21 CFR 10.30 - Citizen petition
| Cite as | 21 CFR 10.30 |
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1286 practice notes
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Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
...the regulatory authority for food safety) for the state or foreign government to FDA in the form of a citizen petition in accordance with 21 CFR 10.30. In proposed Sec. 112.173, we propose that, in addition to the requirements set forth in Sec. 10.30, the Statement of Grounds (which is spec......
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Sanitary Transportation of Human and Animal Food
...rule, we stated that we will consider whether to waive a requirement of this rule on our own initiative or on a petition submitted under 21 CFR 10.30. In proposed Sec. 1.918 we outlined what must be included in the Statement of Grounds in the petition. And in proposed Sec. 1.924 we outlined......
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Public Health Security and Bioterrorism Preparedness and Response Act of 2002;
Food facilities registration,
...that improvements would serve the public interest, and interested persons may request such modification by following the procedures in 21 CFR 10.30, regarding citizen petitions. The process for any amendment to an existing FDA regulation must conform to the requirements of the Administrativ......
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Separate Parts In This Issue
Part VI
Health and Human Services Department, Food and Drug Administration,
...that improvements would serve the public interest, and interested persons may request such modification by following the procedures in 21 CFR 10.30, regarding citizen petitions. The process for any amendment to an existing FDA regulation must conform to the requirements of the Administrativ......
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153 cases
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Neurelis, Inc. v. Aquestive Therapeutics, Inc., D077984, D078186
...this petition process, the FDA permits private entities to provide comments and opinions on draft guidance by filing these petitions. ( 21 C.F.R. § 10.30 (2021).) A petition can request that the FDA "issue, amend, or revoke a regulation or order or take or refrain from taking any other form......
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O'Neal v. Smithkline Beecham Corp., No. CIV S-06-1063 FCD/DAD.
...drugs during clinical studies. (UF ¶ 9.)8 Page 998 In late 1990 and early 1991, two groups filed "Citizen Petitions" pursuant to 21 C.F.R. § 10.30, asking the FDA to withdraw approval of the NDA for Prozac, the only approved SSRI at the time. These petitions alternatively sought warning sta......
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Abigail Alliance v. Von Eschenbach, No. 04-5350.
...proposal by letter dated April 25, 2003, outlining the FDA's policy. On June 11, 2003, Alliance filed a Citizen Petition, pursuant to 21 C.F.R. § 10.30, challenging the FDA's policy barring the sale of investigational new drugs that have successfully completed Phase I trials to terminally i......
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Guckin v. Nagle, No. CIV.A. 02-5648.
...to bring about changes in the manner in which the FDCA is administered may do so either by filing a citizen petition with the FDA, 21 C.F.R. § 10.30, or through a suit brought against the FDA under the Administrative Procedures Act. 5 U.S.C. § 702, 706. There is no provision in the FDCA, th......
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29 firm's commentaries
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'Fully Informing' The FDA
...through a citizen petition (which produces a "formal" agency decision of the sort Albrecht requires, id., see 21 U.S.C. §355(q)(1)(F); 21 C.F.R. §10.30(i)), or by inviting the FDA to present its views via an amicus curiae brief. See Kisor v. Wilkie, 139 S. Ct. 2400, 2418 n.6 (2019) (an agen......
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“Fully Informing” the FDA
...through a citizen petition (which produces a “formal” agency decision of the sort Albrecht requires, id., see 21 U.S.C. §355(q)(1)(F); 21 C.F.R. §10.30(i)), or by inviting the FDA to present its views via an amicus curiae brief. See Kisor v. Wilkie, 139 S. Ct. 2400, 2418 n.6 (2019) (an agen......
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Response/Rebuttal to Plaintiffs’ Albrecht Arguments
...to have the drug in question removed from the market. FDA rulings on such petitions are final agency action. 21 U.S.C. §355(q)(1)(F); 21 C.F.R. §10.30(e)(3) (requiring publication of the FDA’s decision in the Federal Register). Citizen petitions also produce “an official administrative reco......
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How the Other Side Views Albrecht
...not. That post-Albrecht courts have largely “sided with defendants” is not surprising. The citizen petition process is a formal one, 21 C.F.R. §10.30, and thus provides the “official administrative record for an FDA decision” that Albrecht finds to be an appropriate basis for preemption. 13......
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4 books & journal articles
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Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety
...USA TODAY (Oct. 4, 2004, 12:09 AM), http://usatoday30. usatoday.com/money/industries/health/drugs/2004-10-04-vioxx-insurers_x.htm. 226. 21 C.F.R. § 10.30 (2012). 227 . Id. § 10.30(b). 228 . An ANDA is an application from a generics company to the FDA to approve a generic drug product. After......
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The More Things Change: Improvement Patents, Drug Modifications, and the FDA
...Regulation of Drugs and Devices: An Evolution , 13 HEALTH AFF. 47 (1994) (describing the “drug model” of FDA regulation). 381 . See 21 C.F.R. § 10.30. Confidentiality of sponsor data, however, could be a barrier here, as demonstrated in the course of challenges to other FDA decisions. See, ......
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Antitrust
...not delay approval of a pending ANDA or 505(b)(2) application as a result of a citizen petition submitted to the agency pursuant to 21 C.F.R. § 10.30 (citizen petition) or § 10.35 (petition for stay of action), unless FDA “determines, upon reviewing the petition, that a delay is necessary t......
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Petition to Request a Change from a Listed Drug
...circumstances exist that may significantly affect the human environment as discussed under 21 CFR §25.21. Economic Impact As provided in 21 CFR §10.30(b), the petitioner agrees to submit economic impact information only if requested by the Commissioner of Food and Drugs following review of ......