SOLICITATION NOTICE
B -- Rodent PK and mouse MTD DRF analysis
- Notice Date
- 5/18/2015
- Notice Type
- Presolicitation
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-NOI-15-243
- Archive Date
- 6/16/2015
- Point of Contact
- Andrea McGee, Phone: 3014358718
- E-Mail Address
-
amcgee@nida.nih.gov
(amcgee@nida.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SOLICITATION NUMBER: HHS-NIH-NIDA-SSSA-NOI-15-243 TITLE: Rodent PK and mouse MTD DRF analysis INTRODUCTION This is a pre-solicitation non-competitive (notice of intent) synopsis to award a contract without providing for full or open competition (including brand-name). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institute on Drug Abuse (NIDA), Consolidated Station Support and Simplified Acquisitions (CSS/SA) Branch intends to negotiate and award a purchase order to MicroSource Discovery Systems Inc for small molecules without providing for full and open competition (including brand-name). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE This acquisition is unrestricted. The associated NAICS code 325413 with a size standard of 500 employees. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the through Federal Acquisition Circular (FAC) 2005-80 effective March 2, 2015. This acquisition is for a commercial item or service and is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures. This acquisition is NOT expected to exceed the simplified acquisition threshold. STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1. DESCRIPTION OF REQUIREMENT Purpose and Objectives The purpose of this acquisition is to purchase Rodent PK analysis for 38 compounds and mouse MTD DRF analysis for 2 compounds. Project Description 1) Rodent PK analysis for 38 compounds 2) Mouse MTD DRF analysis for 2 compounds 3) Data turnaround or "Lead Time": data will be obtained with 5 working days of compound receipt 4) Comprehensive services: any company should be able to provide all the services that are listed (in vitro ADME and in vivo PK) 5) Analysis should be supported by appropriate positive controls to ensure robustness and reproducibility of the service. a. Examples (but not limited to) including: i. known CYP inhibitors for CYP inhibition analysis ii. known hERG inhibitors for hERG inhibition analysis iii. compounds with known permeability in the Caco-2 and MDCK-MDR1 permeability analysis iv. compounds with known metabolic stability in the rat, mouse and human liver microsome analysis. 6) Company must provide a professional and comprehensive report with all the relevant results from the service rendered. 7) For in vivo PK analysis, the company will provide preliminary formulation work to find an acceptable formulation when requested. 8) The company will survey a collection of acceptable pre-clinical formulations for dosing NCATS compounds for in vivo PK analysis. In some instances the desired formulation will be provided by NCATS 9) Company must provide a protocol for in vivo analysis to the client for approval before the service is carried out. 10) The detailed report will be provides as a word document with the exact details of the experiment included but not limited to 11) Dose level (mg/kg), Dose volume (ml/kg), Route of administration, number of animals, PK time points (should be minimum of 8), sample collecting and processing procedures, cage observations, 12) Details of rodent (species, sex, strain, age and weight), dosing formulation and PK parameters (t1/2, C0, Cmax, tmax, CL, Vss, MRT, AUClast, AUCinf, F) Specifically NCAT requires:  Rodent PK analysis for 38 compounds (Rodent PK, iv or po., plasma exposure  Mouse MTD DRF analysis for 2 compounds (Mouse (CD-1) non GLP MTD study - single dose @25, 50, 100, 150, 200 mpk, 3 mice/dose) Delivery/Period of Performance: To begin from time of award date until 12/31/2015 CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Pharmaron Inc is the only vendor in the current market place that can provide the unique services required by the of National Center for Advancing Translational Sciences. In accordance with FAR part 10, extensive market research was conducted to reach this determination. Specifically, a small business sources sought notice was posted to FedBizOpps referencing the above detailed requirements and no responses were received. Therefore, only Pharmaron Inc is capable of meeting the needs of this requirement. The intended source is: Pharmaron Inc 201 East Jefferson Street Ste 304 Louisvill, KY 40202 CLOSING STATEMENT 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 shall be submitted no later than June 1, 2015 at 4:30pm EST. Responses may be submitted electronically to amcgee@nih.gov or by U.S. mail to the National Institute of Drug Abuse (NIDA), Station Support / Simplified Acquisition Branch (SS/SA), Attention: Andrea McGee. Fax responses will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-NOI-15-243/listing.html)
- Place of Performance
- Address: 9800 Medical Center, Rockville, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN03735043-W 20150520/150518235507-ddd3941c5b410d2705e1b95f91d97df5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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