NOT-OD-18-106: Reminder: Policy on Funding Opportunity Announcements (FOA) for Clinical Trials Takes Effect January 25, 2018

Reminder: Policy on Funding Opportunity Announcements (FOA) for Clinical Trials Takes Effect January 25, 2018

Notice Number: NOT-OD-18-106

Key Dates
Release Date: November 30, 2017

Related Announcements
NOT-OD-18-010
NOT-OD-18-001
NOT-OD-17-043
NOT-OD-16-147
NOT-DA-23-033

Issued by
National Institutes of Health (NIH)

Purpose

This notice reminds the community that, effective for due dates on or after January 25, 2018, NIH will require all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed and designated for clinical trials. This policy improves our ability to identify proposed clinical trials, ensure that key pieces of trial-specific information are submitted with each application, and uniformly apply trial-specific review criteria.

Implementation Update

Included a clinical trial allowability indicator in Section II. Award Information? of all FOAs
Specified the allowability of clinical trials in the title and included clinical trial specific review criteria in clinical trial FOAs
Provided guidance on special considerations for Career Development, Fellowship, Training, and Research Education Programs in NOT-OD-18-001.

Parent Announcements

All current (FORMS-D) Parent Announcements will be reissued with updated application forms (FORMS-E). Many activity codes will have two Parent Announcements - one designated as "Clinical Trial Not Allowed" and another as "Clinical Trial Required".

This table indicates our target posting/reissue date for parent announcements and identifies the activity codes which will have a "Clinical Trial Required" parent announcement option.

Activity Code	Clinical Trial Not Allowed Parent	Clinical Trial Required Parent
F30	February 8, 2018	N/A - NOT-OD-18-001
F31	February 8, 2018	N/A - NOT-OD-18-001
F32	February 8, 2018	N/A - NOT-OD-18-001
F33	February 8, 2018	N/A - NOT-OD-18-001
K01	PA-18-369	PA-18-363
K02	PA-18-371	PA-18-370
K08	PA-18-373	PA-18-372
K23	PA-18-375	PA-18-374
K24	PA-18-394	PA-18-393
K25	PA-18-396	PA-18-395
K99/R00	December 12, 2017	December 12, 2017
R01	December 5, 2017	Available - PA-18-345
R03	December 16, 2017	N/A
R13	February 12, 2018	N/A
R15	December 22, 2017	N/A
R21	December 16, 2017	Available - PA-18-344
R41/R42	January 19, 2018	January 19, 2018
R43/R44	January 19, 2018	January 19, 2018
T32	PA-18-403	N/A - NOT-OD-18-001
T35	PA-18-404	N/A - NOT-OD-18-001

Important notes for "Clinical Trial Required" parent FOAs

The participating organizations may vary between the "Clinical Trial Not Allowed" Parent FOA and the "Clinical Trial Required" Parent FOA for the same activity code. Read the details of each FOA carefully.
Some institutes that participate on a "Clinical Trial Required" parent may limit their participation to mechanistic studies. Check the Related Notices section of the FOA for any restrictions.

Inquiries

Please direct all inquiries to:

NIH Grants Information
grantsinfo@od.nih.gov (preferred method of contact)
Telephone: 301-945-7573