21 U.S.C. § 387v (FOOD AND DRUGS)
§ 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 submit 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 required 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 balance from fees collected.
(4) The amount obligated by the Center for Tobacco Products for each of the following activities:
(A) Compliance and enforcement.
(B) Public education campaigns.
(C) Scientific research and research infrastructure.
(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 pathway 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(E) withdrawn;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 environmental information request letter; or
(I) referred to the Tobacco Products Scientific 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 applications, whether such regulations and guidance documents were issued as required by statute or by other legal or regulatory requirements, 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 applications 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 requests 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 employees funded pursuant to fees collected under section 387s of this title, including identification of the centers and offices within the Food and Drug Administration in which such positions are located.
(10) The number of inspections and investigations conducted at domestic and foreign establishments required to register under section 387e of this title.
(11) The total number of compliance and enforcement actions issued or taken with respect to tobacco products, including warning letters, civil money penalties, no-tobacco-sale orders, and other enforcement actions (including seizures, injunctions, and criminal prosecution).
(c) Public availability
The Secretary of Health and Human Services shall make the reports required under this section 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 statement 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 accounting 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 information regarding how the Food and Drug Administration will align systems and apply learning across the agency to allow for accurate reporting.
(Pub. L. 117–103, div. P, title I, § 112, Mar. 15, 2022, 136 Stat. 790.)
heading: Editorial Notes
heading: Codification
text: Section was enacted as part of the Consolidated Appropriations Act, 2022, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.