Standard: HHS - 21 CFR PART 16

REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

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Scope:

The procedures in this part apply when:

(a) The Commissioner is considering any regulatory action, including a refusal to act, and concludes, as a matter of discretion, on the Commissioner’s initiative or at the suggestion of any person, to offer an opportunity for a regulatory hearing to obtain additional information before making a decision or taking action.

(b) The act or a regulation provides a person with an opportunity for a hearing on a regulatory action, including proposed action, and the act or a regulation either specifically provides an opportunity for a regulatory hearing under this part or provides an opportunity for a hearing for which no procedures are specified by regulation. Listed below are the statutory and regulatory provisions.

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 16
Publish Date: 2016-04-01
Page Count: 8
Change Type: COMPLETE REVISION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 16 Change Type: COMPLETE REVISION Update Date: 2015-04-01 Status: ACTV
21 CFR PART 16 Change Type: STCH Update Date: 2014-04-01 Status: INAC

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