AMENDMENT No.: 02, from January 29, 2021

PROPOSAL DUE DATE: 11:00 a.m., Eastern Time, on February 1, 2021 (Unchanged)

This amendment No.: 2 is to answer questions received by interested parties.

The amendment No.:2 (G. Mod_2_5888985 -75N95021Q00046_Mod_and_questions) is attached in full.

END OF AMENDMENT No.: 02 from January 29, 2021

AMENDMENT No.: 01, from January 22, 2021

PROPOSAL DUE DATE: 11:00 a.m., Eastern Time, on February 1, 2021 (Unchanged)

This amendment No.: 1 is to modify the combined synopsis/solicitation 75N95021Q00046 and to answer to questions received by interested parties.

The amendment No.:1 (G. Mod_1_5888985 -75N95021Q00046_Mod_and_questions) is attached in full.

END OF AMENDMENT No.: 01 from January 22, 2021

(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 75N95021Q00046 and the solicitation is issued as a request for quotation (RFQ).

This acquisition is for a commercial item or service 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.

(iii)       The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2021-02, with effective date November 23, 2020.

(iv)       The associated NAICS code 541380 and the small business size standard is $16.5M. This requirement is for full and open competition with no set-aside restrictions.

DESCRIPTION

(v)        The National Center for Advancing Translational Sciences (NCATS) requires the testing of 20 (twenty) small molecule compounds in rat pharmacokinetic studies.  These compounds are drug molecules being evaluated for a kinase inhibitor program.  Testing of the compounds for their pharmacokinetic properties in rat will provide critical information on compound clearance, exposure, and bioavailability.

(vi)       The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), with a mission to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

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 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.

Prior work at NCATS has produced a series of small molecule inhibitors, including NCGC00371481 and its structural analogs.  Compounds such as ‘1481 have shown promising results in cellular and mouse models of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).  Further optimization of the biochemical, physiochemical and pharmacokinetic properties of these compounds is required, and may eventually produce a clinical candidate that could be used to treat cancers such as MDS and / or AML. 

In order for a candidate compound to advance into clinical trials, it must display a wide range of acceptable properties.  For this program, a potential clinical candidate must display potent inhibition of the desired targets.  It must also display suitable pharmacokinetic (PK) properties in a range of preclinical species, including at least one rodent species (mouse or rat), as well as at least one higher preclinical species (dog or monkey).  Good PK profiles in these species are required 1) in order to build models that predict good pharmacokinetic properties in humans, and 2) so that compounds can be given at high doses and high plasma exposure levels in preclinical safety studies.

In order to characterize and optimize the pharmacokinetic properties of our compounds in rat, we need to run a series of rat pharmacokinetic experiments.  Testing a set of 20 small molecule compounds in rat PK experiments will provide critical data that identify the strengths and weaknesses of our current compounds’ PK profiles, and will help us optimize those profiles so that we can identify a suitable candidate for clinical trials.

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:

1. Test each of 20 small molecule compounds in rat pharmacokinetic studies comprised of two dosing arms (one oral, one IV, n = 3 rats per arm).  Test compounds will be administered as a single doses (either oral or IV, depending on the study arm), and in each study arm, 8 serial blood draws will be taken at 8 different time points covering a range of at least 8 hours, and up to 24 hours, post-dose.  Plasma samples will be analyzed by LCMS to determine the concentration of test compound at each time point.
2. Provide one comprehensive report for each of the 20 compounds detailing results from the pharmacokinetic experiment.  The reports must contain the following:

• A graphical plot of plasma concentration of test compound vs. time
• A table of raw data showing the plasma concentration of test compound at each time point in each rat, as well as the average or mean concentration across all 3 rats, and the standard deviation or standard error for each mean value.
• Calculated oral bioavailability (F%), clearance rate (Clp), half-life (t1/2), area under the curve (AUC), maximal concentration (Cmax), and volume of distribution (Vd) for the compound. 

Government Responsibilities:

Government will not furnish property, facilities, workspace, computers, or other equipment. Contractor will not use federal facilities. Government will have the responsibility to review and approve the final report. Government will have the responsibility to provide sufficient quantities of the lead compound in order for contractor to accomplish the necessary work.

The Government anticipates, but does not guarantee, sending these compounds in 3 (three) to 6 (six) batches, with the first batch being sent shortly after contract award and each subsequent batch being sent after the other, during the performance of the contract with reasonable time for the contractor to perform the services.

Delivery or Deliverables:

Contractor will provide the data analysis and 1 (one) report for the 20 compounds detailing results from the pharmacokinetic studies provided in the content of this statement of work.

Reporting Requirements:

Contractor will provide monthly updates on the progress of the project, or more often as appropriate. Updates shall be provided electronically to Scott Hoyt at [email protected].

Evaluating Factors:

Notwithstanding the evaluating factors provided in this combined synopsis/solicitation, the following relevant experience shall be addressed by the contractor on its quote:

• Contractor shall run the assays using scientists that have significant experience (>3 years) in the testing of small molecule compounds in rat pharmacokinetic experiments; and
• Contractor shall have significant experience (>3 years) in running rat pharmacokinetic experiments.

(vii)      The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is 12 months from the date of contract award.

SPECIAL CONTRACT REQUIREMENTS (LIVE VERTEBRATE ANIMALS)

(viii)     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.

(ix)      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.

(x)      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.

TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

(xi)       The provision at FAR 52.212-1, Instructions to Offerors-Commercial Items (Jun 2020), apply to this acquisition

The following provisions apply to this acquisition and are 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)
• FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2020)

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses:

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

(End of clause)

The following clauses apply to this acquisition 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)
• FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Oct 2018). Addendum to this FAR clause applies to this acquisition and is attached.
• HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)

(xii)      The Quoters to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its quote.

Offerors must complete and return the FAR representation 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) and 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020), attached.

(xiii)     The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached.

• FAR 52.212-4 Addendum – Supplier License Agreements, attached.
• FAR 52.212-4(g), Invoice, is supplemented by:
  • NIH Invoice and Payment Instructions (12/2020), attached
  • NIH electronic invoice instructions, attached

(xiv)     The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and is attached in full text.

(xv)      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: [email protected]; Phone: 301-496-7163).

(End of provision)

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

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: [email protected]; website: http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare).

(End of clause)

EVALUATION

(xvii)    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:

a. Technical capability of the item offered to meet the Government requirement;

Ability of the Offeror to understand the SOW and requirements, adequately describe the proposed approach, identify problems and potential challenges, and demonstrate how all contract requirements will be met. Offerors shall provide evidence of sufficient planning to show that the work will be accomplished and how it will be accomplished within time and other constraints specified in the SOW or as applicable. The Offeror shall utilize all available resources to include controlling the execution of assigned activities, tasks, sub-tasks, monitoring progress, status reporting, resolving critical issues and/or mitigating risks and fulfilling all delivery requirements.

b. Price; and

c. Past performance [see FAR 13.106-2(b)(3)].”

Offerors shall show documented evidence of personnel experience related to the subject requirement. Specific and specialized relevant experience, knowledge, skills, abilities, and education of proposed personnel shall be clearly documented. The offeror must submit with their proposal a list of the last two (2) contracts completed during the past three (3) years and / or contracts awarded currently in process that are similar in nature to the work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Newly formed entities without prior contracts should list contracts and subcontracts as required above for such key personnel. For each contract, subcontract, or reference include:

1. Name of Contracting Organization;
2. Contract Number (for subcontracts, provide the prime and subcontract numbers);
3. Contract Type;
4. Total Contract Value;
5. Description of Requirement;
6. North American Industry Classification System (NAICS) code
    

SUBMISSION INSTRUCTIONS

(xviii)    Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include: 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.

Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.

Responses must also include the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), the certification of business size, the OLAW Animal Welfare Assurance number, a Vertebrate Animal Section (VAS), Institutional Animal Care and Use Committee (IACUC) project approval, the completed representation in FAR Provisions 52.204-24 and 52.204-26 (attached). All Quoters must have an active registration in the System for Award Management (SAM) www.sam.gov.

All questions must be received by 11:00 a.m., Eastern Time, on January 22, 2021, and reference Solicitation Number 75N95021Q00046. Questions may be submitted by email to Renato Gomes, Contract Specialist, [email protected]

All responses must be received by 11:00 a.m., Eastern Time, on February 1, 2021, and reference Solicitation Number 75N95021Q00046. Responses must be submitted by email to Renato Gomes, Contract Specialist, [email protected], tel. (301) 451-2596.

(xix)     The name and telephone number of the individual to contact for information regarding the solicitation:

Renato Gomes, Contract Specialist

Phone: (301) 451-2596

Email: [email protected]

ATTACHMENTS

(xx)      The following are attached in full text:

1. Statement of Work
2. VAS Worksheet
3. The provision at FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020)
4. The provision at FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
5. FAR 52.212-4 Addendum – Supplier License Agreements
6. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items (Nov 2020)
7. NIH Invoice and Payment Provisions (12/2020)
8. NIH Electronic Invoice Submission Instructions