B_Sources Sought Notice.docx

Sources Sought notice # 75N95025Q00046

Title: Toxicology Consultant Support Services

This is a Small Business Sources Sought notice. THIS IS NOT A REQUEST FOR PROPOSALS, ABSTRACTS, OR QUOTATIONS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement.

The purpose of this notice is to obtain information regarding:

1. The availability and capability of qualified small business sources.

2. Whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and

3. Their size classification relative to the 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.

The applicable NAICS code for this acquisition is 541690 - Other Scientific and Technical Consulting Services. An organization that is not considered a small business under this NAICS code should not submit a response to this notice.

PROJECT REQUIREMENTS

The National Institute of Neurological Disorders and Stroke (NINDS) is seeking executive (senior scientific)-level, industry-experienced drug discovery and development consultants with expertise in Toxicology to provide technical guidance to the following programs:

The NIH Blueprint for Neuroscience Research, a consortium of 8 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services can be provided without cost to the PI through NIH contracts.

The purpose of this requirement is to procure subject matter expert (SME) consultant services to provide technical recommendations and advice to the NIH Blueprint Neurotherapeutics Network.

The SMEs will provide Toxicology consulting services related to candidate small molecule and biologics therapeutics development. The NINDS anticipates that this acquisition will result in one (1) solicitation for an anticipated award of 1-2 Purchase Orders.

Toxicology consultants will be expected to provide executive (senior scientific)-level Toxicology expertise and contribute feedback and guidance on projects to the NIH and to LDT members. The role of the Toxicology consultant may include but is not limited to the following responsibilities and tasks:

Education and work experience requirements

technical difficulties, and making strategic decisions that make wise use of limited resources (including terminating projects that appear unlikely to succeed).

Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc.

All capability statements must provide the following: 1) company name, address and UEI number; 2) point of contact, 3) phone/email; 4) NAICS Codes; 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type of small business your organization classifies itself as.

Electronic capability statements will be accepted by the primary point of contact at polina.klimenkova@nih.gov in the form of a single PDF file with the subject line: “Capability Statement 75N95025Q00046” NO LATER THAN December 3rd, 2024 at 12:00 PM EST.

THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not obligate the Government to award a contract or otherwise pay for the information provided in this response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. 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). 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 synopsis and solicitation may be published in SAM. However, responses to this notice will not be considered adequate responses to the subsequent solicitation.