21 CFR 10.20 - Submission of documents to Division of Dockets Management; computation of time; availability for public disclosure
| Cite as | 21 CFR 10.20 |
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1717 practice notes
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Securing Updated and Necessary Statutory Evaluations Timely
...of 5 U.S.C. 553(e)'s petition process. --------------------------------------------------------------------------- \205\ See, e.g., 21 CFR 10.20, 10.30, Comment: Some commenters stated that it was arbitrary for HHS to not meaningfully consider other ``strong incentives'' to revisit its own ......
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Submission of Food and Drug Administration Import Data in the Automated Commercial Environment
...identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, ......
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Debarment orders: Girdhari, Premchand,
...above). All such submissions are to be filedin four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Dated......
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Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
...by individuals in their individual capacity. If you wish to submit any information under a claim of confidentiality, please refer to 21 CFR 10.20. Information Identifying the Person Submitting the Please note that your name, contact information, and other information identifying you will be......
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4 cases
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Tummino v. Hamburg, No. 12–CV–763 (ERK)(VVP).
...their own consideration of materials that were not part of the Citizen Petition docket. The only regulation cited by the defendants is 21 C.F.R. § 10.20(c), which provides that “[i]nformation referred to or relied upon in a submission is to be included in full and may not be incorporated by......
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Tummino v. Hamburg, No. 12-CV-763 (ERK)(VVP)
...their own consideration of materials that were not part of the Citizen Petition docket. The only regulation cited by the defendants is 21 C.F.R. § 10.20(c), which provides that "[i]nformation referred to or relied upon in a submission is to be included in full and may not be incorporated by......
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Torpharm, Inc. v. Thompson, No. CIV.A. 03-0254(ESH).
...how to establish that nebulous distinction. Nor do any of the regulations cited by the parties actually govern this issue. See, e.g., 21 C.F.R. § 10.20(e) (general rule for FDA docket submissions); 21 C.F.R. § 314.100(a) (timeframes for reviewing NDAs and ADAs); 314 C.F.R. § 314.101(a)(2) I......
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Torpharm, Inc. v. Thompson, Civil Action No. 03-0254 (ESH) (D. D.C. 4/25/2003), Civil Action No. 03-0254 (ESH).
...how to establish that nebulous distinction. Nor do any of the regulations cited by the parties actually govern this issue. See, e.g., 21 C.F.R. § 10.20(e) (general rule for FDA docket submissions); 21 C.F.R. § 314.100(a) (timeframes for reviewing NDAs and ANDAs); 314 C.F.R. § 314.101(a)(2) ......