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Information Collections on Medical Devices, Petroleum Refineries Under Review

Monday, October 19, 2015
Sandler, Travis & Rosenberg Trade Report

Medical Devices. The Food and Drug Administration is accepting through Dec. 19 comments on the proposed extension of an information collection regarding administrative detention and banned medical devices.

FDA has the statutory authority to detain during established inspections devices that are believed to be adulterated or misbranded. Under FDA regulations on administrative detention, an applicant of a detention order must show documentation of ownership if devices are detained at a place other than that of the appellant. In addition, the owner or other responsible person must supply records about how the devices may have become adulterated or misbranded as well as records of distribution of the detained devices.

FDA also has the authority to ban devices that present substantial deception or an unreasonable and substantial risk of illness or injury. Under FDA regulations, a manufacturer, distributor or importer of a device may be required to submit all relevant and available data and information to enable the FDA to determine whether the device presents substantial deception, unreasonable and substantial risk of illness or injury, or unreasonable, direct and substantial danger to the health of individuals.

Petroleum Refineries. U.S. Customs and Border Protection is requesting through Dec. 19 comments on the proposed extension without change of an information collection concerning petroleum refineries in foreign-trade subzones. The Foreign Trade Zones Act permits refiners and CBP to assess the relative value of petroleum refinery products at the end of the manufacturing period when the actual quantities resulting from the refining process can be measured with certainty. CBP regulations require the operator of the refinery subzone to retain all records relating to such activities for five years after the merchandise is removed from the subzone. Further, the records must be readily available for CBP review at the subzone.

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