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(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 75N95022Q00048 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.
(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.
National Center for Advancing Translational Sciences (NCATS) is one of 27 Institutes and Centers at the NIH and its mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The NCATS Division of Preclinical Innovation (DPI) plans, conducts and uses both internal and contract resources to advance collaborative research projects across the preclinical phases of the translational science spectrum.
The biogenic amine dopamine is an essential neurotransmitter in the brain and periphery. The cerebral dopaminergic system is implicated in a variety of physiological and pathophysiological processes. It comprises the regulation of motion, emotion and cognition. An imbalance in the dopaminergic neurotransmission and dopamine receptors underlies manifold neurological and psychiatric disorders. All drugs of abuse either directly or indirectly increase dopamine levels in the mesolimbic regions of the brain. The dopamine receptor subtype D3 is localized in the key neurocircuits that underlie motivation and cognition, and in contrast to D2R do not appear to play a major role in movement. Hence D3R has been proposed as a promising target for development of psychostimulant addiction and relapse pharmacotherapy. Also, seminal reports have shown increased D3R subtype in the basal ganglia in post-mortem brains of cocaine and methamphetamine overdose victims using PET studies thus further validating this approach.
The Therapeutics for Rare and Neglected Diseases (TRND) Program at NCATS in collaboration with the investigators at the National Institute on Drug Abuse (NIDA) has embarked on a journey to find novel D3R antagonists while displaying significant selectivity from the highly homologous D2 receptors. Working on the bitopic ligands identified by earlier investigations, the team has identified several lead chemotypes that display around a 500-fold selectivity over D2R in the binding assays. These lead molecules occupy an orthosteric binding site (OBS) at D3R and also connect to a secondary binding pocket (SBP), via a 4-carbon linker, responsible for achieving selectivity amongst the dopamine receptor subtypes. The lead molecules from different chemotype series, identified by the team are being considered for development.
Towards a successful translation of these lead molecules and to study pharmacodynamics of these compounds, the team has proposed ex-vivo and in-vivo receptor occupancy studies in Sprague Dawley rats.
In this study, NCATS will determine the differential binding of D3 selective antagonists in D2 and D3 receptor rich regions by using in vivo rat brain micro PET model to exploit the differential localization of D2 and D3 receptors in the rat striatum, Substantia Nigra, Ventral Tegmental Area, Olfactory tubercle, and Cerebellum lobes 9 and 10. While Substantia Nigra, VTA, OT and Cerebellar lobes 9 and 10 have been shown to be rich in D3R receptor expression, the receptor binding in the striatum can serve as the D2 rich control.
(vi) The Division of Preclinical Innovation (DPI) within the National Center for Advancing Translational Sciences (NCATS) requires in vivo radiographic imaging services for two (2) D3 Antagonists, 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 23, 2021 through February 16, 2022 (2-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:
(x) The clause at 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.
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:
The provision at HHSAR 352.270-5a, Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (December 18, 2015) applies to this acquisition and is provided in full text:
The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) establishes a number of requirements for research activities involving animals. Before awarding a contract to an offeror, the organization shall file, with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), a written Animal Welfare Assurance (Assurance) which commits the organization to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC). In accordance with the PHS Policy, offerors must establish an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members, to oversee the institution’s animal program, facilities, and procedures. Offerors must provide verification of IACUC approval prior to receiving an award involving live vertebrate animals. No award involving the use of animals shall be made unless OLAW approves the Assurance and verification of IACUC approval for the proposed animal activities has been provided to the Contracting Officer. Prior to award, the Contracting Officer will notify Contractor(s) selected for projects involving live vertebrate animals of the Assurance and verification of IACUC approval requirement. The Contracting Officer will request that OLAW negotiate an acceptable Assurance with those Contractor(s) and request verification of IACUC approval. For further information, contact OLAW at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 Bethesda, Maryland 20892-7982 (E-mail: [email protected]; Phone: 301-496-7163).
(End of provision)
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:
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.
The clause at HHSAR 352.270-5b, Care of Live Vertebrate Animals (December 18, 2015) applies to this acquisition and is provided in full text:
Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail: [email protected]; website: http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare).
(End of clause)
SPECIAL CONTRACT REQUIREMENTS (LIVE VERTEBRATE ANIMALS)
(xiii) The services under this contract involves live vertebrate animals. Quoters must include with its quotation:
(xiv) Vertebrate Animals Section (VAS). The VAS should be no more than two (2) pages and must address the following criteria:
For more discussion regarding the VAS, see NIH Guide Notice NOT-OD-16-006 at:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html.
The VAS Worksheet is provided as an attachment to this solicitation to assist in the preparation of the VAS.
(xv) Animal Welfare. All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: http://grants1.nih.gov/grants/olaw/references/phspol.htm. In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the Contractor’s quotation.
(xvi) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.
EVALUATION
(xvii) 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 will compare:
(a) Technical capability of the item offered to meet the Government requirement in accordance with the salient characteristics specified in the Statement of Work;
(b) Price; and
(c) Past Performance as defined under FAR 13.106-2(b)(3). Quoters shall provide documented evidence of relevant experience with:
- Performing rat brain PET scanning and subsequent measurement of the occupancy in the relevant brain areas using scientists that have significant experience and expertise in studying the relevant dopaminergic brain regions in live animals with published literature in peer-reviewed journals.
- Using Fallypride (retro-orbitally) for baseline PET scans in live animals and as a measure for displacement by the tested D3/D2 antagonists in rat brain PET scanning.
If only one quotation is received it will be evaluated on the preceding.
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
(xviii) 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.
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 questions must be received by 9:00 a.m., Eastern Time, on December 14, 2021, and reference Solicitation Number 75N95022Q00048. Questions may be submitted by email to Renato Gomes, Contract Specialist, [email protected]
All responses must be received by 9:00 a.m., Eastern Time, on December 21, 2021 and reference Solicitation Number 75N95022Q00048. Responses must be submitted by email to Renato Gomes, Contract Specialist, [email protected], tel. (301) 451-2596.
(xix) The name and telephone number of the individual to contact for information regarding the solicitation:
Renato Gomes
Contract Specialist
Phone: (301) 451-2596
Email: [email protected]
ATTACHMENTS
(xx) Attachments: