FedBizOpps SSSN HHS_NIH_NCI_SBSS_TSB_30520-94.pdf

Small Business Sources Sought Notice

Title: Preclinical Pharmacokinetic and Pharmacology Evaluations of Agents Being Developed for Cancer Patients

Notice No. HHS-NIH-NCI-SBSS-TSB-30520-94

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether there are small businesses;

HUBZone small businesses; service-disabled sources, veteran-owned small businesses; 8(a) small businesses; veteran owned small businesses; woman-owned small businesses; or small disadvantaged business; and (3) their size classification relative to North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

A determination by the Government not to compete this requirement as a set-aside based upon responses to this notice is solely within the discretion of the Government.

Interested parties are expected to review this notice and the draft Statement of Work (SOW) to familiarize themselves with the requirement of this project; failure to do so will be at your firm’s own risk.

Background:

The central mission of the NCI Experimental Therapeutics (NExT) Program is the discovery and development of agents with clinical anticancer activity. Pharmacokinetic and metabolism evaluations are an integral part of the drug development process from discovery to clinical trials. Characterization of the pharmacokinetics of new compounds provides critical information for the selection of optimal drug development candidates and design and interpretation of preclinical efficacy evaluations. NExT represents a significant expansion and reinvigoration of NCI drug discovery and developmental efforts.

Purpose:

The purpose of this Small Business Sources Sought Notice is to identify qualified small business concerns including HUBZone small businesses; service disabled, veteran-owned small businesses; 8(a) small businesses; women-owned small businesses; or small disadvantaged businesses that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information received.

As a result of this SBSS notice, the NCI may issue a Request for Proposal (RFP). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claim against the NCI shall arise as a result of a response to this Small Business Sources Sought Notice or the NCI’s use of such information as either part of our evaluation process or in developing specification for any subsequent requirement.

Project Requirements & Objectives:

NCI is seeking services for implementation of bioanalytical methods and conduct of pharmacokinetic evaluations in animals with compounds of interest to the NCI Experimental Therapeutics (NExT) program. Analysis of samples provided by the NCI from other sources, including human clinical trials, may be requested. Please reference the attached, draft Statement of Work (SOW) for specifics.

The purpose of this acquisition is to obtain analytical, pharmacokinetic, metabolism, pharmacodynamic, and other pharmacologic data on new agents (including small molecules, peptides, oligonucleotides, and other biologicals) for the treatment of cancer. Awardees will implement and validate appropriate established analytical methodologies to quantify compounds in biological fluids and tissues from multiple species and rapid pharmacokinetic assessments to the NCI. Data generated will be used in all phases of the drug development process, from lead selection and development to the support of early clinical trials. For those agents that are selected for clinical trial, the reports generated under these contracts will comprise a portion of the Investigational New Drug (IND) submission to the Food and Drug Administration (FDA).

Anticipated Period of Performance:

It is anticipated that the award(s) from this solicitation will be an Indefinite Delivery/Indefinite Quantity (IDIQ) contract. Task orders issued under this IDIQ contract are anticipated to be Cost Reimbursement (CR) and/or Firm Fixed Price (FFP). The duration of the IDIQ contract(s) will be for a seven (7) year period. The anticipated start date is on or about July 1, 2021.

If an RFP is issued, the NCI anticipates that up to three (3) IDIQ awards may result from the issuance of the RFP.

NAICS Code and Size Standard:

In the event an RFP is issued, the NAICS code for this acquisition is 541715, Research & Development (R&D) in the Physical, Engineering, and Life Sciences, which has a size standard of 1,000 employees.

Capability Statement/Information Sought:

Sources are expected to furnish the necessary services, qualified personnel, materials, facilities, equipment and experience to meet the requirements in the attached, draft SOW. Respondents must be qualified and prepare a tailored capability statement that demonstrates a clear understanding of all Task Areas outlined in the attached, draft Statement of Work.

To determine qualifications, the Capability Statement will be evaluated based on the information provided in relation to the project requirements and the respondent’s current capability and capacity to:

1) Perform the work outlined in the Task Area(s) in the attached, draft Statement of Work;

2) Provide appropriate Personnel for the project;

3) Access appropriate resources (e.g., Facilities & Equipment); and

4) Implement appropriate Quality Management programs.

Information Submission Instructions:

1. Page Limitations: Interested, qualified small business organizations should submit a tailored capability statement for this requirement not to exceed twenty (20) single-sided pages excluding all attachments, resumes, charts, and other relevant supporting documentation (single spaced, 12 point font minimum) that clearly details the firm’s ability to perform the aspects of the notice described above and in the draft SOW. Tailored capability statements should also include an indication of current certified small business status. This indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern’s name and address) as well as the eligible small business concern’s name, point of contact, address and DUNS number. All pages must be numbered including attachments, resumes, charts, etc.

2. Delivery Point:

All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to Alexis Hudak, Contracting Officer at alexis.hudak@nih.gov in Microsoft Word or Adobe Portable Document Format (PDF). The subject line must specify HHS-NIH-NCI-SBSS-TSB-30520-94. Facsimile responses will not be accepted.

3. Common Cut-Off Date:

Electronically submitted tailored capability statements are due no later than 2:00 PM (Eastern Time) on Tuesday, April 7, 2020. CAPABILITY STATEMENTS RECEIVED AFTER THIS

DATE AND TIME WILL NOT BE CONSIDERED.

DISCLAIMER AND IMPORTANT NOTES: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate.

Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

After a review of the responses received, a pre-solicitation notice may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

mailto:alexis.hudak@nih.gov

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).