Notice Number: NOT-MH-14-003
Key Dates
Release Date: January 10, 2014
PAR-13-267
Issued by
National Institute of Mental Health (NIMH)
Purpose
The purpose of this Notice is to clarify the instructions posted under Section IV. Application and Submission Information in the Funding Opportunity Announcement (FOA) PAR-MH-13-267 “Novel NeuroAIDS Therapeutics: Integrated Preclinical/Clinical Program (P01)”. This notice modifies the language in two locations in the FOA to clarify the instructions for Clinical Research Projects.
1) In Section IV. Application and Submission Information, 2. Content and Form of Application Submission, Instructions for the Submission of Multi-Component Applications, Research Project:
The current instructions under the section Research & Related Other Project Information (Research Project) state:
“Other Attachments: Applications that include a clinical research project should include the following "Other Attachments" with the research project component in order to aid in the peer review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image. The Milestone Plan and Complete Clinical Protocol must be included as a single PDF attachment, not to exceed three pages, and loaded as a file titled, "Clinical Research Project".
Applications that propose a clinical research project yet lack a Milestone Plan and Complete Clinical Protocol document, will not be reviewed.
Applications that do not include the following details for clinical research projects will be considered incomplete:”
The language is modified to read:
“Other Attachments: Applications that include a clinical research project that is authorized by the FDA for IND status, "IND-ready", should include the following in order to aid in the peer review of applications. There should be a single PDF attachment which includes a Milestone Plan and a Complete Clinical Protocol, not to exceed three pages in total. The filename used will be bookmarked as such in the application image and should be titled "Clinical Research Project".
A Complete Clinical Protocol is not required for review for those applications that propose a clinical research project that has yet to be authorized by the FDA for IND status known as "IND-ready". However, the Milestone Plan is required and should be loaded as indicated in "Other Attachments" above with the exception that only 1 page is allowed.
Applications that do not include the following details for “IND-ready” clinical research projects will be considered incomplete and will be returned without review:”
2) In Section IV. Application and Submission Information, 2. Content and Form of Application Submission, Instructions for the Submission of Multi-Component Applications, Research Project, PHS398 Research Plan (Research Project):
The current instructions under the section Research Strategy state:
“Note: Applications that do not include a Milestone Plan and Complete Clinical Protocol, yet propose a clinical research project, will not be reviewed. It is recognized that while the details of the clinical study will change as a result of scientific progress and as a function of review by various institutional and governmental bodies, a Milestone Plan and Complete Clinical Protocol are required and should be loaded as a file as instructed in "Other Attachments" above.”
The language is modified to read:
All other aspects of the FOA instructions remain unchanged.“Note: Applications that do not include a Milestone Plan and Complete Clinical Protocol, yet propose an “IND-ready” clinical research project, will not be reviewed. The Milestone Plan and Complete Clinical Protocol for "IND-ready" clinical research projects should be included as a single pdf,not to exceed 3 pages, asinstructed in "Other Attachments" above.
For those applications that propose a clinical research project that is not "IND-ready", a Complete Clinical Protocol is not required for review. However, the Milestone Plan is required and should be included as a single PDF, not to exceed 1 page, as noted in "Other Attachments", above. Further, such applications should address the instructions provided in the Research Strategy section entitled, "Clinical Research Projects" including the Significance, Innovation, and Approach. Applications must include a brief description of the study in the Approach section, including elements such as study design, endpoints, rationale for the study population and length of study, statistical design and analysis, management and quality control of data, receipt and storage of human samples, proposed clinical sites and investigators.All NIH-required human subjects issues, including protection against research risks and gender, minority, and child representation must be addressed as described in the PHS 398 Research Plan Form of theapplication. A detailed clinical protocol is not required since it would be based on research results that cannot be anticipated at the time of submission.
Inquiries
Please direct all inquiries to:
Deborah Colosi, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-6100
Email: [email protected]
and Human Services (HHS)
