75N95021Q00234

Submitted by pluggern on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Dog pharmacokinetics study for cAbl and RP182 Compounds
Contracting Office
National Center for Advancing Translational Sciences (NCATS)

Contact Points

Primary Contract Specialist

Scott
Bredow
scott.bredow@nih.gov
NAICS Code Number
541380
Testing Laboratories
Small Business Size Standard
$16.5 Million
FPDS Classification Code
Q301 - Medical - Laboratory Testing
Estimated Period of Performance
4 weeks after award
Competition Status
Competitive
Background/Description of Requirement

Date Quotation Due: All responses to this request for quote must be received by 3:00 PM Eastern Standard Time on June 24, 2021 and must reference the request number cited above. Responses must be submitted electronically to the contact person cited above.  Fax responses will not be accepted.

IMPORTANT: This is a request for quotations. If you are unable to quote, please so indicate in a reply email to the point of contact cited herein.  This request does not commit the Government to pay any costs incurred in the preparation of the submission of a quotation or to contract for supplies or service. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotation must be completed by the quoter.

Description of Requirement:

The National Center for Advancing Translational Sciences (NCATS) is in need of determining any possible toxicity with our leading compound in the cAbl program and the RP182 program.  The studies will help determine if there is any toxicity with our leading compounds after being administered for 14 days in three (3) beagle dogs in order to determine the feasibility of taking the compounds forward as pre-clinical candidates.

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:

NCATS will provide the required amounts of the cAbl compound and the RP182 compound, NCGC00413972 for the PK studies. The contractor shall carry out the PK studies on three (3) beagle dogs for each study.

Period of Performance:

Documentation of results and presentation of these results to NCATS via email and biweekly conference calls by the contractor over a 1-month period after receipt of a purchase order.

Special Contract Requirements:

1. Contractor Requirements. The services under this contract involves live vertebrate animals.

Respondents must have:

1. An active OLAW Animal Welfare Assurance

2. Institutional Animal Care and Use Committee (IACUC) project approval for this work. The date of IACUC approval must not be more than 36 months prior to the anticipated date of award.

2. 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.

3. Vertebrate Animals Section (VAS). 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 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.

Government Responsibilities:

NCATS will provide the cAbl compound and the RP182 compound, NCGC00413972 for the PK studies.

Delivery or Deliverables:

The contractor is responsible for providing the following deliverables:

1. Blood work results.

2. PK results on day 1 and day 14 of the studies

3. Results will be sent to Raul Calvo (raul.calvo@nih.gov) and Juan Marugan (maruganj@mail.nih.gov) at NCATS via email.

Reporting Requirements:

The contractor shall report results via email to both Juan Marugan and Raul Calvo at their respective emails.

Data Rights:

NCATS shall have sole possession of the data generated by the contractor.

Publications and Publicity:

NCATS shall be free to publish the results of the studies.

Confidentiality of Information:

No information shall be shared by the contractor except with the scientists involved in the project.

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:

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 June 30, 2021.

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. The provisions of FAR Clause 52.212-1 Instructions to Offerors—Commercial Items (Jun 2020) is applicable to this solicitation.
  2. The provisions of FAR Clause 52.212.2 Evaluation—Commercial Items (Oct 2014) 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. 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 (Feb 2021), is applicable to this solicitation.
  4. The provisions of FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items (OCT 2018) with Addenda: Stop Work Order, FAR Clause 52.242-15 (August 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 (Jan 2021) is applicable to this solicitation:
  6. 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020)

52.219-28 Post Award Small Business Program Rerepresentation (Nov 2020) (15 U.S.C. 632(a)(2)). May require contractor completion.

52.222-3 Convict Labor (Jun 2003)

52.222-19 Child Labor-Cooperation With Authorities and Remedies (Jan 2020)

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 (Oct 2020)

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

52.225-13 Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

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

7.The provisions of 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) and HHSAR 352.270-5b, Care of Live Vertebrate Animals (December 18, 2015) are applicable to this solicitation.

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).

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 a completed copy as a separate document with their quotation.  

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


DELIVERY DATE:  Four (4) weeks after 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.

Interested parties may identify in writing their interest and capability in response to this requirement. 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.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

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