MODIFICATION
Q -- Evaluating Pharmacokinetics of Compounds from Dystonia Project
- Notice Date
- 7/16/2021 4:42:55 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95021Q00256
- Response Due
- 7/23/2021 12:00:00 PM
- Archive Date
- 08/07/2021
- Point of Contact
- Scott Bredow, Phone: 3014807503
- E-Mail Address
-
scott.bredow@nih.gov
(scott.bredow@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 75N95021Q00256 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; FAR Subpart 13.5�Simplified Procedures for Certain Commercial Items; 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 2021-06, with effective date July 12, 2021. (iv)�The associated NAICS code 541380 and the small business size standard is $16.5 million.� No set-aside restriction is applicable. (v)�Background and Objectives: In DYT1 dystonia, there is a delta E mutation in the torsin A protein that leads to its mislocalization, that is, instead of having a diffuse distribution it forms dots (puncta) with cells. With the National Center for Advancing Translational Sciences (NCATS) collaborators at Duke University, the NCATS embarked on a high throughput screening campaign followed by the identification of hit compounds that were further optimized by medicinal chemistry into compounds that are able to rectify a torsion mislocalization at less than 100 nanomolar concentrations. In vitro, these compounds have a range of stabilities in mouse liver microsomes and a range of permeabilities as determined by a PAMPA BBB assay. However, the NCATS needs to determine their actual levels in mice in order to discover a compound that is ready for proof of concept in a relevant dystonia animal model. This also seeks to determine the partition coefficient of the free fractions in brain versus free fraction in plasma which is an important parameter to rank order compounds that are predicted to have better efficacy specially in neurological diseases such as dystonia. (vi)�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 attached to this solicitation. Special Contract Requirements:���� Contractor Requirements. The services under this contract involves live vertebrate animals. Respondents must have: 1. An active OLAW Animal Welfare Assurance 2. Institutional Animal Care and Use Committee (IACUC) project approval for this work. The date of IACUC approval must not be more than 36 months prior to the anticipated date of award. 2. � 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: https://olaw.nih.gov/policies-laws. 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. 3. � Vertebrate Animals Section (VAS). It is intended that live vertebrate animals will be used during performance of this contract. The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (authority derived from the Health Research Extension Act of 1985) specifies that certain information is required from offerors in contract proposals submitted to the NIH that will use live vertebrate animals. The VAS should be no more than two (2) pages and must address the following criteria: 1. 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. 2. 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). 3. Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury. 4. 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. (vii)�The Government anticipates award of a firm fixed-price purchase order for this acquisition with an anticipated period of performance of one year after the date 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 (Jun 2020) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (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� (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 52.204-25, Prohibition on Contract for Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Oct 2018). 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 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 (Oct 2020) 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 (Jul 2021) NIH Invoice Instructions (ix)��The provision at FAR clause 52.212-2, Evaluation � Commercial Items, 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: a. Technical capability of the service offered to meet the Government requirement; b. Price; and c. Past Performance. Technical and past performance, when combined, are significantly more important than cost or 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. (x)�The Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer. (xi)�The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii)�The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and is attached in full text. (xiii)��There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiv)�The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xv)�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 Dun & Bradstreet Number (DUNS), 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 from responsible sources must be received by 3:00 p.m., Eastern Time, on Friday, July 23, 2021 and reference Solicitation Number 75N95021Q00256. Responses must be submitted electronically (by email) to Scott Bredow, Contracting Officer, at scott.bredow@nih.gov. � Fax responses will not be accepted. (xvi)�The name and telephone number of the individual to contact for information regarding the solicitation is the following: ����������� Scott Bredow ����������� 301-480-7503 ����������� Scott.bredow@nih.gov
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/8bb2c1d381bd4fd68bbe4e5ee5b03172/view)
- Record
- SN06063903-F 20210718/210716230109 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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