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U.S. Code of Federal Regula...
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Title 21-Food and Drugs
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CHAPTER I—FOOD AND DRUG ADM...
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PART 3—PRODUCT JURISDICTION
PART 3—PRODUCT JURISDICTION
§ 3.1 - Purpose.
§ 3.2 - Definitions.
§ 3.3 - Scope.
§ 3.4 - Designated agency component.
§ 3.5 - Procedures for identifying the designated agency component.
§ 3.6 - Product jurisdiction officer.
§ 3.7 - Request for designation.
§ 3.8 - Letter of designation.
§ 3.9 - Effect of letter of designation.
§ 3.10 - Stay of review time.