Notice of Change to PAR-18-952 Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R03 Clinical Trial Not Allowed)

Notice Number: NOT-TR-19-011

Key Dates
Release Date: October 29, 2018

Related Announcements
PAR-18-952

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

This Notice amends PAR-18-952 "Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R03 Clinical Trial Not Allowed)" with updates to the Funding Opportunity Description, Eligibility Information, and Application and Submission Information.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Currently Reads:

No studies aimed at determining the safety, pharmacokinetics, efficacy, or effectiveness of an intervention (drug, biologic, device, etc.) will be supported through this mechanism.

Revised to Read:

No studies aimed at determining the safety, pharmacokinetics, efficacy, or effectiveness of an intervention (drug, biologic, device, etc.) in humans will be supported through this mechanism.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Currently Reads:

Governments
State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government - Including the NIH Intramural Program
U.S. Territory or Possession

Revised to Read:

Governments
State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession

Currently Reads:

Section IV. Application and Submission Information

7. Other Submission Requirements and Information

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

Revised to Read:

Section IV. Application and Submission Information

7. Other Submission Requirements and Information

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to: