; (B) does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a reasonable or short period of time; and (C) does not include interruptions in manufacturing of components or raw materials so long as such interruptions do not result in a shortage of finished product and the manufacturer expects to resume operations in a reasonable or short period of time. (3) Shortage The term shortage , with respect to a device, means a period of time when the demand or projected demand for the device within the United States exceeds the supply of the device. . 4132. GAO report on intra-agency coordination (a) In general Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report examining the Food and Drug Administration's intra-agency coordination, communication, and decision-making in assessing device shortages and risks associated with the supply of devices, and any efforts by the Food and Drug Administration to mitigate any device shortages or to take corrective actions. (b) Content The report shall include— (1) consideration of— (A) risks of creating, worsening, or extending a shortage of a device associated with violations of current good manufacturing practices; (B) corrective and preventative actions with respect to such violations requested by the Food and Drug Administration; (C) the effects of potential manufacturing disruptions or shut-downs on potential device shortages, which may include the discontinuance of device manufacturing and marketing, or the manufacturing of device components or parts