new drug clearance procedure

new drug clearance procedure Sec. 104. (a) Section 505(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a)), is amended to read as follows: “(a) No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) is effective with respect to such drug.” (b) Section 505(c) of such Act (21 U.S.C. 355(c)) is amended to read as follows: “(c) Within one hundred and eighty days after the filing of an application under this subsection, or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either— “(1) approve the application if he then finds that none of the grounds for denying approval specified in subsection (d) applies, or “(2) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the question whether such application is approvable. If the applicant elects to accept the opportunity for hearing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary’s order thereon shall be issued within ninety days after the date fixed by the Secretary for filing final briefs.” (c) Section 505(f) of such Act (21 U.S.C. 355(f)) is amended to read as follows: “(f) Whenever the Secretary finds that the facts so require, he shall revoke any previous order under subsection (d) or (e) refusing, withdrawing, or suspending approval of an application and shall approve such application or reinstate such approval, as may be appropriate.” (d) (1) The first four sentences of section 505(h) of such Act (21 U.S.C. 355(h)) are amended to read as follows: “An appeal may be taken by the applicant from an order of the Secretary refusing or withdrawing approval of an application under this section. Such appeal shall be taken by filing in the United States court of appeals for the circuit wherein such applicant resides or has his principal place of business, or in the United States Court of Appeals for the District of Columbia Circuit, within sixty days after the entry of such order, a written petition praying that the order of the Secretary be set aside. A copy of such petition shall be forthwith transmitted by the clerk of the court to the Secretary, or any officer designated by him for that purpose, and thereupon the Secretary shall certify and file in the court the record upon which the order complained of was entered, as provided in section 2112 of title 28, United States Code. Upon the filing of such petition such court shall have exclusive jurisdiction to affirm or set aside such order, except that until the filing of the record the Secretary may modify or set aside his order.” 76 Stat. 785 (2) The ninth sentence of such section 505(h) is amended to read as follows: “The judgment of the court affirming or setting aside any such order of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28 of the United States Code.” (3) The amendments made by this subsection shall not apply to any appeal taken prior to the date of enactment of this Act. (e) (1) Section 301(1) of such Act (21 U.S.C. 331(1)) is amended by (1) inserting “approval of” before “an application”, and (2) striking out “effective” and inserting in lieu thereof “in effect”. (2) Clause (C) of section 503(b)(1) of such Act (21 U.S.C. 353(b)(1)) is amended by striking out “effective” and inserting in lieu thereof “approved”. (f) (1) Clause (A) of paragraph (3) of section 409(c) of such Act (21 U.S.C/ 348(c)) is amended by inserting before the semicolon at the end thereof the following: “, except that this proviso shall not apply with respect to the use of a substance as an ingredient of feed for animals which are raised for food production, if the Secretary finds (i) that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and (ii) that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsections (f) and (g)) in any edible portion of such animal after slaughter or in any food yielded by or derived from the living animal”. (2) Subparagraph (B) of paragraph (5) of section 706(b) of such Act (21 U.S.C. 376(b)) is amended by inserting before the period at the end of the subparagraph a colon and the following proviso: “Provided, That clause (i) of this subparagraph (B) shall not apply with respect to the use of a color additive as an ingredient of feed for animals which are raised for food production, if the Secretary finds that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive win not adversely affect the animals for which such feed is intended, and that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsection (d)) in any edible portion of such animals after slaughter or in any food yielded by or derived from the living animal”.