A checklist and timeline to assist counsel in determining the scope of 35 U.S.C. § 271(e)(1)'s safe harbor, which was created by the Hatch-Waxman Act and exempts from infringement certain activities related to the submission of information under Federal law to gain approval to commercially market drugs and certain products. The checklist provides an overview of the safe harbor's scope and the linked timeline identifies activities courts have found to fall within, and not within, the safe harbor.