75N95022Q00144

Post Date/ Solicitation Issue Date

April 7, 2022 12:00 pm

Closing Response Date

April 18, 2022 9:00 am

Proposed Award Date

April 22, 2022 12:00 pm

Project Title

Pharmacokinetics assessment in Mice and Rats

Contracting Office

National Center for Advancing Translational Sciences (NCATS)

Small Business Size Standard

$16.5 Million

FPDS Classification Code

6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

Estimated Period of Performance

12 months

Competition Status

Non-Competitive

Single-Sole Source Determination

This notice of proposed acquisition is posted as an intent to award a purchase order on a non-competitive basis to Pharmaron, Inc. 201 East Jefferson St., Louisville, KY 40202 T:1-313-618-1689

The Non-Competitive (Single-sole Source (Including brand-name)) Determination is based upon the market research conducted. Specifically, only one source is capable of providing the supplies or services required pursuant to FAR 13.106-1(b)(1)(i), only one source is reasonably available.

Background/Description of Requirement

Background Information and Objective:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting, and making medical discoveries that improve people’s health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a translational science center that prides itself on its tremendously productive pipeline and is innovative in a number of ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve people’s lives. Included in this process is the development of unique small molecules as potential anticancer agents or as potential for regenerative medicine.

Pharmacokinetics plays a critical role in determining the available drug in a living system for the target of interest, by determining the overall level of the drug. This parameter is key to assessing the potential in vivo efficacy of the drug.

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

1. 8 compounds in a Pharmacokinetics assay

       a. The assay will have an N= 3 on the number of animals used

       b. The animals to be used will be either CD-1 or C57 mice, or alternatively Sprague Dawley or Han Wistar rats

       c. 8 time points will be assessed over 24 hours

       d. Plasma levels of the given small molecule will be measured at each of these time points

       e. An excel spreadsheet will be provided as a report with the necessary information

See Attachment 1 – Statement of Work.

QUOTER TERMS AND CONDITIONS: (To be completed by the Offeror):

1. Period of Performance OR Delivery Date After Receipt of Order:
2. Shipping Point (F.O.B. OR Destination):
3. Payment Discount Terms:
4. Open Market; GSA FSS Contract Number; Other Government Agency (OGA) Contract Number, Government-wide Agency (GWAC) Contract Number; or National Institute of Health (NIH) Blanket Purchase Agreement (BPA) Number:
5. DUNS No:
6. Name of Company:
7. Street Address, City, State, Zip code:
8. Name of Person Authorized to Provide Quote:
9. Telephone Number and Email Address of Person Authorized to Provide Quote:

CONTRACT TYPE:

A Fixed-Price type of Purchase Order award not exceeding the Simplified Acquisition Threshold is anticipated for any contract resulting from this requirement. The anticipated award date is 4/22/2022.

ADDITIONAL TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

The FAR Clauses are incorporated by reference and are provided in full text at https://www.acquisition.gov/

1. 1. 1. 1. FAR Provision 52.212-1 Instructions to Offerors—Commercial Items (NOV 2021) is applicable to this solicitation.
         2. FAR Provision 52.212.2 Evaluation—Commercial Items (NOV 2021) is applicable to this solicitation. The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:
            1. 1. 1. 1. Technical capability of the service offered to meet the Government requirement;
                     2. Price; and
                     3. Past performance [see FAR 13.106-2(b)(3)].
         3. FAR Provision 52.212-3, Offeror Representations and Certifications—Commercial Items (NOV 2021), is applicable to this solicitation (Attachment 2).
         4. FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items (NOV 2021) with Addendum (Attachment 3). FAR Clause 52.242-15 Stop-Work Order (AUG 1989) is applicable to this solicitation and is incorporated by reference.
         5. FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (JAN 2022) is applicable to this solicitation.  See Attachment 4 for the FAR clauses the Contractor shall comply with in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services.

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 this/these address(es):

www.acquisition.gov

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of provision)

In addition, the following FAR provisions are applicable to this solicitation and incorporated by reference:

FAR 52.204-7 System for Award Management (OCT 2018)

FAR 52.204-16 Commercial and Government Entity Code Reporting (AUG 2020)

HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice (December 18, 2015)

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 this/these address(es):

www.acquisition.gov

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of clause)

In addition, the following clauses are applicable to this solicitation and are incorporated by reference:

FAR 52.204-13 System for Award Management Maintenance (Oct 2018)

FAR 52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020)

HHSAR 352.239-74 Electronic and Information Technology Accessibility (December 18, 2015)

The following provisions and clauses apply to this acquisition and are included in full text below or as attachments to the RFQ. Offerors MUST complete, sign and submit the provision at 52.204-24 and 52.204-26 or 52.212-3 pursuant to FAR 4.2103 Procedures as a separate document with their quotation. 

1. FAR Provision 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021) – Attachment 5
2. FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020)
3. FAR Provision 52.204-26, Covered Telecommunications Equipment or Services-Representation (OCT 2020) – Attachment 6
4. NIH Invoice and Payment Provisions (Rev. 2/10/2021) – Attachment 7

SPECIAL CONTRACT REQUIREMENTS TO BE INCLUDED ONLY FOR REQUIREMENTS INVOLVING LIVE VERTEBRATE ANIMALS

The services under this contract involves live vertebrate animals. Quoters must have an active OLAW Animal Welfare Assurance. In addition, Quoters must include with its quotation:

1. Vertebrate Animal Section (VAS) (see below)
2. Institutional Animal Care and Use Committee (IACUC) project approval. The date of IACUC approval must not be more than 36 months prior to the anticipated date of award.

Vertebrate Animals Section (VAS). The VAS should be no more than two (2) pages and must address the following criteria:

1. Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the Statement of Work. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work.
2. 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).
3. Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury.
4. 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.

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 VAS Worksheet is provided as an attachment to this solicitation to assist in the preparation of the VAS.

Animal Welfare. All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: http://grants1.nih.gov/grants/olaw/references/phspol.htm. In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the Contractor’s quotation.

The provision at 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: olaw@od.nih.gov; Phone: 301-496-7163).

(End of provision)

The clause at HHSAR 352.270-5b, Care of Live Vertebrate Animals (December 18, 2015).

1. 1. 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.
   2. 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.
   3. 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.
   4. 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/animalwelfare).

(End of clause)

Attachment 8 - VAS Worksheet

PERIOD OF PERFORMANCE: The anticipated period of performance shall be 12-months from date of purchase order award. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852.  A firm fixed price type order is anticipated to be awarded as a result of this RFQ.

 SUMMARY STATEMENT: Responses to this notice must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service.  The response shall include: the unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision.  Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.