SPECIAL NOTICE
Q -- Non-GLP 50 ASOs Liver Tox Study in Mice
- Notice Date
- 5/4/2023 11:02:58 AM
- Notice Type
- Special Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95023Q00274
- Response Due
- 5/12/2023 1:00:00 PM
- Point of Contact
- Maggie Brant, Phone: 3018271771, KJ Shaikh, Phone: 3014436677
- E-Mail Address
-
maggie.brant@nih.gov, kj.shaikh@nih.gov
(maggie.brant@nih.gov, kj.shaikh@nih.gov)
- Description
- NOTICE OF INTENT to Sole Source SOLICITATION NUMBER:� 75N95023Q00274 TITLE: ��Non-GLP 50 ASOs Liver Tox Study in Mice CLASSIFICATION CODE: Q301- MEDICAL- LABORATORY TESTING NAICS CODE: 541380 - Testing Laboratories RESPONSE DATE: May 12, 2023, at 4:00 PM EST PRIMARY POINT OF CONTACT: Maggie Brant Maggie.brant@nih.gov Phone: 301.827.1771 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 Center for Advancing Translational Sciences (NCATS) intends to negotiate on a sole source basis with Charles River Laboratories, Inc., 251 Ballardvale St, Wilmington, MA 01887-1096 for a Liver Tox Study in Mice. The anticipated award date is May 23, 2023.� NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 541380 - Testing Laboratories with a Size Standard of $19 million. � This acquisition is NOT set aside for small businesses, but rather is a sole source acquisition to Charles River Laboratories, Inc. 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) 2023-02 dated March 16, 2023. DESCRIPTION OF REQUIREMENT The purpose of this requirement is to evaluate the liver toxicity associated with the systemic administration of antisense oligonucleotides (ASOs) in a mouse animal model. The project's primary goal is to develop a predictive model of candidate ASO therapies' safety and acute toxicity. The National Center for Advancing Translational Sciences (NCATS) focuses on treating rare diseases. A significant emphasis of NCATS is the rapid development of effective therapies for patients diagnosed with these conditions. Although each condition is individually rare, cumulative rare diseases lead to considerable morbidity and mortality among the American population. NCATS is directly addressing this problem by discovering new technologies and other approaches, such as ASO therapies, that could significantly accelerate developing and deploying solutions that all translational researchers can use. The Government will provide the 50 candidate ASOs to the Contractor for evaluation. The Contractor shall be responsible for providing all consumable supplies, standard assay reagents (e.g., PBS), facilities, and equipment to carry out the animal experiments. This will include scoring, documentation, and writing the final reports describing the results of each animal experiment. The contractor shall perform the non-GLP ASO study in mice as follows: The contractor will provide animals. The animals will comprise 200 (plus extras) C57Bl/6 male and female mice aged 7-8 weeks. Study description: N=4 mice per group (2 males and 2 females in each group), 50 groups in total, one group per candidate ASO. The animals will be housed for three weeks. The animals will receive three doses of ASO via the subcutaneous route. There will be a 7-day break between doses. Plasma will be collected from the animals on one occasion, namely, three days after the last dose before terminal collection. At the time of terminal collection (3 days after the last dose): The animals will be anesthetized with isoflurane and perfused with PBS. The contractor will collect and analyze the terminal plasma for ALT/AST via ELISA. The terminal liver tissues will be removed, fixed, then transferred to PBS, and shipped to NCATS for histopathological analysis. Reports: The data from the animal experiments will be provided in a standard non-GLP report in Excel document format. The vendor must submit documentation of an approved OLAW Assurance (such as an Assurance number) (OLAW, IACUC) from PHS Policy on Humane Care and Use of Laboratory Animals, of IACUC approval within the prior 36 months (such as the approval letter), and AAALAC Accreditation. NCATS intends to negotiate on a sole source basis with Charles River Laboratories, Inc. for non-GLP 50 ASOs Liver Tox Study in Mice. ESTIMATED PERIOD OF PERFORMANCE: The period of performance is 2 months. � Start date: June/01/2023 � End date: August/01/2023 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, Charles River Laboratories, Inc. is the only vendor in the marketplace that can provide the services required by NCATS due to the fact that this is a continuation and extension of work that we are already conducting in partnership with Charles River Laboratories, Inc. and continuing with Charles River Laboratories, Inc. will ensure the consistency of methods and technical support.� The intended source is: Charles River Laboratories, Inc. 251 Ballardvale St Wilmington, MA 01887-1096 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 Unique Entity ID (UEI), 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, 75N95023Q00274.� Responses must be submitted electronically to Maggie Brant, Contract Specialist, at maggie.brant@nih.gov.� U.S. Mail and fax responses will not be accepted.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/d594ffd344c74aa191642a51c0077e86/view)
- Place of Performance
- Address: Wilmington, MA 01887, USA
- Zip Code: 01887
- Country: USA
- Zip Code: 01887
- Record
- SN06671639-F 20230506/230504230112 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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