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Do I have to approve the submission?

Yes. After initial submission, an email notification will be sent from the National Institute of Health Manuscript Submission System (NIHMS) to the Principal Investigator (PI) of the NIH grant. If the PI was not an author of the paper in question, the corresponding author will instead receive the notification. This ‘Reviewer’ will then need to approve both the initial PDF receipt of the submitted manuscript files, and the web version of the manuscript as it will eventually appear on PubMed Central (following the expiry of the embargo period).