Problem: As an IND holder a sponsor must submit a IND annual report within 60 days of the anniversary data of when the IND went into effect. You as a project manager is a project manager for product A that is in late stage of phase 3 development. Due to busy schedule you forgot to submit an IND annual report to the FDA as per 21 CFR Part 312.33 regulation. After 60 days of anniversary passed, you received a clinical hold letter from the FDA by not obligating the rule under IND. You received an escalation email from the CEO of your company to take immediate action to handle this situation.