A19-RFQ 75D301-25-Q-78721.pdf

75D301-25-Q-78721

COMBINED SYNOPSIS/SOLICITATION FOR PIPETTE

Solicitation Number: 75D301-25-Q-78721

PART 1: INTRODUCTION

The Centers of Disease Control and Prevention (CDC), Division of Vector Diseases (DVD), has a requirement for professional pipette calibration services that ensure all laboratory pipettes meet established performance specifications for accuracy and precision in accordance with Clinical Laboratory Improvement Amendments regulation and applicable quality standards.

1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

2. The solicitation number is 75D30125Q78721. This solicitation is issued as a Request for Quotation (RFQ), using the Simplified Acquisition Procedures of FAR Part 13 and FAR Part 12.

3. The associated North American Industry Classification System (NAICS) Code is 811210- Electronic and Precision Equipment Repair and Maintenance; Small Business Size Standard is $34 Million. This requirement is being solicited as a total women owned small business set-aside.

PART 2: PRICING SHEET

The Government respectfully requests any additional discount that is most favorable to the customer.

1. The offeror shall fill out the following pricing sheet for the procurement of Pipette Calibration Services.

Line Items

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 On Site Calibration: Manual Single

Channel

Firm Fixed Price

Severable Services

P.o.P- 09/29/2025-09/28/2026

1214 Each

0002 On Site Calibration: Electric Single Channel

Firm Fixed Price

Severable Services

P.o.P- 09/29/2025-09/28/2026

180 Each

0003 On Site Calibration Manual Multichannel

Firm Fixed Price

Severable Services

P.o.P- 09/29/2025-09/28/2026

431 Each

0004 On Site Calibration: Electric Multichannel

Firm Fixed Price

Severable Services

P.o.P- 09/29/2025-09/28/2026

145 Each

0005 On site Calibration: Repeater

Firm Fixed Price

Severable Services

P.o.P- 09/29/2025-09/28/2026

82 Each

0006 On Site Calibration: Motorized Pipette Controller

Firm Fixed Price

Severable Services

P.o.P- 09/29/2025-09/28/2026

63 Each

0007 Repair, labor and parts Repair, labor and parts

Firm Fixed Price

Severable Services

P.o.P- 09/29/2025-09/28/2026

1 Each

Total Amount: $_____________________

SECTION C – STATEMENT OF WORK (SOW)

Centers for Disease Control and Prevention Pipette Calibration, Prevention Maintenance, and Repair in a GLP Environment

National Center for Immunization and Respiratory Diseases (NCIRD), Influenza Division (ID)

SECTION 1 – INTRODUCTION

The Centers for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases (NCIRD), Influenza Division is responsible for developing Candidate Vaccine Viruses based on circulating and novel influenza strains. Candidate Vaccine Viruses (CVVs) are influenza viruses that are starting materials for seasonal and pandemic vaccines. CDC and the U.S. Food and Drug Administration (FDA) require CVVs meet regulated sterility requirements as defined in Title 21 of the U.S. Code of Federal Regulations (21 CFR), which requires equipment/pipettes to be calibrated based on use and the manufacturer’s recommendations.

Calibrations, preventative maintenance, and repair of its pipettes, repeaters, and motorized pipette controllers are to be done by an organization accredited to the International Organization for Standardization (ISO) 17025:2017 standard, with a preference for American National Standards Institute (ANSI)/ National Conference of Standards Laboratories (NCSL) Z540.3-2016 certification and ISO 8655 accreditation. Nearly all businesses offering Z540.3 calibration services can, in fact, calibrate all the required types of equipment.

SUBSECTION A – Definitions

1. Manual Single Channel: A manual single-channel pipette is a laboratory tool used to transport a measured volume of liquid. It has one channel, meaning it can dispense one volume of liquid at a time. The user manually adjusts the desired volume and operates the pipette.

2. Electric Single Channel: An electric single-channel pipette is similar to a manual single-channel pipette, but a motor powers it. The motor reduces the effort required to aspirate and dispense the liquid, reducing user fatigue and improving accuracy, particularly for large volumes or viscous liquids.

3. Manual Multichannel: Manual multichannel pipettes have multiple channels (usually 8 or 12), allowing users to simultaneously aspirate or dispense multiple volumes of liquid. This is particularly useful for tasks like filling multi-well plates.

4. Electric Multichannel: An electric multichannel pipette operates similarly to a manual multichannel pipette, but with a motor assisting the aspiration and dispensing of liquids. This can improve accuracy and precision and reduce user fatigue.

5. Repeater: A repeater pipette allows for multiple dispensing of the same volume of liquid without the need for refilling. This can greatly speed up tasks like filling multi-well plates or dispensing reagents.

6. Motorized Pipette Controller: This device is used with glass or plastic pipettes and uses a motor to control the aspiration and dispensing of liquid. They can handle much larger volumes than single-channel or multichannel pipettes. The leading brand name, Pipette-Aid, is so ubiquitous that it is often used in lieu of the general term for the device, motorized pipette controller.

7. Calibration: Calibration is the process of checking and adjusting a pipette’s accuracy. Over time, pipettes can lose accuracy due to wear and tear, so regular calibration is necessary to ensure they continue to dispense accurate volumes of liquid.

8. Service and Repair: Service and repair refer to the regular maintenance and fixing of pipettes. This can involve cleaning, replacing worn parts, and other tasks to ensure the pipette remains in good working condition. It’s important to have pipettes serviced and repaired regularly to ensure accurate and reliable performance.

9. Title 21 of the Code of Federal Regulations (21 CFR): 21 CFR is part of the United States law and governs food and drugs, including how equipment must be maintained and calibrated to be used in cGLP production environments.

10. Current Good Laboratory Practice (cGLP): These are regulations issued by the U.S. Food and Drug

Administration (FDA), particularly under 21 CFR Part 58. They provide a framework for properly conducting non-clinical laboratory activity in producing pharmaceutical materials.

11. Candidate Vaccine Virus (CVV): An engineered or wild-type virus used for the manufacturing and developing of vaccines, particularly those created within the cGLP environment at the CDC.

12. ISO/IEC 17025:2017: This is an international standard set by the International Organization for

Standardization (ISO) and the International Electrotechnical Commission (IEC). It sets the general requirements for the competence of testing and calibration laboratories. It applies to all organizations performing laboratory activities, regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. The standard covers areas like impartiality, confidentiality, complaints and appeals procedures, risk-based thinking, and management system requirements.

Obtaining ISO 17025:2017 Certification also satisfies the requirements of ISO 9001:2015.

13. American National Standards Institute (ANSI): A private, non-profit organization overseeing voluntary consensus standards development in the United States. ANSI's mission is to enhance the competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems and safeguarding their integrity.

14. ANSI National Accreditation Board (ANAB): a non-governmental organization that provides accreditation services to public- and private-sector organizations. ANAB is a member of the International Laboratory Accreditation Cooperation (ILAC), and its accreditation standards are recognized internationally.

15. ANAB certification to ISO 17025:2017: When a laboratory is ANAB-certified to ISO 17025:2017, it means that the laboratory has met the requirements of the ISO/IEC 17025:2017 standard and has demonstrated its competence to carry out specific tests or calibrations or types of tests or calibrations.

The ANAB certification process includes assessing the laboratory's quality management system and demonstrating the laboratory's technical competence. Once certified, the laboratory undergoes regular assessments to maintain its certification.

16. ANSI/NCSL Z540.3-2016: ANSI and the National Conference of Standards Laboratories (NCSL) titled "Requirements for the Calibration of Measuring and Test Equipment," sets out the requirements for calibration laboratories and the calibration of measuring and test equipment and is the chief calibration requirement called out in cGLP guidance. The older standard, ANSI/Z540.3, can still be used, but organizations certified under the older guidelines are encouraged to be certified by the newest guidelines by 2026 (10 years post-publication).

17. ISO 8655: A standard developed by the ISO that pertains specifically to piston-operated volumetric apparatuses. These apparatuses, including pipettes, burettes, and dilutors, are largely the types of equipment that need to be calibrated. There is not a requirement under this purchase order to have ISO 8655 certification if ISO 17025:2017 is in place but ISO 8655 is preferred.

SECTION 2 – PURPOSE/OBJECTIVE

The overall objective of this purchase order is to provide the Influenza Division with ISO 17025:2017-complainant calibration, preventative maintenance, and repair of pipettes, repeaters, and motorized pipette controllers onsite at the CDC Roybal campus.

The Vaccine Preparedness Team of the Virology, from the Virology Surveillance and Diagnosis Branch within the Influenza Division of the CDC shall be the principal scientific and technical party representing the Government’s needs, working with an indetermined Contractor from selected Offerors.

The CDC will provide the pipettes, repeaters, and motorized pipette controllers to the Contractor, as well as clean and safe laboratory space temporarily designated for sole use by the Contractor for calibration and repair.

SECTION 3 – SCOPE OF WORK

The Contractor shall provide calibration, preventative maintenance, and repair services for pipettes, repeaters, and motorized pipette controllers. Calibration tasks are to handle onsite at the Roybal campus, and pricing must include whatever costs are needed to perform the service onsite. All calibrations must be ISO 17025 compliant, with additional preference given for ANSI/NCSL Z540.3-2016 and/or ISO 8655 certifications.

SECTION 4 – TASKS TO BE PERFORMED

Calibration typically occurs during four (4) on-site visits per year, traditionally in January, February, July, and August. These dates and the number of visits may vary and are determined in coordination with CDC. Calibration is required for the following types of equipment:

Task 1:

1. Calibration and repair of 1214 manual single-channel pipettes.

a. A certificate of calibration must be issued for each calibration of each pipette.

b. Any basic servicing, such as lubrication of pistons, repairs, or mechanical failures that can be done onsite, should be done onsite.

2. Calibration and repair of 180 electronic single-channel pipettes.

3. Calibration and repair of 431 manual multichannel pipettes.

4. Calibration and repair of 145 electronic multichannel pipettes.

5. Calibration and repair of 82 repeaters/repeating dispensers.

a. A certificate of calibration must be issued for each calibration of each repeater or repeating dispenser.

6. Calibration and repair of 63 motorized pipette controllers.

a. Any basic servicing, such as changing of filters, repairs, or mechanical failures that can be done onsite, should be done onsite.

7. Additional Repairs

a. Any repairs that cannot be onsite shall be done offsite either by the Contractor of the Original Equipment Manufacturer, as arranged by the Contractor.

Task 2: Preventative maintenance. The Contractor shall provide preventative maintenance services in accordance with original equipment manufacturer (OEM) recommendations. Preventative maintenance shall be performed concurrent to calibrations. Preventative maintenance shall include internally cleaning and inspecting each piece of equipment; disassembling each pipette; polishing pistons and ejectors;

replacing all seals; if required, replacing O-rings; removing and re-applying lubrication, where lubrication is required for the equipment; re-assembling each pipette; and externally cleaning and inspecting each piece of equipment.

Task 3: Repair. The Contractor shall provide repair services for any pipette, repeater, or motorized pipette controller found to be damaged or defective during calibration or preventative maintenance services, including the replacement of worn parts. The Contractor shall provide repair services as requested by the CDC in-between onsite calibration visits.

Additionally, the Contractor shall provide repair services as requested by CDC in-between on-site calibration visits. Repair services provided in-between on-site visits are anticipated to be performed at the Contractor’s facility; CDC will ship the equipment to be repaired to the Contractor and the Contractor will ship the equipment back to CDC after the repair is completed.

Original manufacturer’s parts are preferred for replacements but are not required. Before undertaking any repair that does not use original manufacturer’s parts, the Government must approve the Contractor’s vendor list for all repair parts to be used.

SECTION 5 – GOVERNMENT-FURNISHED PROPERTY

The Government (CDC) will furnish the pipettes, repeaters, and motorized pipette controllers to the

Contractor, as well as clean and safe laboratory space temporarily designated for sole use by the Contractor for calibration, preventative maintenance, and repair.

The Contractor shall furnish all equipment and supplies required to perform the calibration, preventative maintenance, and repair services.

All equipment provided for calibration, preventative maintenance, and repair is expected to be returned to the CDC immediately following the completion of services. Any CDC equipment brought or shipped off-site for repair at the Contractor’s facility(ies) shall be returned within four weeks.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

The principal place of performance will be at Building 17 of the CDC Roybal campus, located at 1600 Clifton Road, Atlanta, Georgia 30333. Performance is also expected at the Contractor’s facility(ies) for repairs that either cannot be completed onsite or are requested by CDC in-between on-site calibration visits.

Work will be conducted 80% at the CDC’s Roybal campus, constituting the majority of calibration and repair time. 20% of the work is anticipated to be conducted at the contractor’s facility, principally involving the paperwork required to produce certificates and meet regulatory compliance, but also on rare occasions when the repairs cannot be completed onsite.

The Contractor will determine the support hours needed to complete all tasks to be performed under this contract. The number and dates of on-site visits will be determined in coordination with CDC.

The cancellation of a scheduled on-site visit by either the Government or the Contractor requires notice provided to the other party at least three business days in advance.

SECTION 7 – TRAVEL

Limited local travel to the CDC is expected in this award, and no travel will be directly compensated from this work. Any Offeror must include transport costs within the costs of calibration and repair of equipment.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Deliverables will be presented to a Subject Matter Expert (SME) from the Influenza Division in an electronic format (PDF) for certificates, and the return of calibrated equipment will be required immediately. Repairs, depending on their nature, will have a longer turnaround time, not to exceed four

(4) weeks.

On-site visits shall be scheduled four times within the period of performance to establish times acceptable to the Contractor and CDC for calibration.

A certificate of calibration or certified calibration report will be provided electronically in PDF format to the COR no later than one week following each calibration.

Following each on-site visit, the Contractor shall provide to the COR a summary report of all services provided during the visit. The report shall be provided by e-mail.

Prior to the first on-site calibration session, CDC shall receive access to the Contractor’s PipetteNET encrypted cloud database. The Contractor shall load and maintain CDC’s pipette inventory in PipetteNET and add all standard and customary data to PipetteNET during the period of performance. CDC shall retain access to PipetteNET through the end of the period of performance of this purchase order.

SECTION 9 – REFERENCE MATERIALS

None.

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

1. ISO 17025:2017 Certification by an ANSI or ILAC member organization (e.g., ANAB certification)

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy. The Contractor (and/or any subcontractor) shall not have access to, or host, and/or maintain any Government information system(s) in relation to the proposed work. All data will be provided via secured web portal or service (e.g., Amazon Web Services or File Share). No sensitive data, patient information, or personally identifiable information will be provided to the Contractor on the basis of the proposed work.

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.

(End of verbiage)

Information Security and Privacy

1. Information Security and Privacy

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 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: [ x ] Low [ ] Moderate [ ] High Availability: [ x ] Low [ ] Moderate [ ] High 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 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) 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:

f) 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/support 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.

g) 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 a current FIPS 140 validation certificate from the

NIST CMVP.

h) 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).

i) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol must comply with

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

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

k) Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS must enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to 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.

l) 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.

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

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

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

n) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the 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)1, 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).2"

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 a 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, can 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 stop 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.

Deliverable Title/Deliverable Type

Description Due Date

Roster Roster Within 30-days of the 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

Within 60-90-days after 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

Personnel Security Responsibilities

List of Personnel with defined roles and responsibilities

Within 7-days; that is before an employee begins working on this contract.

Personnel Security Responsibilities

Off-boarding documentation, equipment and badge when leaving contract

Within 5-days or less after the Government’s final acceptance of the work under this contract, or in the event of a termination of the contract.

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 documentation will be required, such as Disposition/Decommission Plan

At contract expiration.

Standard-2 Requirements for Procurements Involving Privacy Act

It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records on individuals.

The System of Records Notices (SORN) that are applicable to this contract are GSA/GOVT-4, “Contracted Travel Services Program (E-Travel)” and 09-90-1402, "HHS Payroll Records ". The design, development, or operation work the Contractor is to perform is outlined above in Section 4, “Tasks to be Performed”.

The disposition to be made of the Privacy Act records upon completion of contract performance is Records kept for a Federal agency are maintained in accordance with the General Records Retention Schedules issued by the National Archives and…