21 CFR 10.40 - Promulgation of regulations for the efficient enforcement of the law

Cite as21 CFR 10.40
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103 practice notes
  • Securing Updated and Necessary Statutory Evaluations Timely
    • United States
    • Centers For Medicare And Medicaid Services,Public Health Service,The Inspector General Office
    • Invalid date
    ...internet on any proposed regulation, with a comment period that should generally be at least 60 days.''). \116\ A commenter pointed to 21 CFR 10.40(b)(2) as counseling in favor of a 60-day comment period. But that provision by its terms applies only to the FDA Commissioner. The proposed rul......
  • Human drugs, biological products, or medical devices: Strategic National Stockpile; product labeling requirements; exceptions or alternatives,
    • United States
    • Federal Register December 28, 2007
    • December 28, 2007
    ...issue a rule without providing notice and public comment. FDA has determined that there is good cause under 5 U.S.C. 553(b)(3)(B) and 21 CFR 10.40(d) to publish this regulation as an interim final rule. An emergency requiring deployment of medical products in the SNS could happen at any tim......
  • 799 F.Supp. 281 (E.D.N.Y. 1992), CV-92-3161, Benten v. Kessler
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • July 14, 1992
    ...pursuant to which the drug was seized. If it is a substantive rule, notice and comment procedure was mandatory. 5 U.S.C. § 553(b); 21 C.F.R. § 10.40. A 'substantive regulation' is one which 'grant[s] rights, impose[s] obligations, or produce[s] other significant effects on private interests......
  • 989 F.2d 123 (3rd Cir. 1993), 92-7229, Hanover Potato Products, Inc. v. Shalala
    • United States
    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • March 19, 1993
    ...52 Fed.Reg. 46,968 (Dec. 10, 1987). In the FDA's notice of proposed rulemaking, it stated that, in accordance with the requirements of 21 C.F.R. § 10.40 (1987), the various documents comprising the administrative record were on file at the agency's Dockets Management Branch. The comment per......
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11 cases
  • Nve, Inc. v. Department of Health and Human Serv., No. 04-4481.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • February 7, 2006
    ...administrative record is complete. FDA rules establish the contents of the administrative record for any promulgation of regulations, 21 C.F.R. § 10.40(g), and the administrative record is intended to be the sole basis for the Agency's decision, 21 C.F.R. § 10.45(f). NVE supports its call f......
  • U.S. v. Nova Scotia Food Products Corp., No. 758
    • United States
    • United States Courts of Appeals. United States Court of Appeals (2nd Circuit)
    • December 15, 1977
    ...relies for the proposal (copies or a full list of which shall be a part of the administrative file on the matter Page 252 . . . )." 21 C.F.R. § 10.40(b) (1) (1977). And this is, undoubtedly, the trend. See, e. g., National Nutritional Foods v. Weinberger, 512 F.2d 688 (2d Cir.), cert. denie......
  • Nemphos v. Nestle Waters N. Am., Inc., No. 13–2146.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (4th Circuit)
    • January 8, 2015
    ...NLEA's amendments, the FDA now establishes standards of identity through the agency's conventional rulemaking process. 21 U.S.C. § 371; 21 C.F.R. § 10.40; see James T. O'Reilly, 1 Food and Drug Administration § 10:29 & n. 8 (3d ed.2014). Standards of identity have been utilized to delineate......
  • Nemphos v. Nestle Waters N. Am., Inc., No. 13–2146.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (4th Circuit)
    • January 8, 2015
    ...NLEA's amendments, the FDA now establishes standards of identity through the agency's conventional rulemaking process. 21 U.S.C. § 371; 21 C.F.R. § 10.40; see James T. O'Reilly, 1 Food and Drug Administration § 10:29 & n. 8 (3d ed.2014). Standards of identity have been utilized to delineate......
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2 firm's commentaries
  • Industry Tries Again For Clarity Concerning Off-Label Promotion
    • United States
    • JD Supra United States
    • July 11, 2011
    ...Alternatively, if the petition is granted and rulemaking follows, those regulatory proceedings will also be subject to review. E.g., 21 C.F.R. §10.40. While the Citizen Petition itself, at this early stage, does not mention the First Amendment, we fully expect that free speech issues will b......
  • Industry Tries Again For Clarity Concerning Off-Label Promotion
    • United States
    • LexBlog United States
    • July 8, 2011
    ...Alternatively, if the petition is granted and rulemaking follows, those regulatory proceedings will also be subject to review. E.g., 21 C.F.R. §10.40. While the Citizen Petition itself, at this early stage, does not mention the First Amendment, we fully expect that free speech issues will b......
2 books & journal articles

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