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 FOOD DR S 21 § 355
 For purpos_ of _is sc_tion, the _rm "patent" means & pa_t L_u_ by the
 Paint and Trademark Office of _e Department of CComraer_eo
 (,A._ amended Aug. 16, I_2, PuboL 92-_,_7, § _d), 86 Seal 562; Sep_ _A, 1984, Pab. L _-.,_17_
 H|a_eal asd $_tu_ry Non _b.L %.4_7, _ |_4_, su_tJ_u_ _ r,L
 § _X|), _:_ _ (D _ f_l_d_ _u_ m for witHdrawN of _r_q_ by _e S_.re_'_, t_
 _ply with the nozi_ requi_a_ _
 n_t_ the _xi_g _rcv_o_ ˘_ _b_,ac_ (b) sa per. _ _oa o_ _ _p|y w_ the _ veqe/se_
 (A) _hrough (F) _hez_f. tc_pecfivc|y. Subset. fj). _UboL ?g-41?, _ 10L _ mb-
 Psb, L 9g--4_7, § 102(a_l), added rvquireme,z_ _. 0_. Former S_bs,_˘, fi) wts rcdes_'_at_ (k).
 _hat th* applicant file wt_b the ap#icafi_ tim Suhsoc_ _). P_b.L 9g-_t170 § 10L r_desi_m-
 _eat which oh/ms the dug f_ which _h˘ s_p_io S_ (k_1)o Fub. L %.J,_[7. § 102(b_5)_
 _ submitted the _pl_k_ o_ which c_ a s'_bsfituted _u_d_ _ul_c_c_ (_) _˘ 0"_ of
 method of _sin S _h dzu_ sad _d_h tespsc_ go _'tic_" for ,p_r_uaat _o thit _ec'aoa"o
 which _ claim of p_zent [_frMgemem could re_ _ub,_vcs. (_, (f_}. _b.L. _.T, § 10_,
 sonsbly b_ a_,ser_ ff • person _o_ licensed by the subsc˘_. (_ _d (m).
 owns engag_ in _he m_ufaczur_ use, or _ of
 the deug_ t_ the applicant _eml the app|icafion 197_ Am_dm.*_. Sub_._. (n). _ub.L
 to _nclude such _forraat_oa ff sm _p#_c_˘_o_ h_ 92-387 _r_ "og to comply .,dth the _ice
 filed u_6er this _ubscc_. for • drug and a _teat requirements of r_ec_oes 360(i) (_)" m clause (t) of
 which chilis such drug or s me_hod of using _ch _he second s_a_ce reining to the rc_ntenar_e of
 _g is issued d_ the _l_ag elsie b;._ before r_ord,_,
 approv#J of the application, and LhaL _pon ap.- Chg_ag, of N_ '_e _par_m_nt of HAth,
 provat of the app|icauo_, the ._r˘_r_ publish the Educa_oa. and Welfare w_ t_gnal_d the
 }nforwmfion _ub_te_:L l_ment of He_lt_ sad Human _r_,c_s, and _he
 $_1:_:. (bX2_ (3). Fub. L 9_-417, § i0Ma)o _retxry of Heath, Eduction, _d Welf_e
 _,_te_ _ (2) _ (_}. shy other ofiqci_l of the Depanmem M He_dt_
 ..... $˘bsas_. (cXI}. P_b.L, 91_.-_17, § 102(aX2)o FE_u_fion aad Wel[are w_ redesig_'m_ed fl_ .T_c-
 . desi_t_azed the ei_stin$1_a'ov_s of subset. {c) s _,gx_d or off_G_, as a_ptopri_te, of H_th _
 l_'- (1) ther_f _md _ _u'. (I) _ m desig_qag_ Human S_rv/_c_ m_ m) tefer_ to tl_ D_o
 r_:l_ign_ _orr_r lmrs. (1) _ (2) _ sut_rs_ lmmm_t of H_|_, _lu_icm. aad Welfa_v., the
 (A) ann _), m_,iveiy. _ecr_'y of Hcsith, F2u_tion, _od Welf_.,, or
 Psb. L 9f_.._,t_7, _ 102(b_2). substitu_:t "st_ my ot_i_ of the _k_:_'_._m_t M Ht_._th., Edu-
 _e_ioa (b) _ this _es_n" for _his s_bsentwa". _do_, and We_a_e, in aay _w. _ regtda6c_,
 certfflcaze, dir_ive, m_ctiOno or o_h_ c_cm_
 S_,_bs_, (c)_2}. _b.L 9g.._7, § 102(a_2k _l_r in force _'_ the effective d.a_e of 1%b.L.
 _ pat. (2). 96--$_, s_ pr_sc_ t_' section 60_ of Pub. L
 Subset, (eX3}. Pub. L 9_g-4_7, § I03C_), _6sc_ 96-.g8, Title VI, OcL 17. |979. _3 $_t. 696,
 _. (_). o_ _s a note under _ 3401 of Title 20,
 Sub's_c, (dX6). Pab,L 9g.*_]7, § _0_(eX3XA), _uc_t_on, deemed to refer sad apply _lo the
 added _L (6) r_l_ting _o the f_lure of the _p#hm_ Dilate.merit of H_hh and Human ._erv_:es _" _e
 fiou _ c_,_mm the [intent mform_˘_ce pr_sezibact 5_::r_m.r_ of He,ith _l Human S_r_,_ r_peco
 by s_bus_. _ d this s_i_:_. _ormer cL (6) _ zively, ea_l_ to _he ex_l sum r_qer_r_e is to
 r_:_es/gD_a_ (_. func't_c_ or o_ce tt_ns[err_g_ to 'she ,_c_tary of
 $_bs_... (C_X7). _b.L 9g--_17, § _02(a)_Ag Education or _ke Dep._nment of Educazion ,ander
 ...... rectesign_eed for_' cL (6) _ (7). _b.L. 964g, Tit_ HL {§ 30| _o 307, Oct. ]7
 _66_L m t_ first _atea_ covering the gr_:_..m_ 3,_7 _ 3_ of Title 20.
 _ (4) _tiag to tl't_ fait˘_ W _ t_ Imt_ ]0_ of Pub. L 9g.-,_.17 pro_6c_ed Me:
 iaforemt_.oe preemibed _ _br,_._ (©} a _ _ '_} The ,T_.a_, of H_h _ Humsn _.
 t_t_ within _ cL_s _ _ _pt _ ,znitte_ _ _ pt_t_ L_ s_:_:xm:lr,.ace with
 f_ _ _ sl_ymg t_ f_ t_ _ _nd _ _p_ir_x_m_s of tee $$3
 tfih_ s_h inforra_6o_g. _ _,d_fi_t_:_ _ f_ of title 5, United S_ea Code [mort _$3 of "i_tk
 i_'o_Asiom of _l_ s_co_d _nc_ pnsc_:l_$ eL (_} si_r_/sfistre_io_ of s_ctioe _)_ of the Fed_.t Foe_L
 of _ _tumes'tfio_ of ciat.tte_g cove_'_,ng _ _"u_ _ Cc_.meg_ Art [tbJ$ s_@n], as _uttend-
 t_rouads far withansw_ of _pprov_ by the _ _ by mom_ 101, |(_ _ 10_ o_ _'_s A_
 tsr_, flu phr_s_ _sba_zt_ _odet _ubs_fioa _) [en,._.,,_ia$ _ub_.sc. _ _" _his _._c_ aad _m_:lin$ ,,
 d aa sppli_fi_". _ _6_c_[a) _ _b] _ 'flti$ _de], within one
 ..... 117

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