75N95022Q00549

Post Date/ Solicitation Issue Date

August 29, 2022 12:00 pm

Closing Response Date

September 7, 2022 3:00 pm

Proposed Award Date

September 15, 2022 12:00 pm

Project Title

Liver organoids - An in vitro model that can mimic the physiology and functions of a human liver. iPSC-derived hepatocyte organoids

Contracting Office

National Institute on Drug Abuse (NIDA)

Small Business Size Standard

1250

FPDS Classification Code

6505 - Drugs And Biologicals

Estimated Period of Performance

This is a one time delivery.

Delivery of Goods

4-6 weeks

Competition Status

Non-Competitive

Single-Sole Source Determination

This is a continuous project by using 3Dnamics liver organoids to evaluate chemical effect.
3Dnamics liver organoids have been evaluated and found that these liver organoids showed normal liver function and liver-mimicking cell populations, which is ideal. If we change the vendor to produce liver organoids, we must restart this process to evaluate the quality of liver organoids.

If we change the vendor that produces liver organoids, we must re-qualify the liver organoids from them to make sure we can repeat and confirm the previous experiment data before the further assay development.

Other in vitro cell models for hepatic compound toxicity testing, such as HepG2 and HepaRG, lack the cell complexity to simulate human liver function in vivo, resulting in some erroneous negative predictions

Background/Description of Requirement

ELECTRONIC REQUEST FOR QUOTATION (E-RFQ)

Liver organoids - An in vitro model that can mimic the physiology and functions of a human liver.

iPSC-derived hepatocyte organoids

REQUEST NUMBER: 75N95022Q00549

DATE ISSUED: August 29^th, 2022

ISSUED BY CONTRACTING OFFICE:  Department of Health and Human Services / National Institutes of Health / National Institute on Drug Abuse (NIDA)/ OA / 16071 Industrial Dr., Gaithersburg, MD 20877

FOR INFORMATION CONTACT:  Claudia Ventola claudia.ventola@nih.gov

NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

SMALL BUSINESS SIZE STANDARD: 1,250 employees

SET-ASIDE STATUS: N/A

Competition Status:  This requirement is non-competitive.

Non-Competitive (Single-sole Source (Including brand-name)) Determination: I hereby determine that the item or service listed herein is available from only one source and competition is precluded for the reasons that there are no substitutes or alternatives available.

This is a continuous project by using 3Dnamics liver organoids to evaluate chemical effect.

3Dnamics liver organoids have been evaluated and found that these liver organoids showed normal liver function and liver-mimicking cell populations, which is ideal. If we change the vendor to produce liver organoids, we must restart this process to evaluate the quality of liver organoids.

If we change the vendor that produces liver organoids, we must re-qualify the liver organoids from them to make sure we can repeat and confirm the previous experiment data before the further assay development.

Other in vitro cell models for hepatic compound toxicity testing, such as HepG2 and HepaRG, lack the cell complexity to simulate human liver function in vivo, resulting in some erroneous negative predictions

 

DATE QUOTATION DUE:

All responses to this RFQ must be received by 3:00 PM Eastern, on September7^th, 2022 and must reference the request number cited above. Responses must be submitted electronically to the contact person cited above. Fax responses will not be accepted.

IMPORTANT: This is a request for quotations. If you are unable to quote, please so indicate in a reply email to the contract specialist cited herein.  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 service. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotation must be completed by the quoter.

Purchase Description: Liver organoids - The Tox21 group (NCATS) requires a more precise and functional in vitro liver model for toxicity testing. These liver organoids will be used to develop high-throughput assays for toxicology testing.

Salient characteristics

The minimum characteristics required are as follows:

Liver organoids:

• An in vitro model that can mimic the physiology and functions of a human liver.
• Invaluable to developing assays for drug metabolism and toxicology, screening for potential antiviral agents.
• Express liver-specific proteins-Cytochrome P450 3A4 (CYP3A4), Albumin, α-fetoprotein (AFP), Sulfotransferase family 2A member 1 (SULT2), Hepatocyte nuclear factor 4 alpha (HNF-4α), and others-that may provide a more accurate and predictive liver model for drug development than pre-existing models

Quantity:

Five hundred and fifty (550) total liver organoids - iPSC-derived hepatocyte organoids

Delivery/Warranty

Delivery shall be 4-6 weeks. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Building C, Room 307W Rockville, MD 20852.

An estimated number of days for delivery after receipt of an order must be specified in any quote submitted. Delivery terms anticipated for FOB-Destination shall apply.

Contract Type:

A Fixed-Price type of Purchase Order award not exceeding the Simplified Acquisition Threshold is anticipated for any contract resulting from this requirement. The anticipated award date is September, 15^th, 2022.

QUOTER TERMS AND CONDITIONS (to be filled out by the Offeror):

1. Period of Performance OR Delivery Date After Receipt of Order:
2. Shipping Point (F.O.B. OR Destination):
3. Payment Discount Terms:
4. Select One: Open Market; GSA FSS Contract Number; Other Government Agency (OGA) Contract Number, Government-wide Agency (GWAC) Contract Number; or National Institute of Health (NIH) Blanket Purchase Agreement (BPA) Number:
5. DUNS No:
6. Name of Company:
7. Street Address, City, State, Zip code:
8. Name of Person Authorized to Provide Quote:
9. Telephone Number and Email Address of Person Authorized to Provide Quote:                                                                                             ADDITIONAL TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

The FAR Clauses are incorporated by reference and are provided in full text at https://www.acquisition.gov/

1. 1. 1. 1. The provisions of FAR Clause 52.212-1 Instructions to Offerors—Commercial Items (OCT 2018) is applicable to this solicitation.
         2. The provisions of FAR Clause 52.212.2 Evaluation—Commercial Items (Oct 2014) is applicable to this solicitation. The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:
            1. 1. 1. 1. Technical capability of the item offered to meet the Government requirement;
                     2. Price; and
                     3. Past performance [see FAR 13.106-2(b)(3)].
         3. The provisions of FAR Clause 52.212-3, Offeror Representations and Certifications—Commercial Items (Feb 2021), is applicable to this solicitation.
         4. The provisions of FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items (OCT 2018) with Addenda: Stop Work Order, FAR Clause 52.242-15 (August 1989) is applicable to this solicitation.
         5. The provisions of FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Jul 2021) is applicable to this solicitation:

52.222-3 Convict Labor (June 2003)

52.222-19 Child Labor-Cooperation With Authorities and Remedies (Jan 2018)

52.222-21 Prohibition of Segregated Facilities (Apr 2015)

52.222-26 Equal Opportunity (Sep 2016)

52.222-36 Equal Opportunity for Workers With Disabilities (Jul 2014)

52.222-50 Combating Trafficking in Persons (Mar 2015)

52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011)

52.232-33 Payment by Electronic Funds Transfer-- System for Award Management (Jul 2013)

6.         H.22 - The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

The following FAR provisions are incorporated in full text:

52.225-1 Buy American-Supplies (Jan 2021)

      (a) Definitions. As used in this clause—

      Commercially available off-the-shelf (COTS) item—

           (1) Means any item of supply (including construction material) that is–

                (i) A commercial item (as defined in paragraph (1) of the definition at Federal Acquisition Regulation (FAR) 2.101);

                (ii) Sold in substantial quantities in the commercial marketplace; and

                (iii) Offered to the Government, under a contract or subcontract at any tier, without modification, in the same form in which it is sold in the commercial marketplace; and

           (2) Does not include bulk cargo, as defined in 46 U.S.C.40102(4), such as agricultural products and petroleum products.

      Component means an article, material, or supply incorporated directly into an end product.

      Cost of components means—

           (1) For components purchased by the Contractor, the acquisition cost, including transportation costs to the place of incorporation into the end product (whether or not such costs are paid to a domestic firm), and any applicable duty (whether or not a duty-free entry certificate is issued); or

           (2) For components manufactured by the Contractor, all costs associated with the manufacture of the component, including transportation costs as described in paragraph (1) of this definition, plus allocable overhead costs, but excluding profit. Cost of components does not include any costs associated with the manufacture of the end product.

      Domestic end product means—

           (1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both-

                (i) An unmanufactured end product mined or produced in the United States;

                (ii) An end product manufactured in the United States, if-

                     (A) The cost of its components mined, produced, or manufactured in the United States exceeds 55 percent of the cost of all its components. Components of foreign origin of the same class or kind as those that the agency determines are not mined, produced, or manufactured in sufficient and reasonably available commercial quantities of a satisfactory quality are treated as domestic. Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic; or

                     (B) The end product is a COTS item; or

           (2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of foreign iron and steel constitutes less than 5 percent of the cost of all the components used in the end product. The cost of foreign iron and steel includes but is not limited to the cost of foreign iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the end product and a good faith estimate of the cost of all foreign iron or steel components excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the definition of "cost of components".

      End product means those articles, materials, and supplies to be acquired under the contract for public use.

      Fastener means a hardware device that mechanically joins or affixes two or more objects together. Examples of fasteners are nuts, bolts, pins, rivets, nails, clips, and screws.

      Foreign end product means an end product other than a domestic end product.

      Foreign iron and steel means iron or steel products not produced in the United States. Produced in the United States means that all manufacturing processes of the iron or steel must take place in the United States, from the initial melting stage through the application of coatings, except metallurgical processes involving refinement of steel additives. The origin of the elements of the iron or steel is not relevant to the determination of whether it is domestic or foreign.

      Predominantly of iron or steel or a combination of both means that the cost of the iron and steel content exceeds 50 percent of the total cost of all its components. The cost of iron and steel is the cost of the iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the product and a good faith estimate of the cost of iron or steel components excluding COTS fasteners.

      Steel means an alloy that includes at least 50 percent iron, between 0.02 and 2 percent carbon, and may include other elements.

      United States means the 50 States, the District of Columbia, and outlying areas.

      (b) 41 U.S.C. chapter 83, Buy American, provides a preference for domestic end products for supplies acquired for use in the United States. In accordance with 41 U.S.C. 1907, the domestic content test of the Buy American statute is waived for an end product that is a COTS item (see 12.505(a)(1)), except that for an end product that consists wholly or predominantly of iron or steel or a combination of both, the domestic content test is applied only to the iron and steel content of the end product, excluding COTS fasteners.

      (c) Offerors may obtain from the Contracting Officer a list of foreign articles that the Contracting Officer will treat as domestic for this contract.

      (d) The Contractor shall deliver only domestic end products except to the extent that it specified delivery of foreign end products in the provision of the solicitation entitled "Buy American Certificate."

(End of clause)

 52.225-2 Buy American Certificate (Feb 2021)

      (a) (1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product.

           (2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products.

           (3) The terms "domestic end product," "end product," and "foreign end product" are defined in the clause of this solicitation entitled "Buy American-Supplies."

      (b) Foreign End Products:

Line Item No	Country of Origin

 

     [List as necessary]

      (c) The Government will evaluate offers in accordance with the policies and procedures of part  25 of the Federal Acquisition Regulation.

(End of provision)

52.225-13- Restrictions on certain foreign purchases (Feb 2021)

      (a) Except as authorized by the Office of Foreign Assets Control (OFAC) in the Department of the Treasury, the Contractor shall not acquire, for use in the performance of this contract, any supplies or services if any proclamation, Executive order, or statute administered by OFAC, or if OFAC’s implementing regulations at 31 CFR ChapterV, would prohibit such a transaction by a person subject to the jurisdiction of the United States.

      (b) Except as authorized by OFAC, most transactions involving Cuba, Iran, and Sudan are prohibited, as are most imports from Burma or North Korea, into the United States or its outlying areas. Lists of entities and individuals subject to economic sanctions are included in OFAC’s List of Specially Designated Nationals and Blocked Persons at https://home.treasury.gov/policy-issues/financial-sanctions/specially-designated-nationals-and-blocked-persons-list-sdn-human-readable-lists. More information about these restrictions, as well as updates, is available in the OFAC’s regulations at 31 CFR ChapterV and/or on OFAC’s website at https://home.treasury.gov/policy-issues/office-of-foreign-assets-control-sanctions-programs-and-information.

      (c) The Contractor shall insert this clause, including this paragraph (c), in all subcontracts.

(End of clause)

52.225-20- Prohibition on Conducting Restricted Business Operations in Sudan-Certification (Aug 2009)      (a) Definitions. As used in this provision-

      Business operations means engaging in commerce in any form, including by acquiring, developing, maintaining, owning, selling, possessing, leasing, or operating equipment, facilities, personnel, products, services, personal property, real property, or any other apparatus of business or commerce.

      Marginalized populations of Sudan means-

           (1) Adversely affected groups in regions authorized to receive assistance under section 8(c) of the Darfur Peace and Accountability Act (Pub. L. 109-344) ( 50 U.S.C. 1701 note); and

           (2) Marginalized areas in Northern Sudan described in section 4(9) of such Act.

           Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate-

                (1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

                (2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

                (3) Consist of providing goods or services to marginalized populations of Sudan;

                (4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

                (5) Consist of providing goods or services that are used only to promote health or education; or

                (6) Have been voluntarily suspended.

      (b) Certification. By submission of its offer, the offeror certifies that the offeror does not conduct any restricted business operations in Sudan.

(End of provision)

52.225-25-Prohibition on Contracting With Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications (Jun 2020)

      (a) Definitions. As used in this provision-

      Person—

           (1) Means–

                (i) A natural person;

                (ii) A corporation, business association, partnership, society, trust, financial institution, insurer, underwriter, guarantor, and any other business organization, any other nongovernmental entity, organization, or group, and any governmental entity operating as a business enterprise; and

                (iii) Any successor to any entity described in paragraph (1)(ii) of this definition; and

           (2) Does not include a government or governmental entity that is not operating as a business enterprise.

      Sensitive technology-

           (1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically-

                (i) To restrict the free flow of unbiased information in Iran; or

                (ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

           (2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

      (b) The offeror shall e-mail questions concerning sensitive technology to the Department of State at CISADA106@state.gov.

      (c) Except as provided in paragraph (d) of this provision or if a waiver has been granted in accordance with Federal Acquisition Regulation (FAR) 25.703-4, by submission of its offer, the offeror—

           (1) Represents, to the best of its knowledge and belief, that the offeror does not export any sensitive technology to the government of Iran or any entities or individuals owned or controlled by, or acting on behalf or at the direction of, the government of Iran;

           (2) Certifies that the offeror, or any person owned or controlled by the offeror, does not engage in any activities for which sanctions may be imposed under section 5 of the Iran Sanctions Act. These sanctioned activities are in the areas of development of the petroleum resources of Iran, production of refined petroleum products in Iran, sale and provision of refined petroleum products to Iran, and contributing to Iran's ability to acquire or develop certain weapons or technologies; and

           (3) Certifies that the offeror, and any person owned or controlled by the offeror, does not knowingly engage in any transaction that exceeds the threshold at FAR 25.703-2(a)(2) with Iran's Revolutionary Guard Corps or any of its officials, agents, or affiliates, the property and interests in property of which are blocked pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) (see OFAC's Specially Designated Nationals and Blocked Persons List at https://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx).

      (d) Exception for trade agreements. The representation requirement of paragraph (c)(1) and the certification requirements of paragraphs (c)(2) and (c)(3) of this provision do not apply if-

           (1) This solicitation includes a trade agreements notice or certification (e.g., 52.225-4, 52.225-6, 52.225-12, 52.225-24, or comparable agency provision); and

           (2) The offeror has certified that all the offered products to be supplied are designated country end products or designated country construction material.

(End of provision)

In addition, the following FAR provisions are applicable to this solicitation and incorporated by reference: 52.204-7 System for Award Management (Oct 2018),

52.204-13 System for Award Management Maintenance (Oct 2018),

52.204-16 Commercial and Government Entity Code Reporting (Jul 2016),

52.204-18 Commercial and Government Entity Code Maintenance (Jul 2016).

The following provisions and clauses apply to this acquisition and are incorporated as an attachment. Offerors MUST complete the provision at 52.204-24 and submit a completed copy as a separate document with their quotation.

1. FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020)
2. FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
3. NIH Invoice and Payment Provisions (2/2021)

 

SUMMARY STATEMENT:

Responses to this notice must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service.  The response shall include a QUOTATION that includes: unit price, list price, total price, any shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision.  Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.