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 Ch. 9 FOOD, DRUG_ AND COSMETIC ACT 21 § 355
 631; June II, 1960, Pub. L° $6-507, § 1(18)_ 74 Stat. 201; Oct. I0,
 1962, Pub.L. 87-781, Title I, §§ 102(b)-(d), I03(I_), (b), !04(a)-(d)
 (2), 76 star. 781-783, 784° 785.
 Xls_e_l _o_ta
 Amend_s_ Subseco (aL Pub. L° drug has the effect it la represented to
 87-78YL $ 10_(aL inserted "an app_aval have, and provided that if the Secretary,
 o_' preceding °°an ap_ltcatlouo*' or acting Secretary, finds thete is an ira°
 mlnent hn_rd to p_blle health, he may
 Subeeco (bL FuboL. 87-751, | I02(b), suspend approval immediately, notify the
 Inserted "and whether such drug is e_ o
 applicant., sad 8i_'e him opportunity for
 fective in u_ _' following "is safe for aa expedited hearing, that the Secretary
 u_/' _nay withdraw a_-proval if the applicant
 auha_, (el. Pub. L. _7-781, § I04(b), fai_s to estab|tsh a system for maintain-
 suhetltuted provisions requiring the Sec- lag required reccrds, o_ has repeatedly
 ret.gFy, within 180 days after filing aa or dellberately retied to maintain ree-
 spplicatian_ or such edditionak period as orals and make reports, or hue re-
 the S_retary and the applicant agree fused access to, ar copying or vet!fleas
 upon, t_ either approve the application, tton of _uch records, or if the Secretary
 ff meet!nit the requirements of subset, finds on new evi_',enee that the methods,
 fscilitlea and coz,trala Is _he manufac-
 (d) of thls section, or give notice of op-
 portunity foe hearing on question of turn,go processlnS:, end packing are in-
 whether such appllca_ion t_ epprovable, adequate to a_s_ee sad preserve the
 _rugs' identity, strength° quality and
 sad providing that if appllcan_ _uests purity, and were not made adequate
 hearing in writing within 30 days, the
 wlt_n a reasonable !line after receipt
 hearing _ha|l begin within gO days after
 of written notice, thereof, or finds on
 e_piratieu of _aid 30 days, unions the
 Secretary and epplica_t agree otherwise, new evtdenceo that the labeling is false
 or mlsieadlug a:_d wan _t corrected
 that _uch hea_l_g shall be expedited, wlthls_ a reasonable alma after receipt
 an4 that the Secretary's order shslI b_ of writteu notice thereof°
 iseue4 within 90 days after date for fi_l_g
 final briefs, for pray!sloes which had an Subset. (_)o Fub. L. $7-751, | 104(eL
 applieetlan become effective on the uubstltuted profusions requlrlng the
 si_tleth day after flilng thereof unless Secretary tu revoke any previous order
 prlo_ the_to the Secretary postponed under subsee_. (d) or (e_ of this section
 the date by written notice to such time0 refusing, withdrawing, or suspemilng up-
 but not _ore than I_0 days after filing, provsl of an epp:icatlou and to approve
 a_ the Secretary deemed neces_ry to such application or reinstate such ap-
 etudy and investigate the applicetion° provaL for provisions which requieed
 him to re_oi_e an order refusing effective°
 Subse,_o (d). Pub.L. _7-7_, _ 1_(c),
 inserted rcfecenc¢_ to subset° (eL adde_i nesa to aa applic_Ciou.
 clue (_) _nd (_)° provide4 that ff after Sub_. (hL Pub. L. 87-75I, | 104(d)
 noLic_ s_i opportunity for hear!he, the _lt, (2L tn_rted '°us provtd_ iu _ectlon
 _ecrretary flnd_ that elSo (1)-{6) do n_ 2112 of Title 2_", _nd **except that until
 apply, h_ zhall approve the appllcation, the filing of the r_cord the Secretory may
 and de_n_i '_euhstaatlal evidence _' a_ modify or net aside his order"° _ubstl-
 used lu thin subeectt_n and subset. {el tuted "or withdrawing approval of an
 ...... of thin section, application under this section" for "to
 Snbaeco {et. Pub°L. 87-781, _ 102id) permit the application to become effec-
 amended subsection geuerally, end among tire, or suspending the effectivenes_ of
 o_her changes, directed the Secretary to tha application", "I.'_ted States court
 withdraw approval of su application if of appeala for C.he circuit" for "district
 by tecta, other _ientiftc data or _peri- court of the Uutt_.] States within any
 ence. or new evidence of clinics| experl° district", "Courg of Appeals for the Dls-
 en_ aug contained ta the application or trier of Co_mbie Circuit" for "District
 avai_bie at the tir_ of lie apprreval, the Court for the Dl_tr|c_ of Columbia",
 drug is shown to b¢ nnsafe, or on th$ "transmitted by the clerk of tha court
 haata of new information, there is shown to" for "_ezvefi upon"° and °'by the Su-
 n leek o_ substaatla_ evldenc_e that the prema Court of the United States upon
 393