75N95023Q00632

Post Date/ Solicitation Issue Date

August 15, 2023 12:00 pm

Closing Response Date

August 21, 2023 3:00 pm

Proposed Award Date

August 31, 2023 12:00 pm

Project Title

Mouse PK Studies

Contracting Office

National Center for Advancing Translational Sciences (NCATS)

Small Business Size Standard

$19 million

FPDS Classification Code

Q301 - Medical- Laboratory Testing

Estimated Period of Performance

One year after award

Competition Status

Non-Competitive

Single-Sole Source Determination

This vendor has provided NCATS with services for similar studies in the past. Therefore, it is critical for continuity of research and to compare results from the past, that this is solicited non-competitively to Pharmaron, Inc.

Background/Description of Requirement

The National Center for Advancing Translational Sciences (NCATS) requires the assessment of eight (8) novel compounds in a pharmacokinetics assessment.

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.

Scope of Work:

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:

The contractor shall provide the animals and the scientists needed to conduct three studies:

1. Eight (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

Level of Effort:

1 Biologist, ~40 hours

Government Responsibilities:

Government has the responsibility to send the compounds, and review the data.

Delivery or Deliverables:

The contractor shall deliver one (1) final report and interim reports as needed.

Reporting Requirements:

The contractor shall provide reports monthly by e-mail.

Data Rights:

All data shall be considered confidential and property of the government.

Publications and Publicity:

Data shall not be published without permission of the government.

Confidentiality of Information:

Data shall be kept confidential.

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. NIH 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:

Special Requirement:

The services under this request for quotations 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.
3. Please include your NIH OLAW assurance number on the quote.

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.

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 August 31, 2023.

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. The provisions of FAR Clause 52.212-1 Instructions to Offerors—Commercial Items (Mar 2023) is applicable to this solicitation.
         2. The provisions of FAR Clause 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. The provisions of FAR Clause 52.212-3, Offeror Representations and Certifications—Commercial Items (Dec 2022), is applicable to this solicitation.
         4. The provisions of FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items (Dec 2022) with Addenda: Stop Work Order, FAR Clause 52.242-15 (Aug 1989) is applicable to this solicitation.
         5. The provisions of FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Jun 2023) is applicable to this solicitation:

52.204-27 Prohibition on a ByteDance Covered Application (Jun 2023)

52.219-28 Post Award Small Business Program Rerepresentation (Mar 2023)

52.222-3 Convict Labor (Jun 2003)

52.222-21 Prohibition of Segregated Facilities (Apr 2015)

52.222-26 Equal Opportunity (Sep 2016)

52.222-36 Equal Opportunity for Workers With Disabilities (Jun 2020)

52.222-50 Combating Trafficking in Persons (Nov 2021)

52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020)

52.225-13 Restrictions on Certain Foreign Purchases (Feb 2021)

52.232-33 Payment by Electronic Funds Transfer-- System for Award Management (Oct 2018)

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

52.204-7 System for Award Management (Oct 2018),

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

52.204-16 Commercial and Government Entity Code Reporting (Aug 2020),

52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020).

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) is applicable.

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).

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

The following provisions and clauses apply to this acquisition and are incorporated as an attachment. Offerors MUST complete the provision at 52.204-24 and 52.204-26 and submit completed copies as a separate document with their quotation.

1. FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
2. FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
3. FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
4. NIH Invoice and Payment Provisions (3/20/2023)

Period of Performance/Delivery Date:  12 months after contract 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.