(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75N95019Q00305 and the solicitation is issued as a request for quotation (RFQ).

This acquisition is for a commercial item and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures and FAR Part 12-Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health (NIH) intends to negotiate and award a purchase order without providing for full and open competition (Including brand-name) to Covance Laboratories, Inc., at 3301 Kinsman Blvd, Madison, WI 53704-2523.

This acquisition is conducted as non-competitive for a commercial service and is conducted under the authority of the FAR Part 13 - Simplified Acquisition Procedures, and FAR 13.106-1(b) - Soliciting from a single source. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted that produced no other sources capable of providing this Government requirement due to the need for continuity of science.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-04, effective August 7, 2019.

(iv) The associated NAICS code is 541380 and the small business size standard is $15M.

DESCRIPTION

(v) The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) requires mass balance studies to be conducted on a lead compound that the NIH is advancing into the clinic.

See attached Statement of Work for additional details.

(vii) The anticpated period of performance is September 1, 2019 - August 31, 2020.

(viii) The anticipated award date is August 23, 2019.

EVALUATION

(ix) The Government plans to award a contract resulting from this solicitation. The award will be made to the responsible offeror whose offer is most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotations: Technical Capability, Past Performance, and Price. Comparative evaluations will be conducted in the event that multiple quotations are received.

VENDOR AND SUBMISSION REQUIREMENTS

(x) Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

(xi) Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of performing the required service. Responses must also include the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size.

(xii) The price quote must include the unit price, total price, shipping and handling price, prompt payment discount terms, product or catalog number(s), product/services description, and any other information or factors that may be considered in the award decision.

(xiii) All responses must be received by 12:00pm EDT on August 21, 2019, and reference solicitation number 75N95019Q00305. Responses must be submitted via email to Jeff Schmidt, Contracting Officer, at [email protected].

(xiv) For information regarding the solicitation, contact Jeff Schmidt, Contracting Officer, at 301.402.1488 or [email protected].

(xvi) All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

PROVISIONS AND CLAUSES

(xv) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998). This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at www.acquisition.gov.

The following provisions apply to this acquisition and are incorporated by reference:
• The provision at FAR 52.204-7, System for Award Management (Oct 2018)
• The provision at FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul 2016)
• The provision at FAR 52.212-1, Instructions to Offerors - Commercial Items (Oct 2018)
• The provision at 52.212-3, Offeror Representations and Certifications-Commercial Items (Oct 2018)

(xvi) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998). This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at www.acquisition.gov.

In addition to the clauses checked in FAR 52.212-5 (attached), the following clauses also apply to this acquisition and are incorporated by reference:
• The clause at FAR 52.204-13, System for Award Management Maintenance (Oct 2018)
• The clause at FAR 52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016)
• The clause at FAR 52.212-4, Contract Terms and Conditions - Commercial Items (Oct 2018)
• The clause at FAR 52.227-17, Rights in Data - Special Works (Dec 2007)
• The clause at HHSAR 352.222-70, Contractor Cooperation in Equal Employement Opportunity Investigations (December 18, 2015)

(xvii) Additional contract requirement(s) or terms and conditions applicable to this acquisition:

Confidential Treatment of Sensitve Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

Publication and Publicity

The Contractor will not write artciles regarding or publish the results of work under this contract without the express written permission of the Government. If given permission to publicize the Contractor's work under this contract, the Contractor will acknowledge the support of the NIH whenever publicizing the work under this contract in any media by including an acknowledgment substantially the same as follows:

"This project has been funded in whole or in part with Federal funds from the National Center for Advancing Translational Sciences, National Institutes of Healht, Deparement of Health and Human Services, under Contract No. TBD."

HHSAR 352.270-5a, 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: [email protected]; Phone: 301-496-7163).

(End of provision)

HHSAR 352.270-5b, 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 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: [email protected] ; website: http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare).

(End of clause)

Research Involving Live Vertebrate Animals

It is intended that live vertebrate animals will be used during performance of this contract. The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (authority derived from the Health Research Extension Act of 1985) specifies that certain information is required from offerors in contract proposals submitted to the NIH that will use live vertebrate animals. The following criteria must be addressed in a separate section of the Technical Proposal titled "Vertebrate Animal Section" (VAS):

(a) Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the Request for Proposal (RFP) Statement of Work. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work. If dogs or cats are proposed, provide the source of the animals.

(b) Justifications. Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).

(c) Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury.

(d) Euthanasia. State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification.

A concise (no more than 1-2 pages), complete description addressing these criteria must be provided. The description must be cohesive and include sufficient information to allow evaluation by reviewers and NIH staff. For more discussion regarding the VAS, see NIH Guide Notice NOT-OD-16-006 at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html.

The Contract Proposal VAS Worksheet is provided as an Attachment in SECTION J of this solicitation to assist in the preparation of the VAS as part of the Technical Proposal. It can be accessed at: http://grants.nih.gov/grants/olaw/VAScontracts.pdf.

(xviii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.