Draft Guidance for Industry; Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996; Extension of Comment Period

Streszczenie

The Food and Drug Administration (FDA) is extending to November 24, 1998, the comment period for the draft guidance document that appeared in the Federal Register of June 12, 1998 (63 FR 32219). The draft guidance document addressed issues concerning the exportation of human drugs, animal drugs, biologics, food additives, and devices under the FDA Export Reform and Enhancement Act, as well as the importation of components, parts, accessories, or other articles for incorporation or further processing into articles intended for export. This action is being taken in response to a request from the Health Industry Manufacturers Association.