Pre-Solicitation NICHD-21-109.pdf

NICHD-21-109

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5/25/2021 to 6/10/2021

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A

CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION.

The National Institutes of Health, National Institute of Child Health and Development (NICHD) intends to award a purchase order without providing for full and open competition to Cyagen US INC., 2255 Martin Avenue, Suite E, Santa Clara, CA. 95050, USA, for generation of conditional knock-in/out mouse lines.

Our research focuses on the development of the mammalian hematopoietic system. A long-term area of interest for our laboratory is the study of signal transduction molecules and pathways that regulate T lymphocyte maturation in the thymus. Currently, we are analyzing transgenic and conditional nonsignaling mutants of T cell antigen receptor (TCR) signaling subunits to evaluate the importance of individual TCR signaling chains and motifs at specific stages of T cell development and in mature T cells. We are also using gene profiling to identify proteins that are important for fine-tuning the T cell–signaling response in developing and mature T lymphocytes. In conjunction with checkpoint inhibitors for immunotherapy in humans, these molecules may also be targets. We are also investigating the function of new T cell–specific proteins that we identified by subtraction library screening. We have identified two gene candidates: LAX1 and SIT1, that we would like to make conditional knockin/knockout mouse models of to future investigate. LAX1 and SIT1 are involved in the T cell receptor pathways and are genes that are related to our ongoing Themis 1 & 2 and 6Y/6F projects in the lab.

Cyagen offers a proprietary service called TurboKnockout, which allows for the generation of conditional knockin/knockout mouse models though ES targeting cell lines in 6-8 months instead of the conventional 10-14 months. They are the only company that offers the TurboKnockout ES cell targeting conditional knock-in/out mouse model generation service. They have a “super” competent ES cell line that generations 100% ESC-derived founder mice rather than chimeras, eliminating the need to screen for germline transmission. The company also has a selection cassette on the targeting construct capable of removing itself after ES cell targeting without the need to breed to Flp delete mice. Both of these proprietary steps eliminate the need for two generations of breeding and shortens the production time by 4-6 months as compared to conventional standards, which has more steps that require more time. The shortened time would greatly benefit our program goals.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS 325414 of with a Size Standard of or 1,250.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2021-05 effective 3-10-2021. This acquisition is conducted under the procedures as prescribed in FAR subpart 13 - Simplified Acquisition

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

Procedures at an amount not exceeding the simplified acquisition threshold ($250,000) and FAR Subpart 12 - Acquisition of Commercial Items.

STATUTORY AUTHORITY

This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1—Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1).

Place of Performance National Institutes of Health 9000 Rockville Pike Bethesda MD 20892 United States

DESCRIPTION OF REQUIREMENT

Generation of conditional knock-in/out mouse lines for research purposes

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 to this notice shall be submitted electronically by 5:00PM Eastern Standard Time (EST), on Tuesday, June 8th, 2021 to jacob.balenson@nih.gov and shall include solicitation # NICHD-21-109 in the subject line.

Evaluation Evaluation of quotations or offers to be made based on best value to include price and other factors:

technical capability, past performance, service features, delivery milestones, terms and conditions.

http://www.sam.gov/ mailto:jacob.balenson@nih.gov

Clauses

352.270-5a Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals.

Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (December 18, 2015)

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) establishes a number of requirements for research activities involving animals. Before awarding a contract to an offeror, the organization shall file, with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), a written Animal Welfare Assurance (Assurance) which commits the organization to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC). In accordance with the PHS Policy, offerors must establish an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members, to oversee the institution’s animal program, facilities, and procedures.

Offerors must provide verification of IACUC approval prior to receiving an award involving live vertebrate animals. No award involving the use of animals shall be made unless OLAW approves the Assurance and verification of IACUC approval for the proposed animal activities has been provided to the Contracting Officer. Prior to award, the Contracting Officer will notify Contractor(s) selected for projects involving live vertebrate animals of the Assurance and verification of IACUC approval requirement. The Contracting Officer will request that OLAW negotiate an acceptable Assurance with those Contractor(s) and request verification of IACUC approval. For further information, contact OLAW at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 Bethesda, Maryland 20892-7982 (E-mail: olaw@od.nih.gov; Phone: 301–496–7163).

(End of provision)

352.270-5b Care of Live Vertebrate Animals.

Care of Live Vertebrate Animals (December 18, 2015)

(a) Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

(b) The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

(c) The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on mailto:olaw@od.nih.gov

Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

(d) If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with Animal Welfare Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail: ace@aphis.usda.gov; website: http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/anim alwelfare).

(End of provision)

Clauses Incorporated by Reference:

52.212-1 Instructions to Offerors-Commercial Items 52.212-2 Evaluation-Commercial Items 52.212-3 Offeror Representations and Certifications-Commercial Items 52.212-4 Contract Terms and Conditions-Commercial Items 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items mailto:ace@aphis.usda.gov http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare