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. 379g D09002ee180df8153-USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379g.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379g.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379g 21USC379g http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379g/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379g.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379g.htm 21 U.S.C. 379g 21 USC 379g 21 U.S.C. 379g 21 USC 379g; FOOD AND DRUGS; Definitions 280 LEAF USCODE-2010-title21-chap9-subchapVII-partC-subpart2-sec379g Sec. 379g section standard 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. 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 Dates of 2002 Amendment 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. amendments <b>2010</b>-Par. (1)(B). Pub. L. 111-148 substituted “subsection (a) or (k) of section 262 of title 42” for “section 262 of title 42”.<b>2007</b>-Pub. L. 110-85, §§102(1), 106(a), in introductory provisions, temporarily substituted “For purposes of this subpart” for “For purposes of this part”. See Effective and Termination Dates of 2007 Amendment note below.Par. (1). Pub. L. 110-85, §§102(2)(D), 106(a), temporarily substituted “subparagraph (B)” for “subparagraph (C)” in concluding provisions. See Effective and Termination Dates of 2007 Amendment note below.Par. (1)(A). Pub. L. 110-85, §§102(2)(A), 106(a), temporarily substituted “355(b) of this title, or” for “355(b)(1) of this title,”. See Effective and Termination Dates of 2007 Amendment note below.Par. (1)(B), (C). Pub. L. 110-85, §§102(2)(B), (C), 106(a), temporarily redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: “approval of a new drug submitted under section 355(b)(2) of this title after September 30, 1992, which requests approval of-Par. (3)(C). Pub. L. 110-85, §§102(3), 106(a), temporarily substituted “355(j)(7)(A) of this title (not including the discontinued 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. See Effective and Termination Dates of 2007 Amendment note below.Par. (4). Pub. L. 110-85, §§102(4), 106(a), temporarily inserted “(such as capsules, tablets, or lyophilized products before reconstitution)” before period at end. See Effective and Termination Dates of 2007 Amendment note below.Par. (6)(F). Pub. L. 110-85, §§102(5), 106(a), temporarily 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 information on the drugs, including adverse event reports, during a period of time after approval of such applications or supplements, not to exceed three years.” See Effective and Termination Dates of 2007 Amendment note below.Par. (8). Pub. L. 110-85, §§102(6), 106(a), temporarily substituted “October of the preceding fiscal year” for “April of the preceding fiscal year” and “October 1996” for “April 1997”. See Effective and Termination Dates of 2007 Amendment note below.Pars. (9) to (11). Pub. L. 110-85, §§102(7), (8), 106(a), temporarily added pars. (9) and (10) and redesignated former par. (9) as (11). See Effective and Termination Dates of 2007 Amendment note below.<b>2002</b>-Par. (1). Pub. L. 107-188, §§503(1), 509, temporarily substituted “licensure, as described in subparagraph (C)” for “licensure, as described in subparagraph (D)” in concluding provisions. See Effective and Termination Dates of 2002 Amendment note below.Par. (3). Pub. L. 107-188, §§503(2)(D), 509, which directed the temporary 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 probable intent of Congress. See Effective and Termination Dates of 2002 Amendment note below.Par. (3)(C). Pub. L. 107-188, §§503(2)(A)-(C), 509, temporarily added subpar. (C). See Effective and Termination Dates of 2002 Amendment note below.Par. (6)(F). Pub. L. 107-188, §§503(3), 509, temporarily added subpar. (F). See Effective and Termination Dates of 2002 Amendment note below.Par. (8). Pub. L. 107-188, §§503(4), 509, temporarily struck out designations of subpars. (A) and (B) and text of subpar. (B) and concluding provisions, substituting definition of “adjustment factor” as the Consumer Price Index for definition of Index as the lower of the Consumer Price Index or the total of discretionary budget authority provided for programs in the domestic category for the immediately preceding fiscal year divided by such budget authority for fiscal year 1997. See Effective and Termination Dates of 2002 Amendment note below.<b>1997</b>-Par. (1). Pub. L. 105-115, §§102(1), 107, in closing provisions, temporarily struck out “and” before “does not include an application” 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 include an application for licensure, as described in subparagraph (D), of a large volume biological product intended for single dose injection for intravenous use or infusion” for “September 1, 1992” before period at end. See Effective and Termination Dates of 1997 Amendment note below.Par. (1)(B) to (D). Pub. L. 105-115, §125(b)(2)(M), inserted “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), 107, in closing provisions, temporarily struck out “and” before “does not include a large volume parenteral drug” and substituted “September 1, 1992, does not include a biological product that is licensed 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 submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion” for “September 1, 1992” before period at end. See Effective and Termination Dates of 1997 Amendment note below.Par. (4). Pub. L. 105-115, §§102(3), 107, temporarily substituted “without substantial further manufacturing” for “without further manufacturing”. See Effective and Termination Dates of 1997 Amendment note below.Par. (5). Pub. L. 105-115, §§102(4), 107, temporarily amended first sentence generally. Prior to amendment, first sentence read as follows: “The term ‘prescription drug establishment’ means a foreign or domestic place of business which is-Par. (7)(A). Pub. L. 105-115, §§102(5), 107, temporarily substituted “contractors of the Food and Drug Administration,” for “employees under contract with the Food and Drug Administration who work in facilities owned or leased for the Food and Drug Administration,” and “and committees and to contracts with such contractors,” for “and committees,”. See Effective and Termination Dates of 1997 Amendment note below.Par. (8)(A). Pub. L. 105-115, §§102(6)(A), 107, temporarily substituted “April of the preceding fiscal year” for “August of the preceding fiscal year” and “April 1997” for “August 1992”. See Effective and Termination Dates of 1997 Amendment note below.Par. (8)(B). Pub. L. 105-115, §§102(6)(B), 107, temporarily 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”. See Effective and Termination Dates of 1997 Amendment note below.Par. (9). Pub. L. 105-115, §§102(7), 107, temporarily added par. (9). See Effective and Termination Dates of 1997 Amendment note below. savingsProvision Pub. L. 110-85, title I, §108, Sept. 27, 2007, 121 Stat. 842, provided that: “Notwithstanding section 509 of the Prescription Drug User Fee Amendments of 2002 (21 U.S.C. 379g note) [Pub. L. 107-188], and notwithstanding 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 effect 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 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 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, 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], continues 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, 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, set out above], the Secretary shall retain the authority to assess and collect any fee required by part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] for a human drug application or supplement accepted for filing prior to October 1, 1997, and to assess and collect any product or establishment fee required by such Act for a fiscal year prior to fiscal year 1998.” false false false

Title 21 Section 379gnote 21 U.S.C. 379gnote Volume 106 Page 4491 106 Stat. 4491 Volume 106 Page 4491 Volume 106 Page 4498 Volume 106 Page 4500 106 Stat. 4491 106 Stat. 4498 106 Stat. 4500 Volume 111 Page 2298 111 Stat. 2298 Volume 111 Page 2298 Volume 111 Page 2304 Volume 111 Page 2305 111 Stat. 2298 111 Stat. 2304 111 Stat. 2305 Volume 116 Page 688 116 Stat. 688 Volume 116 Page 687 Volume 116 Page 692 Volume 116 Page 694 116 Stat. 687 116 Stat. 692 116 Stat. 694 Volume 121 Page 825 121 Stat. 825 Volume 121 Page 825 Volume 121 Page 842 121 Stat. 825 121 Stat. 842 Volume 124 Page 818 124 Stat. 818 Public Law 102-571 Public Law 102-571 Public Law 105-115 Public Law 105-115 Public Law 107-188 Public Law 107-188 Public Law 110-85 Public Law 110-85 Public Law 111-148 Public Law 111-148 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