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. 360bb D09002ee180df8153-USCODE-2010-title21-chap9-subchapV-partB-sec360bb.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapV-partB-sec360bb.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partB-sec360bb 21USC360bb http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partB-sec360bb/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partB-sec360bb.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partB-sec360bb.htm 21 U.S.C. 360bb 21 USC 360bb 21 U.S.C. 360bb 21 USC 360bb; FOOD AND DRUGS; Designation of drugs for rare diseases or conditions 219 LEAF USCODE-2010-title21-chap9-subchapV-partB-sec360bb Sec. 360bb section standard June 25, 1938, ch. 675, §526, as added Pub. L. 97-414, §2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98-551, §4(a), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99-91, §3(a)(2), Aug. 15, 1985, 99 Stat. 387; Pub. L. 100-290, §2, Apr. 18, 1988, 102 Stat. 90; Pub. L. 105-115, title I, §125(b)(2)(H), (I), Nov. 21, 1997, 111 Stat. 2326. amendments <b>1997</b>-Subsec. (a)(1). Pub. L. 105-115, §125(b)(2)(H), struck out “the submission of an application for certification of the drug under section 357 of this title,” before “or the submission of an application for licensing of the drug” in introductory provisions, inserted “or” at end of subpar. (A), redesignated subpar. (C) as (B), and struck out former subpar. (B) which read as follows: “if a certification for such drug is issued under section 357 of this title, or”.Subsec. (b)(1). Pub. L. 105-115, §125(b)(2)(I)(i), struck out “,a certificate was issued for the drug under section 357 of this title,” before “or a license was issued”.Subsec. (b)(2). Pub. L. 105-115, §125(b)(2)(I)(ii), struck out “,a certificate has not been issued for the drug under section 357 of this title,” before “or a license has not been issued” and “,approval of an application for certification under section 357 of this title,” before “or approval of a license”.<b>1988</b>-Subsec. (a)(1). Pub. L. 100-290, §2(a), inserted after first sentence “A request for designation of a drug shall be made before the submission of an application under section 355(b) of this title for the drug, the submission of an application for certification of the drug under section 357 of this title, or the submission of an application for licensing of the drug under section 262 of title 42.”Subsecs. (b) to (d). Pub. L. 100-290, §2(b), added subsec. (b) and redesignated former subsecs. (b) and (c) as (c) and (d), respectively.<b>1985</b>-Subsec. (a)(1). Pub. L. 99-91 struck out “or” at end of subpar. (A), struck out subpar. (B) and substituted subpars. (B) and (C), and inserted “,certification,” after “approval”.<b>1984</b>-Subsec. (a)(2). Pub. L. 98-551 substituted “which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which” for “which occurs so infrequently in the United States that”. 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 2817 98 Stat. 2817 Volume 99 Page 387 99 Stat. 387 Volume 102 Page 90 102 Stat. 90 Volume 111 Page 2326 111 Stat. 2326 Public Law 97-414 Public Law 98-551 Public Law 98-551 Public Law 99-91 Public Law 99-91 Public Law 100-290 Public Law 100-290 Public Law 105-115 Public Law 105-115 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