Drug Development Portfolio consulting services with the National Institute of Mental Health (NIMH) Small Business Innovation Research Program/Small Business Technology Transfer Program (SBIR/STTR).
NOTICE OF INTENT to Sole Source
1. SOLICITATION NUMBER:
NIMH19005909
2. TITLE: Drug Development Portfolio consulting services with the National Institute of Mental Health (NIMH) Small Business Innovation Research Program/Small Business Technology Transfer Program (SBIR/STTR).
3. CLASSIFICATION CODE:
R -- Professional, administrative, and management support services
4. NAICS CODE: 541690 - OTHER SCIENTIFIC AND TECHNICAL CONSULTING SERVICES
5. RESPONSE DATE:
July 17, 2019 at 12:00 PM EST
6. PRIMARY POINT OF CONTACT:
Thien Nguyen
Thien.Nguyen2@nih.gov
Phone: 301-827-0914
7. DESCRIPTION:
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).
The National Institute of Mental Health (NIMH) intends to negotiate on a sole source bases with Gian Luca Araldi, 57 Varsity Blvd, East Setauket, New York 11733
NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS
The intended procurement is classified under NAICS code 541690 - OTHER SCIENTIFIC AND TECHNICAL CONSULTING SERVICES with a Small Business Size Standard of 15 million.
REGULATORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization).
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 20019-01 dated December 1, 2018.
PURPOSE AND OBJECTIVES:
The National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), is the largest scientific organization in the world dedicated to research focused on transforming the understanding, treatment, and prevention of mental disorders and the promotion of mental health. The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.
The NIMH Small Business Innovation Research Program (SBIR) supports research and development by small businesses of innovative technologies that have the potential to succeed commercially or to provide significant societal benefits. The Small Business Technology Transfer Program (STTR) has the same objectives but requires academic research involvement. The SBIR and STTR programs support research aimed at the development and validation of new methods, tools and technologies to advance understanding, prevention, and treatment of mental illness and to understand normal brain function.
Areas of Emphasis in the Category of Drug Development for Psychiatric Disorders:
• Preclinical drug discovery/development
• IND-enabling studies
• Preclinical in vitro or in vivo assays for screening compounds
• First in human clinical testing
• Development of biomarkers for the purposes of identifying target engagement of drug agents in preclinical or clinical studies
• Development of biomarkers as potential stratification measures for use in clinical trials or for measures of treatment response, disease progression, or toxicity
DESCRIPTION OF REQUIREMENT
The Contractor shall provide consulting services to the NIMH as follows:
• Act as an ad hoc scientific consultant for drug development to the NIMH SBIR/STTR program, including assisting NIMH program staff on pre-SBIR projects and providing technical expertise to Principle Investigators on future SBIR/STTR funding.
• Provide technical expertise to NIMH on SBIR/STTR applications in the scientific areas of Central Nervous System (CNS) preclinical drug discovery/drug development, (discovery phase, new compounds and targets, compound chemistry, Investigational New Drug (IND)-enabling studies to first-in-human, etc.).
• Provide technical expertise on the state of compounds in terms of potential toxicity issues, stability, CNS effects, appropriateness as a CNS compound.
• Provide technical expertise on the path to getting the compounds into human studies, evaluating the proposed path, and specific studies proposed.
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, Gian Luca Araldi is the only vendor in the marketplace that can provide the services required by NIMH.
The intended source is:
Gian Luca Araldi
57 Varsity Blvd
East Setauket, NY 11733
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.
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. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. 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.
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.
All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIMH19005909. Responses must be submitted electronically to Thien Nguyen, Contract Specialist, at thien.nguyen2@nih.gov. and Valerie Whipple, Contracting Officer, at valerie.whipple@nih.gov. U.S. Mail and fax responses will not be accepted.
Thien T. Nguyen, Contract Specialist, Phone 3018275218, Email thien.nguyen2@nih.gov - Valerie Whipple, Contracting Officer, Phone 3018275218, Email Valerie.whipple@nih.gov
