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.
Background: Usher syndrome (USH) is the primary cause of genetic deafness and blindness, with type III being the rarest, comprising just 2-5% of all USH cases. USH3 patients typically have normal hearing and vision at birth, by age 30 to 50, most become legally blind and profoundly deaf. Hearing loss generally occurs before visual decline and while cochlear implants can mitigate deafness, there is currently no treatment or cure for USH3-related vision loss. BF844, a novel small molecule is a potential therapeutic for USH3 patients. BF844 administration attenuated progressive hearing loss and prevented deafness in these models, however, its effect on vision is unknown due to lack of appropriate animal models. Retinal organoids are an alternate approach and have been used to test different therapeutics in various studies (e.g. PMID: 40118996, PMID: 38323188). Retinal organoids with the visual phenotype of USH3 can be used to test the effect of BF844 on vision.
Purpose and Objectives: The scope of this contract involves producing USH3 retinal organoids followed by measuring the effect of BF844 drug.
Project requirements:
GENERAL REQUIREMENTS
1. Project Management
The Contractor shall provide project management for its own core team to ensure planning, execution, delivery of reports, and accurate and timely communication with the Contracting Officer’s Representative (COR), Contracting Officer (CO), and other stakeholders. The Contractor shall immediately (within 1 working day) contact the COR if there are any adverse results or difficulties with the study that would impact the project or timeline. The communications shall include proposed solutions. The Contractor shall immediately (within 1 working day) respond to any email communications sent by the Government and flagged as important.
The Contractor shall manage bi-weekly teleconference meetings to keep the COR and the project team apprised of project progress. At the discretion of the COR, the frequency or method of meetings may be changed. It is expected that during each task initiation and study protocol development, communication will be more frequent.
The Contractor shall communicate via e-mail when teleconferences are cancelled as agreed upon by the Government. The Contractor shall also manage ad hoc meetings as requested by COR, which shall be scheduled by the Contractor within 48 hours of request. The Contractor shall be responsible for setting up the meeting with technology that enables screen sharing (ex. MS Teams, etc.), including a call-in number and passcode for the relevant participants and be responsible for moderating and participating in the meeting.
The Contractor shall submit Pre-Meeting Status Updates/Agendas, and Post-Meeting Minutes, as described in Paragraphs E and F below. The Contractor shall provide any CRO Standard Operating Procedures, protocols, and methods within forty-eight (48) hours upon request as outlined in Paragraph F below. Status updates and progress of experiments including new preliminary data generated between meetings will be reviewed and discussed at each teleconference meeting.
2. Standard Operating Procedures
The Contractor shall follow all site-specific standard operating procedures (SOPs); or if a deviation from an SOP is required, notify the COR of the deviation and document as appropriate. At the request of the COR, the Contractor shall submit to the Government any SOPs, method descriptions, and references used in the implementation of studies. The Government will treat Contractor SOPs as confidential.
3. Record Retention
The Contractor shall provide all data, information, and records required for the writing and submission of Investigator’s Brochures and Investigational New Drug, New Drug, and Biologics License applications.
Upon study completion, the Government may require all study documentation to be placed in secure storage for a period of up to seven years. During this period, the Contractor shall be responsible for the integrity and organization of the material and its confidentiality. At the end of the period, all such documentation will be transferred or disposed of at the direction of the COR.
4. Government-Furnished Data
The Contractor will have access to any data available at NCATS or the NCATS partner related to each task order that the Government deems necessary to successfully perform under the task order. The Government will ensure all candidate therapeutics and any known safety data for storage and handling are supplied to the Contractor.
TECHNICAL REQUIREMENTS
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the tasks described below.
The Contractor shall be expected to perform the following tasks. All experiments must be performed with appropriate controls and results reported with statistical analyses. The Government will provide technical direction, and will closely monitor the characterization of iPSCs and organoids according to standard protocols.
Task A: Production of human iPSC (hiPSC) lines
The Contractor shall:
- Produce and characterize two patient-derived USH3 iPS and two control cell lines using standard protocols.
- Provide a complete study report for the work performed.
The Contractor shall not proceed to Task B (if exercised) without receiving prior concurrence from the Government.
Task B: Produce USH3 retinal organoids and measure drug effect
The Contractor shall:
- Produce and characterize USH3 and control retinal organoids from the cell lines generated in Task A using standard protocols.
- Measure the effect of the drug BF844 (provided by the Government) in USH3 and control retinal organoids by conducting standard molecular, biochemical and functional assays.
- Provide a complete study report for the work performed. The Government may direct the Contractor to combine data from both Tasks A and B into a single study report.
DELIVERABLES
Contractor shall prepare and submit the following deliverables in accordance with the below.
1. Pre-Meeting Status Report/Agenda
A Pre-meeting Status Report/Agena that documents the efforts performed in the completion of each task and highlights updates that occur between teleconference meetings. The Pre-meeting Status Reports shall include, at a minimum, the following information:
- Program status, to include objectives met, work completed, data generated, and outstanding work
- Notable achievements, and a review of data generated through visualization (ex. tables, graphs, images, figures, spreadsheets)
- Issues or obstacles impeding progress and recommended solutions
- Description of work completed and plans for next reporting period
- Agenda for corresponding team meeting
- Status of deliverables/milestones
- Issues and resolutions
- Resource planning/status
2. Post-Meeting Minutes and Materials
Post-Meeting Minutes and Materials, including action items, slide decks, summary data and follow up documents.
3. Draft Study Protocol
A Draft Study Protocol that contains critical aspects of the study to be discussed during the conference calls.
4. Final Study Protocol
A Final Study Protocol that incorporates the Government’s comments and any joint discussions from the Draft Study Protocol.
5. Draft Study Report
A Draft Study Report that includes, at a minimum, the following information:
i. Title page containing:
- Contract number, Task Order number
- Title of study, internal experiment ID, and test compound identifier
- Contractor’s name and address
- Start and end dates for the study
- Report date and date of submission
- Name of submitter and submitter email address
- Sponsor and organization name
- Sponsor Submitter Name and Sponsor Submitter email address
ii. Synopsis
iii. Introduction
iv. Study Objectives
v. Study Design (e.g. cell lines/model used, control and investigational products administered, dose levels, detailed procedures for product administration and collection of all study protocol parameters)
vi. Study Plan
vii. Test System
viii. Experimental procedures (including prospectively designed protocol and listing of all protocol amendments, if needed)
ix. Results (Complete data sets for all parameters evaluated, including individual data and tabulated/summary data and statistical analysis)
x. Conclusions
xi. References
xii. Appendices
xiii. Appropriate Tables, Figures
xiv. Abbreviations
xv. Copy of raw data as requested by COR
6. Final Study Report
A Final Study Report that incorporates the Government’s comments and any joint discussions from the Draft Study Report.
7. Transition Plan
A proposed Transition Plan for an orderly and complete transition/relocation of the task order resources to a successor Contractor or to the Government. The plan shall include details on the relocation/disposition of: unused materials and supplies; manuals and directories developed by the Contractor; and all other Government property not listed. The Transition Plan shall specify that all raw data will be transferred to the Government. The Transition Plan shall also specify that unused test agents will be returned to the submitter at the submitter’s expense or destroyed at the conclusion of the task order, as determined by the Government, and a cumulative list of test samples disposed and the method of disposition will be provided to the Government. Upon written direction by the Government, the Contractor shall transfer all Government property as directed, and shall fully cooperate with any successor Contractor and the Government to ensure an efficient transfer.
Anticipated period of performance: Vendors may propose the period of performance necessary to perform and complete these services.
Other important considerations: In case domestic sources are available and capable of fulfilling the Government’s need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25.
Capability statement /information sought.
Companies that believe they possess the capabilities to provide the required products or services 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.
One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing.
The information submitted must 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.
The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested.
All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted.
The response must be submitted to the Contract Specialist at e-mail address mark.mcnally@nih.gov.
The response must be received on or before 11:00 AM Eastern Time, July 7, 2025.
“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.
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).”
