75N95021Q00358

Post Date/ Solicitation Issue Date

August 12, 2021 12:00 pm

Closing Response Date

September 3, 2021 3:00 pm

Proposed Award Date

September 15, 2021 12:00 pm

Project Title

Pharmacokinetics and Protein Plasma Binding Assessment

Contracting Office

National Center for Advancing Translational Sciences (NCATS)

Small Business Size Standard

$16.5 Million

FPDS Classification Code

Q301 – MEDICAL - LABORATORY TESTING

Estimated Period of Performance

09/15/2021 – 09/14/2022

Delivery of Goods

1 report, including the results of the assay and the procedure used. Sub-reports may be required if compounds are not all submitted at once.

Competition Status

Competitive

Single-Sole Source Determination

N/A

Background/Description of Requirement

General Requirements:
Pharmacokinetics and Protein Plasma binding play a critical role in determining the available drug in an living system for the target of interest. Pharmacokinetics determines the overall level of the drug. Protein Plasma Binding determines the free fraction of the drug available. With these two parameters, the relative availability of the drug in living systems can be determined.

Specific Requirements:
1. Assessment of 5 novel compounds in a pharmacokinetics assessment
2. Assessment of 20 novel compounds in a Protein Plasma Binding assay
3. A report on the results of these assays

The pharmacokinetics experiments are:
5 compounds, 2 arm experiments in mice (CD-1 or C57), with an N=3 on the number of mice, and 8 timepoints, for plasma PK.

The contractor shall:
1. Formulate the compound into an injectable solution.
2. Inject it into the mice. (or administer orally)
3. Withdraw the blood at the desired timepoints.
4. Isolate the plasma.
5. Determine by HPLC the relative concentration of the compound.
6. Return a comprehensive report with the amount of compound in solution.

"2 arm" refers to either two different routes of administration or 2 different doses of the same compound.
5 compounds refers to 5 different compounds.
N=3 refers to three different biological replicates per timepoint. (IE, inject 3 different mice, and withdraw the blood from each of the 3 different mice)

The protein plasma binding experiments are by equilibrium dialysis for a small molecule. 20 of these.
1. Have a compartment divided by a semipermeable membrane
2. Have plasma with proteins on one side, protein-free compartment on the other side
3. Add compound, allow to equilibrate
4. Measure by LC-MS the amount of compound in each compartment
5. Report results.

Level of Effort:
1 Biologist, ~40 Hours

Government Responsibilities:
Government has the responsibility to send the compounds and review the data.

Delivery or Deliverables:
1 report, including the results of the assay and the procedure used.
Sub-reports may be required if compounds are not all submitted at once.

Reporting Requirements:
The contractor shall report results monthly via email.

Data Rights:
All data will be considered confidential and the property of the government.

Publications and Publicity:
Data will not be published without permission of the government.

Confidentiality of Information:
Data will 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:    
    

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 September 15, 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 (Jul 2021) 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 (Jul 2021) is applicable to this solicitation: See attachment

In addition, the following FAR provisions and clauses 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

 

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.

 

To request attachments for this requirement, please email Hashim.Dasti@nih.gov.