21 CFR 1316.42 - Definitions

Cite as21 CFR 1316.42
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3 practice notes
  • Edge Pharmacy; Decision and Order
    • United States
    • Federal Register October 19, 2016
    • October 19, 2016
    ...in support of the proposed revocation. In Respondent's view, the Government is simply a ``person'' under the Agency's regulation (21 CFR 1316.42(e)) entitled to a hearing or to participate in a hearing, or to submit a written statement of position. Respondent argues that ``a hearing may onl......
  • Trinity Pharmacy II; Decision and Order
    • United States
    • Federal Register February 20, 2018
    • February 20, 2018
    ...should receive. \52\ ``The term presiding officer means an administrative law judge qualified and appointed as provided in the'' APA. 21 CFR 1316.42(f) (citing 5 U.S.C. 556). The APA, in turn, characterizes an ALJ as a ``presiding or participating employee'' of the Agency. 5 U.S.C. 556(b). ......
  • Richard J. Settles, D.O.; Decision and Order
    • United States
    • Federal Register September 21, 2016
    • September 21, 2016
    ...Once again, Respondent is mistaken. Notwithstanding that an agency regulation applicable to hearings (21 CFR 1316.42(e)) defines the ``the term person to include an individual, corporation, government or governmental subdivision or agency,'' when the Government initiates an Order to Show Ca......

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