Antivirals for neurotropic viruses of pandemic potential
NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Antivirals for neurotropic viruses of pandemic potential (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 75N95023Q00431 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 teshold. 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 Translational Sciences (NCATS), intends to negotiate and award a purchase orcer without providing for full and open competition (including brand-name) to Stemcell Technologies, Inc.; 6425 S 216th St.; Kent, WA 98032-1392 for DPI-APP Biology products. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). (iii) The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular (FAC) Number 2023-04, with effective date June 2, 2023. (iv) The associated NAICS code is 325414 – Biological Product (Except Diagnostic) Manufacturing and the small business size standard is 1,250 employees. This requirement has no set-aside restrictions. (v) This requirement is for the following: 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 30 days after receiving the order. Delivery will be f.o.b. destination. The place of delivery and acceptance will be 9808 Medical Center Drive, Bldg. B, Rockville, MD 20850 between the hours of 8:00 a.m. and 5:00 p.m., Eastern Standard Time, Monday tough 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 (Mar 2023) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Dec 2022) FAR 52.225-2, Buy American Certificate (Oct 2022) 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 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) 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, 52.204-26, and 52.225-2 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 (Jun 2023) FAR 52.225-2, Buy American Certificate (Oct 2022) NIH Invoice and Payment Provisions (ix) 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) price; (iii) past performance. 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 Products and Commercial Services (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. 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 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 quotations must be received by 4:00 p.m., EST, on Tuesday, July 18, 2023, and reference Solicitation Number 75N95023Q00431. Responses must be submitted electronically to Maggie Brant, Contract Specialist, maggie.brant@nih.gov. Fax responses will not be accepted. 75N95023Q00431 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
7/13/23, 11:09 AM Antivirals for neurotropic viruses of pandemic potential
SOURCES SOUGHT NOTICE Solicitation Number: 75N95023Q00433 Title: Antivirals for neurotropic viruses of pandemic potential Classification Code: 6505-DRUGS AND BIOLOGICALS NAICS Code: 325414 – Biological Product (Except Diagnostic) Manufacturing Size Standard: 1,250 employees Description: Antivirals for neurotropic viruses of pandemic potential 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. The 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. NCATS requires the components listed below as part of a specialized custom media formulation used to support functional neuronal firing in NCATS 3DTBL designer brain region specific spheroids for high toughput screening and disease modeling. Quantity Unit BrainPhys Neuronal Medium 60.00 bottle N2 Supplement-B (100X) 30.00 bottle NeuroCult SM1 Neuronal Supplement 20.00 bottle N2 Supplement-A (100X), 5mL 20.00 bottle Hu Recom BDNF, ACF, 10ug 15.00 bottle Hu Recom GDNF, ACF, 10ug 15.00 bottle Dibutyryl-cAMP, 500 mg 15.00 bottle Purpose and Objectives: The purpose of this procurement is acquisition of Quantity Unit BrainPhys Neuronal Medium 60.00 bottle N2 Supplement-B (100X) 30.00 bottle NeuroCult SM1 Neuronal Supplement 20.00 bottle N2 Supplement-A (100X), 5mL 20.00 bottle Hu Recom BDNF, ACF, 10ug 15.00 bottle Hu Recom GDNF, ACF, 10ug 15.00 bottle Dibutyryl-cAMP, 500 mg 15.00 bottle Project requirements: 60 bottle BrainPhys Neuronal Medium 30 bottle N2 Supplement-B (100X), 5mL 20 bottle NeuroCult SM1 Neuronal Supplement 20 bottle N2 Supplement-A (100X), 5mL 15 bottle Hu Recom BDNF, ACF, 10 ug 15 bottle Hu Recom GDNF, ACF, 10ug 15 bottle Dibutyryl-cAMP, 500 mg Salient characteristics: Must support neuronal culture in monolayer culture and in neuronal spheroid culture for at least 4 weeks. Must support neuronal culture in spheroids with media changes every M,W,F. Must be stable for at least 1 week post combination of all components into complete media. Must support synconized active neuronal firing as measurable by calcium dyes Base media must be defined and serum-free Components and media must support neurological function and activity Media and components must support long-term culture of iPSC derived neurons and astrocytes BDNF and GDNF must be >95% pure, as well as human in origin and animal component free Dibutyryl-cAMP must be >95% pure and stable for at least 12 months after receipt Must reproducibly support survival and maturation of functional neurons Must be stable at indicated temperatures Quantity: Quantity Unit BrainPhys Neuronal Medium 60.00 bottle N2 Supplement-B (100X) 30.00 bottle NeuroCult SM1 Neuronal Supplement 20.00 bottle N2 Supplement-A (100X), 5mL 20.00 bottle Hu Recom BDNF, ACF, 10ug 15.00 bottle Hu Recom GDNF, ACF, 10ug 15.00 bottle Dibutyryl-cAMP, 500 mg 15.00 bottle Anticipated period of performance: 30 days after receipt of order Other important considerations: Cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition. 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 or services 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 Maggie Brant at e-mail address maggie.brant@nih.gov. The response must be received on or before July 7, 2023, 5:00 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).” 75N95023Q00433 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
6/29/23, 11:07 AM