CDC infrastructure or systems overseas unless prior approval is received from CDC CISO.

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 CDC 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 HHS/CDC 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.

ii. Categorize all information owned and/or collected/managed on behalf of CDC and information systems that store, process, and/or transmit HHS 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 ISSO, CISO, CDC CPO, or other representative, 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:

[ x ] Low [ ] Moderate [ ] High

· Integrity:

· Availability:

· Overall Impact Level:

[ x ] 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 CDC 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).

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the CDC 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 all applicable security and privacy policies by contacting the CO/COR or CDC security and/or privacy officials.

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 CDC privacy policies, and complete all the requirements below:

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. To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, CDC uses a privacy analysis process to assess the risks associated with CDC's collection and maintenance of PII and to ensure information is handled in accordance with applicable legal, regulatory, and policy requirements. PTAs analyze how information is handled in IT systems and electronic information collections and determines if the IT system or electronic information collection collects, disseminates, maintains, or disposes of PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how CDC collects, disseminates, maintains, or disposes of the public's 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 PII is collected, disseminated, maintained, or disposed as part of the contract. The PTA will determine if 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 within 60 days after completion of the PTA and in accordance with CDC policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

· 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 HHS/CDC 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. Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by CDC or collected by the contractor on behalf of CDC 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 CDC 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/CDC policies. Unauthorized disclosure of information will be subject to the HHS/CDC 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).

h. 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).

i. 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.

j. 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 always assume HTTPS 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 HHS/CDC Policy for Internet and Email Security for additional information.

k. Contract Documentation. The Contractor must use provided templates, policies, forms and other agency documents specify which documents/forms will be provided to contractor] to comply with contract deliverables as appropriate.

l. 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 encryption solution that is validated with current FIPS 140 validation certificate 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 and CDC Component-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 certificate 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 CDC 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 CSPO.

m. 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 CDC non-disclosure agreement, 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.

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 CDC Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees must complete CDC Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training must be compliant with CDC 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/CDC policy and the CDC Role-Based Training (RBT) of Personnel with Significant Security Responsibilities.

c. Training Records. The Contractor (and/or any subcontractor) must maintain training records for all its employees working under this contract in accordance with CDC 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 CDC Implementation of the HHS Rules of Behavior for Use of HHS Information Technology Resources.

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 CDC 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 CDC Computer Security Incident Response Center (CSIRC) IRT teams within 24 hours, whether the response is positive or negative. In accordance with FISMA and 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 CDC breach response process, please see the CDC Standard for Responding to Breaches of Personally Identifiable Information (PII).

b. Contracts with entities that collect, maintain, use, or operate Federal information or information systems on behalf of CDC must include in the following requirements:

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

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

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

iv. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If instructed by the Contracting Officer or representative, the Contractor must send [CDC Component] approved notifications to affected individuals [insert CDC Component Specific timeline, process, and format].

v. Report all suspected and confirmed information security and privacy incidents and breaches to the CSPO Incident Response Team (IRT) [CDC Component inserted contact information should be cited here], COR, CO, CDC CPO (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 CDC Component and CDC 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, 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.

vi. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, and CDC Component and CSPO privacy breach response policies when handling PII breaches.

vii. 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 [CDC Component insert timeline if required].

viii. 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.

ix. 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.

x. 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.

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:

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; CDC HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

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 30 days prior to the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted immediately upon the 30 days change. 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, CDC 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 CDC EPLC framework and methodology and in accordance with the CDC Office of Financial Resources (OFR) Contract Closeout Guide and HHS Closeout Guide: Contracts and Orders.

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to CDC 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 to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and system ISSO within 15 days before an employee stops working under this contract.

e. Contractor Responsibilities upon Physical Completion of the Contract. The contractor (and/or any subcontractors) must return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor must provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with CDC policies.

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the CDC Out-Processing Checklist (http://intranet.cdc.gov/od/hcrmo/pdfs/hr/Out_Processing_Checklist.pdf) when an employee terminates work under this contract within 15 days of the employee's exit from the contract. All documentation must be available to the CO and/or COR upon request.

9. Records Management and Retention

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

b. If a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, he/she must document and report the incident in accordance with CDC policies.

10. High Value Asset (HVA):

If a system is identified as HVA, the contractor must comply with the HHS Policy for the High Value Asset (HVA) Program and the Department of Homeland Security (DHS) HVA Control Overlay[22] in addition to the above requirements.

11. Deliverables

Certification of Sanitization of Government and Government Activity-

Related Files, Information, and Devices.

Standard-2 Requirements for Procurements Involving Privacy

Appropriate security controls and Rules of Behavior should be incorporated to protect the confidentiality of information, proprietary, sensitive, and Personally Identifiable Information (PII) the Contractor may come in contact with during the performance of this contract.

Standard-5.

Other IT Procurements

1. Hardware Procurements

a. Card Readers. The Contractor (and/or any subcontractor) must include Federal Information Processing Standard (FIPS) 201-compliant smart card readers (referred to as LACS Transparent Readers) with the purchase of servers, printers, desktops, and laptops.

b. Mobile Devices. The contractor must follow NIST 800-124, Rev. 1, Guidelines for Managing the Security of Mobile Devices in the Enterprise and comply with Public Law 115-232 § 889, when purchasing mobile devices that process or store CDC data.

2. Non-Commercial and Open-Source Computer Software Procurements

The Contractor (and/or any subcontractor) must follow secure coding best practice requirements, as directed by the 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. The contractor will be liable for malicious or defective code or failure to reduce risk.

3. Information Technology Application Design, Development, or Support

a. The Contractor (and/or any subcontractor) must ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges.

b. The contractor must consult the guidelines from NIST SP 800-160 volume 1, Systems Security Engineering: Considerations for a Multidisciplinary Approach in the Engineering of Trustworthy Secure Systems, NIST SP 800-160 volume 2, Systems Security Engineering: Considerations for a Multidisciplinary Approach in the Engineering of Trustworthy Secure Systems, and NIST SP 800-53 to implement security during the development of all applications and throughout the life cycle stages of software development.

c. The Contractor (and/or any subcontractor) must follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards, the Open Web Application Security Project (OWASP), System Admin, Audit, Network and Security (SANS), HHS Policy for Software Development Secure Coding Practices and CDC Secure Software Development Standard that will limit system software vulnerability exploits.

d. The Contractor (and/or any subcontractor) must ensure that computer software developed on behalf of CDC or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The contractor must test applicable products and versions with all relevant and current updates and patches updated prior to installing in the CDC environment. No sensitive data must be used during software testing.

e. The contractor must, at a minimum, segregate physically or logically, all test and development systems from production systems as applicable in accordance with the HHS Standard for Segregation of Dev/Test Environments from Production.

f. The Contractor (and/or any subcontractor) must protect information that is deemed sensitive from unauthorized disclosure to persons, organizations or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by CDC must be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract.

4. Physical Access to Government Controlled Facilities

(NOTE: For procurements involving physical access to government facilities, selected language from Appendix B: Standards may apply. This includes, but not limited to security awareness, incident response, and HSPD-12. Consult with the CDC Component Information Systems Security Officer (ISSO), CDC CPO, and other relevant stakeholders to select applicable language.)

Additionally, due to the COVID-19 Epidemic of 2020 (Effective as of March 30, 2020), The below contract language must be included in all COVID-19 contract actions until such time the CDC Director makes a determination to issue rated contracts related to items used for allowing CDC employees/contractors to physically use and/or operate in CDC facilities and spaces.

"CDC reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System."

5. Deliverables

Standard-6:

Installation and Servicing of Equipment Contractor shall scan all media (CDs, DVDs, portable hard drives, thumb drives, etc.) used for upgrading and installing the vendor’s software/firmware with antivirus software that has the latest virus signatures. The scans shall occur before using the media in a CDC computer/device and when moving the media between CDC computers/devices.

If in the performance of this contract, the contractor must replace an information storage device (hard drive, non-volatile flash memory module, etc.) or service equipment offsite, the contractor must remove the information storage device(s) from the equipment and provide it to CDC to be either destroyed or erased. The contractor shall not bring off-site any part of the equipment they are servicing that contains CDC data.

Human Subjects Protections in Research

Section 508 Compliance

Electronic and Information Technology Accessibility

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-aboard.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria

302 Functional Performance Criteria

502 Inoperability with Assistive Technology

504 Authoring Tools

602 Support Documentation

603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Safety and Health (December 2015)

(a) To help ensure the protection of the life and…