SSN_75N95024Q00453.pdf

SOURCES SOUGHT NOTICE

1. Solicitation Number: 75N95024Q00453

2. Title: Research improved outcomes of clinical trials for substance use disorders.

3. Classification Code: AN26 - Drug Dependency (Management Support)

4. NAICS Code: 541690 - Other Scientific and Technical Consulting Services

5. Size Standard: $19 mil

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations.

The purpose of this notice is to obtain information regarding the availability and capability of qualified business sources; whether they are small businesses or other than small businesses.

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes.

No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.

This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes.

No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Small businesses are encouraged to respond.

Purpose and Objectives: The goal of this project is to research improved outcomes in clinical trials for substance use disorders (SUDs), including stimulant and opioid use disorders (StUD and OUD). Specifically, NIDA IRP aims to examine reduced use and improved function rather than total abstinence and to see whether such endpoints may improve the effect size of medications tested for StUd and OUD. This approach and the findings will provide novel and potentially impactful information for the field, which is consistent with the overall goal of our lab, and the NIDA IRP at large, to identify barriers and develop effective treatments for patients afflicted with SUD.

Project requirements:

The objective of the proposed project is to manage and analyze harmonized datasets of StUD and OUD clinical trials to examine novel and clinically relevant outcome measures.

Specifically, we aim to investigate whether changing the endpoint of clinical trials from total abstinence to reduced use may improve the effect size of some medications that have been tested in patients with SUDs. These findings will provide important information for the field and help design more efficient and clinically relevant trials in the future.

Contract staff will be responsible for pulling, organizing and cleaning the specific harmonized data. NIDA IRP will lead the development and submission of the manuscript after receiving a detailed description of the methods and results. The contractor will be completing data management and analysis for this project. We will regularly meet with the team to brainstorm about and outline the specifics of the project. The contract team will run the analyses and will provide a final report of the methods and results, which will only include aggregate data (no raw data or personally identifiable information).

Other important considerations:

The contract team will lead this project and will provide service in biostatistical and data analysis/management. The deliverables will be used by NIDA IRP to develop (in collaboration with the contract team) one or more peer-review publications to disseminate the findings to the scientific community.

Capability statement /information sought. Companies that believe they possess the capabilities to provide the required products should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately.

Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice.

However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number.

The information submitted may be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required.

All responses to this notice must be submitted electronically to the Contract Specialist.

Facsimile responses are NOT accepted. The response must be submitted to Polina Klimenkova Polina.Klimenkova@nih.gov.

The response must be received on or before July 24, 2024 at 12:00 PM, Eastern Time.

“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 presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

mailto:Polina.Klimenkova@nih.gov