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SAMDAILY.US - ISSUE OF DECEMBER 09, 2021 SAM #7313
SOLICITATION NOTICE

Q -- Testing of compounds in Cytochrome P450 (CYP) inhibition assays

Notice Date

12/7/2021 12:18:43 PM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541380 — Testing Laboratories
 

Contracting Office

NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
 

ZIP Code

20892
 

Solicitation Number

75N95022Q00044
 

Response Due

12/14/2021 6:00:00 AM
 

Archive Date

12/29/2021
 

Point of Contact

Renato Gomes
 

E-Mail Address

renato.gomes@nih.gov
(renato.gomes@nih.gov)
 

Description

(i)������� This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii)������� The solicitation number is 75N95022Q00044 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13�Simplified Acquisition Procedures; and FAR Part 12�Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).� The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Cyprotex US, LLC, 313 Pleasant St., Watertown, MA 02472 for testing of compounds in Cytochrome P450 (CYP) Inhibition Assays. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). The rationale for the brand-name justification is based on the vendor�s previous work with Cyprotex's existing assays for CYP inhibition used to generate prior data on the program in order to maintain continuity of service and allow a direct, apples-to-apples comparison of newly generated and previously generated data. (iii)������ The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2022-01, with effective date December 6, 2021. (iv)������ The associated NAICS code 541380 Testing Laboratories and the small business size standard $16.5M. There are no set-aside restrictions for this requirement. DESCRIPTION (v)������� The National Institutes of Health (NIH) is the nation�s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people�s health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a translational science center that prides itself on its productive pipeline and is innovative in a number of ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve people�s lives. Included in this process is the development of unique small molecules as potential anticancer agents. Prior work at NCATS has produced a series of small molecule IRAK4 / FLT3 kinase dual inhibitors, including NCGC00371481 and its structural analogs. Compounds such as �1481 have shown promising results in cellular and mouse models of MDS and AML. Further optimization of the ADME (Absorption, Distribution, Metabolism, and Excretion) and pharmacokinetic properties of these compounds is required and may eventually produce a clinical candidate that could be used to treat cancers such as MDS and / or AML. NCATS is currently synthesizing structurally novel analogs of NCGC00371481 that may show improved properties relative to previous analogs. In order to assess these analogs� ADME properties, NCATS needs to test the compounds in assays that measure inhibition of CYP450 enzymes. For a candidate compound to advance into clinical trials, it must display a wide range of acceptable properties.� For instance, compounds must not potently inhibit major CYP450 enzymes such as CYP2C9, CYP2D6 and CYP3A4.� These enzymes are responsible for oxidizing and metabolizing a majority of the toxins the body is exposed to, as well as for metabolizing many of the drug medications a patient may be taking.� If a compound causes unwanted inhibition of these CYP450 enzymes, it could interfere with the metabolism and elimination of toxins from the body.� The compound could also disrupt the metabolism of other drug medications a patient is taking, causing an undesired and potentially dangerous buildup of the unmetabolized drug in the body.� This situation is referred to as a drug-drug interaction. The required testing of eighty (80) novel small molecule compounds in CYP450 inhibition assays will provide critical information on whether these compounds will not cause unwanted drug-drug interactions or interfere with the elimination of toxins from the body. (vi)������ This requirement is for the testing of eighty (80) novel small molecule compounds in three (3) cytochrome P450 (CYP) Inhibition assays: CYP3A4 (midazolam substrate), CYP2C9, and CYP2D6, as per the specific requirements provided in the attached STATEMENT OF WORK. (vii)����� The Government anticipates award of a firm fixed-price purchase order for this requirement, and the anticipated period of performance is December 17, 2021 through December 16, 2022 (12-months). TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS (viii)���� The provision at FAR clause 52.212-1, Instructions to Offerors � Commercial Products and Commercial Services (Nov 2021), applies to this acquisition. (ix)������ The Quoters are to include a completed copy of the attached provision at FAR 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services (Nov 2021), with its quote. ����������� The Offeror shall complete only paragraph (b) of the FAR 52.212-3 provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of the FAR 52.212-3 provision. ����������� If applicable, the following FAR Provision Representations and Certifications must be completed, signed, and returned by the quoters with its quote pursuant to FAR 4.2103 Procedures: FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) � Attached.����������� FAR 52.204-26 Covered Telecommunications Equipment or Services -Representation (Oct 2020) � Attached. (x)������� The clause at FAR 52.212-4, Contract Terms and Conditions�Commercial Products and Commercial Services (Nov 2021) applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. The additional contract terms and conditions are as follows. FAR 52.212-4(g), Invoice, is supplemented by: NIH Invoice and Payment Instructions (Rev. Feb 2021) - Attached FAR 52.212-4(u), NIH considers unenforceable any provision in your mass-market commercial sales and/or license agreement terms and conditions that are inapplicable to Federal procurement contracts, including, without limitation, any term or condition that: (1) Contravenes a right granted NIH under U.S. copyright law (e.g., fair use, right to archive, copying for interlibrary loan), (2) Violates the Federal Acquisition Regulation or other Federal law (e.g., Antideficiency Act, Principles of Federal Appropriations Law), (3) Departs from reasonable consumer expectations, or (4) Violates fundamental public policy. Please be advised that the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH) is a Federal agency. Your mass-market commercial sales and/or license agreement terms and conditions may include provisions that are customarily found in the commercial sector but which are not enforceable under a contract with a Federal agency. By submission of a quotation/proposal and execution of the order/contract, the Contractor hereby accepts and agrees to the terms and conditions of the order/contract. (xi)������ The clause at FAR 52.212-5 Contract Terms and Conditions�Commercial Products and Commercial Services (Nov 2021) applies to this acquisition and is attached in full text. (xii) ���� The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:� https://www.acquisition.gov/browse/index/far�� https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html�� (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.212-1, Instructions to Offerors�Commercial Products and Commercial Services (Nov 2021) 52.212-1 Instructions to Offerors�Commercial Products and Commercial Services (Nov 2021) FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (OCT 2020) HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses: https://www.acquisition.gov/browse/index/far���� https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html� (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.212-4 Contract Terms and Conditions�Commercial Products and Commercial Services (Nov 2021) FAR 52.227-14, Rights in Data-General (May 2014) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) HHSAR 352.224-71, Confidential Information (December 18, 2015) HHSAR 352.224-71 (c)(2)(i) The publication or dissemination of the following types of information are restricted under this contract: 1) the compound structures provided by the Government and results of the analysis. HHSAR 352.224-71 (c)(2)(ii) The reason for restricting the types of information identified in subparagraph (i) is: 1) The analysis results are commercial confidential information and may be used in the development of a future commercial treatment HHSAR 352.239-74 Electronic and Information Technology Accessibility (December 18, 2015) The FAR 52.223-99 Ensuring Adequate COVID Safety Protocols for Federal Contractors (OCT 2021) (DEVIATION) applies to this acquisition and is attached in full text. The clause shall not be enforced in contracts subject to court order. (xiii)���� The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. EVALUATION (xiv)���� The Government plans to award a fixed-price purchase order resulting from this solicitation. The resulting award will be made to Cyprotex US, LLC, provided it is technically acceptable and at a fair and reasonable price. If multiple quotations are received, the Government may perform a comparative evaluation of responses in accordance with FAR 13.106-2(b) to select the contractor that is best suited and provides the best value, considering the evaluation factors in this solicitation. The evaluation shall compare: Technical capability of the item offered to meet the Government requirement in accordance with the requirements specified in the Statement of Work, Price, and Past Performance as defined under FAR 13.106-2(b)(3). An award will be made to the vendor whose quotation is most advantageous to the Government. The government reserves the right to select a response that provides benefit to the government that exceeds the minimum; the government is not required to select a response that exceeds the minimum; responses may exceed the requirements; each response must meet the solicitation requirement statement at a minimum; and the government is not requesting or accepting alternate proposal(s). SUBMISSION INSTRUCTIONS (xv)����� This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this solicitation must include sufficient information to establish the interested parties� bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, 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. Responses to this solicitation must include clear and convincing evidence of the offeror�s capability of fulfilling the requirement as it relates to the technical evaluation criteria. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. The Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. All responses must be received by 9:00 a.m., Eastern Time, on December 14, 2021 and reference Solicitation Number 75N95022Q00044. Responses must be submitted by email to Renato Gomes at renato.gomes@nih.gov. (xvi)���� The name and telephone number of the individual to contact for information regarding the solicitation: Renato Gomes Contract Specialist Phone: (301) 451-2596 Email: renato.gomes@nih.gov ATTACHMENTS (xvii)���� Attachments: Statement of Work (SOW) FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-3, Offeror Representations and Certifications�Commercial Products and Commercial Services (Nov 2021) FAR 52.212-5, Contract Terms and Conditions�Commercial Products and Commercial Services (Nov 2021) FAR 52.223-99 Ensuring Adequate COVID Safety Protocols for Federal Contractors (Oct 2021) (DEVIATION) NIH Invoice and Payment Provisions (Rev. February 10, 2021) Addendum to FAR 52.212-4 Terms and Conditions � Commercial Items
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/3cc939144dbd4ab9b464aa037834cf16/view)
 

Place of Performance

Address: Bethesda, MD 20892, USA

Zip Code: 20892

Country: USA
 

Record

SN06192566-F 20211209/211207230107 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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