21 U.S.C. § 387v — Reporting on tobacco regulation activities

Page 699 TITLE 21—FOOD AND DRUGS § 387v 1 So in original. Probably should be plural. (A) the actual knowledge that the manu- facturer or distributor had; or (B) the knowledge which a reasonable per- son would have had under like cir- cumstances or which would have been ob- tained upon the exercise of due care. (e) Consultation In carrying out this section, the Secretary shall consult with the Attorney General of the United States and the Secretary of the Treas- ury, as appropriate. (June 25, 1938, ch. 675, § 920, as added Pub. L. 111–31, div. A, title III, § 301, June 22, 2009, 123 Stat. 1850.) Editorial Notes REFERENCES IN TEXT Section 201 of the Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (a)(1), is section 201 of div. A of Pub. L. 111–31. § 387u. Studies of progress and effectiveness (a) FDA report Not later than 3 years after June 22, 2009, and not less than every 2 years thereafter, the Sec- retary of Health and Human Services shall sub- mit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Com- mittee on Energy and Commerce of the House of Representatives, a report concerning— (1) the progress of the Food and Drug Admin- istration in implementing this division, in- cluding major accomplishments, objective measurements of progress, and the identifica- tion of any areas that have not been fully im- plemented; (2) impediments identified by the Food and Drug Administration to progress in imple- menting this division and to meeting statu- tory timeframes; (3) data on the number of new product appli- cations received under section 387j of this title and modified risk product applications re- ceived under section 387k of this title, and the number of applications acted on under each category; and (4) data on the number of full time equiva- lents engaged in implementing this division. (b) GAO report Not later than 5 years after June 22, 2009, the Comptroller General of the United States shall conduct a study of, and submit to the Commit- tees described in subsection (a) a report con- cerning— (1) the adequacy of the authority and re- sources provided to the Secretary of Health and Human Services for this division to carry out its goals and purposes; and (2) any recommendations for strengthening that authority to more effectively protect the public health with respect to the manufacture, marketing, and distribution of tobacco prod- ucts. (c) Public availability The Secretary of Health and Human Services and the Comptroller General of the United States, respectively, shall make the reports re- quired under subsection 1 (a) and (b) available to the public, including by posting such reports on the respective Internet websites of the Food and Drug Administration and the Government Ac- countability Office. (Pub. L. 111–31, div. A, title I, § 106, June 22, 2009, 123 Stat. 1841.) Editorial Notes REFERENCES IN TEXT This division, referred to in subsecs. (a)(1), (2), (4) and (b)(1), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776, known as Family Smoking Prevention and To- bacco Control Act. For complete classification of divi- sion A to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables. CODIFICATION Section was enacted as part of the Family Smoking Prevention and Tobacco Control Act, and not as part of the Federal Food, Drug, and Cosmetic Act which com- prises this chapter. Statutory Notes and Related Subsidiaries MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION With respect to any time periods specified in div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fis- cal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title. § 387v. Reporting on tobacco regulation activities (a) In general For fiscal year 2022 and each subsequent fiscal year for which fees are collected under section 387s of this title, the Secretary of Health and Human Services shall, not later than 180 days after the end of the fiscal year, prepare and sub- mit to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, an annual report that contains the information re- quired under subsection (b). (b) Required information Each report submitted under subsection (a) shall contain the following information for the previous fiscal year: (1) Total annual user fee collections. (2) Total amount of fees obligated. (3) The amount of unobligated carryover bal- ance from fees collected. (4) The amount obligated by the Center for Tobacco Products for each of the following ac- tivities: (A) Compliance and enforcement. (B) Public education campaigns. (C) Scientific research and research infra- structure. 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.].