Federal Register Notice: FDA is denying James A. Holland’s request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act debarring him for five years from providing services in any capacity to a person who has an approved or pending drug product application. Holland was convicted of a misdemeanor under federal law for conduct relating to the development or approval of a drug product. Holland has failed to file with the agency a genuine and substantial issue of fact sufficient to create a basis for a hearing on this action. To view this notice, click here.