SARS-CoV-2 Spike AlphaLISA assays (Covid-19 Action)

NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: SARS-CoV-2 Spike AlphaLISA assays (Covid-19 Action) RFQ: 75N95021Q00403 (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 75N95021Q00403 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), NIDA Office of Acquisitions - NCATS Section, on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a firm-fixed price purchase order without providing for full and open competition (including brand-name) to PerkinElmer Health Sciences, Inc., 710 Bridgeport Ave., Shelton, CT 06484-4750, to purchase SARS-CoV-2 Spike AlphaLISA assays. The anticipated award date is on or around September 10, 2021. This acquisition is non-competitive. NCATS previously purchased assay development and reagent production services from Perkin Elmer for the same reagents required for this procurement for its ongoing COVID-19 research projects. The reagents were validated to work in live virus assays and additional reagents are needed for the completion of the drug repurposing screening. The Contractor shall provide only the reagents to NCATS, not compounds (typically defined as small molecules). NCATS will use the analysis of comparability to ensure that the reagents perform similarly to those provided previously by the contractor. The Spike AlphaLISA Assays are essential to avoid disruption and ensure continuity of the research and therefore limits the availability to a sole source. Only this suggested source can furnish the requirements, to the exclusion of other sources, because the Spike AlphaLISA Assays that NCATS requires have previously been used by its scientists and researchers in its current COVID-19 research project being conducted. Additional reagents of the same batch is required to ensure consistency and avoid possible disruption and delays in its research and outcomes for the completion of NCATS drug repurposing screening. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-06 dated July 12, 2021. (iv) The associated NAICS code is 325413 In-Vitro Diagnostic Substance Manufacturing and the small business size standard is 1,250 employees. This acquisition is not set aside for small business. (v) Requirement The National Center for Advancing Translational Sciences (NCATS) requires the procurement of these reagents for SARS-CoV-2 drug repurposing screening. NCATS requires confirmation that the reagents that are produced by the contractor perform comparably to those purchased previously by NCATS for its SARS-CoV-2 drug repurposing screening. Contractor is required to evaluate the reagents they produce to ensure that their performance is comparable to what they have produced previously. NCATS had previously purchased assay development and reagent production services from Perkin Elmer for the same reagents required in this purchase order in support of Covid-19 research. The reagents were validated to work in live virus assays and more reagents are required for completion of drug repurposing screening. The contractor is to deliver only reagents to NCATS, not compounds (typically defined as small molecules). NCATS objective is to use the reagents provided by the contractor to conduct drug repurposing screening. NCATS will use the analysis of comparability to ensure that the reagents perform similarly as those provided by contractor before. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below: The Contractor shall provide the following which NCATS will conduct drug repurposing screening. Contractor is not required to use the reagents for anything other than a small comparability study that compares the data from these reagents to data produced in prior batches. CLIN 00001 Custom SARS-CoV2 Spike S1 AlphaLISA assay Includes QC and reproducibility 8 x 1,000 tests in 80uL final volume The Contractor shall test the performance of the reagents is in line with previously delivered AlphaLISA Spike assay reagents (75N95021P00034). The Contractor shall provide directions and guidance for use of the reagents in order for them to perform similarly as with the previous batch of reagents described in 2) above. For complete requirements please refer to Attachement 1 - Statement of Work. (vi) Delivery shall be thirty (30) days After Receipt of Order (ARO). Delivery shall be FOB Destination and shall be made to: National Center for Advancing Translational Sciences (NCATS) 9800 Medical Center Drive Bldg C / Room 313W Rockville, MD 20850 (vii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (viii) FAR 52.212-2 Evaluation-Commercial Items (Oct 2014) (a) The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: technical capability of the item offered to meet the Government requirement; price; past performance Technical and past performance, when combined, are significantly more important than cost or price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful Offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of provision) (ix) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications'Commercial Items, with offers. See Attachment 4. (x) The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. FAR 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998) 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 are incorporated by reference: FAR 52.204-7 System for Award Management (Oct 2018) FAR 52.204-16 Commercial and Entity Code Reporting (Aug 2020) FAR 52.225-25 Prohibition on Contracting With Entities Engaging in Certain Activities or Transactions Relating to Iran'Representation and Certifications (Jun 2020) The following provisions are included in full text: 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) & 52.204-26 Covered Telecommunications Equipment or Services-Representation (See full text in Attachment 2 and 3). If Quoter has previously represented that it - does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument in paragraph (v) of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Items (accessible at https://sam.gov/SAM/), it is NOT required to complete these certifications wth its offer. If this is applicable, please indicate in writing in your response. If the Quoter has NOT previously completed this representation, then it MUST complete the certifications pursuant to FAR 4.2103 Procedures. FAR 52.225-4 Buy American-Free Trade Agreements-Israeli Trade Act Certificate (Feb 2021)-Alternate I (Jan 2021) (a) (1) The Offeror certifies that each end product, except those listed in paragraph (b) or (c) of this provision, is a domestic end product. (2) The terms "Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product," "domestic end product," "end product," "foreign end product," "Free Trade Agreement country," "Free Trade Agreement country end product," "Israeli end product," and "United States" are defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act." (b) The Offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act": Free Trade Agreement Country End products (Other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian End products) or Israeli End products: (See attachment) (c) The Offeror shall list those supplies that are foreign end products (other than those listed in paragraph (b) of this provision) as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act." The Offeror shall list as other foreign end products those end products manufactured in the United States that do not qualify as domestic end products. (d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation. (End of provision) Alternate I (Jan 2021). As prescribed in 25.1101(b)(2)(ii), substitute the following paragraph (b) for paragraph (b) of the basic provision: (b) The Offeror certifies that the following supplies are Canadian end products as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act": Canadian End products: line item No. ___________________________________________________________________ [List as necessary] HHSAR 352.239-73 Electronic and Information Technology Accessibility Notice (December 18, 2015) (a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency. (b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards. (c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility. In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document'in detail'whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website http://www.hhs.gov/web/508. In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues. (d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense. (End of provision) 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 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 Items (Oct 2018) FAR 52.225-13 Restrictions on Certain Foreign Purchases (Feb 2021) The following clauses are included in full text: HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) (a) In addition to complying with the clause at FAR 52.222-26, Equal Opportunity, the Contractor shall, in good faith, cooperate with the Department of Health and Human Services (Agency) in investigations of Equal Employment Opportunity (EEO) complaints processed pursuant to 29 CFR part 1614. For purposes of this clause, the following definitions apply: (1) Complaint means a formal or informal complaint that has been lodged with Agency management, Agency EEO officials, the Equal Employment Opportunity Commission (EEOC), or a court of competent jurisdiction. (2) Contractor employee means all current Contractor employees who work or worked under this contract. The term also includes current employees of subcontractors who work or worked under this contract. In the case of Contractor and subcontractor employees, who worked under this contract, but who are no longer employed by the Contractor or subcontractor, or who have been assigned to another entity within the Contractor's or subcontractor's organization, the Contractor shall provide the Agency with that employee's last known mailing address, e-mail address, and telephone number, if that employee has been identified as a witness in an EEO complaint or investigation. (3) Good faith cooperation cited in paragraph (a) includes, but is not limited to, making Contractor employees available for: (i) Formal and informal interviews by EEO counselors or other Agency officials processing EEO complaints; (ii) Formal or informal interviews by EEO investigators charged with investigating complaints of unlawful discrimination filed by Federal employees; (iii) Reviewing and signing appropriate affidavits or declarations summarizing statements provided by such Contractor employees during the course of EEO investigations; (iv) Producing documents requested by EEO counselors, EEO investigators, Agency employees, or the EEOC in connection with a pending EEO complaint; and (v) Preparing for and providing testimony in depositions or in hearings before the MSPB, EEOC and U.S. District Court. (b) The Contractor shall include the provisions of this clause in all subcontract solicitations and subcontracts awarded at any tier under this contract. (c) Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause may be grounds for the Contracting Officer to terminate this contract for default. (End of clause) HHSAR 352.239-74 Electronic and Information Technology Accessibility (December 18, 2015) (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 electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the - Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the - Access Board) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards. (b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense. (c) The Section 508 accessibility standards applicable to this contract are: _______________________________________________________________ (Contract staff must list applicable standards) (d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense. (e) If this is an Indefinite Delivery contract, an Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense. (End of clause) (xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders'Commercial Items, applies to this acquisition. See Attachment 5. This synopsis is not a request for competitive proposals. All responsible sources may submit a bid, proposal or quotation which shall be considered by the agency. 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. There are no additional contract requirement(s) or terms and conditions applicable to this acquisition The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. 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. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. Responses to this solicitation must include the completed and signed FAR Provision Certifications at FAR 52.204-24 and FAR 52.204-26 pursuant to FAR 4.2103 Procedures. See Attachment 2 - FAR 52.204-24 Certification and Attachment 3 - FAR 52.204-26 Certification. Any resultant award made from this solicitation shall include the following language required for all COVID-19 procurements: HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A'Health Resources Priorities and Allocations System. Any resultant award shall include the following language: 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. In accordance with 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. 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. (xviii) In addition, 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 responses must be received by 9:00 a.m., Eastern Standard Time, September 7, 2021, and reference solicitation no. 75N9521Q00403. Responses must be submitted by email to Nick Niefeld, Contract Specialist, contact@example.gov. The name and telephone number of the individual to contact for information regarding the solicitation. Nick Niefeld Contract Specialist Email: contact@example.gov Phone: +1 (555) 000-0000 RFQ Attachments Attachment 1 - Statement of Work Attachment 2 - FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) Attachment 3 - FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) Attachment 4 - FAR 52.212-3 Offeror Representations and Certifications-Commercial Items (Feb 2021) Attachment 5 - FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders'Commercial Items (Jul 2021) Attachment 6 - NIH Invoice and Payment Instructions (Rev 2/10/2021)