Neurohistology, imaging and image analysis of human mini brain pieces
THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION.
The National Center for Advancing Translational Sciences (NCATS) intends to negotiate on a sole source bases with Neuroscience Associates, Inc. for neurohistology, imaging and image analysis of human mini brain pieces.
NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS
The intended procurement is classified under NAICS code 541714 - Research and Development in Biotechnology (except Nanobiotechnology) with a Size Standard of 1000 employees.
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, the contracting officer 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) No. 2020-04 dated January 15, 2020.
Background / Purpose / Objective:
The National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS) focuses on getting more treatments to more patients more quickly. Several thousand genetic diseases affect humans, of which only about 500 have any treatment. NCATS is directly addressing this problem by discovering new technologies and other approaches that could greatly accelerate the process of developing and deploying solutions that can be used by all translational researchers.
Within NCATS, the Therapeutic Development Branch (TDB) biology group works to encourage and speed the development of new treatments for diseases with high-unmet medical needs. This acquisition specifically addresses the NIH HEAL (Helping to End Addiction Long-term) initiative, which specifically applies breakthroughs in translational science to advancing new treatments for opioid misuses and addiction for pain.
The TDB biology group is requesting a service to conduct an exploratory study for characterizing 3d minibrain models. The main goal will be to find differentiation and maturation stages of these minibrains for future drug testing. If it is confirmed, the program will move ahead with additional work to study opioid effects.
Anticipated period of performance / delivery date:
The period of performance is for two (2) months with a start date of March 30, 2020.
Project Requirements:
Independently, and not as an agent of the Government, the Contractor shall provide all the
necessary personnel, facilities, supplies, and services (except for those to be furnished by the
Government as specified elsewhere in this contract) to perform the work required by this contract as set forth in this section.
Specific Requirements:
This requirement is to put in place a contract to conduct an exploratory study for the National Institutes of Health (NIH) Helping to End Addiction Long-term (HEAL) initiative for the National Center for Advancing Translational Sciences (NCATS) Therapeutic Development Branch (TDB) program. The main goal will be to characterize minibrains by different neuronal marker and identify differentiation stages of 3D brain models to test future opioid medications in these models.
The contractor shall perform the following stains through the entire human minibrain samples on every 24th section spaced at 840μ intervals, yielding eighteen (18) “2 x 3” glass slides (eighteen (18) stained sections per brain, four hundred fifty (450) stained sections total) per stain:
• Immunohistochemistry to reveal GABAergic elements
• GFAP Immunohistochemistry to reveal astrocyte activity
• mu Opioide Receptor Immunohistochemistry to reveal mu Opioide
• Fluorescent Immunohistochemistry to reveal GABAergic elements, counterstained with Blue fluorescent stain to reveal
nucleic acid
• Iba1(f)/GFAP(f)/Hoechst(f) Immunohistochemistry
·The contractor shall provide placement of coverslips, labeling, serial ordering and placement of slides in protective slide boxes or folders and shipped to NIH
The contractor shall perform Digital Imaging of all tissue on each slide at 40x. Each tissue individually imaged per slide, of the slides stained with GABA IHC, GFAP IHC, MOR IHC
The contractor shall perform Image Analysis on 1 level per brain in 54 brains: GABA, GFAP. MOR, GABA(f), Iba1(f)/GFAP(f)/Hoechst(f)
This study shall be conducted in accordance with GLP principles but will not fulfill the complete set of GLP requirements such as QA audited reports.
The contractor shall be available to consult with scientists from NCATS throughout the project period and after deliverables are sent. Support will be provided by email, phone, or web meeting per the sponsor preference.
The contractor shall send email updates to NCATS every other week. This email will include a summary of progress from the previous weeks, any technical difficulties encountered, and a timeline update.
Level of Effort:
Slicing and immunocytochemistry for minibrain samples: 2-3 weeks
Imaging: 1-2 weeks
Image analysis: 1-2 weeks
Government Responsibilities:
The Government will provide the human minibrain samples to the contractor. All samples, data used and analyzed are the sole property of the Government. The Government shall have unlimited rights to, and ownership of all deliverables provided under this contract including reports, recommendations, briefings, work plans and all other deliverables. definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General," and will be incorporated by reference and made a part of the contract. At the end of the contract period and on instruction from the Contracting Officer Representative (COR) the remaining samples will be shipped back or discarded at the end of 2020.
Delivery or Deliverables:
The contractor shalll deliver to NCATS, TDB Bio lab a complete data package including all the images, slides and an electronic copy of the excel spreadsheet of raw data as well as a complete data analysis excel files. The slides and image files will be shipped to NCATS.
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, Neuroscience Associates, Inc. is the only vendor in the marketplace that can provide the services required by NCATS.
The intended source is:
Neuroscience Associates, Inc.
10915 Lake Ridge Dr
Knoxville, TN, 37934-4919
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, NCATS-NOI-20-002142. Responses must be submitted electronically to kim.stapleton@nih.gov and valerie.whipple@nih.gov.
U.S. Mail and fax responses will not be accepted.
NCATS-NOI-20-002142 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
2/24/20, 3:56 PM