All grants going into the NIH now have to have a mandated Foreign Justification (was there in the past but grants not withdrawn for this in the past). Now, the NIH is withdrawing applications that don’t have this document. If you are working on an application with foreign components, obtain this document from your PI and upload in Other Attachments. Please see page 63 of the link below for details on what is required in that document.
https://grants.nih.gov/grants/how-to-apply-application-guide/forms-i/general-forms-i.pdf
6. Does this project involve activities outside of the United States or partnerships with international collaborators?
This field is required.
Indicate whether this project involves activities outside of the United States or partnerships with international collaborators. Check “Yes” or “No.”
Applicants to NIH and other PHS agencies must check “Yes” if the applicant organization is a foreign organization or if the project includes a foreign component. See NIH Glossary for a definition of a foreign component.
If you have checked “Yes” to Question 6, you must include a “Foreign Justification” attachment in Field 12, Other Attachments. Describe special resources or characteristics of the research project (e.g., human subjects, animals, disease, equipment, and techniques), including the reasons why the facilities or other aspects of the proposed project are more appropriate than a domestic setting. In the body of the text, begin the section with a heading indicating “Foreign Justification” and name the file “Foreign Justification.”
6.a. If yes, identify countries:
This field is required if you answered “Yes” to Question 6. Enter the countries with which international cooperative activities are planned.
You may use abbreviations. Your entry is limited to 55 characters.
This is the linked definition of foreign component (https://grants.nih.gov/grants/glossary.htm#ForeignComponent):
The performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that would meet this definition include, but are not limited to, (1) the involvement of human subjects or animals,(2) extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities, or (3) any activity of the recipient that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country. Examples of other grant-related activities that may be significant are:
- collaborations with investigators at a foreign site anticipated to result in coauthorship;
- use of facilities or instrumentation at a foreign site; or
- receipt of financial support or resources from a foreign entity.
Foreign travel for consultation is not considered a foreign component. (See NIH Grants Policy Statement: 16 Grants to Foreign Organizations, International Organizations, and Domestic Grants with Foreign Components).