SOLICITATION NOTICE
Q -- Nanobody production against endocytic proteins
- Notice Date
- 8/10/2023 6:46:07 AM
- Notice Type
- Combined Synopsis/Solicitation
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95023Q00493-RFQ
- Response Due
- 8/17/2023 6:00:00 AM
- Archive Date
- 09/01/2023
- Point of Contact
- Renato Gomes, Rieka Plugge
- E-Mail Address
-
renato.gomes@nih.gov, rieka.plugge@nih.gov
(renato.gomes@nih.gov, rieka.plugge@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 75N95023Q00493-RFQ 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. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-04, with effective date 06/02/2023. �(iv)����� The associated NAICS code is 541380 - Testing Laboratories and the small business size standard is $19M. This requirement has no set-aside restrictions. (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 Institute of Neurological Disorders and Stroke (NINDS) is one of 27 Institutes and Centers at the NIH, and its mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people. The NINDS Synaptic Transmission Section (STS) combines physiological and cell-biological approaches to understand the mechanism and dynamics of cell membrane modulation during vesicle endocytosis. Various proteins orchestrate exo- and endocytosis in living cells at the nanometer scale. These events include vesicle docking and fusion, curvature generation, endocytosis, and others. NINDS STS characterizes these proteins, especially their spatial distribution and mechanisms of action in vivo with super-resolution imaging technique, and quantify several parameters related to their performance. Then NINDS STS wants to determine how these underlying mechanisms contribute to neurodevelopmental and neurodegenerative disorders, where synaptic signaling is severely impacted. Single-molecule localization microscopy is the most advanced super-resolution fluorescence imaging technique to identify cellular components and quantify various parameters. Over more than 20 years, NINDS STS has invested efforts to understand the molecular underpinnings of the synaptic transmission process. The most critical aspect of understanding synaptic transmission and associated pathologies is to explore how the vesicle recycling process is regulated at the synapse. Previous studies from STS lab and others have shown the involvement of thousands of proteins at the presynaptic terminal to form specialized regions and facilitate vesicle fission and fusion by avoiding molecular crowding. However, the specialized arrangements have never been visualized at the nerve terminal at the single-nanometer resolution, which is the actual molecular resolution. Therefore, much of the mechanistic regulation has remained as speculative ideas. While antibodies are the preferred choice of binders to identify endogenous proteins due to their simplicity and availability, the size of each antibody corresponds to about 8nm, while two antibodies used for immunocytochemistry would be around 16nm together. The current microscope in the lab can resolve up to 1-3nm. The dual antibody staining method would create a much larger (16nm) localization error. In addition, two large antibodies would create substantial molecular crowding in the already crowded synaptic environment, thus, creating artifacts and affecting quantification. The answer to these problems lies with the nanobodies or single-domain antibody binders due to their tiny size (<3nm) and customizability. The nanobodies are produced in Camelids, such as Alpacas, and are the ideal molecules for Single-molecule localization microscopy (SMLM) using the microscope in the lab. Thus, the nanobodies will be used to perform fluorescence imaging of endogenous proteins for identifying the nanoscale structures at the cell membrane and synaptic compartment and tracking the dynamics of a variety of cell-surface proteins regulating vesicle exocytosis and endocytosis in the cells during synaptic transmission and plasticity. Moreover, the nanobodies will be used to identify the nanoscale anatomy of endocytic machinery in chromaffin cells and nerve terminals. The nanoscale organization (also called the nano anatomy) of molecules and their spatial relationship regulate key aspects of vesicle fission-fusion and, thus, synaptic transmission. It is, therefore, essential to understand the operation of multiple proteins together in the cellular context to further the research on neurodevelopmental and neurodegenerative disorders. (vi)������ The Statement of Work (SOW) with the general and specific requirements is included as an attachment to this Solicitation. NINDS STS requires the production of nanobodies against five (5) major endocytic proteins expressed in neurons to further the research on neurodevelopmental and neurodegenerative disorders. (vii)����� The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is twelve (12) months from award. (viii)���� 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 (Mar 2023) FAR 52.212-3, Offeror Representations and Certifications�Commercial Products and Commercial Services (Dec 2022) FAR 52.214-34, Submission of Offers in the English Language (Apr 1991) FAR 52.214-35, Submission of Offers in U.S. Currency (Apr 1991) FAR 52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran�Representation and Certifications (Jun 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 (Dec 2022) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at FAR 52.204-24 and FAR 52.204-26 and submit completed copies as separate documents with their proposal. 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 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders�Commercial Products and Commercial Services (Jun 2023) 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) HHSAR 352.270-5b, Care of Live Vertebrate Animals (December 18, 2015) Invoice and Payment Provisions with and without IPP (Oct 2022 and Mar 2023) (ix)������ The Government will perform a comparative evaluation of responses in accordance with FAR 13.106-2(b) to award a purchase order from this solicitation to the responsible offeror whose response meets the solicitation�s requirements and, as a whole, provides the best value, considering price and other factors in this solicitation. The evaluation will compare: (a) Technical capability of the service offered to meet the Government requirement; (b) Price; and (c) Past Performance as defined under FAR 13.106-2(b)(3). If only one quotation is received it will be evaluated on the preceding basis. Responses may exceed capability or performance characteristics of the solicitation�s requirements. The Government reserves the right, but is not required, to award to a response that exceeds capability or performance characteristics of the solicitation�s requirements if it provides a benefit to the Government; and the Government is not requesting or accepting alternate proposal(s). (x)������� The Offerors to include a completed copy of the provision at FAR provision 52.212-3, Offeror Representations and Certifications�Commercial Products and Commercial Services (Dec 2022), with its offer. If the offeror has completed FAR provision 52.212-3 at www.sam.gov , then the offeror does not need to provide a completed copy with its offer. (xi)������ The clause at FAR 52.212-4, Contract Terms and Conditions�Commercial Products and Commercial Services (Dec 2022) applies to this acquisition. (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 services under this contract involves live vertebrate animals. Quoters must have an active OLAW Animal Welfare Assurance. In addition, Quoters must include with its quotation: Vertebrate Animal Section (VAS) (see below) Institutional Animal Care and Use Committee (IACUC) project approval. The date of IACUC approval must not be more than 36 months prior to the anticipated date of award. Vertebrate Animals Section (VAS). The VAS should be no more than two (2) pages and must address the following criteria: Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the Statement of Work. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work. Justifications. Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro). Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury. Euthanasia. State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification. 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. 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. FAR 52.212-4 � Addendum. Please be advised that the National Institute of Neurological Disorders and Stroke (NINDS) is an Institute within the National Institutes of Health (NIH), which is a Federal agency.� Your mass-market commercial sales and/or license agreement may include provisions that are customarily found in the commercial sector, but which are not appropriate for a contract with a Federal agency. Specifically, NINDS considers any provision in your mass-market commercial sales and/or license agreement to be inappropriate and unenforceable that: Contravenes a right granted NINDS under U.S. copyright law (e.g., fair use, right to archive, copying for interlibrary loan), Violated the Federal Acquisition Regulation or other Federal law (e.g., Antideficiency Act, Principles of Federal Appropriations Law), Departs from reasonable consumer expectations and was not disclosed by the Licensor prior to agreement, or Violates fundamental public policy. NIH shall assume that you are in agreement with the statements herein if you submit a quotation/proposal and accept NIH's order/contract. CONTRACTING OFFICER�S REPRESENTATIVE (COR) The following Contracting Officer�s Representative (COR) will represent the Government for the purpose of this contract: [To be specified at time of award] The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as an agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in the contract. The Government may unilaterally change its COR designation in writing, any time during the contract�s period of performance. (xiii)���� The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiv)���� 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. The Unique Entity ID from SAM.gov, 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 questions must be received by 9 a.m., Eastern Time, on August 14, 2023, and reference Solicitation Number 75N95023Q00493-RFQ. Questions may be submitted electronically to Renato Gomes at renato.gomes@nih.gov. All quotations must be received by 9 a.m., Eastern Time, on August 17, 2023, and reference Solicitation Number 75N95023Q00493-RFQ. Responses must be submitted electronically to Renato Gomes at renato.gomes@nih.gov. Fax responses will not be accepted. Attachments: Purchase Description (PD) 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 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders�Commercial Products and Commercial Services (Jun 2023) HHSAR 352.270-5a and HHSAR 352.270-5b VAS Worksheet Invoice and Payment Provisions with and without IPP (Oct 2022 and Mar 2023)
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/8288a297d02d4b1982f3c202650eb1d1/view)
- Place of Performance
- Address: Bethesda, MD 20892, USA
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN06785005-F 20230812/230810230050 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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