HHS-NIH-NCI-SBSS-TSB-00305-55.pdf

Small Business Sources Sought Notice

Preclinical Toxicology of Small Molecule Drugs Developed for Cancer and Other Indications

HHS-NIH-NCI-SBSS-TSB-00305-55

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 requirements of this project; failure to do so will be at your firm’s own risk.

Background:

The Toxicology and Pharmacology Branch (TPB) of the Developmental Therapeutics Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is the focus for obtaining and evaluating preclinical toxicology and pharmacology data on anti-cancer drugs and biologicals that have been approved for NCI discovery and development. The ultimate goal is to identify and characterize the toxicologic profile and pharmacokinetic properties of potential drug candidates and to support an Investigational New Agent Application (IND) or a Drug Master File (DMF) with the USFDA.

The objective of the “Preclinical Toxicology of Small Molecule Drugs Developed for Cancer And Other Indications” contract will be to conduct toxicology studies that will be used in the preclinical development of drugs for patients with cancer and other diseases.

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:

The overall requirements and objective of the current acquisition, designated as the Preclinical Toxicology Of Small Molecule Drugs Developed For Cancer And Other Indications, encompasses four main toxicology study areas: (1) analytical; (2) pharmacokinetic; (3) exploratory or dose range-finding toxicology; and (4) IND-directed toxicology, as described in detail in the attached draft Statement of Work. The key objective of the Preclinical Toxicology of Small Molecule Drugs Developed for Cancer and Other Indications contract is to conduct toxicology studies that will be used in the preclinical development of small drugs for patients with cancer and other diseases. These toxicology studies are an integral part of the information supplied to the FDA for an Investigational New Drug (IND) application.

Please reference the attached, draft Statement of Work (SOW) for specifics.

Anticipated Period of Performance:

It is anticipated that the award from this solicitation will be a cost-reimbursement contract. The duration of the contract will be a one-year base period, with six subsequent one-year option periods, for a total period of performance of seven years. The anticipated start date is on or about July 1, 2021.

If an RFP is issued, the NCI anticipates that one award 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 541714, Research & Development (R&D) in Biotechnology (except Nanobiotechnology), 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 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 respondents current capability and capacity to:

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

Technical Approach and Awareness;

2) Provide appropriate Personnel for the project;

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

4) Organizational Experience

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 Randall Tiqui, Contracting Officer at randall.tiqui@nih.gov in Microsoft Word or Adobe Portable Document Format (PDF). The subject line must specify HHS-NIH-NCI-SBSS-TSB-00305-55. 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 Prevailing Time) on Tuesday, April 21, 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.

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).

mailto:randall.tiqui@nih.gov