Inactive

COMBINED SYNOPSIS / SOLICITATION Title: Multiple formulation related laboratory tools and equipment (Brand name or Equal) (i) This is a combined synopsis/solicitation for commercial items prepared in ... COMBINED SYNOPSIS / SOLICITATION Title: Multiple formulation related laboratory tools and equipment (Brand name or Equal) (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 75N95023Q00246 and the solicitation is issued as a Request for Quote (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 2023-02, with effective date March 16, 2023. (iv) The associated NAICS code 334516 and the small business size standard is 1,000 employees. This requirement is full and open with no set-aside restrictions. (v) DESCRIPTION Quantity: See attached Purchase Description Salient characteristics: See attached Purchase Description. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated delivery date is September 30, 2023. Delivery will be f.o.b. destination. The place of delivery and acceptance will be 9808 Medical Center Drive, Bldg. E, Rockville, MD 20850 between the hours of 8:00 a.m. and 5:00 p.m., Eastern Standard Time, Monday through Friday (except on Federal Holidays). (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 (Oct 2022) FAR 52.225-2, Buy American Certificate (Oct 2022) FAR 52.225-4, Buy American-Free Trade Agreements-Israel Trade Act Certificate (Dec 2022) 52.212-5 attachment, then also include Alternate I, II, or III (March 2023) FAR 52.225-6, Trade Agreements Certificate (Feb 2021) 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 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) HHSAR 352-232-71 Electronic Submission of Payment Requests (Feb 2022) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (March 2023) NIH Invoice and Payment Provisions (Apr 2022) EVALUATION (ix) 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). The provision at FAR clause 52.212-2, Evaluation – Commercial Items (Nov 2021), applies to this acquisition. (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: (i)Technical Capability of the item offered to meet the Government requirement; (ii) Past Performance; and (iii) Cost/Price. Technical Capability of the item offered to meet the Government requirement 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. (x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Dec 2022), 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 (Dec 2022), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (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. (xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. SUBMISSION INSTRUCTIONS (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. Quote must include shipping and handling costs to provide single delivery of compounds to NCATS. ** Please provide two quotes if pricing varies based on foreign vs. domestic sourcing. Each quote must state whether the quote is a domestic and/or foreign quote. The Unique Entity ID from SAM.gov, UEI Number, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must submit a Buy American Certificate with their quote. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All quotations must be received by 4:00 p.m., EST, on May 10, and reference Solicitation Number 75N95023Q00246. Responses must be submitted electronically to Michele Pastorek, Contract Specialist, at michele.pastorek@nih.gov. Fax responses will not be accepted. (xv) The name and telephone number of the individual to contact for information regarding the solicitation: Michele Pastorek, Contract Specialist Phone: (301) 827-1739 Email: michele.pastorek@nih.gov ATTACHMENTS Purchase Description FAR 52.212-4 Addendum FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes Executive Orders–Commercial Items (Mar 2023) FAR 52.225-2 Buy American Certificate (Oct 2022) NIH Invoice and Payment Instructions with IPP (April 2022)

Inactive

SAM.gov SOURCES SOUGHT NOTICE Solicitation Number: 75N95023Q00246 Title: Multiple formulation related laboratory tools and equipment (Brand name or Equal) Classification Code: 6640 – Laboratory Equipm... SAM.gov SOURCES SOUGHT NOTICE Solicitation Number: 75N95023Q00246 Title: Multiple formulation related laboratory tools and equipment (Brand name or Equal) Classification Code: 6640 – Laboratory Equipment and Supplies NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing Size Standard: 1,000 Employees Description: See attached document with salient characteristics and quantities listed. This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Small businesses are encouraged to respond. For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). 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. 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 DPI plans and conducts collaborative research projects across the preclinical phases of the translational science spectrum, using both internal and contract resources to advance them. The goal of the NCATS TDB is to help close the gap between basic research and preclinical testing of new small-molecule and biologic drugs, as well as cell-based and gene therapies. Work spans the entire preclinical development pipeline, including medicinal chemistry, toxicology, formulation, and other studies required to support an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). NCATS has become a key partner in the Antiviral Program for Pandemics (APP), a multi-agency initiative that includes National Institute of Allergy and Infectious Diseases (NIAID) and Biomedical Advanced Research and Development Authority (BARDA), to accelerate antiviral development through early discovery and preclinical development of safe and effective oral antivirals. The initial priority for the APP is to develop treatments for SARS-CoV-2 and other coronaviruses, with the program expanding to address other virus families with pandemic potential. NCATS will apply its proficiency in drug discovery and development and its cutting-edge technologies to fill critical needs of the APP, such as (i) target validation, (ii) high-throughput screening (HTS) for drug starting points, (iii) medicinal chemistry for lead optimization, and (iv) preclinical, investigational new drug (IND)-enabling development. 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 will be 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. The tools listed above are essential formulation related laboratory equipment for day-to-day operation in a laboratory. Purpose and Objectives: NCATS is in need of purchasing multiple small formulation related laboratory tools and equipment for the Formulation Lab within the Therapeutic Development Branch (TDB), under the Division of Preclinical Innovation (DPI) at NCATS. Anticipated delivery: September 2023 Other important considerations: In case domestic sources are available and capable of fulfilling the Government’s need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required products should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Michele Pastorek, Contract Specialist at e-mail address michele.pastorek@nih.gov. The response must be received on or before May 3, 4:00 pm, Eastern Time. “Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”