21 U.S.C. § 387s — User fees

Page 695 TITLE 21—FOOD AND DRUGS § 387s ings of the committee or otherwise engaged in its business, shall be entitled to receive com- pensation at rates to be fixed by the Sec- retary, which may not exceed the daily equiv- alent of the rate in effect under the Senior Ex- ecutive Schedule under section 5382 of title 5, for each day (including travel time) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, in- cluding per diem in lieu of subsistence, as au- thorized by section 5703 of title 5 for persons in the Government service employed intermit- tently. (2) Administrative support The Secretary shall furnish the Advisory Committee clerical and other assistance. (3) Nonapplication of chapter 10 of title 5 Section 1013 of title 5 does not apply to the Advisory Committee. (e) Proceedings of advisory panels and commit- tees The Advisory Committee shall make and maintain a transcript of any proceeding of the panel or committee. Each such panel and com- mittee shall delete from any transcript made under this subsection information which is ex- empt from disclosure under section 552(b) of title 5. (June 25, 1938, ch. 675, § 917, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1824; amended Pub. L. 117–286, § 4(a)(160), Dec. 27, 2022, 136 Stat. 4323.) Editorial Notes AMENDMENTS 2022—Subsec. (d). Pub. L. 117–286, § 4(a)(160)(A), sub- stituted ‘‘chapter 10 of title 5’’ for ‘‘FACA’’ in heading. Subsec. (d)(3). Pub. L. 117–286, § 4(a)(160)(B), sub- stituted ‘‘chapter 10 of title 5’’ for ‘‘FACA’’ in heading and ‘‘Section 1013 of title 5’’ for ‘‘Section 14 of the Fed- eral Advisory Committee Act’’ in text. Statutory Notes and Related Subsidiaries MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION With respect to any time periods specified in an amendment by 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 cal- culation of such time periods shall commence on the first day of the first fiscal 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 re- duce the duration of one or more such time periods, ex- cept 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. § 387r. Drug products used to treat tobacco de- pendence (a) In general The Secretary shall— (1) at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 356 of this title; (2) consider approving the extended use of nicotine replacement products (such as nico- tine patches, nicotine gum, and nicotine loz- enges) for the treatment of tobacco depend- ence; and (3) review and consider the evidence for addi- tional indications for nicotine replacement products, such as for craving relief or relapse prevention. (b) Report on innovative products (1) In general Not later than 3 years after June 22, 2009, the Secretary, after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and non- governmental entities, the Institute of Medi- cine of the National Academy of Sciences, and the Society for Research on Nicotine and To- bacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine- based and non-nicotine-based products and treatments) to better achieve, in a manner that best protects and promotes the public health— (A) total abstinence from tobacco use; (B) reductions in consumption of tobacco; and (C) reductions in the harm associated with continued tobacco use. (2) Recommendations The report under paragraph (1) shall include the recommendations of the Secretary on how the Food and Drug Administration should co- ordinate and facilitate the exchange of infor- mation on such innovative products and treat- ments among relevant offices and centers within the Administration and within the Na- tional Institutes of Health, the Centers for Disease Control and Prevention, and other rel- evant agencies. (June 25, 1938, ch. 675, § 918, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1825.) Statutory Notes and Related Subsidiaries MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION With respect to any time periods specified in an amendment by 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 cal- culation of such time periods shall commence on the first day of the first fiscal 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 re- duce the duration of one or more such time periods, ex- cept 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. § 387s. User fees (a) Establishment of quarterly fee Beginning on June 22, 2009, the Secretary shall in accordance with this section assess user fees on, and collect such fees from, each manufac- turer and importer of tobacco products subject Page 696 TITLE 21—FOOD AND DRUGS § 387s to this subchapter. The fees shall be assessed and collected with respect to each quarter of each fiscal year, and the total amount assessed and collected for a fiscal year shall be the amount specified in subsection (b)(1) for such year, subject to subsection (c). (b) Assessment of user fee (1) Amount of assessment The total amount of user fees authorized to be assessed and collected under subsection (a) for a fiscal year is the following, as applicable to the fiscal year involved: (A) For fiscal year 2009, $85,000,000 (subject to subsection (e)). (B) For fiscal year 2010, $235,000,000. (C) For fiscal year 2011, $450,000,000. (D) For fiscal year 2012, $477,000,000. (E) For fiscal year 2013, $505,000,000. (F) For fiscal year 2014, $534,000,000. (G) For fiscal year 2015, $566,000,000. (H) For fiscal year 2016, $599,000,000. (I) For fiscal year 2017, $635,000,000. (J) For fiscal year 2018, $672,000,000. (K) For fiscal year 2019 and each subse- quent fiscal year, $712,000,000. (2) Allocations of assessment by class of to- bacco products (A) In general The total user fees assessed and collected under subsection (a) each fiscal year with re- spect to each class of tobacco products shall be an amount that is equal to the applicable percentage of each class for the fiscal year multiplied by the amount specified in para- graph (1) for the fiscal year. (B) Applicable percentage (i) In general For purposes of subparagraph (A), the applicable percentage for a fiscal year for each of the following classes of tobacco products shall be determined in accord- ance with clause (ii): (I) Cigarettes. (II) Cigars, including small cigars and cigars other than small cigars. (III) Snuff. (IV) Chewing tobacco. (V) Pipe tobacco. (VI) Roll-your-own tobacco. (ii) Allocations The applicable percentage of each class of tobacco product described in clause (i) for a fiscal year shall be the percentage de- termined under section 518d(c) of title 7 for each such class of product for such fiscal year. (iii) Requirement of regulations Notwithstanding clause (ii), no user fees shall be assessed on a class of tobacco products unless such class of tobacco prod- ucts is listed in section 387a(b) of this title or is deemed by the Secretary in a regula- tion under section 387a(b) of this title to be subject to this subchapter. (iv) Reallocations In the case of a class of tobacco products that is not listed in section 387a(b) of this title or deemed by the Secretary in a regu- lation under section 387a(b) of this title to be subject to this subchapter, the amount of user fees that would otherwise be as- sessed to such class of tobacco products shall be reallocated to the classes of to- bacco products that are subject to this subchapter in the same manner and based on the same relative percentages other- wise determined under clause (ii). (3) Determination of user fee by company (A) In general The total user fee to be paid by each man- ufacturer or importer of a particular class of tobacco products shall be determined for each quarter by multiplying— (i) such manufacturer’s or importer’s percentage share as determined under paragraph (4); by (ii) the portion of the user fee amount for the current quarter to be assessed on all manufacturers and importers of such class of tobacco products as determined under paragraph (2). (B) No fee in excess of percentage share No manufacturer or importer of tobacco products shall be required to pay a user fee in excess of the percentage share of such manufacturer or importer. (4) Allocation of assessment within each class of tobacco product The percentage share of each manufacturer or importer of a particular class of tobacco products of the total user fee to be paid by all manufacturers or importers of that class of to- bacco products shall be the percentage deter- mined for purposes of allocations under sub- sections (e) through (h) of section 518d of title 7. (5) Allocation for cigars Notwithstanding paragraph (4), if a user fee assessment is imposed on cigars, the percent- age share of each manufacturer or importer of cigars shall be based on the excise taxes paid by such manufacturer or importer during the prior fiscal year. (6) Timing of assessment The Secretary shall notify each manufac- turer and importer of tobacco products subject to this section of the amount of the quarterly assessment imposed on such manufacturer or importer under this subsection for each quar- ter of each fiscal year. Such notifications shall occur not later than 30 days prior to the end of the quarter for which such assessment is made, and payments of all assessments shall be made by the last day of the quarter in- volved. (7) Memorandum of understanding (A) In general The Secretary shall request the appro- priate Federal agency to enter into a memo- randum of understanding that provides for the regular and timely transfer from the head of such agency to the Secretary of the information described in paragraphs Page 697 TITLE 21—FOOD AND DRUGS § 387s (2)(B)(ii) and (4) and all necessary informa- tion regarding all tobacco product manufac- turers and importers required to pay user fees. The Secretary shall maintain all disclo- sure restrictions established by the head of such agency regarding the information pro- vided under the memorandum of under- standing. (B) Assurances Beginning not later than fiscal year 2015, and for each subsequent fiscal year, the Sec- retary shall ensure that the Food and Drug Administration is able to determine the ap- plicable percentages described in paragraph (2) and the percentage shares described in paragraph (4). The Secretary may carry out this subparagraph by entering into a con- tract with the head of the Federal agency re- ferred to in subparagraph (A) to continue to provide the necessary information. (c) Crediting and availability of fees (1) In general Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in ad- vance in appropriations Acts, subject to para- graph (2)(D). Such fees are authorized to re- main available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. (2) Availability (A) In general Fees appropriated under paragraph (3) are available only for the purpose of paying the costs of the activities of the Food and Drug Administration related to the regulation of tobacco products under this subchapter and the Family Smoking Prevention and To- bacco Control Act (referred to in this sub- section as ‘‘tobacco regulation activities’’), except that such fees may be used for the re- imbursement specified in subparagraph (C). (B) Prohibition against use of other funds (i) In general Except as provided in clause (ii), fees col- lected under subsection (a) are the only funds authorized to be made available for tobacco regulation activities. (ii) Startup costs Clause (i) does not apply until October 1, 2009. Until such date, any amounts avail- able to the Food and Drug Administration (excluding user fees) shall be available and allocated as needed to pay the costs of to- bacco regulation activities. (C) Reimbursement of start-up amounts (i) In general Any amounts allocated for the start-up period pursuant to subparagraph (B)(ii) shall be reimbursed through any appro- priated fees collected under subsection (a), in such manner as the Secretary deter- mines appropriate to ensure that such al- location results in no net change in the total amount of funds otherwise available, for the period from October 1, 2008, through September 30, 2010, for Food and Drug Administration programs and activi- ties (other than tobacco regulation activi- ties) for such period. (ii) Treatment of reimbursed amounts Amounts reimbursed under clause (i) shall be available for the programs and ac- tivities for which funds allocated for the start-up period were available, prior to such allocation, until September 30, 2010, notwithstanding any otherwise applicable limits on amounts for such programs or activities for a fiscal year. (D) Fee collected during start-up period Notwithstanding the first sentence of paragraph (1), fees under subsection (a) may be collected through September 30, 2009 under subparagraph (B)(ii) and shall be available for obligation and remain avail- able until expended. Such offsetting collec- tions shall be credited to the salaries and ex- penses account of the Food and Drug Admin- istration. (E) Obligation of start-up costs in anticipa- tion of available fee collections Notwithstanding any other provision of law, following the enactment of an appro- priation for fees under this section for fiscal year 2010, or any portion thereof, obligations for costs of tobacco regulation activities during the start-up period may be incurred in anticipation of the receipt of offsetting fee collections through procedures specified in section 1534 of title 31. (3) Authorization of appropriations For fiscal year 2009 and each subsequent fis- cal year, there is authorized to be appro- priated for fees under this section an amount equal to the amount specified in subsection (b)(1) for the fiscal year. (d) Collection of unpaid fees In any case where the Secretary does not re- ceive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Gov- ernment subject to subchapter II of chapter 37 of title 31. (e) Applicability to fiscal year 2009 If the date of enactment of the Family Smok- ing Prevention and Tobacco Control Act occurs during fiscal year 2009, the following applies, subject to subsection (c): (1) The Secretary shall determine the fees that would apply for a single quarter of such fiscal year according to the application of sub- section (b) to the amount specified in para- graph (1)(A) of such subsection (referred to in this subsection as the ‘‘quarterly fee amounts’’). (2) For the quarter in which such date of en- actment occurs, the amount of fees assessed shall be a pro rata amount, determined ac- cording to the number of days remaining in Page 698 TITLE 21—FOOD AND DRUGS § 387t 1 So in original. Probably should be ‘‘the Family’’. the quarter (including such date of enactment) and according to the daily equivalent of the quarterly fee amounts. Fees assessed under the preceding sentence shall not be collected until the next quarter. (3) For the quarter following the quarter to which paragraph (2) applies, the full quarterly fee amounts shall be assessed and collected, in addition to collection of the pro rata fees as- sessed under paragraph (2). (June 25, 1938, ch. 675, § 919, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1826.) Editorial Notes REFERENCES IN TEXT The Family Smoking Prevention and Tobacco Con- trol Act, referred to in subsec. (c)(2)(A), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classification of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title. The date of enactment of the Family Smoking Pre- vention and Tobacco Control Act and such date of en- actment, referred to in subsec. (e), is the date of enact- ment of Pub. L. 111–31, which was approved June 22, 2009. § 387t. Labeling, recordkeeping, records inspec- tion (a) Origin labeling (1) Requirement Beginning 1 year after June 22, 2009, the label, packaging, and shipping containers of tobacco products other than cigarettes for in- troduction or delivery for introduction into interstate commerce in the United States shall bear the statement ‘‘sale only allowed in the United States’’. Beginning 15 months after the issuance of the regulations required by section 1333(d) of title 15, as amended by sec- tion 201 of Family 1 Smoking Prevention and Tobacco Control Act, the label, packaging, and shipping containers of cigarettes for intro- duction or delivery for introduction into inter- state commerce in the United States shall bear the statement ‘‘Sale only allowed in the United States’’. (2) Effective date The effective date specified in paragraph (1) shall be with respect to the date of manufac- ture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic com- merce of the United States any product, irre- spective of the date of manufacture, that is not in conformance with such paragraph. (b) Regulations concerning recordkeeping for tracking and tracing (1) In general The Secretary shall promulgate regulations regarding the establishment and maintenance of records by any person who manufactures, processes, transports, distributes, receives, packages, holds, exports, or imports tobacco products. (2) Inspection In promulgating the regulations described in paragraph (1), the Secretary shall consider which records are needed for inspection to monitor the movement of tobacco products from the point of manufacture through dis- tribution to retail outlets to assist in inves- tigating potential illicit trade, smuggling, or counterfeiting of tobacco products. (3) Codes The Secretary may require codes on the la- bels of tobacco products or other designs or devices for the purpose of tracking or tracing the tobacco product through the distribution system. (4) Size of business The Secretary shall take into account the size of a business in promulgating regulations under this section. (5) Recordkeeping by retailers The Secretary shall not require any retailer to maintain records relating to individual pur- chasers of tobacco products for personal con- sumption. (c) Records inspection If the Secretary has a reasonable belief that a tobacco product is part of an illicit trade or smuggling or is a counterfeit product, each per- son who manufactures, processes, transports, distributes, receives, holds, packages, exports, or imports tobacco products shall, at the re- quest of an officer or employee duly designated by the Secretary, permit such officer or em- ployee, at reasonable times and within reason- able limits and in a reasonable manner, upon the presentation of appropriate credentials and a written notice to such person, to have access to and copy all records (including financial records) relating to such article that are needed to assist the Secretary in investigating poten- tial illicit trade, smuggling, or counterfeiting of tobacco products. The Secretary shall not au- thorize an officer or employee of the govern- ment of any of the several States to exercise au- thority under the preceding sentence on Indian country without the express written consent of the Indian tribe involved. (d) Knowledge of illegal transaction (1) Notification If the manufacturer or distributor of a to- bacco product has knowledge which reason- ably supports the conclusion that a tobacco product manufactured or distributed by such manufacturer or distributor that has left the control of such person may be or has been— (A) imported, exported, distributed, or of- fered for sale in interstate commerce by a person without paying duties or taxes re- quired by law; or (B) imported, exported, distributed, or di- verted for possible illicit marketing, the manufacturer or distributor shall prompt- ly notify the Attorney General and the Sec- retary of the Treasury of such knowledge. (2) Knowledge defined For purposes of this subsection, the term ‘‘knowledge’’ as applied to a manufacturer or distributor means—