Copley Inhaler Testing Kit

(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 75N95024Q00407 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 Translationsl Sciences (NCATS) intends to negotiate and award a Firm Fixed Priced contract without providing for full and open competition (including brand-name) to TSI Incorporated, 500 Cardigan Road, Shoreview, MN 55126-3903, for Copley Inhaler Testing Kit. 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 essential characteristics that limit the availability to a sole source are: that only this suggested source has the essential characteristics such as; HCP6 Pump, TPK 100i, Flow meter, NGI Impactor, Induction port, Preseparator, Gentle rocker, DUSA tube, DUSA shaker, Alberta Idealized throat for adult, Alberta Idealized throat for pediatric, and Inhalytix software. Only this suggested source can furnish the requirements, to the exclusion of other sources, because they are the only manufactures of the required items needed. Additionally, changing equipment may yield different results for data collected via the device. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2024-05 dated May 22, 2024. (iv) The associated NAICS code 334516 - Analytical Laboratory Instrument Manufacturing Manufacturing and the size standard in number of employees is 1,000. (v) This requirement is for Copley Inhaler Testing Kit. (vi) Background: 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. Many programs within NCATS enable research collaborations to advance candidate therapeutics for both common and rare diseases into clinical testing. One of the focuses of the DPI, TDB, is to partner with researchers to generate preclinical data and clinical-grade material for use in Investigational New Drug (IND) applications to a regulatory authority. To accomplish these goals, a brand-new formulation laboratory dedicated to preclinical research was opened in the fall of 2023. In the new laboratory, scientists will research formulation and manufacturing processes to optimize products composition, dosage form, and delivery system to ensure that they are safe, stable, and effective. Specialized instruments essential for formulation development include equipment for formulation preparation, analytical assay, and stability studies. Moreover, the newly established formulation laboratory will be responsible for producing small-scale engineering batches of the studied drugs. The expertise and insights gained from these manufacturing processes and analytical tests will be shared with our collaborators to ensure the successful production of high-quality, GMP-compliant formulations suitable for human consumption in clinical trials. Furthermore, this system will be used to assist in the formulation development of lead APP candidates and other drug substances into phase I clinical trials. Inhalation therapy has become a cornerstone in the management of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis. It has also been utilized to deliver centrally acting medication such as pain analygesic and endocrine compounds. The efficacy and safety of inhalation products heavily depend on the performance of the inhaler device itself. Therefore, investing in comprehensive inhaler testing kits, such as those offered by Copley Scientific Limited, is crucial for ensuring the quality, reliability, and regulatory compliance of these essential medical devices. Purpose: To procure Copley Inhaler Testing Kit. Project Requirements: 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 requirements of the purchase description. Specific Requirements: The specific requirements are listed below: - HCP6 High Capacity Pump 120V/60 Hz: designed for use in the testing of MDIs, DPIs, nebulisers and nasal products in accordance with the specifications laid down in the Ph. Eur. and USP. - Critical Flow Controller TPK 100i Rev Uni Voltage: designed to measure the pressure drop across the device and control the flow conditions during testing. - Flow Meter DFM 2000, 200L/min Air O2 N2 110V: Capable of measuring volumetric flow and calibrated for exit flow as opposed to inlet flow. - ADAPT 4043/DFM2000 to IP/DUSA (MSP): Adaptor for Flow Meter DFM 2000 "NGI+" Next Gen Impactor: high performance, precision cascade impactor suitable for the APSD characterisation of all types of OINDPs. Ideal for testing at all flow rates specified in the relevant pharmacopoeias. - Induction Port NGI USP Type: Designed for the measurement Adapter can be placed between the inhaler and the NGI induction port to measure the pressure drop (P1) over the inhaler under test in the absence of a DUSA for DPIs. - Cup Set/8 (2Lrg/6Sm) for NGI: Sample collection cups - NGI Cup Tray Standard: For the convenient storage of a full set of NGI Cups, protecting the critical surfaces from inadvertent damage and dust collection when not in use. - Preseparator NGI Nickel-Coated Insert: to catch any powder boluses and large non-inhalable particles. Offeringhigh capacity, high efficiency, two-stage separation, the NGI Preseparatorprovides a sharp and reproducible cut-point of between 10 and 15microns depending on flow rate. - Adapt OInhal RS01 MOD7 DPI to IP/DUSA: Adaptor for IP/DUSA tube. - GENTLE ROCKER GR200I: Agitates the NGI Collection Cup Tray in a controlled, repeatable manner to ensure complete dissolution of the active drug prior to analysis. - DOC IQ/OQ GENTLE ROCKER GR200i: Performance test and qualification. - Kit DUSA-DPI Tecapro PTC Silic: Dose Uniformity Sampling Apparatus measurestotal amount of drug emitted from the drug device that is available to the user, when the device is actuated correctly. - Tub DUSA-DPI w/o P1 w/oCapTec: DUSA accessories - Cap Rins DUSA-DPI Tec Silic: DUSA accessories - Inhal Test WorkSta-Baseplate and Upright: Baseplate to support Inhaler Testing Workstation. - Holder Inhal Test Worksta DPI DUSA: holder for Inhlation Testing Workstation. - Holder Inhal Test Worksta DFM2000: holder for Dose Flow Meter. - DUSA Shaker w/o Coll Tubes DTS100i Univ: Holding up to 21 MDI DUSA collection tubes, the DUSA shaker automates the internal rinsing of the tubes to ensurefull, fast and repeatable drug dissolution and drug recovery from internal surfaces. - Doc IQ/OQ DUSA Shaker: Performance and qualification for the shaker - Doc IQ/OQ Inhaler Test Systems: Performance and qualification for the Inhaler test system - Trav IQ/OQ Dom 1st Day Inha Prod: Travel for performance, qualification testing, and training for day 1 - Trav IQ/OQ Dom 2nd/Sub Day Inha Prod: Travel for performance, qualification testing, and training for day 2 - Throat Albert Ideal ADULT Alum: Adult throat and lung simulator - Adapt FlowMeter to AIT Adult: Adaptor for Albert Idealised Throat - Inlet Cap/Outlet Adapt AIT Adu: Adaptor for inlet and outlet for the adult Albert Idealised Throat - Throat Albert Ideal CHILD Alum: pediatric throat and lun simulator - Adapt FlowMeter to AIT Child Version: Adaptor for pediatric Albert Idealised Throat - Inlet Cap/Outlet Adapt AIT Chi: Adaptor for inlet and outlet for the pediatric Albert Idealised Throat - Glass Fiber Filters, 47 mm, Pkg 100 - Sftwr Inhalytix 3-User License - PC: Inhalytix Software licence for three user (vii) The Government anticipates award of a firm fixed-price contract for this acquisition, and the anticipated delivery is: 8-14 weeks after receipt of 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 Items (Nov 2021) - FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021) - FAR 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Certification (May 2014) - HHSAR 352.239-73, Electronic and Information 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 Items (DEC 2022). Addendum to this FAR clause applies to this acquisition and is attached. - HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 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 Items (May 2024) - FAR 52.225-2, Buy American Certificate (Oct 2022) - NIH Invoice and Payment Provisions (Mar 2023) (ix) 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: a. Technical capability of the item offered to meet the Government requirement; b. Price; and c. Past performance [see FAR 13.106-2(b)(3)]. (x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 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 Items (Nov 2023), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiv) 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. The Unique Entity ID (UEI), 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 offers must be received by 2:00p.m., Eastern Daylight/Standard Time, on July 15, 2024, and reference solicitation number 75N95024Q00407. Responses must be submitted electronically to Morgen Slager, Contract Specialist at morgen.slager@nih.gov. Fax responses will not be accepted.