Notice Number: NOT-DK-18-010
Key Dates
Release Date: February 5, 2018
PAR-18-108
Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Purpose
The purpose of the Notice is to make changes to Section IV. Application and Submission Information within PAR-18-108, “NIDDK Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required)” to update the resources for clinical protocol development; to add where correspondence with the Food and Drug Administration (FDA) should be included in the application; and to indicate that the Complete Clinical Trial Protocol is no longer a permitted Appendix item.
Section IV. Application and Submission Information, 2. Content and Form of Application Submission, PHS 398 Research Plan, Research Strategy, Clinical Protocol Synopsis is being updated to correct a hyperlink to clinical trial protocol development resources.
Previously read:
Note: Discuss the following without duplicating information collected in the PHS Human Subjects and Clinical Trials Information Form.
Protocol Synopsis: For the proposed clinical trial, this section should include:
A summary of the study protocol’s objectives describing the scientific rationale and clinical need for the trial, the condition or focus of study, the trial’s potential impact, an assessment of the previous preclinical and clinical studies and their quality, including a discussion of information or data from preliminary studies that address the need for and feasibility of the proposed trial.
Applicants planning clinical trials that require investigational new drug (IND) or investigational device exemption (IDE) applications should provide elements that are consistent with the requirements of the Food and Drug Administration (FDA) IND or IDE. A proposed template for such studies can be found here http://osp.od.nih.gov/sites/default/files/Protocol_Template_05Feb2016_508.pdf
Now reads:
Note: Discuss the following without duplicating information collected in the PHS Human Subjects and Clinical Trials Information Form.
Protocol Synopsis: For the proposed clinical trial, this section should include:
A summary of the study protocol’s objectives describing the scientific rationale and clinical need for the trial, the condition or focus of study, the trial’s potential impact, an assessment of the previous preclinical and clinical studies and their quality, including a discussion of information or data from preliminary studies that address the need for and feasibility of the proposed trial.
Applicants planning clinical trials that require investigational new drug (IND) or investigational device exemption (IDE) applications should provide elements that are consistent with the requirements of the Food and Drug Administration (FDA) IND or IDE. Applicants may use the electronic protocol writing tool, which aims to facilitate the development of phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application: https://e-protocol.od.nih.gov/
Section IV. Application and Submission Information, 2. Content and Form of Application Submission, PHS Human Subjects and Clinical Trials Information, 5.1. Other Clinical Trial Related Attachments is being updated to include where information pertaining to correspondence with the FDA may be included in the application package:
5.1. Other Clinical Trial Related Attachments, the addition of item 5 below:
5. Regulatory Documents (Required for Phase IIB applications)
SBIR Phase IIB applicants are required to provide documentation that they have consulted formally with the FDA concerning the research needed for the development of a drug, biologic or medical device and that the proposed research will address these regulatory requirements. Such evidence should include FDA correspondence from a pre-IND meeting for an IND application or a pre-IDE meeting for an IDE application, and the status of the project in a timeline related to Federal regulatory approval processes.
Other applicants are not required to provide regulatory documents. However, when available, applicants should provide correspondence with the FDA documenting the status of a protocol submitted to the FDA, a "may proceed" email or letter from the FDA, or other determinations pertaining to the application by an IRB, the FDA or other cognizant agency.
Section IV. Application and Submission Information, 2. Content and Form of Application Submission, PHS 398 Research Plan, Appendix is being modified to indicate that The Complete Clinical Trial Protocol is no longer a permitted Appendix item.
Previously read:
Do not use the Appendix to circumvent page limits. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide.
Note that Phase I SBIR/STTR Appendix materials are not permitted.
The following additional document should be included in the Appendix as a single .pdf file:
- The Complete Clinical Trial Protocol (Required)
Now reads:
Do not use the Appendix to circumvent page limits. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide.
Note that Phase I SBIR/STTR Appendix materials are not permitted. Limited items are allowed in the Appendix of other small business applications. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide Instructions.
Note, the Protocol Synopsis, as part of the PHS Human Subjects and Clinical Trials Information Form, is required.
All other aspects of this Funding Opportunity Announcement remain the same.
Inquiries
Please direct all inquiries to:
Daniel Gossett, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7723
Email: daniel.gossett@nih.gov
and Human Services (HHS)
