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This amendment to a federal solicitation notifies offerors of new disclosure requirements for foreign relationships. Small businesses submitting proposals must disclose any ties to foreign talent recruitment programs, foreign subsidiaries or joint ventures, contractual obligations with foreign entities, foreign ownership, foreign investment, foreign licensing of intellectual property, or other foreign relationships. Disclosures must be provided using the attached form and certified by signature. The solicitation remains open with the same response deadline.

This federal contract opportunity seeks proposals from small businesses to conduct research and development in support of the National Institutes of Health and Centers for Disease Control and Prevention missions. The anticipated solicitation number is PHS-2023-1 with an expected release date of August 4, 2022 and a proposal receipt deadline of November 4, 2022. The solicitation will include over 125 topics across multiple NIH Institutes and CDC Centers seeking innovation in areas such as cancer treatment, aging, infectious diseases, heart and lung health, and drug abuse. Awards will be in the form of contracts. Eligible small businesses must meet defined ownership, affiliation, and employee size criteria.

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AMENDMENT TWO (2)

Solicitation Number: PHS 2023-1

Date of Solicitation Issuance: 08/08/2022

Date of Amendment No.1 Issuance: 09/30/2022

Date of Amendment No. 2 Issuance: 11/02/2022

Number of Pages: 1

Attachments: Attachment 1, ‘Disclosure of Foreign Relationships’

Points of Contact: George Kennedy, Contracting Officer E-mail: kennedyg@mail.nih.gov

Cherie Wells, Contracts Analyst (Contractor) E-mail: ncioasbir@nih.gov

ISSUING OFFICE OF ACQUISITIONS

National Institute of Allergy and Infectious Diseases (NIAID) 5601 Fishers Lane, Suite 300, MSC 9821 Rockville, MD 20852

PURPOSE OF SOLICITATION AMENDMENT

In accordance with Public Law 117-183, “SBIR and STTR Extension Act of 2022”, each small business concern submitting a proposal for a Federally funded award under this solicitation must disclose ties to foreign relationships.

The purpose of Amendment 2 is to notify offerors of this disclosure requirement, and provide Attachment 1:

‘Disclosure of Foreign Relationships’, for provision and certification of the required disclosures.

Attachment 1: ‘Disclosure of Foreign Relationships’, should be utilized to provide the required disclosures, and can be included in the offerors Business Proposal. Proposals that provide insufficient evidence to meet this requirement may be requested to submit supplemental information or disclosures during negotiations. All information must be received prior to award.

The hour and date specified for receipt of Offers remains unchanged.

Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full effect.

End of Amendment 2 mailto:kennedyg@mail.nih.gov mailto:ncioasbir@nih.gov

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS), THE NATIONAL INSTITUTES OF HEALTH

(NIH) AND THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

Solicitation No. PHS 2023-1

Disclosure of Foreign Relationships

Instructions

Each small business concern must disclose ties to foreign relationships with its application for a Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) award. (15 U.S.C. § 638(g),(o)).

Each small business concern must update its disclosures about ties to foreign relationships during the period of performance of an award if: (i) there is any change to a disclosure required under questions 1- 7 below, (ii) there is any material misstatement that the federal agency could determine poses a risk to national security, or (iii) there is a change in ownership, change to entity structure, or other substantial change in the circumstances of the small business concern that the Federal agency could determine poses a risk to national security.

The Federal agency has the right to require the small business concern to provide true copies of any contractual or financial obligation or other agreement specific to a business arrangement, or joint-venture like arrangement with an enterprise owned by a foreign state or any foreign entity in effect during the 5-year period preceding submission of the application.

The Federal agency will not make an award to the small business concern if it is determined that:

(A) the small business concern submitting the proposal-

(i) has an owner or covered individual that is party to a malign foreign talent recruitment program;

(ii) has a business entity, parent company, or subsidiary located in the People’s Republic of China or another foreign country of concern; or

(iii) has an owner or covered individual that has a foreign affiliation with a research institution located in the People’s Republic of China or another foreign country of concern; and

(B) the relationships and commitments described in (i) through (iii) of subparagraph (A)

(i) interfere with the capacity for activities supported by the Federal agency to be carried out;

(ii) create duplication with activities supported by the Federal agency;

(iii) present concerns about conflicts of interest;

(iv) were not appropriately disclosed to the Federal agency;

(v) violate Federal law or terms and conditions of the Federal agency; or

(vi) pose a risk to national security.

Solicitation No. PHS 2023-1

Definitions

The term “covered individual” means an individual who contributes in a substantive, meaningful way to the scientific development or execution of a research and development project proposed to be carried out with a research and development award from a Federal research agency, and includes individuals designated as a covered individual by the Federal research agency concerned.

The term “foreign affiliation” means a funded or unfunded academic, professional, or institutional appointment or position with a foreign government or government-owned entity, whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).

The term “foreign country of concern” means the People’s Republic of China, the Democratic People’s Republic of Korea, the Russian Federation, the Islamic Republic of Iran, or any other country determined to be a country of concern by the Secretary of State.

The term “malign foreign talent recruitment program” has the meaning given such term in section 10638 of the Research and Development, Competition, and Innovation Act (division B of Public Law 117– 167).

Questions:

1. Are there any owners or covered individuals at your small business concern who are a party to any foreign talent recruitment program of any foreign country of concern? ☐ Yes ☐ No If yes, please disclose the name of each owner or covered individual and the foreign talent recruitment program.

Name Foreign Talent Recruitment Program

2. Is there a joint venture or subsidiary of your small business concern that is based in, funded by, or has a foreign affiliation with any foreign country of concern? ☐ Yes ☐ No If yes, please disclose the name and address of each joint venture or subsidiary.

Name and Address of Joint Venture or Subsidiary https://www.gpo.gov/fdsys/pkg/PLAW-117publ167/pdf/PLAW-117publ167.pdf https://www.gpo.gov/fdsys/pkg/PLAW-117publ167/pdf/PLAW-117publ167.pdf

Solicitation No. PHS 2023-1

3. Does your small business concern have any current or pending contractual or financial obligation or other agreement specific to a business arrangement, or joint venture-like arrangement with an enterprise owned by a foreign state or any foreign entity? ☐ Yes ☐ No If yes, please disclose the name and address of the enterprise and the nature of the business relationship.

Name and Address of Enterprise Business Relationship

4. Is your small business concern wholly owned in a foreign country? ☐ Yes ☐ No If yes, please disclose the foreign country:

Foreign Country

5. Does your small business concern have any venture capital or institutional investment by an entity that has a general partner or individual holding a leadership role in such entity who has a foreign affiliation with any foreign country of concern? ☐ Yes ☐ No If yes, please disclose name of the venture capital or institutional investor and the percentage of venture capital or institutional investment.

Venture Capital or Institutional Investor Percentage of Investment

6. During the 5-year period preceding the submission of this proposal, did your small business concern have any technology licensing or intellectual property sales to a foreign country of concern? ☐ Yes ☐ No If yes, please disclose the name and address of the institution that licensed or purchased the intellectual property.

Name and Address of Licensee or Intellectual Property Buyer

Solicitation No. PHS 2023-1

7. Is there any foreign business entity, offshore entity, or entity outside the United States related to your small business concern? ☐ Yes ☐ No If yes, please disclose the name and address of the entity and the relationship to your small business concern not already documented in question 6.

Name and Address of Entity Relationship

Certification

I certify to the best of my knowledge and belief that the information contained in this Disclosure of Foreign Relationships is true, complete, and accurate. I understand that any false, fictitious, or fraudulent information, misrepresentations, half-truths, or omissions of any material fact, may subject me to criminal, civil or administrative penalties for fraud, false statements, false claims or otherwise. (18 U.S.C. §§ 1001 and 287, and 31 U.S.C. 3729-3733 and 3801-3812).

I understand that the small business concern will be required to repay all amounts received under the award if there is a material misstatement that the Federal agency determines poses a risk to national security, or there is a change in ownership, change to entity structure, or other substantial change in the circumstances of the small business concern that the Federal agency determines poses a risk to national security. (15 U.S.C. § 638(g)).

I further understand and agree that (1) the statements and representations made herein are material to the Federal agency’s award decision, and (2) I have a responsibility to update the disclosures during the period of performance of the award if: (i) there is any change to a disclosure required under questions 1- 7, (ii) there is any material misstatement that the Federal agency could determine poses a risk to national security, or (iii) there is a change in ownership, change to entity structure, or other substantial change in the circumstances of the small business concern that the Federal agency could determine poses a risk to national security. (15 U.S.C. § 638(g)).

The Disclosure of Foreign Relationships is a part of the Federal agency’s due diligence program under 15 U.S.C. § 638(vv) and is exempt from the Paperwork Reduction Act.

Signature Date__/__/__

Print Name (First, Middle, Last)

Role/Title

Name of Small Business Concern

Amendment_No._2_-_PHS-2023-1
The hour and date specified for receipt of Offers remains unchanged.
End of Amendment 2

Disclosure of Foreign Relationships - PHS 2023-1

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