21 CFR 12.22 - Filing objections and requests for a hearing on a regulation or order
| Cite as | 21 CFR 12.22 |
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24 practice notes
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Prescription Polyethylene Glycol 3350; Denial of a Hearing and Order Withdrawing Approval of Abbreviated New Drug Applications
...facts and legal analyses controverting FDA's position, and intends to supplement this information in its `60 day' submission pursuant to 21 CFR 12.22 and 314.200.'' (Nexgen Comment at 2). Regarding the new information and allegations Nexgen submitted in its Objection, Nexgen made no attempt......
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Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing
...of information technology. Administrative Practices and Procedures (21 CFR 10.30, 10.33, 10.35, 10.85); Formal Evidentiary Public Hearing (21 CFR 12.22, 12.45) (OMB Control Number The Administrative Procedures Act (5 U.S.C. 553(e)) provides that every Agency shall give an interested person ......
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Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing
...technology. Administrative Practices and Procedures (21 CFR 10.30, 10.33, 10.35, and 10.85); Formal Evidentiary Public Hearing (21 CFR 12.22 and (OMB Control Number 0910-0191)--Extension The Administrative Procedures Act (5 U.S.C. 553(e)) provides that every Agency shall give an interested ......
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Administrative practice and procedure: New animal drug applications; designated journals list; removals,
...amends 21 CFR 10.20 Submission of documents to the Dockets Management Branch; computation of time; availability for public disclosure and 21 CFR 12.22 Filing objections and requests for a hearing on a regulation or order by eliminating the designated journals exception to the requirement th......
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1 cases
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Marshall Minerals, Inc. v. Food and Drug Administration, No. 80-7369
...the place of a reasoned and articulated response" to the safety issues raised in said order. According to FDA, 21 C.F.R. § 571.10 and 21 C.F.R. §§ 12.22 and 12.24 any petitioner for whom a food additive petition has been denied and who desires a hearing to submit reasons why the application......