United States Government Printing Office printer prt distributor dst United States Congress House of Representatives Office of the Law Revision Counsel author aut Government Organization text government publication eng USCODE Bills and Statutes 2006_uscode_suppl_4 legislative 2011-09-06 Sec. 379h D09002ee180df8153-USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379h.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379h.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379h 21USC379h http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379h/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379h.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379h.htm 21 U.S.C. 379h 21 USC 379h 21 U.S.C. 379h 21 USC 379h; FOOD AND DRUGS; Authority to assess and use drug fees 281 LEAF USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379h Sec. 379h section standard June 25, 1938, ch. 675, §736, as added Pub. L. 102-571, title I, §103, Oct. 29, 1992, 106 Stat. 4494; amended Pub. L. 105-115, title I, §103(a)-(g), Nov. 21, 1997, 111 Stat. 2299-2304; Pub. L. 107-109, §5(a), Jan. 4, 2002, 115 Stat. 1413; Pub. L. 107-188, title V, §504, June 12, 2002, 116 Stat. 689; Pub. L. 110-85, title I, §103(a)-(h)(1), Sept. 27, 2007, 121 Stat. 826-832. futureAmend For termination of amendment by section 106(a) of Pub. L. 110-85, see Effective and Termination Dates of 2007 Amendment note below.For termination of amendment by section 509 of Pub. L. 107-188, see Effective and Termination Date of 2002 Amendments note below.For termination of amendment by section 107 of Pub. L. 105-115, see Effective and Termination Dates of 1997 Amendment note below.For termination of section by section 105 of Pub. L. 102-571, see Termination Date note below. referencesInText Section 357 of this title, referred to in subsec. (a)(3)(B), was repealed by Pub. L. 105-115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325.The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in subsec. (a)(3)(B), is Pub. L. 98-417, Sept. 24, 1984, 98 Stat. 1585. For complete classification of this Act to the Code, see Short Title of 1984 Amendment note set out under section 301 of this title and Tables. amendments <b>2007</b>-Subsec. (a). Pub. L. 110-85, §§103(a)(1), 106(a), temporarily substituted “2008” for “2003” in introductory provisions. See Effective and Termination Dates of 2007 Amendment note below.Subsec. (a)(1)(A). Pub. L. 110-85, §§103(g), 106(a), temporarily substituted “(c)(5)” for “(c)(4)” in cls. (i) and <!-- PDFPage:338 -->(ii). See Effective and Termination Dates of 2007 Amendment note below.Subsec. (a)(1)(D). Pub. L. 110-85, §§103(a)(2)(A), 106(a), temporarily inserted “or withdrawn before filing” after “refused for filing” in heading and “or withdrawn without a waiver before filing” before period at end of text. See Effective and Termination Dates of 2007 Amendment note below.Subsec. (a)(1)(E) to (G). Pub. L. 110-85, §§103(a)(2)(B), (C), 106(a), temporarily added subpar. (E) and redesignated former subpars. (E) and (F) as (F) and (G), respectively. See Effective and Termination Dates of 2007 Amendment note below.Subsec. (a)(2)(A). Pub. L. 110-85, §§103(a)(3)(A), (g), 106(a), temporarily substituted “subparagraphs (B) and (C)” for “subparagraph (B)” in introductory provisions and “(c)(5)” for “(c)(4)” in concluding provisions. See Effective and Termination Dates of 2007 Amendment note below.Subsec. (a)(2)(C). Pub. L. 110-85, §§103(a)(3)(B), 106(a), temporarily added subpar. (C). See Effective and Termination Dates of 2007 Amendment note below.Subsec. (a)(3)(A). Pub. L. 110-85, §§103(g), 106(a), temporarily substituted “(c)(5)” for “(c)(4)”. See Effective and Termination Dates of 2007 Amendment note below.Subsec. (b). Pub. L. 110-85, §§103(b), 106(a), temporarily amended subsec. (b) generally, substituting provisions contained in pars. (1) to (4) relating to fee revenue amounts for fiscal years 2008 through 2012 for undesignated provisions relating to fee schedules for fiscal years 2003 to 2007. See Effective and Termination Dates of 2007 Amendment note below.Subsec. (c)(1). Pub. L. 110-85, §§103(c)(1), 106(a), temporarily amended par. (1) by substituting “For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b)” for “The revenues established in subsection (b)” in introductory provisions, adding subpar. (C), and substituting “fiscal year 2008” for “fiscal year 2003” in concluding provisions. See Effective and Termination Dates of 2007 Amendment note below.Subsec. (c)(2). Pub. L. 110-85, §§103(c)(2)(A), 106(a), temporarily substituted “For fiscal year 2009 and subsequent fiscal years,” for “Beginning with fiscal year 2004,” in introductory provisions. See Effective and Termination Dates of 2007 Amendment note below.Subsec. (c)(2)(A). Pub. L. 110-85, §§103(c)(2)(B), 106(a), temporarily substituted “human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph), efficacy supplements, and manufacturing supplements submitted to the Secretary, and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available.” for “human drug applications, commercial investigational new drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary.” in first sentence. See Effective and Termination Dates of 2007 Amendment note below.Subsec. (c)(2)(B). Pub. L. 110-85, §§103(c)(2)(C), 106(a), temporarily inserted at end “Any adjustment for changes in review activities made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would have been in the absence of the adjustment for changes in review activities.” See Effective and Termination Dates of 2007 Amendment note below.Subsec. (c)(2)(C). Pub. L. 110-85, §§103(c)(2)(D), 106(a), temporarily added subpar. (C). See Effective and Termination Dates of 2007 Amendment note below.Subsec. (c)(3). Pub. L. 110-85, §§103(c)(3), 106(a), temporarily added par. (3). Former par. (3) redesignated (4). See Effective and Termination Dates of 2007 Amendment note below.Subsec. (c)(4). Pub. L. 110-85, §§103(c)(3)(A), (4), 106(a), temporarily redesignated par. (3) as (4) and amended it generally. Prior to amendment, text read as follows: “For fiscal year 2007, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenues and fees established in subsection (b) of this section if such an adjustment is necessary to provide for not more than three months of operating reserves of carryover user fees for the process for the review of human drug applications for the first three months of fiscal year 2008. If such an adjustment is necessary, the rationale for the amount of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2007. If the Secretary has carryover balances for such process in excess of three months of such operating reserves, the adjustment under this paragraph shall not be made.” Former par. (4) redesignated (5). See Effective and Termination Dates of 2007 Amendment note below.Subsec. (c)(5). Pub. L. 110-85, §§103(c)(3)(A), (5), 106(a), temporarily redesignated par. (4) as (5) and substituted “2007” for “2002”. Former par. (5) redesignated (6). See Effective and Termination Dates of 2007 Amendment note below.Subsec. (c)(6). Pub. L. 110-85, §§103(c)(3)(A), 106(a), temporarily redesignated par. (5) as (6). See Effective and Termination Dates of 2007 Amendment note below.Subsec. (d)(1). Pub. L. 110-85, §§103(d)(1), 106(a), temporarily inserted “to a person who is named as the applicant in a human drug application” after “The Secretary shall grant” and “to that person” after “one or more fees assessed” in introductory provisions. See Effective and Termination Dates of 2007 Amendment note below.Subsec. (d)(2), (3). Pub. L. 110-85, §§103(d)(2), (3), 106(a), temporarily added par. (2) and redesignated former par. (2) as (3). Former par. (3) redesignated (4). See Effective and Termination Dates of 2007 Amendment note below.Subsec. (d)(4). Pub. L. 110-85, §§103(d)(2), 106(a), temporarily redesignated par. (3) as (4). See Effective and Termination Dates of 2007 Amendment note below.Subsec. (d)(4)(A). Pub. L. 110-85, §§103(d)(4), 106(a), temporarily inserted before period at end “,and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce”. See Effective and Termination Dates of 2007 Amendment note below.Subsec. (g)(1). Pub. L. 110-85, §§103(h)(1), 106(a), temporarily substituted “Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended.” for “Fees collected for a fiscal year pursuant to subsection (a) of this section shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration and shall be available in accordance with appropriation Acts until expended without fiscal year limitation.” See Effective and Termination Dates of 2007 Amendment note below.Subsec. (g)(3). Pub. L. 110-85, §§103(e)(1), 106(a), temporarily amended par. (3) generally. Prior to amendment, par. (3) authorized appropriations for fiscal years 2003 to 2007. See Effective and Termination Dates of 2007 Amendment note below.Subsec. (g)(4). Pub. L. 110-85, §§103(e)(2), 106(a), temporarily reenacted heading without change and amended text generally. Prior to amendment, text read as follows: “Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.” See Effective and Termination Dates of 2007 Amendment note below.Subsec. (k). Pub. L. 110-85, §§103(f), 106(a), temporarily added subsec. (k). See Effective and Termination Dates of 2007 Amendment note below.<b>2002</b>-Subsec. (a). Pub. L. 107-188, §§504(a)(1), 509, temporarily substituted “fiscal year 2003” for “fiscal year <!-- PDFPage:339 -->1998” in introductory provisions. See Effective and Termination Dates of 2002 Amendment note below.Subsec. (a)(1)(A)(i). Pub. L. 107-188, §§504(a)(2)(A), 509, temporarily substituted “under subsection (c)(4)” for “in subsection (b)”. See Effective and Termination Dates of 2002 Amendment note below.Subsec. (a)(1)(A)(ii). Pub. L. 107-188, §§504(a)(2), 509, temporarily substituted “under subsection (c)(4)” for “in subsection (b)” and inserted “Such fee shall be half of the amount of the fee established under clause (i).” at end. See Effective and Termination Dates of 2002 Amendment note below.Subsec. (a)(1)(F), (G). Pub. L. 107-109 redesignated subpar. (G) as (F) and struck out heading and text of former subpar. (F). Text read as follows: “A supplement to a human drug application proposing to include a new indication for use in pediatric populations shall not be assessed a fee under subparagraph (A).”Subsec. (a)(2)(A). Pub. L. 107-188, §§504(a)(3), 509, in concluding provisions, temporarily substituted “under subsection (c)(4)” for “in subsection (b)” and “payable on or before October 1” for “payable on or before January 31”. See Effective and Termination Dates of 2002 Amendment note below.Subsec. (a)(3)(A). Pub. L. 107-188, §§504(a)(4)(A), 509, temporarily amended heading and text of subpar. (A) generally. Prior to amendment, text read as follows: “Except as provided in subparagraph (B), each person-Subsec. (a)(3)(B). Pub. L. 107-188, §§504(a)(4)(B), 509, temporarily substituted “A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section 355(j)(7)(A) of this title with a potency described in terms of per 100 mL, or if such product is the same product as another product approved under an application filed under section 355(b)” for “The listing of a prescription drug product under section 360 of this title shall not require the person who listed such product to pay the fee prescribed by subparagraph (A) if such product is the same product as a product approved under an application filed under section 355(b)(2)”. See Effective and Termination Dates of 2002 Amendment note below.Subsec. (b). Pub. L. 107-188, §§504(b), 509, temporarily amended heading and text of subsec. (b) generally, substituting “Fee revenue amounts” for “Fee amounts” in heading and substituting fee schedules for fiscal years 2003 to 2007 for fee provisions relating to fiscal years 1998 to 2002. See Effective and Termination Dates of 2002 Amendment note below.Subsec. (c)(1). Pub. L. 107-188, §§504(c)(1)(A), (D), 509, temporarily substituted “revenues” for “fees and total fee revenues” in introductory provisions and “fiscal year 2003” for “fiscal year 1997” in concluding provisions. See Effective and Termination Dates of 2002 Amendment note below.Subsec. (c)(1)(A). Pub. L. 107-188, §§504(c)(1)(B), 509, temporarily struck out “during the preceding fiscal year” before “in the Consumer Price Index” and substituted “for the 12 month period ending June 30 preceding the fiscal year for which fees are being established, or” for “,or”. See Effective and Termination Dates of 2002 Amendment note below.Subsec. (c)(1)(B). Pub. L. 107-188, §§504(c)(1)(C), 509, temporarily substituted “for the previous fiscal year” for “for such fiscal year”. See Effective and Termination Dates of 2002 Amendment note below.Subsec. (c)(2) to (5). Pub. L. 107-188, §§504(c)(2)-(4), 509, temporarily added pars. (2) and (3), redesignated former pars. (2) and (3) as (4) and (5), respectively, and amended heading and text of par. (4) generally. Prior to amendment, text of par. (4) read as follows: “Subject to the amount appropriated for a fiscal year under subsection (g) of this section, the Secretary shall, within 60 days after the end of each fiscal year beginning after September 30, 1997, adjust the establishment and product fees described in subsection (b) of this section for the fiscal year in which the adjustment occurs so that the revenues collected from each of the categories of fees described in paragraphs (2) and (3) of subsection (b) of this section shall be set to be equal to the revenues collected from the category of application and supplement fees described in paragraph (1) of subsection (b) of this section.” See Effective and Termination Dates of 2002 Amendment note below.Subsec. (d)(1)(C) to (E). Pub. L. 107-188, §§504(d)(1), 509, temporarily inserted “or” at end of subpar. (C), redesignated subpar. (E) as (D), and struck out former subpar. (D) which read as follows: “assessment of the fee for an application or a supplement filed under section 355(b)(1) of this title pertaining to a drug containing an active ingredient would be inequitable because an application for a product containing the same active ingredient filed by another person under section 355(b)(2) of this title could not be assessed fees under subsection (a)(1) of this section, or”. See Effective and Termination Dates of 2002 Amendment note below.Subsec. (d)(3)(A), (B). Pub. L. 107-188, §§504(d)(2), 509, temporarily substituted “paragraph (1)(D)” for “paragraph (1)(E)”. See Effective and Termination Dates of 2002 Amendment note below.Subsec. (f). Pub. L. 107-188, §§504(e)(1), 509, temporarily substituted “Limitations” for “Assessment of fees” in heading. See Effective and Termination Dates of 2002 Amendment note below.Subsec. (f)(1). Pub. L. 107-188, §§504(e)(2), 509, temporarily substituted “In general” for “Limitation” in heading and “Fees under subsection (a) of this section shall be refunded for a fiscal year beginning” for “Fees may not be assessed under subsection (a) of this section for a fiscal year beginning” in text. See Effective and Termination Dates of 2002 Amendment note below.Subsec. (g)(1). Pub. L. 107-188, §§504(f)(1), 509, which directed the temporary amendment of par. (1) by striking “Fees collected for a fiscal year” and all that follows through “fiscal year limitation.” and inserting “Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended.”, was not executed because the phrase “fiscal year limitation.” appeared in two places and because of the corrective amendment by Pub. L. 110-85, §103(h)(1), which is effective as if included in Pub. L. 107-188, §504. See 2007 Amendment note above and Effective and Termination Dates of 2002 Amendment note and Effective and Termination Dates of 2007 Amendment note below.Subsec. (g)(2). Pub. L. 107-188, §§504(f)(2), 509, temporarily amended par. (2) by designating existing provisions as subpar. (A), inserting subpar. (A) heading, adding subpar. (B), redesignating former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A), substituting “shall be retained in each fiscal year in an amount not to exceed the amount specified” for “shall be collected in each fiscal year in an amount equal to the amount specified” in cl. (i), and realigning margin of cl. (ii). See Effective and Termination Dates of 2002 Amendment note below.Subsec. (g)(3)(A) to (E). Pub. L. 107-188, §§504(f)(3), 509, temporarily added subpars. (A) to (E) and struck out former subpars. (A) to (E) which read as follows:“(A) $106,800,000 for fiscal year 1998;“(B) $109,200,000 for fiscal year 1999;“(C) $109,200,000 for fiscal year 2000;“(D) $114,000,000 for fiscal year 2001; and“(E) $110,100,000 for fiscal year 2002,”.<b>1997</b>-Subsec. (a). Pub. L. 105-115, §§103(a)(1), 107, temporarily substituted “Beginning in fiscal year 1998” for “Beginning in fiscal year 1993” in introductory provisions. See Effective and Termination Dates of 1997 Amendment note below.Subsec. (a)(1)(B). Pub. L. 105-115, §§103(a)(2)(A), 107, temporarily amended heading and text of subpar. (B) generally. Prior to amendment, text read as follows:“(i) <cap-smallcap>First payment</cap-smallcap>.-50 percent of the fee required by subparagraph (A) shall be due upon submission of the application or supplement.“(ii) <cap-smallcap>Final payment</cap-smallcap>.-The remaining 50 percent of the fee required by subparagraph (A) shall be due upon-Subsec. (a)(1)(D). Pub. L. 105-115, §§103(a)(2)(B), 107, temporarily substituted “refused” for “not accepted” in heading and “75 percent” for “50 percent”, “subparagraph (B)” for “subparagraph (B)(i)”, and “refused” for “not accepted” in text. See Effective and Termination Dates of 1997 Amendment note below.Subsec. (a)(1)(E) to (G). Pub. L. 105-115, §§103(a)(2)(C), 107, temporarily added subpars. (E) to (G). See Effective and Termination Dates of 1997 Amendment note below.Subsec. (a)(2). Pub. L. 105-115, §§103(a)(3), 107, temporarily reenacted heading without change and amended text generally. Prior to amendment, text read as follows: “Each person that-Subsec. (a)(3)(A). Pub. L. 105-115, §§103(a)(4)(A), 107, temporarily substituted, in cl. (i), “has been submitted for listing” for “is listed” and, in closing provisions, “Such fee shall be payable for the fiscal year in which the product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be payable on or before January 31 of each year. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.” for “Such fee shall be payable at the time of the first such listing of such product in each calendar year. Such fee shall be paid only once each year for each listed prescription drug product irrespective of the number of times such product is listed under section 360 of this title.” See Effective and Termination Dates of 1997 Amendment note below.Subsec. (a)(3)(B). Pub. L. 105-115, §§103(a)(4)(B), 107, temporarily substituted “355(j) of this title, under an abbreviated application filed under section 357 of this title (as in effect on the day before November 21, 1997), or under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984.” for “355(j) of this title.”. See Effective and Termination Dates of 1997 Amendment note below.Subsec. (b). Pub. L. 105-115, §§103(b), 107, temporarily amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee amounts, including a schedule of fees in par. (1) and fee exceptions for certain small businesses in par. (2). See Effective and Termination Dates of 1997 Amendment note below.Subsec. (c). Pub. L. 105-115, §§103(c)(1), 107, temporarily substituted “Adjustments” for “Increases and adjustments” in heading. See Effective and Termination Dates of 1997 Amendment note below.Subsec. (c)(1). Pub. L. 105-115, §§103(c)(2), 107, temporarily substituted “Inflation adjustment” for “Revenue increase” in heading, “The fees and total fee revenues established in subsection (b) of this section shall be adjusted by the Secretary” for “The total fee revenues established by the schedule in subsection (b)(1) of this section shall be increased by the Secretary” in introductory provisions, and “change” for “increase” after “total percentage” in subpars. (A) and (B), and inserted at end “The adjustment made each fiscal year by this subsection will be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 1997 under this subsection.” See Effective and Termination Dates of 1997 Amendment note below.Subsec. (c)(2). Pub. L. 105-115, §§103(c)(3), 107, temporarily substituted “September 30, 1997, adjust the establishment and product fees described in subsection (b) of this section for the fiscal year in which the adjustment occurs so that the revenues collected from each of the categories of fees described in paragraphs (2) and (3) of subsection (b) of this section shall be set to be equal to the revenues collected from the category of application and supplement fees described in paragraph (1) of subsection (b) of this section.” for “October 1, 1992, adjust the fees established by the schedule in subsection (b)(1) of this section for the following fiscal year to achieve the total fee revenues, as may be increased under paragraph (1). Such fees shall be adjusted under this paragraph to maintain the proportions established in such schedule.” See Effective and Termination Dates of 1997 Amendment note below.Subsec. (c)(3). Pub. L. 105-115, §§103(c)(4), 107, temporarily substituted “this subsection” for “paragraph (2)”. See Effective and Termination Dates of 1997 Amendment note below.Subsec. (d). Pub. L. 105-115, §§103(d), 107, temporarily struck out introductory provisions which read “The Secretary shall grant a waiver from or a reduction of 1 or more fees under subsection (a) of this section where the Secretary finds that-” and closing provisions which read “In making the finding in paragraph (3), the Secretary may use standard costs.”, inserted designation, heading, and introductory provisions of par. (1), redesignated former pars. (1) to (4) as subpars. (A) to (D), respectively, of par. (1), and added pars. (1)(E), (2), and (3). See Effective and Termination Dates of 1997 Amendment note below.Subsec. (f)(1). Pub. L. 105-115, §§103(e), 107, temporarily substituted “fiscal year 1997” for “fiscal year 1993” and “fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year)” for “fiscal year 1992”. See Effective and Termination Dates of 1997 Amendment note below.Subsec. (g)(1). Pub. L. 105-115, §§103(f)(1), 107, temporarily inserted at end “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. The sums transferred shall be available solely for the process for the review of human drug applications.” See Effective and Termination Dates of 1997 Amendment note below.Subsec. (g)(2)(A). Pub. L. 105-115, §§103(f)(2)(A), 107, temporarily substituted “Acts, or otherwise made available for obligation,” for “Acts”. See Effective and Termination Dates of 1997 Amendment note below.Subsec. (g)(2)(B). Pub. L. 105-115, §§103(f)(2)(B), 107, temporarily substituted “over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997” for “over such costs for fiscal year 1992”. See Effective and Termination Dates of 1997 Amendment note below.Subsec. (g)(3), (4). Pub. L. 105-115, §§103(f)(3), 107, temporarily added pars. (3) and (4) and struck out heading and text of former par. (3). Text read as follows: “There are authorized to be appropriated for fees under this section-Subsecs. (i), (j). Pub. L. 105-115, §§103(g), 107, temporarily added subsec. (i) and redesignated former subsec. (i) as (j). See Effective and Termination Dates of 1997 Amendment note below. false false false

Title 21 Section 379get seq. 21 U.S.C. 379get seq. Title 42 Section 379h 42 U.S.C. 379h Volume 98 Page 1585 98 Stat. 1585 Volume 106 Page 4494 106 Stat. 4494 Volume 111 Page 2299-2304 111 Stat. 2299-2304 Volume 111 Page 2325 111 Stat. 2325 Volume 115 Page 1413 115 Stat. 1413 Volume 116 Page 689 116 Stat. 689 Volume 116 Page 687 116 Stat. 687 Volume 121 Page 826-832 121 Stat. 826-832 Volume 121 Page 832 121 Stat. 832 Public Law 98-417 Public Law 102-571 Public Law 102-571 Public Law 105-115 Public Law 105-115 Public Law 107-109 Public Law 107-109 Public Law 107-188 Public Law 107-188 Public Law 110-85 Public Law 110-85 U.S. Government Printing Office 2010-12-31 monographic 2010 annual deposited born digital 711 p. Y 1.2/5: http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21 P0b002ee180df746e 000645501 21USC DGPO 2011-09-06 2011-09-06 USCODE-2010-title21 machine generated eng fdlp USCODE USCODE-2010-title21 21 true 4 2006 false false 2011-01-07 false false USCODE-title21 Title 21 http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21.htm http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21.pdf U.S.C. Title 21, 2010