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. 360aa D09002ee180df8153-USCODE-2010-title21-chap9-subchapV-partB-sec360aa.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapV-partB-sec360aa.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partB-sec360aa 21USC360aa http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partB-sec360aa/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partB-sec360aa.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partB-sec360aa.htm 21 U.S.C. 360aa 21 USC 360aa 21 U.S.C. 360aa 21 USC 360aa; FOOD AND DRUGS; Recommendations for investigations of drugs for rare diseases or conditions 218 LEAF USCODE-2010-title21-chap9-subchapV-partB-sec360aa Sec. 360aa section standard June 25, 1938, ch. 675, §525, as added Pub. L. 97-414, §2(a), Jan. 4, 1983, 96 Stat. 2049; amended Pub. L. 99-91, §3(a)(1), Aug. 15, 1985, 99 Stat. 387; Pub. L. 105-115, title I, §125(b)(2)(F), (G), Nov. 21, 1997, 111 Stat. 2325, 2326. amendments <b>1997</b>-Subsec. (a). Pub. L. 105-115, §125(b)(2)(G), struck out “,certification of such drug for such disease or condition under section 357 of this title,” before “or licensing of such drug” in closing provisions.Subsec. (a)(1) to (3). Pub. L. 105-115, §125(b)(2)(F), inserted “or” at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2), which read as follows: “if the drug is an antibiotic, it may be certified for such disease or condition under section 357 of this title, or”.<b>1985</b>-Subsec. (a). Pub. L. 99-91 struck out “or” at end of par. (1), inserted par. (2), redesignated former par. (2) as (3) and struck out “before” after “product,”, and in last sentence inserted provisions relating to certification of such drug for disease or condition under section 357 of this title and substituted “licensing of such drug for such disease or condition under section 262 of title 42” for “licensing under section 262 of title 42 for such disease or condition”. effectiveDate amendments Section 8 of Pub. L. 99-91 provided that:“(a) <cap-smallcap>General Rule</cap-smallcap>.-Except as provided in subsection (b), this Act and the amendments made by this Act [amending this section, sections 360bb, 360cc, and 360ee of this title, and sections 295g-1 and 6022 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under section 301 of this title and section 236 of Title 42] shall take effect October 1, 1985.“(b) <cap-smallcap>Exception</cap-smallcap>.-The amendments made by sections 2, 3, and 6(a) [amending this section and sections 360bb and 360cc of this title] shall take effect on the date of the enactment of this Act [Aug. 15, 1985]. The amendment made by section 6(b) [amending section 6022 of Title 42] shall take effect October 19, 1984. The amendments made by section 7 [amending section 295g-1 of Title 42] shall take effect October 1, 1984 and shall cease to be in effect after September 30, 1985.” false false false

Part B Drugs for Rare Diseases or Conditions Title 21 Section 360aaet seq. Title 21 Section 360n(a)(3) 21 U.S.C. 360aaet seq. 21 U.S.C. 360n(a)(3) Title 26 Section 28 26 U.S.C. 28 Volume 96 Page 2049 96 Stat. 2049 Volume 99 Page 387 99 Stat. 387 Volume 102 Page 91 102 Stat. 91 Volume 111 Page 2325 111 Stat. 2325 Volume 123 Page 2127 123 Stat. 2127 Public Law 97-414 Public Law 97-414 Public Law 99-91 Public Law 99-91 Public Law 100-290 Public Law 105-115 Public Law 105-115 Public Law 111-80 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