NOTICE OF INTENT to Sole Source.pdf

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Neurogenomics for Autism
Solicitation number
NIMH25003022
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This is a Notice of Intent to Sole Source issued by the National Institute of Mental Health (NIMH) for Neurogenomics for Autism services. The solicitation (NIMH25003022) is for a non-competitive contract with Children's National at Walter Reed, LLC to provide specialized clinical services in autism spectrum disorders. The contract will be for one base year (9/30/2025 - 9/29/2026) with one option year, requiring approximately 19 hours per week (not to exceed 960 labor hours annually).

The specific requirements include assisting NIMH's Section on Developmental Neurogenomics (SDN) staff with preparing clinical patient reports, providing expert assessment services on neurocognitive data collection and analysis, utilizing gold standard autism diagnostic characterizations, attending weekly meetings, and conducting diagnostic and neuropsychological assessments both in-person and remotely. The government will provide workspace, diagnostic materials, and access to NIH facilities. The contract is classified under NAICS code 541990 with a size standard of $19.5M, and the government maintains sole rights to the generated data. Responses must be submitted electronically to the contract specialist by September 24, 2025.

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NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER: NIMH25003022

2. TITLE: Neurogenomics for Autism

3. CLASSIFICATION CODE:R499 – SCIENTIFIC CONSULTING SERVICES

4. NAICS CODE: 541990 All Other Professional, Scientific and Technical Services

5. RESPONSE DATE: September 24, 2025, at 12:00 PM EST

6. PRIMARY POINT OF CONTACT:

Joe Kennedy Joseph.kennedy@nih.gov Phone: 262-391-7630

7. DESCRIPTION:

INTRODUCTION

This is a notice of intent, not a request for a quotation.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT)

SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR

OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute of Mental Health (NIMH) intends to negotiate on a sole source basis with Children’s National, for one base year and one option year.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

and SET ASIDE STATUS The intended procurement is classified under NAICS code 541990 – All Other

Professional, Scientific and Technical Services with a Size Standard of $19.5M

This intended procurement will be a sole source.

REGULATORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization).

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) Number 2025-04, dated May 12, 2025.

DESCRIPTION OF REQUIREMENT

Purchase Description

The Section on Developmental Neurogenomics (SDN), Human Genetics Branch

(HGB), NIMH has a requirement for clinical services in autism spectrum disorders with the level of expertise necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). These services are needed to help further certain aspects of our existing research. The SDN has reached a crucial point in its research on autism spectrum disorders where the specialized service is critical in support of our research on youth with autism. Any break in support for this contract would directly harm clinical care for the children we see in our protocol, and result in a major loss of decades worth of research, investment and data.

Specific Requirements

The SDN, HGB, Division of Intramural Research Program (DIRP), National Institute of Mental Health (NIMH) has a research program that operates multi-faceted investigations of the brain through genomic, functional, and structural imaging, neurocognitive and diagnostic characterizations of youth with neurogenetic disorders. The contract requests specialist services on the validation of clinical assessment data collected by SDN staff and obtained based on our clinical and research diagnostic characterization of the participants in these studies who have an autism spectrum disorder. The contract also requires that the services be provided to SDN staff members regarding autism specific features as well as address staff inquiries which arise from their investigation in the development of neurocognitive paradigms to measure clinically relevant features in autism, along with how to appropriately collect and score cognitive data for phenotyping and hypothesis generation and the dissemination of our scientific findings.

Salient Characteristics:

1. Assist SDN staff with preparing written clinical patient reports describing diagnostic and neurocognitive findings;

2. Provide expert assessment services on neurocognitive data collection, data analysis, and dissemination of scientific findings both through publications and conference presentations;

3. Utilize expertise in the gold standard autism diagnostic characterizations during their meetings with SDN staff members;

4. Attend weekly meetings and advise SDN Post-baccalaureate IRTAs, Postdoctoral fellows and other SDN staff on clinical considerations for data collection and hypothesis generation when evaluating patients; and

5. Fulfill the above requirements, including diagnostic, cognitive, and neuropsychological assessments with research participants, both in-person and remotely using teleconference technology, such as Microsoft Teams (although another technology may also be used).

Delivery Date

N/A

Period of Performance

The proposed period of performance shall be one year.

Base: 9/30/2025 – 9/29/2026

OP1: 9/30/2026 – 9/29/2027

Level of Effort During the period of performance of one year from date of award, the contractor shall provide approximately nineteen (19) hours per week, not to exceed 960 labor hours per year.

Government Responsibilities

The government will provide workspace, desktop computers and telephones for the contractor’s personnel. The government will also provide diagnostic materials and kits for defining the presence of an autism diagnosis and other psychiatric disorders, as well as cognitive assessment materials. The government will allow the two (2) designated contractors to access NIH Building 10 laboratory and clinic facilities for them to consult with SDN staff.

Reporting Requirements Throughout the period of performance of this contract, the Contractors are required to provide weekly progress and/or updates to the government point of contact (Dr. Armin Raznahan). The Contractor(s) verbal and/or written reports on laboratory staff assessment results are also provided on a weekly basis to Dr.

Armin Raznahan and upon request by lab staff involved with this project.

OTHER CONSIDERARTIONS:

Data Rights

The government has the sole right regarding the use, production, and disclosure of the data generated.

Section 508—Electronic and Information Technology Standards

N/A

Confidentiality of Information:

The Contractor(s) will not disclose, publish, divulge, release, or make known, in any manner or to any extent, to any individual other than the authorized government employee, the content of any sensitive information provided under this contract. For this requirement, the government may provide the contractor(s) information or data of a personal nature about individual(s) or proprietary information or data pertaining to this project, which is confidential. This requirement is expected to generate information or data which is confidential. The Contractor(s) shall handle all sensitive information or data in a secure manner and consult with the authorized government employee prior to any release, disclosure, dissemination, or publication.

(INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted.

Specifically, Children’s National, is the only vendor in the marketplace that can provide the services required by the National Institute of Mental Health.

The intended source is:

Children’s National at Walter Reed, LLC 111 Michigan Ave, NW #5 Washington, DC 20010

The diagnostic services and project management assistance listed herein are available from only one source, and competition is precluded. There are no substitutes available.

CLOSING STATEMENT

THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purpose of determining whether to proceed on a non-competitive basis or to conduct competitive procurement.

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 Unique Entity ID

UEI), the Taxpayer Identification Number (TIN), and the certification of business size.

Responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIMH25003022.

Responses must be submitted electronically to Joe Kennedy, Contract Specialist, at joseph.kennedy@nih.gov

U.S. Mail and fax responses will not be accepted.

mailto:joseph.kennedy@nih.gov

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