21 CFR 1301.16 - Amendments to and withdrawal of applications

Cite as21 CFR 1301.16
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15 practice notes
  • Edge Pharmacy; Decision and Order
    • United States
    • Federal Register October 19, 2016
    • October 19, 2016
    ...must either show that ``good cause'' exists to allow it to withdraw its application or that ``withdrawal is in the public interest.'' 21 CFR 1301.16(a). Accordingly, my Office notified Respondent by email (which was copied to the Government) that for the matter to be dismissed, Respondent n......
  • Mikhayl Soliman, M.D.: Decision and Order
    • United States
    • Federal Register July 22, 2016
    • July 22, 2016
    ...Order, the undersigned counsel learned that the . . . Los Angeles Field Division . . . withdrew Applicant's application pursuant to 21 CFR 1301.16(b), which provides that `failure of the applicant to respond to official correspondence regarding the application, when sent by registered or ce......
  • 4 OTC, Inc.; Decision and Order
    • United States
    • Federal Register June 12, 2012
    • June 12, 2012
    ...Respondent was required to request permission to amend its application and withdraw three of its application. ALJ Exh. 17 at 3 (citing 21 CFR 1301.16(a)). The Deputy Assistant Administrator granted both requests on April 13, 2011. Id. at The hearing was held on January 19, 2011, at DEA Head......
  • James Clopton, M.D.; Decision and Order
    • United States
    • Federal Register January 14, 2014
    • January 14, 2014
    ...fail to respond to this official correspondence by exercising his rights . . . his application shall be deemed withdrawn pursuant to 21 CFR Sec. 1301.16(b).'' On April 2, 2012, the Government personally served the Show Cause Order on Respondent. Request for Final Agency Action, Attachment 2......
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