federal_register: 2016-29774

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2016-29774 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction Rule The Food and Drug Administration (FDA) is correcting a final rule entitled "Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs" that appeared in the Federal Register of August 31, 2016 (81 FR 60169). That final rule amended current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule was published with an incorrect statement in the preamble about the rule's effect on establishments at which investigational drugs are manufactured. This document corrects that error. 2016-12-13 2016 12 https://www.federalregister.gov/documents/2016/12/13/2016-29774/requirements-for-foreign-and-domestic-establishment-registration-and-listing-for-human-drugs https://www.govinfo.gov/content/pkg/FR-2016-12-13/pdf/2016-29774.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is correcting a final rule entitled "Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and...

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