Inactive

NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Evaluation of Exenatide actions on L-DOPA induced dyskinesia in a progressive Parkinson’s disease mouse model (i) This is a combined synopsis/so... NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Evaluation of Exenatide actions on L-DOPA induced dyskinesia in a progressive Parkinson’s disease mouse model (i) This is a combined synopsis/solicitation for other than commercial items prepared in accordance with FAR 13.003. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95022Q00259 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for an other than commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, 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 Institute on Aging (NIA), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Case Western Reserve University, School of Medicine, 19000 Euclid Avenue, Cleveland, OH 44106 for the Evaluation of Exenatide actions on L-DOPA induced dyskinesia in a progressive Parkinson’s disease mouse model. This acquisition is conducted as non-competitive for an other than commercial 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 through Federal Acquisition Circular (FAC) Number 2022-06, with effective date May 26, 2022. (iv) The associated NAICS code 621511 and the small business size standard is $35 million. This requirement has no set aside restrictions. (v) This requirement is for the following service: Evaluation of Exenatide actions on L-DOPA induced dyskinesia in a progressive Parkinson’s disease mouse model. See attached Statement of Work (SOW) for additional details. (vi) The Government anticipates award of a firm fixed-price purchase order for this acquisition with an anticipated period of performance of twelve (12) months after receipt of the purchase order. (vii) 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 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 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 (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 52.213-4 Terms and Conditions - Simplified Acquisitions (Other Than Commercial Products and Commercial Services) (Jan 2022) FAR 52.227-14, Rights in Data – General (May 2014) 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) Invoice Instructions without IPP (viii) 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: (i.) technical capability, (ii.) price, and (iii.) past performance [see FAR 13.1062(b)(3)]. Technical capability and past performance, when combined, are significantly more important than price. (b) 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. (ix) 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. (x) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xi) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xii) 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 quotations must be received by 8:00 a.m., Eastern Daylight/Standard Time, on Wednesday, July 6, 2022 and reference Solicitation Number 75N95022Q00259. Responses must be submitted electronically to Jeanette Russell, Contract Specialist, at jeanette.russell@nih.gov. Fax responses will not be accepted.

Inactive

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the avai... This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. 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. Background: Parkinson’s disease (PD) impacts 6 million people worldwide. As it is an age-related neurodegenerative disorder, the figure is estimated to increase to around 10 million by 2030 due to longevity increasing in most Western countries. The social and economic impact on patients and their caregivers is huge and is estimated at $US14.4 billion per year in the USA. Presently available symptomatic treatments for PD are predominantly directed on augmenting of dopaminergic signaling and can provide symptomatic relief for a limited time but have little effect on nonmotor symptoms, and none have been shown to affect the progressive pathological and clinical decline. The most widely used symptomatic treatment for PD worldwide is levodopa (L-DOPA). The use of L-DOPA elevates dopamine (DA) synthesis in the substantia nigra and restores motor functions in PD patients. However, chronic administration of L-DOPA is often associated with abnormal involuntary movements (AIMs), also called levodopa-induced dyskinesia (LID) in PD patients. Early clinical studies have shown that 20–50% of PD patients developed dyskinesia within 5 years after the initiation of L-DOPA treatment (Rascol et al., 2000; Manson et al., 2012; Bjornestad et al., 2016). The severity of dyskinesia positively correlates with disease duration, Hoehn–Yahr stage, and duration of L-DOPA treatment (Nicoletti et al., 2016). Other studies also suggest that the disease severity and dose of L-DOPA are more important than the duration of L-DOPA treatment for the development of LID (Nutt et al., 2010; Espay et al., 2018). LID has also been established in experimental animals. Chronic administration of L-DOPA to unilaterally 6-OHDA-lesioned rats has been widely used to examine AIMs (Lundblad et al., 2002). Similar to the PD patients, LID in the lesioned rats significantly correlates with the dose of L-DOPA and the magnitude of DA depletion (Putterman et al., 2007). LID can severely impact PD patients and new treatments to mitigate it are sorely needed. NIA recently reported that systemic administration of PT320 (a sustained release formulation of the GLP-1 receptor agonist Exendin-4, given once every 2 weeks to unilaterally 6-hydroxydopamine (6-OHDA)-lesioned rats, provides sustained plasma exendin-4 levels (Chen et al., 2018) and had the ability to significantly mitigate L-DOPA/benserazide-mediated dyskinesia in a rat 6-OHDA model of Parkinsonism. Three doses of PT320 were administered over 3 weeks together with daily L-DOPA/benserazide (a peripherally acting aromatic L-amino acid decarboxylase inhibitor). NIA found that PT320 normalized DA turnover in the striatum and reduced LID behavior in these lesioned animals (Yu et al., 2020). This data supports the future clinical use of PT320 as a co-treatment with L-DOPA for PD. However, importantly, before such development and associated resources are committed, the efficacy of PT320 to mitigate LID requires to be cross-validated in a different preclinical animal model of PD associated LID. Purpose and Objectives: The National Institute of Health (NIH, National Institute on Aging (NIA), Intramural Research Program (IRP), Translational Gerontology (TG) Branch shall procure support services to analyze markers of L-DOPA induced dyskinesia in a progressive animal model of Parkinson’s disease (MitoPark mouse). The support services will evaluate whether the drug Exenatide provides a potential treatment strategy and evaluate the efficacy of an approved and well-tolerated type 2 diabetes mellitus drug, Exenatide, in mitigating L-DOPA-induced dyskinesia in a mouse model of Parkinson’s disease; the MitoPark mouse that has parallels to the human disorder. Brain regional tyrosine hydroxylase quantification are required together with quality control studies, and extensive statistical analyses with other behavioral/biochemical data and report generation. 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 Statement of Work (SOW) attached to this Sources Sought notice. Anticipated period of performance: Twelve (12) months after receipt of purchase order Capability statement /information sought. Small business concerns that believe they possess the capabilities to provide the required 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. Small businesses must also provide their Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. Interested small businesses 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. The respondent must also provide their Unique Entity ID from SAM.gov, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. 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. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. All responses to this notice must be submitted electronically to the Contract Specialist. Facsimile responses are NOT accepted. The response must be received on or before Wednesday, June 8, 2022 at 8:00 am, 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 Federal Business Opportunities. 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).”