21 U.S.C. § 391 — Separability clause

Page 700 TITLE 21—FOOD AND DRUGS § 391 (D) Communications. (E) Leadership, management oversight, and administrative services. (F) Related overhead activities. (5) The numbers of applications, categorized by class of tobacco product and review path- way under sections 387e, 387j, and 387k of this title, that were— (A) submitted; (B) pending; (C) accepted; (D) refused to file; (E) withdrawn; (F) denied; (G) authorized for marketing under an order; (H) issued a deficiency letter or environ- mental information request letter; or (I) referred to the Tobacco Products Sci- entific Advisory Committee. (6) The number and titles of draft and final guidance documents and proposed and final regulations issued on topics related to the process for the review of tobacco product ap- plications, whether such regulations and guid- ance documents were issued as required by statute or by other legal or regulatory re- quirements, and whether the issuance met the deadlines set forth by the applicable statute or other requirements. (7) The number and titles of public meetings related to the review of tobacco product appli- cations by the Center for Tobacco Products or other offices or centers within the Food and Drug Administration. (8) The number of pre-submission meetings relating to applications under section 387j of this title, including the number of meeting re- quests received, the number of meetings held, and the median amount of time between when such meeting requests were made and when the requests were granted or denied. (9) The number of full-time equivalent em- ployees funded pursuant to fees collected under section 387s of this title, including iden- tification of the centers and offices within the Food and Drug Administration in which such positions are located. (10) The number of inspections and inves- tigations conducted at domestic and foreign establishments required to register under sec- tion 387e of this title. (11) The total number of compliance and en- forcement actions issued or taken with respect to tobacco products, including warning let- ters, civil money penalties, no-tobacco-sale or- ders, and other enforcement actions (including seizures, injunctions, and criminal prosecu- tion). (c) Public availability The Secretary of Health and Human Services shall make the reports required under this sec- tion available to the public on the website of the Food and Drug Administration. (d) Limitations Reporting under this section shall include best estimates for any reporting category for which the Food and Drug Administration does not have precise calculations. Such best estimates shall be accompanied with an explanatory state- ment for why the Food and Drug Administration does not have access to, or cannot calculate, the exact figure and a date by which the Food and Drug Administration will update its internal ac- counting procedures to allow for such reporting. If a category is successfully reported by the Food and Drug Administration with regard to another type of user fee but is provided a best estimate by the Center for Tobacco Products, the explanatory statement shall include infor- mation regarding how the Food and Drug Ad- ministration will align systems and apply learn- ing across the agency to allow for accurate re- porting. (Pub. L. 117–103, div. P, title I, § 112, Mar. 15, 2022, 136 Stat. 790.) Editorial Notes CODIFICATION Section was enacted as part of the Consolidated Ap- propriations Act, 2022, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter. SUBCHAPTER X—MISCELLANEOUS Editorial Notes CODIFICATION Former subchapter IX of this chapter was redesig- nated as this subchapter. § 391. Separability clause If any provision of this chapter is declared un- constitutional, or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder of the chap- ter and the applicability thereof to other per- sons and circumstances shall not be affected thereby. (June 25, 1938, ch. 675, § 1001, formerly § 901, 52 Stat. 1059; renumbered § 1001, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.) § 392. Exemption of meats and meat food prod- ucts (a) Law determinative of exemption Meats and meat food products shall be exempt from the provisions of this chapter to the extent of the application or the extension thereto of the Meat Inspection Act, approved March 4, 1907, as amended [21 U.S.C. 601 et seq.]. (b) Laws unaffected Nothing contained in this chapter shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of sec- tion 351 of Public Health Service Act [42 U.S.C. 262] (relating to viruses, serums, toxins, and analogous products applicable to man); the virus, serum, toxin, and analogous products pro- visions, applicable to domestic animals, of the Act of Congress approved March 4, 1913 (37 Stat. 832–833) [21 U.S.C. 151 et seq.]; the Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26, ch. 10), the Filled Milk Act of March 4, 1923 [21 U.S.C. 61 et seq.]; or the Import Milk Act of Feb- ruary 15, 1927 [21 U.S.C. 141 et seq.].