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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.&nb