21 U.S.C. § 379g — Definitions

Page 520 TITLE 21—FOOD AND DRUGS § 379f imposed by or pursuant to the Meat Inspection Act of March 4, 1907, 34 Stat. 1260, as amended or extended (21 U.S.C. 71 and the following) [see section 601 et seq. of this title] or the Poultry Products Inspection Act (21 U.S.C. 451 and the following).’’ EFFECTIVE DATE; ACCELERATION This section was made ‘‘immediately effective’’ by act May 2, 1939, ch. 107, title I, § 1, 53 Stat. 631. TERMINATION OF ADVISORY COMMITTEES Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2- year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees. REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY RATES References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organi- zation and Employees, see section 529 [title I, § 101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5. PART C—FEES SUBPART 1—FREEDOM OF INFORMATION FEES § 379f. Recovery and retention of fees for free- dom of information requests (a) In general The Secretary, acting through the Commis- sioner of Food and Drugs, may— (1) set and charge fees, in accordance with section 552(a)(4)(A) of title 5, to recover all reasonable costs incurred in processing re- quests made under section 552 of title 5 for records obtained or created under this chapter or any other Federal law for which responsi- bility for administration has been delegated to the Commissioner by the Secretary; (2) retain all fees charged for such requests; and (3) establish an accounting system and pro- cedures to control receipts and expenditures of fees received under this section. (b) Use of fees The Secretary and the Commissioner of Food and Drugs shall not use fees received under this section for any purpose other than funding the processing of requests described in subsection (a)(1). Such fees shall not be used to reduce the amount of funds made to carry out other provi- sions of this chapter. (c) Waiver of fees Nothing in this section shall supersede the right of a requester to obtain a waiver of fees pursuant to section 552(a)(4)(A) of title 5. (June 25, 1938, ch. 675, § 731, formerly § 711, as added Pub. L. 101–635, title II, § 201, Nov. 28, 1990, 104 Stat. 4584; renumbered § 731, Pub. L. 102–571, title I, § 106(6), Oct. 29, 1992, 106 Stat. 4499.) Editorial Notes CODIFICATION Section was formerly classified to section 379c of this title prior to renumbering by Pub. L. 102–571. SUBPART 2—FEES RELATING TO DRUGS § 379g. Definitions For purposes of this subpart: (1) The term ‘‘human drug application’’ means an application for— (A) approval of a new drug submitted under section 355(b) of this title, or (B) licensure of a biological product under subsection (a) of section 262 of title 42. Such term does not include a supplement to such an application, does not include an appli- cation with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, does not include an applica- tion with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product sub- mitted pursuant to a notification to the appli- cant from the Secretary regarding the exist- ence of a potency test that measures the aller- genic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with re- spect to an in vitro diagnostic biologic prod- uct licensed under section 262 of title 42, does not include an application with respect to a large volume parenteral drug product ap- proved before September 1, 1992, does not in- clude an application for a licensure of a bio- logical product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not dis- tributed commercially. Such term does in- clude an application for licensure, as described in subparagraph (B), of a large volume biologi- cal product intended for single dose injection for intravenous use or infusion. (2) The term ‘‘supplement’’ means a request to the Secretary to approve a change in a human drug application which has been ap- proved. (3)(A) The term ‘‘prescription drug product’’ means a specific strength or potency of a drug in final dosage form— (i) for which a human drug application has been approved, (ii) which may be dispensed only under prescription pursuant to section 353(b) of this title, and (iii) which is on the list of products de- scribed in section 355(j)(7)(A) of this title (not including the discontinued section of such list) or is on a list created and main- tained by the Secretary of products ap- proved under human drug applications under section 262 of title 42 (not including the dis- continued section of such list). (B) Such term does not include whole blood or a blood component for transfusion, does not Page 521 TITLE 21—FOOD AND DRUGS § 379g include a bovine blood product for topical ap- plication licensed before September 1, 1992, an allergenic extract product licensed before Oc- tober 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before Octo- ber 1, 2022, or an in vitro diagnostic biologic product licensed under section 262 of title 42. Such term does not include a biological prod- uct that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the sub- ject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biologi- cal product intended for single dose injection for intravenous use or infusion. (C)(i) If a written request to place a product in the discontinued section of either of the lists referenced in subparagraph (A)(iii) is sub- mitted to the Secretary on behalf of an appli- cant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the prescription drug program fee under section 379h(a)(2) of this title, the Secretary shall consider such product to have been included in the discon- tinued section on the later of— (I) the date such request was received; or (II) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale. (ii) For purposes of this subparagraph, a product shall be considered withdrawn from sale once the applicant has ceased its own dis- tribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale. (4) The term ‘‘final dosage form’’ means, with respect to a prescription drug product, a finished dosage form which is approved for ad- ministration to a patient without substantial further manufacturing (such as capsules, tab- lets, or lyophilized products before reconstitu- tion). (5) The term ‘‘prescription drug establish- ment’’ means a foreign or domestic place of business which is at one general physical loca- tion consisting of one or more buildings all of which are within five miles of each other and at which one or more prescription drug prod- ucts are manufactured in final dosage form. For purposes of this paragraph, the term ‘‘manufactured’’ does not include packaging. (6) The term ‘‘process for the review of human drug applications’’ means the following activities of the Secretary with respect to the review of human drug applications and supple- ments: (A) The activities necessary for the review of human drug applications and supple- ments. (B) The issuance of action letters which approve human drug applications or which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applica- tions in condition for approval. (C) The inspection of prescription drug es- tablishments and other facilities undertaken as part of the Secretary’s review of pending human drug applications and supplements. (D) Activities necessary for the review of applications for licensure of establishments subject to section 262 of title 42 and for the release of lots of biologics under such sec- tion. (E) Monitoring of research conducted in connection with the review of human drug applications. (F) Postmarket safety activities with re- spect to drugs approved under human drug applications or supplements, including the following activities: (i) Collecting, developing, and reviewing safety information on approved drugs, in- cluding adverse event reports. (ii) Developing and using improved ad- verse-event data-collection systems, in- cluding information technology systems. (iii) Developing and using improved ana- lytical tools to assess potential safety problems, including access to external data bases. (iv) Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (re- lating to risk evaluation and mitigation strategies). (v) Carrying out section 355(k)(5) of this title (relating to adverse event reports and postmarket safety activities). (7) The term ‘‘costs of resources allocated for the process for the review of human drug applications’’ means the expenses in connec- tion with the process for the review of human drug applications for— (A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such offi- cers, employees, and committees and to con- tracts with such contractors, (B) management of information, and the acquisition, maintenance, and repair of com- puter resources, (C) leasing, maintenance, renovation, and repair of facilities and acquisition, mainte- nance, and repair of fixtures, furniture, sci- entific equipment, and other necessary ma- terials and supplies, and (D) collecting fees under section 379h of this title and accounting for resources allo- cated for the review of human drug applica- tions and supplements. (8) The term ‘‘adjustment factor’’ applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the pre- ceding fiscal year divided by such Index for October 1996. (9) The term ‘‘person’’ includes an affiliate thereof. (10) The term ‘‘active’’, with respect to a commercial investigational new drug applica- Page 522 TITLE 21—FOOD AND DRUGS § 379g tion, means such an application to which in- formation was submitted during the relevant period. (11) The term ‘‘affiliate’’ means a business entity that has a relationship with a second business entity if, directly or indirectly— (A) one business entity controls, or has the power to control, the other business entity; or (B) a third party controls, or has power to control, both of the business entities. (12) The term ‘‘skin-test diagnostic prod- uct’’— (A) means a product— (i) for prick, scratch, intradermal, or subcutaneous administration; (ii) expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect; (iii) not intended to be a preventive or therapeutic intervention; and (iv) intended to detect an immediate- or delayed-type skin hypersensitivity reac- tion to aid in the diagnosis of— (I) an allergy to an antimicrobial agent; (II) an allergy that is not to an anti- microbial agent, if the diagnostic prod- uct was authorized for marketing prior to October 1, 2022; or (III) infection with fungal or mycobacterial pathogens; and (B) includes positive and negative controls required to interpret the results of a product described in subparagraph (A). (June 25, 1938, ch. 675, § 735, as added Pub. L. 102–571, title I, § 103, Oct. 29, 1992, 106 Stat. 4491; amended Pub. L. 105–115, title I, §§ 102, 125(b)(2)(M), Nov. 21, 1997, 111 Stat. 2298, 2326; Pub. L. 107–188, title V, § 503, June 12, 2002, 116 Stat. 688; Pub. L. 110–85, title I, § 102, Sept. 27, 2007, 121 Stat. 825; Pub. L. 111–148, title VII, § 7002(f)(3)(A), Mar. 23, 2010, 124 Stat. 818; Pub. L. 112–144, title I, § 102, title IV, § 407, July 9, 2012, 126 Stat. 996, 1039; Pub. L. 117–180, div. F, title I, § 1002, Sept. 30, 2022, 136 Stat. 2140.) TERMINATION OF SECTION For termination of section by section 1005(a) of Pub. L. 117–180, see Termination Date note below. Editorial Notes AMENDMENTS 2022—Par. (1). Pub. L. 117–180, § 1002(a), substituted ‘‘does not include an application with respect to an al- lergenic extract product licensed before October 1, 2022, does not include an application with respect to a stand- ardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to’’ for ‘‘an al- lergenic extract product, or’’ in concluding provisions. Par. (3). Pub. L. 117–180, § 1002(b), substituted ‘‘(3)(A) The term’’ for ‘‘(3) The term’’, redesignated former sub- pars. (A) to (C) as cls. (i) to (iii), respectively, of sub- par. (A), designated concluding provisions as subpar. (B) and substituted ‘‘an allergenic extract product li- censed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the exist- ence of a potency test that measures the allergenic ac- tivity of an allergenic extract product licensed by the applicant before October 1, 2022,’’ for ‘‘an allergenic ex- tract product,’’, and added subpar. (C). Par. (12). Pub. L. 117–180, § 1002(c), added par. (12). 2012—Par. (1)(B). Pub. L. 112–144, § 407, struck out ‘‘or (k)’’ after ‘‘subsection (a)’’. Par. (7). Pub. L. 112–144, § 102, substituted ‘‘expenses in connection with’’ for ‘‘expenses incurred in connec- tion with’’. 2010—Par. (1)(B). Pub. L. 111–148 substituted ‘‘sub- section (a) or (k) of section 262 of title 42’’ for ‘‘section 262 of title 42’’. 2007—Pub. L. 110–85, § 102(1), in introductory provi- sions, substituted ‘‘For purposes of this subpart’’ for ‘‘For purposes of this part’’. Par. (1). Pub. L. 110–85, § 102(2)(D), substituted ‘‘sub- paragraph (B)’’ for ‘‘subparagraph (C)’’ in concluding provisions. Par. (1)(A). Pub. L. 110–85, § 102(2)(A), substituted ‘‘355(b) of this title, or’’ for ‘‘355(b)(1) of this title,’’. Par. (1)(B), (C). Pub. L. 110–85, § 102(2)(B), (C), redesig- nated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: ‘‘approval of a new drug sub- mitted under section 355(b)(2) of this title after Sep- tember 30, 1992, which requests approval of— ‘‘(i) a molecular entity which is an active ingre- dient (including any salt or ester of an active ingre- dient), or ‘‘(ii) an indication for a use, that had not been approved under an application sub- mitted under section 355(b) of this title, or’’. Par. (3)(C). Pub. L. 110–85, § 102(3), substituted ‘‘355(j)(7)(A) of this title (not including the discon- tinued section of such list)’’ for ‘‘355(j)(7)(A) of this title’’ and inserted ‘‘(not including the discontinued section of such list)’’ before period at end. Par. (4). Pub. L. 110–85, § 102(4), inserted ‘‘(such as cap- sules, tablets, or lyophilized products before recon- stitution)’’ before period at end. Par. (6)(F). Pub. L. 110–85, § 102(5), amended subpar. (F) generally. Prior to amendment, subpar. (F) read as follows: ‘‘In the case of drugs approved after October 1, 2002, under human drug applications or supplements: collecting, developing, and reviewing safety informa- tion on the drugs, including adverse event reports, dur- ing a period of time after approval of such applications or supplements, not to exceed three years.’’ Par. (8). Pub. L. 110–85, § 102(6), substituted ‘‘October of the preceding fiscal year’’ for ‘‘April of the preceding fiscal year’’ and ‘‘October 1996’’ for ‘‘April 1997’’. Pars. (9) to (11). Pub. L. 110–85, § 102(7), (8), added pars. (9) and (10) and redesignated former par. (9) as (11). 2002—Par. (1). Pub. L. 107–188, § 503(1), substituted ‘‘li- censure, as described in subparagraph (C)’’ for ‘‘licen- sure, as described in subparagraph (D)’’ in concluding provisions. Par. (3). Pub. L. 107–188, § 503(2)(D), which directed the amendment of concluding provisions of par. (3) by striking ‘‘section 262 of title 42’’ and all that follows through ‘‘biological product’’ and inserting ‘‘section 262 of title 42. Such term does not include a biological product’’, was executed by striking language ending with ‘‘biological product’’ the first time appearing, thereby making the substitution for ‘‘section 262 of title 42, does not include a large volume parenteral drug product approved before September 1, 1992, does not include a biological product’’, to reflect the prob- able intent of Congress. Par. (3)(C). Pub. L. 107–188, § 503(2)(A)–(C), added sub- par. (C). Par. (6)(F). Pub. L. 107–188, § 503(3), added subpar. (F). Par. (8). Pub. L. 107–188, § 503(4), struck out designa- tions of subpars. (A) and (B) and text of subpar. (B) and concluding provisions, substituting definition of ‘‘ad- justment factor’’ as the Consumer Price Index for defi- nition of Index as the lower of the Consumer Price Index or the total of discretionary budget authority Page 523 TITLE 21—FOOD AND DRUGS § 379g provided for programs in the domestic category for the immediately preceding fiscal year divided by such budget authority for fiscal year 1997. 1997—Par. (1). Pub. L. 105–115, § 102(1), in closing provi- sions, struck out ‘‘and’’ before ‘‘does not include an ap- plication’’ and substituted ‘‘September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does in- clude an application for licensure, as described in sub- paragraph (D), of a large volume biological product in- tended for single dose injection for intravenous use or infusion’’ for ‘‘September 1, 1992’’ before period at end. Par. (1)(B) to (D). Pub. L. 105–115, § 125(b)(2)(M), in- serted ‘‘or’’ at end of subpar. (B), redesignated subpar. (D) as (C), and struck out former subpar. (C) which read as follows: ‘‘initial certification or initial approval of an antibiotic drug under section 357 of this title, or’’. Par. (3). Pub. L. 105–115, § 102(2), in closing provisions, struck out ‘‘and’’ before ‘‘does not include a large vol- ume parenteral drug’’ and substituted ‘‘September 1, 1992, does not include a biological product that is li- censed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement sub- mitted by a State or Federal Government entity. Such term does include a large volume biological product in- tended for single dose injection for intravenous use or infusion’’ for ‘‘September 1, 1992’’ before period at end. Par. (4). Pub. L. 105–115, § 102(3), substituted ‘‘without substantial further manufacturing’’ for ‘‘without fur- ther manufacturing’’. Par. (5). Pub. L. 105–115, § 102(4), amended first sen- tence generally. Prior to amendment, first sentence read as follows: ‘‘The term ‘prescription drug establish- ment’ means a foreign or domestic place of business which is— ‘‘(A) at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more prescription drug products are manufactured in final dosage form, and ‘‘(B) under the management of a person that is list- ed as the applicant in a human drug application for a prescription drug product with respect to at least one such product.’’ Par. (7)(A). Pub. L. 105–115, § 102(5), substituted ‘‘con- tractors of the Food and Drug Administration,’’ for ‘‘employees under contract with the Food and Drug Ad- ministration who work in facilities owned or leased for the Food and Drug Administration,’’ and ‘‘and commit- tees and to contracts with such contractors,’’ for ‘‘and committees,’’. Par. (8)(A). Pub. L. 105–115, § 102(6)(A), substituted ‘‘April of the preceding fiscal year’’ for ‘‘August of the preceding fiscal year’’ and ‘‘April 1997’’ for ‘‘August 1992’’. Par. (8)(B). Pub. L. 105–115, § 102(6)(B), substituted ‘‘section 254(c)’’ for ‘‘section 254(d)’’, ‘‘fiscal year 1997’’ for ‘‘fiscal year 1992’’, and ‘‘105th Congress, 1st Session’’ for ‘‘102d Congress, 2d Session’’. Par. (9). Pub. L. 105–115, § 102(7), added par. (9). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2022 AMENDMENT Pub. L. 117–180, div. F, title I, § 1006, Sept. 30, 2022, 136 Stat. 2147, provided that: ‘‘The amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] shall take effect on October 1, 2022, or the date of the enactment of this Act [Sept. 30, 2022], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) shall be assessed for all human drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act.’’ EFFECTIVE DATE OF 2017 AMENDMENT Pub. L. 115–52, title I, § 105, Aug. 18, 2017, 131 Stat. 1012, provided that: ‘‘The amendments made by this title [see section 101(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] shall take effect on October 1, 2017, or the date of the enactment of this Act [Aug. 18, 2017], which- ever is later, except that fees under part 2 of sub- chapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.] shall be assessed for all human drug applications received on or after Oc- tober 1, 2017, regardless of the date of the enactment of this Act.’’ EFFECTIVE DATE OF 2012 AMENDMENT Pub. L. 112–144, title I, § 106, July 9, 2012, 126 Stat. 1002, provided that: ‘‘The amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] shall take effect on October 1, 2012, or the date of the enactment of this Act [July 9, 2012], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all human drug applica- tions received on or after October 1, 2012, regardless of the date of the enactment of this Act.’’ Amendment by section 407 of Pub. L. 112–144 effective Oct. 1, 2012, see section 405 of Pub. L. 112–144, set out as a note under section 379j–51 of this title. EFFECTIVE AND TERMINATION DATES OF 2007 AMENDMENT Pub. L. 110–85, title I, § 106(a), Sept. 27, 2007, 121 Stat. 842, which provided that the amendments made by sec- tions 102, 103, and 104 of Pub. L. 110–85 (enacting section 379h–1 of this title and amending this section and sec- tion 379h of this title) would cease to be effective Oct. 1, 2012, was repealed by Pub. L. 112–144, title I, § 105(c)(1), July 9, 2012, 126 Stat. 1001. Pub. L. 110–85, title I, § 107, Sept. 27, 2007, 121 Stat. 842, provided that: ‘‘The amendments made by this title [enacting sections 379h–1 and 379h–2 of this title and amending this section and sections 379h and 379j–11 of this title] shall take effect on October 1, 2007, or the date of the enactment of this Act [Sept. 27, 2007], whichever is later, except that fees under part 2 of sub- chapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all human drug applications received on or after October 1, 2007, regardless of the date of the enactment of this Act.’’ EFFECTIVE AND TERMINATION DATES OF 2002 AMENDMENT Amendment by Pub. L. 107–188 effective Oct. 1, 2002, see section 508 of Pub. L. 107–188, set out as an Effective Date of 2002 Amendment note under section 356b of this title. Pub. L. 107–188, title V, § 509, June 12, 2002, 116 Stat. 694, which provided that the amendments made by sec- tions 503 and 504 of Pub. L. 107–188 (amending this sec- tion and section 379h of this title) would cease to be ef- fective Oct. 1, 2007, and the amendment by section 505 of Pub. L. 107–188 (enacting provisions set out as a note below) would cease to be effective 120 days after Oct. 1, 2007, was repealed by Pub. L. 112–144, title I, § 105(d)(1)(A), July 9, 2012, 126 Stat. 1001. [Pub. L. 112–144, title I, § 105(d)(1), July 9, 2012, 126 Stat. 1001, provided that the repeal of section 509 of Pub. L. 107–188, formerly set out above, is effective Sept. 30, 2007.] EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT Pub. L. 105–115, title I, § 106, Nov. 21, 1997, 111 Stat. 2305, provided that: ‘‘The amendments made by this subtitle [subtitle A (§§ 101–107) of title I of Pub. L. Page 524 TITLE 21—FOOD AND DRUGS § 379g 105–115, amending this section and section 379h of this title] shall take effect October 1, 1997.’’ Pub. L. 105–115, title I, § 107, Nov. 21, 1997, 111 Stat. 2305, which provided that the amendments by sections 102 and 103 of Pub. L. 105–115 (amending this section and section 379h of this title) would cease to be effective Oct. 1, 2002, and the amendment by section 104 (enact- ing provisions set out as a note below) would cease to be effective 120 days after Oct. 1, 2002, was repealed by Pub. L. 112–144, title I, § 105(d)(2)(A), July 9, 2012, 126 Stat. 1001. [Pub. L. 112–144, title I, § 105(d)(2), July 9, 2012, 126 Stat. 1001, provided that the repeal of section 107 of Pub. L. 105–115, formerly set out above, is effective Sept. 30, 2002.] TERMINATION DATE Pub. L. 117–180, div. F, title I, § 1005(a), Sept. 30, 2022, 136 Stat. 2147, provided that: ‘‘Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective October 1, 2027.’’ Pub. L. 115–52, title I, § 104(a), Aug. 18, 2017, 131 Stat. 1012, which provided that this section and section 379h of this title would cease to be effective Oct. 1, 2022, was repealed by Pub. L. 117–180, div. F, title I, § 1005(c), Sept. 30, 2022, 136 Stat. 2147. [Pub. L. 117–180, div. F, title I, § 1005(c), Sept. 30, 2022, 136 Stat. 2147, provided that the repeal of section 104(a) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.] Pub. L. 112–144, title I, § 105(a), July 9, 2012, 126 Stat. 1001, which provided that this section and section 379h of this title would cease to be effective Oct. 1, 2017, was repealed by Pub. L. 115–52, title I, § 104(c), Aug. 18, 2017, 131 Stat. 1012. [Pub. L. 115–52, title I, § 104(c), Aug. 18, 2017, 131 Stat. 1012, provided that the repeal of section 105(a) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.] Pub. L. 102–571, title I, § 105, Oct. 29, 1992, 106 Stat. 4498, which provided that the amendment by section 103 of Pub. L. 102–571 (enacting this subpart) would not be in effect after Oct. 1, 1997, and the amendment by sec- tion 104 of Pub. L. 102–571 (enacting provisions set out as a note below) would not be in effect after 120 days after Oct. 1, 1997, was repealed by Pub. L. 112–144, title I, § 105(d)(3), July 9, 2012, 126 Stat. 1002. [Pub. L. 112–144, title I, § 105(d)(3), July 9, 2012, 126 Stat. 1002, provided that the repeal of section 105 of Pub. L. 102–571, formerly set out above, is effective Sept. 30, 1997.] SAVINGS PROVISION Pub. L. 117–180, div. F, title I, § 1007, Sept. 30, 2022, 136 Stat. 2147, provided that: ‘‘Notwithstanding the amend- ments made by this title [amending this section and section 379h and 379h–2 of this title and repealing provi- sions set out as notes under this section and section 379h–2 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), as in effect on the day before the date of the enactment of this title [Sept. 30, 2022], shall continue to be in effect with respect to human drug ap- plications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.’’ Pub. L. 115–52, title I, § 106, Aug. 18, 2017, 131 Stat. 1013, provided that: ‘‘Notwithstanding the amendments made by this title [see section 101(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title], part 2 of subchapter C of chap- ter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.], as in effect on the day before the date of the enactment of this title [Aug. 18, 2017], shall continue to be in effect with respect to human drug ap- plications and supplements (as defined in such part as of such day) that on or after October 1, 2012, but before October 1, 2017, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.’’ Pub. L. 112–144, title I, § 107, July 9, 2012, 126 Stat. 1002, provided that: ‘‘Notwithstanding the amendments made by this title [amending this section and section 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this title [July 9, 2012], shall continue to be in effect with respect to human drug applications and supple- ments (as defined in such part as of such day) that on or after October 1, 2007, but before October 1, 2012, were accepted by the Food and Drug Administration for fil- ing with respect to assessing and collecting any fee re- quired by such part for a fiscal year prior to fiscal year 2012.’’ Pub. L. 112–144, title IV, § 406, July 9, 2012, 126 Stat. 1039, provided that: ‘‘Notwithstanding the amendments made by this title [enacting sections 379j–51 to 379j–53 of this title and amending this section and section 379d–4 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this title [July 9, 2012], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Adminis- tration for filing on or after October 1, 2007, but before October 1, 2012, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2013.’’ Pub. L. 110–85, title I, § 108, Sept. 27, 2007, 121 Stat. 842, provided that: ‘‘Notwithstanding section 509 of the Pre- scription Drug User Fee Amendments of 2002 [Pub. L. 107–188] ([former] 21 U.S.C. 379g note), and notwith- standing the amendments made by this title [enacting sections 379h–1 and 379h–2 of this title and amending this section and sections 379h and 379j–11 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in ef- fect on the day before the date of the enactment of this title [Sept. 27, 2007], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007, were accept- ed by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008.’’ Pub. L. 107–188, title V, § 507, June 12, 2002, 116 Stat. 694, provided that: ‘‘Notwithstanding section 107 of the Food and Drug Administration Modernization Act of 1997 [section 107 of Pub. L. 105–115, formerly set out as an Effective and Termination Dates of 1997 Amendment note above], and notwithstanding the amendments made by this subtitle [subtitle A (§§ 501–509) of title V of Pub. L. 107–188, amending this section and sections 356b and 379h of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this Act [June 12, 2002], con- tinues to be in effect with respect to human drug appli- cations and supplements (as defined in such part as of such day) that, on or after October 1, 1997, but before October 1, 2002, were accepted by the Food and Drug Administration for filing and with respect to assessing and collecting any fee required by such Act for a fiscal year prior to fiscal year 2003.’’ Pub. L. 105–115, title I, § 105, Nov. 21, 1997, 111 Stat. 2305, provided that: ‘‘Notwithstanding section 105 of the Prescription Drug User Fee Act of 1992 [section 105 of Pub. L. 102–571, formerly set out as a Termination Date note above], the Secretary shall retain the authority to assess and collect any fee required by part 2 of sub- chapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] for a human drug applica- Page 525 TITLE 21—FOOD AND DRUGS § 379g tion or supplement accepted for filing prior to October 1, 1997, and to assess and collect any product or estab- lishment fee required by such Act for a fiscal year prior to fiscal year 1998.’’ ACCOUNTABILITY AND REPORTS Pub. L. 107–188, title V, § 505, June 12, 2002, 116 Stat. 692, provided that: ‘‘(a) PUBLIC ACCOUNTABILITY.— ‘‘(1) CONSULTATION.—In developing recommenda- tions to the Congress for the goals and plans for meeting the goals for the process for the review of human drug applications for the fiscal years after fis- cal year 2007, and for the reauthorization of sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g, 379h], the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall consult with the Committee on En- ergy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, rep- resentatives of patient and consumer advocacy groups, and the regulated industry. ‘‘(2) RECOMMENDATIONS.—The Secretary shall pub- lish in the Federal Register recommendations under paragraph (1), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such para- graph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide for a period of 30 days for the public to pro- vide written comments on such recommendations. ‘‘(b) PERFORMANCE REPORT.—Beginning with fiscal year 2003, not later than 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Sec- retary of Health and Human Services shall prepare and submit to the President, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 502(4) [sec- tion 502(4) of Pub. L. 107–188, set out below] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. ‘‘(c) FISCAL REPORT.—Beginning with fiscal year 2003, not later than 120 days after the end of each fiscal year during which fees are collected under the part de- scribed in subsection (b), the Secretary of Health and Human Services shall prepare and submit to the Com- mittee on Energy and Commerce of the House of Rep- resentatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report on the im- plementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Adminis- tration, of the fees collected during such fiscal year for which the report is made.’’ CONGRESSIONAL FINDINGS CONCERNING FEES RELATING TO DRUGS Pub. L. 117–180, div. F, title I, § 1001(b), Sept. 30, 2022, 136 Stat. 2140, provided that: ‘‘Congress finds that the fees authorized by the amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activi- ties, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.’’ Pub. L. 115–52, title I, § 101(b), Aug. 18, 2017, 131 Stat. 1006, provided that: ‘‘The Congress finds that the fees authorized by the amendments made in this title [see section 101(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] will be dedicated toward expediting the drug develop- ment process and the process for the review of human drug applications, including postmarket drug safety ac- tivities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.’’ Pub. L. 112–144, title I, § 101(b), July 9, 2012, 126 Stat. 996, provided that: ‘‘The Congress finds that the fees au- thorized by the amendments made in this title [amend- ing this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activi- ties, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the let- ters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Edu- cation, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.’’ Pub. L. 110–85, title I, § 101(c), Sept. 27, 2007, 121 Stat. 825, provided that: ‘‘The Congress finds that the fees authorized by the amendments made in this title [en- acting sections 379h–1 and 379h–2 of this title and amending this section and sections 379h and 379j–11 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.’’ Pub. L. 107–188, title V, § 502, June 12, 2002, 116 Stat. 687, provided that: ‘‘The Congress finds that— ‘‘(1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement of the public health so that patients may enjoy the ben- efits provided by these therapies to treat and prevent illness and disease; ‘‘(2) the public health will be served by making ad- ditional funds available for the purpose of aug- menting the resources of the Food and Drug Adminis- tration that are devoted to the process for the review of human drug applications and the assurance of drug safety; ‘‘(3) the provisions added by the Prescription Drug User Fee Act of 1992 [see section 101(a) of Pub. L. 102–571, set out as a Short Title of 1992 Amendment note under section 301 of this title], as amended by the Food and Drug Administration Modernization Act of 1997 [see Short Title of 1997 Amendment note set out under section 301 of this title], have been suc- cessful in substantially reducing review times for human drug applications and should be— ‘‘(A) reauthorized for an additional 5 years, with certain technical improvements; and ‘‘(B) carried out by the Food and Drug Adminis- tration with new commitments to implement more Page 526 TITLE 21—FOOD AND DRUGS § 379g ambitious and comprehensive improvements in reg- ulatory processes of the Food and Drug Administra- tion, including— ‘‘(i) strengthening and improving the review and monitoring of drug safety; ‘‘(ii) considering greater interaction between the agency and sponsors during the review of drugs and biologics intended to treat serious dis- eases and life-threatening diseases; and ‘‘(iii) developing principles for improving first- cycle reviews; and ‘‘(4) the fees authorized by amendments made in this subtitle [subtitle A (§§ 501–509) of title V of Pub. L. 107–188, amending this section and sections 356b and 379h of this title] will be dedicated towards expe- diting the drug development process and the process for the review of human drug applications as set forth in the goals identified for purposes of part 2 of sub- chapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the chairman of the Committee on Energy and Commerce of the House of Representatives and the chairman of the Committee on Health, Education, Labor and Pen- sions of the Senate, as set forth in the Congressional Record.’’ Pub. L. 105–115, title I, § 101, Nov. 21, 1997, 111 Stat. 2298, provided that: ‘‘Congress finds that— ‘‘(1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement of the public health so that patients may enjoy the ben- efits provided by these therapies to treat and prevent illness and disease; ‘‘(2) the public health will be served by making ad- ditional funds available for the purpose of aug- menting the resources of the Food and Drug Adminis- tration that are devoted to the process for review of human drug applications; ‘‘(3) the provisions added by the Prescription Drug User Fee Act of 1992 [see section 101(a) of Pub. L. 102–571, set out as a Short Title of 1992 Amendment note under section 301 of this title] have been success- ful in substantially reducing review times for human drug applications and should be— ‘‘(A) reauthorized for an additional 5 years, with certain technical improvements; and ‘‘(B) carried out by the Food and Drug Adminis- tration with new commitments to implement more ambitious and comprehensive improvements in reg- ulatory processes of the Food and Drug Administra- tion; and ‘‘(4) the fees authorized by amendments made in this subtitle [subtitle A (§§ 101–107) of title I of Pub. L. 105–115, amending this section and section 379h of this title] will be dedicated toward expediting the drug development process and the review of human drug applications as set forth in the goals identified, for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the chairman of the Com- mittee on Commerce of the House of Representatives and the chairman of the Committee on Labor and Human Resources [now Committee on Health, Edu- cation, Labor, and Pensions] of the Senate, as set forth in the Congressional Record.’’ Pub. L. 102–571, title I, § 102, Oct. 29, 1992, 106 Stat. 4491, provided that: ‘‘The Congress finds that— ‘‘(1) prompt approval of safe and effective new drugs is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and dis- ease; ‘‘(2) the public health will be served by making ad- ditional funds available for the purpose of aug- menting the resources of the Food and Drug Adminis- tration that are devoted to the process for review of human drug applications; and ‘‘(3) the fees authorized by this title [see Short Title of 1992 Amendment note, set out under section 301 of this title] will be dedicated toward expediting the review of human drug applications as set forth in the goals identified in the letters of September 14, 1992, and September 21, 1992, from the Commissioner of Food and Drugs to the Chairman of the Energy and Commerce Committee of the House of Representa- tives and the Chairman of the Labor and Human Re- sources Committee of the Senate, as set forth at 138 Cong. Rec. H9099–H9100 (daily ed. September 22, 1992) [Cong. Rec., vol. 138, pt. 18, p. 26928, Sept. 22, 1992].’’ ANNUAL REPORTS Pub. L. 105–115, title I, § 104, Nov. 21, 1997, 111 Stat. 2304, provided that: ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal year 1998, not later than 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Sec- retary of Health and Human Services shall prepare and submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(4) [section 101(4) of Pub. L. 105–115, set out above] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. ‘‘(b) FISCAL REPORT.—Beginning with fiscal year 1998, not later than 120 days after the end of each fiscal year during which fees are collected under the part de- scribed in subsection (a), the Secretary of Health and Human Services shall prepare and submit to the Com- mittee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report on the implementation of the au- thority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.’’ Pub. L. 102–571, title I, § 104, Oct. 29, 1992, 106 Stat. 4498, provided that: ‘‘(a) FIRST REPORT.—Within 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], the Sec- retary of Health and Human Services shall submit a re- port stating the Food and Drug Administration’s progress in achieving the goals identified in section 102(3) of this Act [set out as a note above] during such fiscal year and that agency’s future plans for meeting such goals. ‘‘(b) SECOND REPORT.—Within 120 days after the end of each fiscal year during which such fees are collected, the Secretary of Health and Human Services shall sub- mit a report on the implementation of the authority for such fees during such fiscal year and on the use the Food and Drug Administration made of the fees col- lected during such fiscal year for which the report is made. ‘‘(c) COMMITTEES.—The reports described in sub- sections (a) and (b) shall be submitted to the Com- mittee on Energy and Commerce of the House of Rep- resentatives and the Committee on Labor and Human Resources of the Senate.’’ ANIMAL DRUG USER FEE STUDY Pub. L. 102–571, title I, § 108, Oct. 29, 1992, 106 Stat. 4500, directed Secretary, in consultation with manufac- turers of animal drug products and other interested persons, to undertake study to evaluate whether, and under what conditions, to impose user fees to supple- ment appropriated funds in order to improve process of reviewing applications (including abbreviated and sup- plemental applications) for new animal drugs under section 360b of this title, and further provided for sub- mission of study to Congress no later than Jan. 4, 1994. Page 527 TITLE 21—FOOD AND DRUGS § 379h § 379h. Authority to assess and use drug fees (a) Types of fees Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows: (1) Human drug application fee (A) In general Each person that submits, on or after Sep- tember 1, 1992, a human drug application shall be subject to a fee as follows: (i) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bio- availability or bioequivalence studies) with respect to safety or effectiveness are required for approval. (ii) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bio- availability or bioequivalence studies) with respect to safety or effectiveness are not required for approval. Such fee shall be half of the amount of the fee established under clause (i). (B) Payment The fee required by subparagraph (A) shall be due upon submission of the application. (C) Exception for previously filed application If a human drug application was submitted by a person that paid the fee for such appli- cation, was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver), the submission of a human drug application for the same prod- uct by the same person (or the person’s li- censee, assignee, or successor) shall not be subject to a fee under subparagraph (A). (D) Refund of fee if application refused for filing or withdrawn before filing The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any application which is refused for filing or withdrawn without a waiver before filing. (E) Fees for applications previously refused for filing or withdrawn before filing A human drug application that was sub- mitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resub- mitted or filed over protest, unless the fee is waived or reduced under subsection (d). (F) Exception for designated orphan drug A human drug application for a prescrip- tion drug product that has been designated as a drug for a rare disease or condition pur- suant to section 360bb of this title shall not be subject to a fee under subparagraph (A), unless the human drug application includes an indication for other than a rare disease or condition. (G) Refund of fee if application withdrawn If an application is withdrawn after the ap- plication was filed, the Secretary may re- fund the fee or a portion of the fee if no sub- stantial work was performed on the applica- tion after the application was filed. The Sec- retary shall have the sole discretion to re- fund a fee or a portion of the fee under this subparagraph. A determination by the Sec- retary concerning a refund under this para- graph shall not be reviewable. (H) Exception for skin-test diagnostic prod- ucts A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A). (2) Prescription drug program fee (A) In general (i) Payment of fees Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pend- ing before the Secretary a human drug ap- plication or supplement, shall pay the an- nual prescription drug program fee estab- lished for a fiscal year under subsection (c)(6) for each prescription drug product that is identified in such a human drug ap- plication approved as of October 1 of such fiscal year. Such fee shall be due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an ap- propriations Act providing for the collec- tion and obligation of fees for such fiscal year under this section. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable. (ii) Special rule for previously discon- tinued drug products If a drug product that is identified in a human drug application approved as of Oc- tober 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list referenced in section 379g(3)(A)(iii) of this title, and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug pro- gram fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for a fiscal year in which the fee is payable. (B) Exception for certain prescription drug products A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is— (i) a large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume great- er than or equal to 100 mL, not including