SOLICITATION NOTICE
R -- Small Molecule Screen for GNAS1 Activity
- Notice Date
- 7/6/2016
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-DE-2016-205-KMA
- Archive Date
- 7/30/2016
- Point of Contact
- Kevin Alvarez,
- E-Mail Address
-
kevin.alvarez@nih.gov
(kevin.alvarez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Trustees of Boston College, 140 Commonwealth Avenue, Chestnut Hill, MA, 02467-3800, to perform experiments on small molecules and test their activity in the GPCR/Gs/CAMP pathway as it relates to Fibrous Dysplasia/McCune-Albright Syndrome (FD/MAS) on behalf of the National Institute of Dental and Craniofacial Research's (NIDCR) Skeletal Clinical Studies Unit. BACKGROUND The mission of the Skeletal Clinical Studies Unit is to advance the understanding of bone and mineral metabolism through clinical and translational studies of human diseases, and animal models and in vitro systems. The approach is primarily the study of rare diseases that serve as model systems. Clinical observations generate testable hypotheses that lead to basic and clinical studies that elucidate both pathophysiology and physiology and lead to the development of novel evidenced-based treatments. The principle disorders currently under investigation include: 1) fibrous dysplasia of bone/McCune-Albright syndrome (FD/MAS), a disease of the skeletal stem cell caused by activating mutations of the GNAS gene, that encodes the Gsα protein; 2) disorders of the phosphate- and vitamin D-regulating hormone, FGF23; and 3) hypoparathyroidism, a disease of parathyroid hormone (PTH) deficiency that allows for not only the study of the PTH/Gsα/cAMP pathway in bone and mineral metabolism, but also serves as a model in which to study FGF23 physiology. PURPOSE The purpose of this acquisition is to procure the services of a Contractor to perform experiments on small molecules and test their activity in the GPCR/Gs/CAMP pathway as it relates to Fibrous Dysplasia/McCune-Albright Syndrome (FD/MAS). The specific aims of the study are two-fold, and will be conducted in two phases. The first is to test 24 compounds for ability to alter PKA activity in genetically-engineered S. pombe strains. The second aim is to determine selectivity for GNAS1R201C versus wild type GNAS1. PROCUREMENT For this procurement, the tasks to be performed will be divided between the two phases. The tasks for each phase are as follows: Phase One: Test 24 compounds for ability to alter PKA activity in genetically-engineered S. pombe strains. •Carry out GFP assays in strains expressing GNAS1R201C with AC1 through AC9. •Further characterize positive hit compounds using strains expressing mammalian ACs in the absence of GNAS1. •Determine whether inactive compounds actually target PDEs, fail to be taken up by yeast or are modified after uptake by yeast. Phase Two: Determine selectivity for GNAS1R201C versus wild type GNAS1. •Carry out GFP assays on 24 compounds at various doses using S. pombe strains expressing GNAS1R201C and AC1 through AC9. •Further characterize hit compounds against strains expressing AC1 through sAC in the absence of GNAS1. •Characterize inactive compounds as PDE regulators or compounds unsuitable for yeast assays. •Construct new strains expressing appropriate target AC enzymes together with wild type GNAS1. •Characterize hit compounds for selectivity against GNAS1R201C versus wild type GNAS1. JUSTIFICATION The sole source determination is based on the fact that Boston College has spent the past few years developing an assay that can query the GNAS1 pathway with the specific gene mutations that result in FD/MAS. This ability is unique to Boston College, and as such, only Boston College can perform the tests necessary to fulfill the Government's requirement. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b), soliciting from a single source (for purchases not exceeding the simplified acquisition threshold) and only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION Industry Classification (NAICS) Code is 541690, Other Scientific and Technical Consulting Services, and the Small Business Size Standard is $15.0M. The acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable (FAR Part 6.001). The resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-88 (June 15th, 2016). This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by July 15, 2016 at 9:00AM EST and must reference synopsis number NHLBI-CSB-DE-2016-205-KMA. Responses shall be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6127, Bethesda, Maryland 20892-7902, Attention: Kevin Alvarez. Responses may be submitted electronically to kevin.alvarez@nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
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