ATTACHMENT_12_Supply_Chain_Risk_Management_Certification.pdf

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Contract Research Organization for the National In
Solicitation number
75N94025R00008
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This is a Supply Chain Risk Assessment Certification and Instructions to Offerors document for RFP 75N94025R00008 issued by the Department of Health and Human Services (HHS).

Offerors must submit a completed Supply Chain Risk Assessment certification as part of their proposal, including all potential subcontractor information. The certification requires offerors to provide descriptions of products, materials, information, or services being supplied; vendor and manufacturer company names and addresses; and known website, Commercial and Government Entity (CAGE) codes, and Unique Entity Identifiers (UEI). Offerors must make representations regarding foreign ownership exceeding 10 percent, foreign business affiliations (technology partnerships, joint ventures, foreign subsidiaries, grants), foreign government or state-owned enterprise investments, company leadership ties to foreign countries, violations of export controls or Foreign Corrupt Practices Act within five years, prohibitions from doing business with U.S. government or foreign governments, affiliations with prohibited entities, suspension or debarment status, bankruptcy filings within ten years, and litigation within ten years. The HHS Office of National Security (ONS) will conduct supply chain risk assessments considering public and non-public information relating to the offeror's supply chain. Mission-critical acquisitions include contract support for HHS research and development, financial databases, intellectual property utilization, continuity of operations functions, critical infrastructure, and high-value acquisitions. Findings from the assessment will inform responsibility and award eligibility determinations. Any necessary mitigation plans will be incorporated into the contract. Offerors must include this certification substance in subcontracts involving mission-critical products, materials, information, or services and submit all subcontractor information and representations with their proposals.

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Supply Chain Risk Assessment Certification and Instructions to Offerors:

As a part of its proposal, the offeror must submit the completed Supply Chain Risk Assessment certification, found below, including all potential subcontractor information and representations as required by paragraph (g).

(a) Definitions. As used in this RFP Attachment— Contract means as defined in FAR 2.101.

Foreign person means as defined in 31 CFR 800.224.

Mission-critical acquisition means the acquisition of products, materials, information, or services that are identified as—

(1) Contract support or development services for HHS or OpDiv/StaffDiv research and development;

(2) Contract support or development services for HHS or OpDiv/StaffDiv financial databases and services;

(3) Contract support services that require utilization or sharing of HHS or OpDiv/StaffDiv Intellectual property;

(4) Contract services supporting HHS or OpDiv/StaffDiv continuity of operations (COOP) mission essential functions;

(5) Contract support services or development initiatives for HHS or OpDiv/StaffDiv critical infrastructure;

(6) An HHS or OpDiv/StaffDiv high-value/dollar acquisition; or

(7) Other acquisitions for critical assets or services as identified by OpDiv/StaffDiv leadership.

Office of National Security (ONS) means the HHS office responsible for the management, oversight, policy, guidance, and implementation of the HHS Enterprise Supply Chain Risk Management (E-SCRM) Program, including the conducting of supply chain risk assessments.

State-owned enterprise means a legal entity that is created by a government in order to partake in commercial activities on the government's behalf. A state-owned enterprise or government-owned enterprise is a business enterprise where the government or state has significant control through full, majority, or significant minority ownership.

Supply chain risk means the potential for harm or compromise that arises as a result of security risks from suppliers, their supply chains, and their products, materials, information, or services. Supply chain risks include exposures, threats, and vulnerabilities associated with the products and services traversing the supply chain as well as the exposures, threats, and vulnerabilities to the supply chain.

ATTACHMENT 12, RFP 75N94025R00008

Supply chain risk assessment means a systematic examination of supply chain risks, likelihoods of their occurrence, and potential impacts.

Supply chain risk management (SCRM) means a systematic process for managing risk to the integrity, trustworthiness, and authenticity of products, materials, information, and services within the supply chain.

It addresses the activities of foreign and other adversaries aimed at compromising the supply chain, which may include the introduction of counterfeit or malicious items into the supply chain. It is conducted through identification of threats, vulnerabilities, and consequences throughout the supply chain and development of mitigation strategies to address the respective risks presented by the supplier, the supplied products, materials, information, and services, or the supply chain at any point during the life cycle.

(b) Supply chain risk assessment. The Office of National Security (ONS) or delegated designee may perform a supply chain risk assessment of the Offeror’s proposal. In performing the supply chain risk assessment, the Government may consider public and non-public information relating to the Offeror’s supply chain.

(c) Required information submittal. The Offeror shall provide the following information for products, materials, information, or services provided under their proposal:

(1) Description of the type of products, materials, information, or services provided.

(2) Vendor and manufacturer’s company, if applicable, including name and address.

(3) If known, vendor’s and manufacturer’s web site, and the Commercial and Government Entity (CAGE) code and Unique Entity Identifier (UEI).

(d) Representations. The Offeror represents that—

(1) It [ ] does, [ ] does not have any foreign ownership, outside of retail shareholders, who control more than 10% of the company’s total shares. If yes, identify the legal name of the owning organization/individual and their country of affiliation.

(2) It [ ] does, [ ] does not have any of the following business affiliations with foreign entities:

technology development partnerships, strategic partnerships, joint ventures, foreign subsidiaries, grants from a foreign entity. If yes, identify the legal name of the organization, its foreign address, and the nature of the relationship.

(3) It [ ] does, [ ] does not have any foreign governments, or state-owned enterprises that have investments or ownership interest in the company. If yes, identify the foreign government, the ownership stake percentage, and the nature of the relationship.

(4) The company leadership (C-Suite executives, Board members, etc.) [ ] does, [ X] does not have any substantial ties to foreign countries, including being citizens of a foreign country, graduates of a foreign university, or investments in a foreign country. If yes, identify the individual, the nature of the tie, and the country they are tied to.

(5) It [ ] has, [ ] has not violated export controls or the Foreign Corrupt Practices Act within 5 years. If yes, enter the event, the date, and any remediation the company committed after the event.

(6) It [ ] has, [ ] has not been prohibited from doing business with the government of the US or any of its administrative subdivisions to include agencies, states, territories or municipalities. If yes, enter the event, the date, and any remediation the company committed after the event.

(7) It [ ] has, [ ] has not been prohibited from doing business with any foreign governments or subdivisions thereof. If yes, enter the event, the date, and any remediation the company committed after the event.

(8) It [ ] has had, [ ] has not had affiliations with any entities prohibited (e.g. Huawei, see SAM.gov “exclusions” page for additional information regarding prohibited entities) from doing business with the government of the US or any of its administrative subdivisions to include agencies, states, territories or municipalities? If yes, enter the event, the date, and any remediation the company committed after the event.

(9) It [ ] has, [ ] has not been suspended or debarred at any point while doing business with the U.S.

Government or any of its administrative subdivisions to include agencies, states, territories or municipalities. If yes, enter the event, the date, and details below.

(10) It [ ] has previously filed for or is currently in, [ ] has not previously filed for or is not currently in bankruptcy in the last 10 years. If yes, enter the event, the date, and details below.

(11) It [ ] was or is currently in, [ ] was not or is not currently in litigation in the last 10 years. If yes, enter the event, the date, and details below.

(e) Supply chain risk determination. Findings from the supply chain risk assessment will be considered in connection with a determination of the Offeror’s responsibility and eligibility for award. Failure of the Offeror to furnish the information required in this provision or provide additional information as requested by the Contracting Officer may render the Offeror non-responsible and ineligible for award.

The Government reserves the right to limit the disclosure of information to the Offeror regarding the risk in accordance with all applicable laws or regulations.

(f) Mitigation plans. Any mitigation plans and amendments determined necessary and to be implemented and sustained during contract performance will be incorporated into the contract.

(g) Subcontracts. The Offeror shall include the substance of this provision, including the information and representations at paragraphs (c) and (d), and including this paragraph (g), in subcontracts with persons or entities proposed to be used involving the development or delivery of any mission-critical products, materials, information, or services. The Offeror shall submit all potential subcontractor information and representations with its proposal for any mission-critical products, materials, information, or services provided for in the proposal.

(End of RFP Attachment)

1 Description of the type of products materials information or services provided: Services in support of coordination and management of multiple-site clinical trials (clinical sites are under separate NIAAA contracts).
2 Vendor and manufacturers company if applicable including name and address:
code and Unique Entity Identifier UEI:
organizationindividual and their country of affiliation:
of the relationship:
ownership stake percentage and the nature of the relationship:
country they are tied to:
yes enter the event the date and any remediation the company committed after the event:
the date and any remediation the company committed after the event:
the event:
event:
municipalities If yes enter the event the date and details below:
11 It was or is currently in was not or is not currently in litigation in the last 10 years If yes:
e Supply chain risk determination Findings from the supply chain risk assessment will be considered in:
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