A19 - 75D30126Q79099 - Final.pdf

75D30126Q79099

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

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

PAGE OF PAGES

1 24

1. REQUEST NO.

75D301-26-Q-79099

2. DATE ISSUED

07/17/2026

3. REQUISITION/PURCHASE REQUEST NO.

000HCKBG-2026-99144

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)

NAME TELEPHONE NUMBER

AREA CODE NUMBER

Eugene Gutierrez (770) 488-0192 x

8. TO: 9. DESTINATION

a. NAME b. COMPANY a. NAME OF CONSIGNEE

c. STREET ADDRESS b. STREET ADDRESS

c. CITY

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

10. PLEASE FURNISH QUOTATIONS TO

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

07/23/2026

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)

Contracting Officer: Eugene Gutierrez

Phone: 770-488-0192 Email: zvm0@cdc.gov

COR: Caryn Kim Phone: 404-369-1001 Email: chk6@cdc.gov

“See Continuation Page”

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS

b. 20 CALENDAR DAYS

c. 30 CALENDAR DAYS

d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations are are not attached.

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

SIGN QUOTATION

15. DATE OF

QUOTATION

a. NAME OF QUOTER

b. STREET ADDRESS 16. SIGNER

a. NAME (Type or print) b. TELEPHONE

c. COUNTY AREA CODE

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

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

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

7. DELIVERY

FOB

DESTINATION

OTHER

(See Schedule)

SECTION B - Line Items

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Procurement of Lateral Flow Strips for the

Rapid HIV Nucleic Acid Diagnostic Test in accordance with the SOW and Contractor’s Proposal

Non-Severable CLIN

Firm-fixed-price

Period of Performance:

August 1, 2026 to December 31, 2026

4000 Each

Purchase Order Total: ___________________

SECTION C - Statement of Work

Period of Performance: August 1, 2026 to December 31, 2026

Title: Procurement of Lateral Flow Strips for the Rapid HIV Nucleic Acid Diagnostic Test.

SECTION 1 – BACKGROUND

According to the Centers for Disease Control and Prevention (CDC), one in seven individuals living with HIV in the United States (US) are unaware of their HIV status, and three in five individuals diagnosed find out more than a year after acquiring the virus. Knowing one’s HIV status is critical for connecting individuals living with HIV to care and starting antiretroviral medications treatment, which prolongs life and prevents further transmission. In resource-limited settings, opportunities for healthcare providers and community-based organizations to offer diagnostic services are rare. Furthermore, connecting patients to care is even more difficult when diagnostic results are delayed until days after an initial appointment. Current rapid diagnostic tests detect antigen and antibody which are most effective after the early acute infection stage when a newly infected person is most transmissible. Thus, an HIV nucleic acid test (NAT) that can provide sensitive and accurate diagnosis within the early acute transmission window (2 weeks to 2 months post exposure) would significantly improve the ability of healthcare providers to identify and link new patients to HIV care.

The Government has developed a rapid HIV-1 nucleic acid test (NAT) based on loop-mediated isothermal AMPlification (LAMP). This diagnostic assay is a simple, rapid, and low-cost alternative to traditional diagnostic nucleic acid assays that do not require complicated and expensive thermal cycling equipment and expert-trained staff. This assay can reliably and specifically amplify HIV nucleic acids within 30-40 minutes when using a lateral flow device for detection.

SUBSECTION A – DEFINITIONS

EHE – Ending the HIV Epidemic in the US – HHS initiative to end the HIV epidemic in the US HIV NAT – Nucleic Acid Test – a highly sensitive detection method for HIV genomes allowing early diagnosis compared standard diagnostic tests.

LAMP – Loop-mediated isothermal amplification – a nucleic acid amplification assay that can be easily implemented in low resource settings

SECTION 2 – PURPOSE

This contract is for the development and production of 4000 lateral flow strips for evaluation of the rapid nucleic acid test. The lateral flow strip must specifically detect amplified HIV DNA using gold-conjugated antibodies to 6-carboxyfluorescein (FAM; or similar antigen) to detect biotin-conjugated nucleic acids produced in the CDC developed LAMP reaction. The HIV products are immobilized on the lateral flow strip using streptavidin. The contractor has the option of designing the lateral flow strips de novo or using existing technology. The contractor must deliver high quality, robust lateral flow strips meeting the characteristics outlined in Section 4 for evaluating the rapid nucleic acid test in both pre-clinical and clinical settings.

SECTION 3 – SCOPE OF WORK

Whether designing the devices de novo, using existing technology, soliciting sub-contractors, or a combination of all three, the Contractor will be responsible for the design and validation of the lateral flow strips. The Government will provide technical input in designing the device and required performance characteristics. A prototype batch of lateral flow strips produced by the Contractor will be submitted for Government evaluation. The Government will review the prototypes and provide feedback within the contract period. The feedback may necessitate the Contractor to revise strips to satisfy all required specifications. The Contractor will consult with the Government during the contract period and perform all tasks at the Contractor’s facility.

SECTION 4 – TASKS TO BE PERFORMED

The Contractor, a commercial medical device company with demonstrated success in designing and producing lateral flow devices, will produce 4000 lateral flow strips that meet the following specifications:

a. The lateral flow strips, when directly exposed to the LAMP reactions, will produce results within 10 minutes.

b. The lateral flow strips must be highly specific with exceedingly low false positive (<0.5%) and false negative (<1% at 1000 copies) rates using the CDC developed LAMP reaction.

c. The lateral flow strips must be designed in a cassette-housing agnostic way, as they will be used by CDC in further evaluations of the whole Rapid HIV detection system.

d. The final product must be easily reproducible for nominal cost.

The Contractor shall perform the following tasks:

Task (1) Hold bi-weekly meetings alternating between technical discussions about the lateral flow strip design changes and a technical presentation/report outlining progress to track deliverables and development schedule.

Task (2) Create, maintain, and deliver a Design History File including final design of lateral flow strips. The strips will be part of CDC’s LAMP test components.

Task (3) Design and produce lateral flow strips that meet the specifications described above in Section 4, a, b, c, and

d. The Contractor may design new the lateral flow strips internally or may use previously designed strips that are deemed suitable for this request.

Task (4) Deliver 200 prototype lateral flow strips for test procedure for evaluation by the Government. The Contractor must make all necessary adjustments to the prototypes and devices to meet performance expectation bench mark of > 99% of sensitivity is achieved.

Task (5) Provide 4000 final lateral flow strips for CDC’s pre-clinical evaluation of the compete test procedure.

Task (6) Provide final design specifications of the lateral flow strips and suggestions for scale-up to support CDC’s future mass production plan.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

N/A

SECTION 6 – PERIOD OF PERFORMANCE

The period of performance shall be: 8/1/2026 to 12/31/2026

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

Items

Description Quantity or No.

of Copies

Delivery Date

Deliver To

Task 1 Slide Deck and/or recorded presentation of technical details during design and optimization.

1 copy or electronic copy

Bi-weekly CDC COR

Task 2 Design History File including final design

1 electronic copy Bi-weekly, as needed design update

CDC COR

Task 4 Prototype lateral flow strips

200 strips for up CDC’s evaluations

By 3 calendar months from the start of the contract

CDC COR

Task 4 Final batch of lateral flow strips.

Plastic consumables for 4000 tests

By 4 calendar months from the start of the contract

CDC COR

Task 6: All relevant specifications and instructions for manufacturing further identical strips including the final design history file.

1 copy/electronic copy By 5 calendar months from the start of the contract

CDC COR

SECTION 8 – REFERENCE MATERIALS

Not applicable.

SECTION 9 – POINT OF CONTACT INFORMATION

The Point of Contact (POC) for this procurement is:

Caryn Kim Centers for Disease Control and Prevention Division of HIV Prevention, Laboratory Branch 1600 Clifton Road, NE, Mail Stop H18-2 Atlanta, Georgia 30329

Telephone Number: 404-639-1001 E-mail Address: chk6@cdc.gov

Preferred method of communication: Email

SECTION 10 – PAYMENT TERMS

Contract on delivery of prototype and final products.

SECTION 11 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

The Contractor must be an established biomedical engineering design firm and/or medical device company with the proven capabilities and expertise required to manufacture and validate the performance of lateral flow devices and associated plastic consumables.

Special consideration:

Section 508 and Accessibility Requirements

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services, or support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order are identified as follows:

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

If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements for review by the agency Section 508 Program.

SECTION D – CLAUSES

Clauses Incorporated By Reference FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

www.acquisition.gov https://www.acquisition.gov/far-overhaul https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

(End of Clause)

FAR SOURCE TITLE AND DATE

52.203-17 Contractor Employee Whistleblower Rights (Nov 2023)

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017)

52.204-13 System for Award Management Maintenance (Nov 2025)

52.204-19 Incorporation by Reference of Representations and Certifications (DEC 2014)

52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (Nov 2025)

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations (Nov 2025)

52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services

(DEVIATION) (RFO APR 2026)

52.222-3 Convict Labor (DEVIATION) (RFO APRIL 2026)

52.222-19 Child Labor-Cooperation with Authorities and Remedies (DEVIATION) (RFO APRIL 2026)

52.222-36 Equal Opportunity for Workers with Disabilities (Nov 2025)

52.222-50 Combating Trafficking in Persons (DEVIATION) (RFO APRIL 2026)

52.222.53 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain

Services-Requirements (DEVIATION) (RFO APRIL 2026) 52.222-90 Addressing DEI Discrimination by Federal Contractors (DEVIATION) (RFO APRIL 2026)

52.223-23 Sustainable Products and Services (DEVIATION)(FEB 2025)

52.225-3 Buy American-Free Trade Agreements-Israeli Trade Act (DEVIATION DATE) (RFO APRIL 2026)

52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving (MAY 2024)

52.232-1 Payments (APR 1984)

52.232-33 Payment by Electronic Funds Transfer-System for Award Management (Oct 2018)

52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013)

52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) 52.233-3 Protest after Award (DEVIATION) (RFO APRIL 2026) 52.233-4

Applicable Law for Breach of Contract Claim (Nov 2025)

FAR clauses incorporated in full text:

52.217-8 Option to Extend Services.

Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 1 day of the contract expiration date.

(End of clause)

HHSAR 352.204-72 Records management (FEB 2024) (DEVIATION)

(a) Applicability. This clause applies to contracts that include Federal records, as defined in paragraph (b).

(b) Definition. As used in this clause—

Federal record means all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. See 44 U.S.C. 3301.

(1) The term Federal record—

• Includes HHS records;

(ii) Does not include personal materials;

(iii)Applies to records created, received, or maintained by Contractors pursuant to their contract;

And

(iv) May include deliverables and documentation associated with deliverables.

(a) Recorded information means all traditional forms of records, regardless of physical form or characteristics, including information created, manipulated, communicated, or stored in digital or electronic form. (See 44 U.S.C. 3301.)

(b) Personal materials means documentary materials belonging to an individual that are not used to conduct agency business. Personal files are excluded from the definition of Federal records and are not owned by the Government. (See 36 CFR 1220.18.)

(c) Requirements.

(2) The Contractor shall comply with all applicable records management laws and regulations, as well as

National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chapters 21, 29, 31, 33), NARA regulations at 36 CFR chapter XII subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all Federal records, regardless of form or characteristics, mode of transmission, or state of completion.

(3) In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C.

chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), and the Privacy Act of 1974 (5 U.S.C. 552a), and must be managed and scheduled for disposition only as permitted by statute or regulation.

(4) In accordance with 36 CFR 1222.32, the Contractor shall maintain all Federal records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

(5) The Contractor is responsible for preventing the alienation or unauthorized destruction of Federal records, including all forms of mutilation. Federal records may not be removed from the legal custody of HHS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Contracting Officer. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. The Contractor shall report to the Contracting Officer any unlawful or accidental removal, defacing, alteration, or destruction of Federal records.

(6) The Contractor shall immediately notify the Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that appropriate personnel are trained to adhere to these contract requirements, and that applicable, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of information, data, documentary material, Federal records and/or equipment is properly protected. The Contractor shall not remove Federal Records from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Contracting Officer. When information, data, documentary material, Federal records and/or equipment are no longer required, it shall be returned to HHS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or as otherwise directed by the Contracting Officer. Destruction of Federal records is expressly prohibited unless in accordance with paragraph (c)(4).

(7) The Contractor shall only use Government information technology equipment for purposes specifically authorized by the contract and in accordance with HHS policy.

(10) The Contractor shall not create or maintain any Federal records containing any non-public HHS information that are not specifically authorized by the contract.

(a) The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

(b) All Contractor employees assigned to this contract handle Federal records are required to take HHS-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

(d) Subcontract flowdown. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract.

(End of clause)

HHSAR 352.232-71 Electronic Submission of Payment Requests (Feb 2022)

(a) Definitions. As used in this clause—

(1) “Payment request” means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End of Clause)

HHSAR 352.239-79 Information and Communication Technology Accessibility Notice (Feb 2024) (Deviation)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, HHSAR Conformed Copy Part 352 (eCFR copy date 03/06/2025) Last Updated: 04/28/2025 Status: DEVIATED HHSAR 352-111 Navigate to: HHSAR Part 352 TOC | Notes | Summary of HHSAR CDs | Structure of HHSAR acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html. (b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense. (c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense. (d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense. (e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of clause)

CDCG.02 Contracting Officer’s Representative (COR) (Jul 2017) Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract.

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

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

The Government COR is not authorized to change any of the terms and conditions of this contract.

Contract changes shall be made only by the Contracting Officer through properly written modification(s) to the contract.

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

CDCG.03 Contracting Officer (Jul 1999)

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

b. No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

CDCG.07 Payment by Electronic Funds Transfer (Jan 2026)

a. The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer –System for Award Management, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

b. In the case that EFT information is not within the System of Award Management, FAR 52.232-

34, Payment by Electronic Funds Transfer-Other than System for Award Management, requires mandatory submission of Contractor’s EFT information directly to the office designated in this contract to receive that information (hereafter: “designated office”); see below. The contractor shall submit the EFT information within the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained from the CDC Office of Financial Resources at 678-475-4500 or cpbapinv@cdc.gov.

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

d. The completed form shall be mailed or sent via facsimile after award, but no later than 15 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention Office of Financial Resources (OFR) P.O. Box 15580 Atlanta, GA 30333

CDCH.14 Records Management Obligations (Jun 2020) A. Applicability The following applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes Centers for Disease Control and Prevention (CDC) records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their CDC contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the

Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C.

chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. CDC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of CDC or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to the Contracting Officer and the Contracting Officer’s Representative. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to CDC control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the contract. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and CDC guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with CDC policy.

8. The Contractor shall not create or maintain any records containing any non-public CDC information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take CDC-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

D. Flowdown of requirements to subcontractors

1. The Contractor shall incorporate the entire substance of the terms and conditions herein, including this paragraph, in all subcontracts under this contract, and must require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth herein will be attributed to the Contractor.

CDCH.16 Non-Disclosure Agreement for Contractor and Contractor Employees (Jun 2020) (a)The contractor and contractor employees shall prepare and submit Non-Disclosure Agreements (NDA) to the Contracting Officer prior to access of government information or the commencement of work at CDC.

(b)The NDAs, at Exhibit I and II, are required in service contracts where contractor’s employees will have access to non-public and procurement-sensitive information while performing functions in support of the Government. The NDA also requires contractor’s employees properly identify themselves as employees of a contractor when communicating or interacting with CDC employees, employees of other governmental entities, and members of the public (when communication or interaction relates to the contractor’s work with the CDC). The Federal Acquisition Regulation (FAR) 37.114 (c), states “All contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are Government officials, unless, in the judgment of the agency, no harm can come from failing to identify themselves. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.”

(c)The contractor shall inform contractor employees of the identification requirements by which they must abide and monitor employee compliance with the identification requirements.

(d)During the contract performance period, the contractor is responsible to ensure that all additional or replacement contractors’ employees sign an NDA, and it is submitted to the Contracting Officer prior to commencement of their work with the CDC.

(e)Contractor employees in designated positions or functions that have not signed the appropriate NDA shall not have access to any non-public, procurement sensitive information or participate in government meetings where sensitive information may be discussed.

(f)The Contractor shall prepare and maintain a current list of employees working under NDAs and submit to the Contracting Officer upon request during the contract period of performance.

The list should at a minimum include: contract number, employee’s name, position, date of hire and NDA requirement.

EXHIBIT I

Centers for Disease Control and Prevention (CDC) Contractor Non-Disclosure Agreement I. Non-public Information [Name of contractor] understands that in order to fulfill the responsibilities pursuant to [contract name and number] between the Centers for Disease Control and Prevention and [Name of CDC contractor] dated [date], employees of [contractor] will have access to non-public information, including confidential and privileged information contained in government-owned information technology systems. For purposes of this agreement, confidential information means government information that is not or will not be generally available to the public.

Privileged information means information which cannot be disclosed without the prior written consent of the CDC.

In order to properly safeguard non-public information, [contractor] agrees to ensure that prior to being granted access to government information or the commencement of work for the CDC, whichever is applicable, all contractor employees will sign a Non-Disclosure Agreement (NDA) provided by the CDC prior to beginning work for the CDC. Contractor agrees to submit to the Contracting Officer the original signed copies of NDAs signed by the contractor’s employees in accordance with the instructions provided by the Contracting Officer. Failure to provide signed NDAs in accordance with this agreement and instructions provided by the Contracting Officer could delay or prevent the employee from commencing or continuing work at the CDC until such agreement is signed and returned to the Contracting Officer.

Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee any non-public information that the employee may obtain in connection with the performance of the employee’s responsibilities to the CDC.

II. Procurement-Sensitive Information Contractor further agrees that it will not cause or encourage any employee to disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual, other than an authorized Government employee, any procurement-sensitive information gained while in connection with fulfilling the employee’s responsibilities at the CDC. For purposes of this agreement, procurement-sensitive information includes, but is not limited to, all information in Statements of Work (SOW), Procurement Requests (PR), and Requests for Proposal (RFP);

Responses to RFPs, including proposals, questions from potential offerors; non-public information regarding procurements; all documents, conversations, discussions, data, correspondence, electronic mail (e-mail), presentations, or any other written or verbal communications relating to, concerning, or affecting proposed or pending solicitations or awards; procurement data; contract information plans; strategies; source selection information and documentation; offerors’ identities; technical and cost data; the identity of government personnel involved in the solicitation; the schedule of key technical and procurement events in the award determination process; and any other information that may provide an unfair competitive advantage to a contractor or potential contractor if improperly disclosed to them, or any of their employees.

Contractor understands and agrees that employee access to any procurement-sensitive information may create a conflict of interest which will preclude contractor from becoming a competitor for any acquisition(s) resulting from this information. Therefore, if an employee participates in any discussions relating to procurement-sensitive information, assists in developing any procurement-sensitive information, or otherwise obtains any procurement-sensitive information while performing duties at the CDC, contractor understands and agrees that contractor may be excluded from competing for any acquisition(s) resulting from this information.

III. Identification of Non-Government Employees Contractor understands that its employees are not agents of the Government. Therefore, unless otherwise directed in writing by the CDC, contractor agrees to assist and monitor employee compliance with the following identification procedures:

A. At the beginning of interactions with CDC employees, employees of other governmental entities, and members of the public (when such communication or interaction relates to the contractor’s work with the CDC), contractors’ employees will identify themselves as an employee of a contractor.

B. Contractors’ employees will include the following disclosures in all written communications, including outgoing electronic mail (e-mail) messages, in connection with contractual duties to the CDC:

Employee’s name Name of contractor Center or office affiliation Centers for Disease Control and Prevention C. At the beginning of telephone conversations or conference calls, contractors’ employees will identify themselves as an employee of a contractor.

D. Contractors’ employees should not wear any CDC logo on clothing, except for a CDC issued security badge while carrying out work for CDC or on CDC premises. The only other exception is when a CDC management official has granted permission to use the CDC logo.

E. Contractors’ employees will program CDC voice mail message to identify themselves as an employee of a contractor.

I understand that federal laws including, 18 U.S.C. 641 and 18 U.S.C. 2071, provide criminal penalties for, among other things, unlawfully removing, destroying or converting to personal use, or use of another, any public records.

Contractor acknowledges that contractor has read and fully understands this agreement Name of contractor: ___________________________________

Signature of Authorized Representative of Contractor:_________________________________

Date:________________

Copies retained by: Contracting Officer and Contractor

EXHIBIT II

Centers for Disease Control and Prevention (CDC) Contractors’ Employee Non-Disclosure Agreement I. Non-Public Information I understand that in order to fulfill my responsibilities as an employee of [Name of CDC contractor], I will have access to non-public information, including confidential and privileged information contained in government-owned information technology systems. For purposes of this agreement, confidential information means government information that is not or will not be generally available to the public. Privileged information means information which cannot be disclosed without the prior written consent of the CDC.

I, [Name of Employee], agree to use non-public information only in performance of my responsibilities to the CDC.

I agree further that I will not disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee, any non-public information that I may obtain in connection with the performance of my responsibilities to the CDC.

II. Procurement-Sensitive Information

I further agree that unless I have prior written permission from the CDC, I will not disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual other than an authorized Government employee, any procurement-sensitive information gained in connection with the performance of my responsibilities to the CDC. I specifically agree not to disclose any non-public, procurement-sensitive information to employees of my company or any other organization unless so authorized in writing by the CDC. For purposes of this agreement, procurement-sensitive information includes, but is not limited to, all information in Statements of Work (SOW), Procurement Requests (PR), and Requests for Proposal (RFP); Responses to RFPs, including proposals, questions from potential offerors; non-public information regarding procurements; all documents, conversations, discussions, data, correspondence, electronic mail (e-mail), presentations, or any other written or verbal communications relating to, concerning, or affecting proposed or pending solicitations or awards; procurement data; contract information plans; strategies; source selection information and documentation; offerors’ identities; technical and cost data; the identity of government personnel involved in the acquisition; the schedule of key technical and procurement events in the award determination process; and any other information that may provide an unfair competitive advantage to a contractor or potential contractor if improperly disclosed to them, or any of their employees.

I understand and agree that my access to any procurement-sensitive information may create a conflict of interest which will preclude me, my current employer, or a future employer from becoming a competitor for any resulting government acquisition derived from this information.