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. 360cc D09002ee180df8153-USCODE-2010-title21-chap9-subchapV-partB-sec360cc.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapV-partB-sec360cc.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partB-sec360cc 21USC360cc http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partB-sec360cc/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partB-sec360cc.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partB-sec360cc.htm 21 U.S.C. 360cc 21 USC 360cc 21 U.S.C. 360cc 21 USC 360cc; FOOD AND DRUGS; Protection for drugs for rare diseases or conditions 220 LEAF USCODE-2010-title21-chap9-subchapV-partB-sec360cc Sec. 360cc section standard June 25, 1938, ch. 675, §527, as added Pub. L. 97-414, §2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98-417, title I, §102(b)(6), Sept. 24, 1984, 98 Stat. 1593; Pub. L. 99-91, §§2, 3(a)(3), Aug. 15, 1985, 99 Stat. 387, 388; Pub. L. 103-80, §3(v), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115, title I, §125(b)(2)(J), (K), Nov. 21, 1997, 111 Stat. 2326; Pub. L. 107-281, §4, Nov. 6, 2002, 116 Stat. 1993. amendments <b>2002</b>-Subsec. (a). Pub. L. 107-281, in concluding provisions, struck out “,of such certification,” after “such approved application” and “,the issuance of the certification,” after “approval of the approved application”.<b>1997</b>-Subsec. (a). Pub. L. 105-115, §125(b)(2)(J), struck out “,issue another certification under section 357 of this title,” before “or issue another license” in closing provisions, inserted “or” at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2) which read as follows: “issues a certification under section 357 of this title, or”.Subsec. (b). Pub. L. 105-115, §125(b)(2)(K), in introductory provisions, struck out “,if a certification is issued under section 357 of this title for such a drug,” after “rare disease or condition”, “,of the issuance of the certification under section 357 of this title,” after “application approval”, “,issue another certification under section 357 of this title,” after “application under section 355 of this title”, and “,of such certification,” after “approved application”.Subsec. (b)(1). Pub. L. 105-115, §125(b)(2)(K), struck out “,of the certification,” after “holder of the approved application”.Subsec. (b)(2). Pub. L. 105-115, §125(b)(2)(K), struck out “,issuance of other certifications,” after “approval of other applications”.<b>1993</b>-Subsec. (b). Pub. L. 103-80 struck out extraneous comma before “or issue a license under section 262” in introductory provisions and substituted “the” for “The” at beginning of par. (1).<b>1985</b>-Pub. L. 99-91, §2(3), struck out “unpatented” before “drugs” in section catchline.Subsec. (a). Pub. L. 99-91, §§2(1), 3(a)(3)(A)-(D), struck out “or” at end of par. (1), added par. (2), redesignated former par. (2) as (3), struck out “and for which a United States Letter of Patent may not be issued” after “rare disease or condition”, inserted in first sentence “,issue another certification under section 357 of this title,” after “section 355 of this title” the second time it appeared, inserted “,of such certification,” after “holder of such approved application”, and inserted “,the issuance of the certification,” after “approval of the approved application”.Subsec. (b). Pub. L. 99-91, §§2(2), 3(a)(3)(E)-(K), struck out “and if a United States Letter of Patent may not be issued for the drug” after “such a drug”, substituted “,if a certification is issued under section 357 of this title for such a drug, or if a license” for “or a license”, inserted “,of the issuance of the certification under section 357 of this title,” after “application approval”, struck out “,if the drug is a biological product,” before “issue a license”, inserted “,issue another certification under section 357 of this title,” after “section 355 of this title”, inserted “,of such certification,” after “holder of such approved application”, inserted “,of such certification,” after “application” in par. (1), and inserted “,issuance of other certifications,” after “other applications” in par. (2).<b>1984</b>-Subsecs. (a), (b). Pub. L. 98-417 substituted “section 355” for “section 355(b)” wherever appearing. effectiveDate amendments Amendment by Pub. L. 99-91 effective Aug. 15, 1985, see section 8(b) of Pub. L. 99-91, set out as a note under section 360aa of this title. false false false Part B Drugs for Rare Diseases or Conditions Volume 96 Page 2050 96 Stat. 2050 Volume 98 Page 1593 98 Stat. 1593 Volume 99 Page 387 99 Stat. 387 Volume 107 Page 778 107 Stat. 778 Volume 111 Page 2326 111 Stat. 2326 Volume 116 Page 1993 116 Stat. 1993 Public Law 97-414 Public Law 98-417 Public Law 98-417 Public Law 99-91 Public Law 99-91 Public Law 103-80 Public Law 103-80 Public Law 105-115 Public Law 105-115 Public Law 107-281 Public Law 107-281 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