Key Dates

Related Announcements

• December 1, 2023 - NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44-Clinical Trial Required). See NOFO PAR-24-066

Issued by

National Eye Institute (NEI)

Purpose

The purpose of this notice is to correct the open date, first application due date, Letter of Intent due date, Application and Submission Information, and Award Administration Information for PAR-24-066 NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44-Clinical Trial Required).  Changes to the NOFO are shown in Italics below.

Currently Reads:

Part 1. Overview Information

Key Dates

     Posted Date

     December 01, 2023

     Open Date (Earliest Submission Date)

     November 30, 2023

L   Letter of Intent Due Date(s)

May 27, 2026

Modified to read:

 Key Dates

    Posted Date

    December 01, 2023

    Open Date (Earliest Submission Date)

    December 1, 2023

 Letter of Intent Due Date(s)

March 8, 2024
 

Section IV. Application and Submission Information

2. Content and Form of Application Submission

SF424(R&R) Other Project Information

Currently reads:

 Data Management, Quality Assurance and Monitoring Plans (required)

This document must provide details of data management, quality assurance and monitoring plans. The description must include but is not limited to the following: methods of data entry, management procedures and systems; data coordination; data storage and security; personnel training and certification procedures; plans for handling deficiencies; participant safety monitoring including activities of the data and safety monitoring committee; appropriate oversight over the conduct of the trial including at a minimum the appropriate clinical monitoring independent of the study team, safety monitoring, regulatory submissions and compliance and quality management; policies and methods for ensuring masking of study results; data confidentiality and participant privacy; preparation of study reports and meeting minutes; other data quality control and monitoring; and, the process for locking the final dataset and sharing.

The filename "DataManagement.pdf" must be used and will be reflected in the final image bookmarking for easy access to reviewers. This attachment must not duplicate information already addressed in “MOP.pdf” attachment. In addition to this "Data Management, Quality Assurance and Monitoring Plans (required)" section, a Data Management and Sharing Plan (DMS Plan) in the Other Plan(s) section must be included to comply with the NIH DMS Plan policy. Two plans must be independent from each other and each plan should be complete on its own. Thus, ovelaps are allowed and details in the two plans must be consistent with each other".

Modified to Read:

Data Management, Quality Assurance and Monitoring Plans (required)

This document must provide details of data management, quality assurance and monitoring plans. The description must include but is not limited to the following: methods of data entry, management procedures and systems; data coordination; data storage and security; personnel training and certification procedures; plans for handling deficiencies; participant safety monitoring including activities of the data and safety monitoring committee; appropriate oversight over the conduct of the trial including at a minimum the appropriate clinical monitoring independent of the study team, safety monitoring, regulatory submissions and compliance and quality management; policies and methods for ensuring masking of study results; data confidentiality and participant privacy; preparation of study reports and meeting minutes; other data quality control and monitoring; and, the process for locking the final dataset and sharing results.

The filename "DataManagement.pdf" must be used and will be reflected in the final image bookmarking for easy access to reviewers. This attachment must not duplicate information already addressed in “MOP.pdf” attachment. In addition to this "Data Management, Quality Assurance and Monitoring Plans (required)" section, a Data Management and Sharing Plan (DMS Plan) in the Other Plan(s) section must be included in compliance with the NIH DMS Policy. Each plan should be complete on its own, with (1) the DMS Plan addressing data management and sharing activities for scientific data generated under this NOFO; and (2) the Data Management, Quality Assurance and Monitoring Plans addressing the sharing of clinical results.

Section IV. Application and Submission Information

Content and Form of Application Submission PHS 398 Research Plan

Currently Reads:

Resource Sharing Plans:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply: 

Modified to Read:

Resource Sharing Plans:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Section VI. Award Administration Information

2. Administrative and National Policy Requirements

Cooperative Agreement Terms and Conditions of Award

Currently Reads:

The PD(s)/PI(s) will have the primary responsibility for:

• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
• Defining objectives and approaches, and planning, conducting, analyzing, interpreting, drawing conclusions from and publishing trial results. The design, methods, and procedures of the clinical trial will be detailed in a recipient-prepared and maintained, study-adopted Manual(s) of Procedures and the recipients will have the responsibility for following the protocol
• Ensuring that study progress, quality and safety reports are prepared and distributed as requested by the medical monitor or Data and Safety Monitoring Committee (DSMC). Ensuring that there is formal documentation of all medical monitor safety reviews, or DSMC deliberations, as applicable. This documentation will clearly list all recommendations and explicit action items and will be reviewed and approved by the medical monitor or quorum of DSMC members as applicable. It is the responsibility of the PD/PI to ensure that their responses to safety or oversight monitoring recommendations or action items are formally reviewed and approved by the medical monitor or quorum of the DSMC. The PD/PI is responsible for ensuring that there is proper administration of applicable medical monitoring and/or management of the Committee. The PD/PI must give all medical monitors or DSMC members the name and contact information of the responsible NEI program director and advise them to contact the NEI program director directly with any concerns about the adequacy of trial safety or study implementation, as applicable. In addition, the trial PD/PI must officially notify the NEI program director within 24 hours whenever the medical monitor or DSMC makes a recommendation to substantively modify or stop the study.
• Ensuring that the NEI and the medical monitor or DSMC receives study progress and safety reports as requested.
• Ensuring that the DSMC receives a copy of the study’s primary manuscript(s) for review and approval in advance of journal submission.
• Implementing DSMC recommendations -Timely implementation of substantive DSMC recommendations is expected.
• Notifying the NEI program director within 24 hours of any FDA regulatory actions including: clinical hold; requests for modification; or termination for trials requiring regulatory approval.
• Reporting details of the safety monitoring process in the grant’s annual non-competing renewal (also called RPPR). Specifically, the renewal must note: 1) actual dates for all medical monitor or DSMC meetings as applicable; 2) verification that monitoring minutes have been reviewed and approved by the medical monitor, or quorum of DSMC and, 3) an update on the status of monitoring and general medical monitor or DSMC action items. Note: status reports must not contain any confidential study data or patient information. NEI guidelines for Data and Safety Monitoring of Clinical Trials can be found at: https://www.nei.nih.gov/grants-and-training/policies-and-procedures/guidelines-data-and-safety-monitoring-clinical-trials
• Documenting progress toward the stated study timeline and milestones as specified in the grant application and/or as modified during pre- or post-award negotiations. Specifically, the annual non-competing renewal must include but not be limited to: 1) actual dates of regulatory approvals if applicable; 2) date of enrollment of 1st study participant; 3) date of ClinicalTrials.gov registration, if applicable; 4) enrollment completion date; 5) date of completion of participant follow-up; 6) date of ClinicalTrials.gov results reporting, and, 7) date of initiation of data sharing.
• Reporting on compliance with NIH policies related to the study. Specifically, for clinical trials, the RPPR must note the status of or compliance with 1) registration on ClinicalTrials.gov (i.e., by providing the clinicaltrials.gov identifier); 2) submission of summary results information on clinicaltrials.gov; 3) Relevant NIH trainings (e.g., GCP, human protection, etc.) for applicable study personnel; 4) data sharing; and 5) public access.

The PD/PI is responsible for the overall conduct of the clinical trial and for providing scientific, technical, and administrative leadership to the study. They will have lead responsibility for planning and directing all phases of the study and for using the study's resources. The PD/PI is usually the individual who developed the idea for the clinical trial and is the leader in preparing the Manual of Procedures and organizing the study components.

"PD/PI are expected to publish and publicly disseminate results, data, and other products of the study, concordant with governance policies and protocols and according to NIH DMS Plan policy: the official link should be attached".

Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NEI/NIH. The PD/PI must ensure that trial publications are entered in Clinicaltrials.gov by including the registered ClinicalTrial.gov “NCT number” to all trial publications.

Support or other involvement of industry or any other third party in the study may be advantageous and appropriate. Participation by the third party; involvement of study resources, citing the name of the study or NEI support, or special access to study results, data, findings or resources requires notification and concurrence by the NEI. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by the NEI.

As applicable, any therapeutic agent manufactured using NEI grant support is reserved for either 1) the sole use of treating participants enrolled in the NEI supported trial or 2) laboratory work attending: study product manufacture, repackaging and distribution; quality assurance (i.e. identity, potency, or other aspects of product integrity); and participant safety. Any alternative use of study product requires the express approval of the NEI.

The recipient institution will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Modified to read:

The PD(s)/PI(s) will have the primary responsibility for:

• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
• Defining objectives and approaches, and planning, conducting, analyzing, interpreting, drawing conclusions from and publishing trial results. The design, methods, and procedures of the clinical trial will be detailed in a recipient-prepared and maintained, study-adopted Manual(s) of Procedures and the recipients will have the responsibility for following the protocol
• Ensuring that study progress, quality and safety reports are prepared and distributed as requested by the medical monitor or Data and Safety Monitoring Committee (DSMC). Ensuring that there is formal documentation of all medical monitor safety reviews, or DSMC deliberations, as applicable. This documentation will clearly list all recommendations and explicit action items and will be reviewed and approved by the medical monitor or quorum of DSMC members as applicable. It is the responsibility of the PD/PI to ensure that their responses to safety or oversight monitoring recommendations or action items are formally reviewed and approved by the medical monitor or quorum of the DSMC. The PD/PI is responsible for ensuring that there is proper administration of applicable medical monitoring and/or management of the Committee. The PD/PI must give all medical monitors or DSMC members the name and contact information of the responsible NEI program director and advise them to contact the NEI program director directly with any concerns about the adequacy of trial safety or study implementation, as applicable. In addition, the trial PD/PI must officially notify the NEI program director within 24 hours whenever the medical monitor or DSMC makes a recommendation to substantively modify or stop the study.
• Ensuring that the NEI and the medical monitor or DSMC receives study progress and safety reports as requested.
• Ensuring that the DSMC receives a copy of the study’s primary manuscript(s) for review and approval in advance of journal submission.
• Implementing DSMC recommendations -Timely implementation of substantive DSMC recommendations is expected.
• Notifying the NEI program director within 24 hours of any FDA regulatory actions including: clinical hold; requests for modification; or termination for trials requiring regulatory approval.
• Reporting details of the safety monitoring process in the grant’s annual non-competing renewal (also called RPPR). Specifically, the renewal must note: 1) actual dates for all medical monitor or DSMC meetings as applicable; 2) verification that monitoring minutes have been reviewed and approved by the medical monitor, or quorum of DSMC and, 3) an update on the status of monitoring and general medical monitor or DSMC action items. Note: status reports must not contain any confidential study data or patient information. NEI guidelines for Data and Safety Monitoring of Clinical Trials can be found at: https://www.nei.nih.gov/grants-and-training/policies-and-procedures/guidelines-data-and-safety-monitoring-clinical-trials
• Documenting progress toward the stated study timeline and milestones as specified in the grant application and/or as modified during pre- or post-award negotiations. Specifically, the annual non-competing renewal must include but not be limited to: 1) actual dates of regulatory approvals if applicable; 2) date of enrollment of 1st study participant; 3) date of ClinicalTrials.gov registration, if applicable; 4) enrollment completion date; 5) date of completion of participant follow-up; 6) date of ClinicalTrials.gov results reporting, and, 7) date of initiation of data sharing.
• Reporting on compliance with NIH policies related to the study. Specifically, for clinical trials, the RPPR must note the status of or compliance with 1) registration on ClinicalTrials.gov (i.e., by providing the clinicaltrials.gov identifier); 2) submission of summary results information on clinicaltrials.gov; 3) Relevant NIH trainings (e.g., GCP, human protection, etc.) for applicable study personnel; 4) data sharing; and 5) public access.

The PD/PI is responsible for the overall conduct of the clinical trial and for providing scientific, technical, and administrative leadership to the study. They will have lead responsibility for planning and directing all phases of the study and for using the study's resources. The PD/PI is usually the individual who developed the idea for the clinical trial and is the leader in preparing the Manual of Procedures and organizing the study components.

"PD/PI are expected to publish and publicly disseminate results, data, and other products of the study, concordant with governance policies and protocols (including the NIH DMS Policy) and consistent with any approved DMS Plan if awarded."

Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NEI/NIH. The PD/PI must ensure that trial publications are entered in Clinicaltrials.gov by including the registered ClinicalTrial.gov “NCT number” to all trial publications.

Support or other involvement of industry or any other third party in the study may be advantageous and appropriate. Participation by the third party; involvement of study resources, citing the name of the study or NEI support, or special access to study results, data, findings or resources requires notification and concurrence by the NEI. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by the NEI.

As applicable, any therapeutic agent manufactured using NEI grant support is reserved for either 1) the sole use of treating participants enrolled in the NEI supported trial or 2) laboratory work attending: study product manufacture, repackaging and distribution; quality assurance (i.e. identity, potency, or other aspects of product integrity); and participant safety. Any alternative use of study product requires the express approval of the NEI.

The recipient institution will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

All other aspects of this NOFO remain unchanged.

Inquiries

Please direct all inquiries to:

Paek Lee, PhD
National Eye Institute (NEI)
Telephone: 301-435-8164 
Email: paek.lee@nih.gov

Tony Gover, PhD
National Eye Institute (NEI)
Telephone: 301-529-7370 
Email: tony.gover@nih.gov