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919
PUBLIC LAW 90&-AUG. 1, 1966 CHAPTER 861
Public Law 905 AN ACT
To amend sections 401 and 701 (e) of the Federal Food, Drug, and Cosmetic Act so as to simplify the procedures governing the prescribing of regulations under certain provisions of such Act, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 401 of the Federal Food, Drug, and Cosmetic Act (21 IJ. S. C, sec. 341) is amended by striking out " (a) " where it appears after "SEC. 401., and subsection (b) of such section is repealed. SEC. 2. Section 701(e) of such Act (21 U.S.C. sec. 371 (e)) is amended to read as follows: "(e)(1) Any action for the issuance, amendment, or repeal of any regulation under section 401, 403 (j),404 (a), 406 (a) or (b),501 (b), 502 (d) or (h), 504, or 604, of this Act shall be begun by a proposal made (A) by the Secretary on his own initiative, or (B) by petition of any interested person, showing reasonable grounds therefor, filed with the Secretary. The Secretary shall publish such proposal and shall afford all interested persons an opportunity to present their views thereon, orally or in writing. As soon as practicable thereafter, the Secretary shall by order act upon such proposal and shall make such order public. Except as provided in paragraph (2), the order shall become effective at such time as may be specified therein, but not prior to the day following the last day on which objections may be filed under such paragraph. " (2) On or before the thirtieth day after the date on which an order entered under paragraph (1) is made public, any person who will be adversely affected by such order if placed in effect may file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating the grounds therefor, and requesting a public hearing upon such objections. Until final action upon such objections is taken by the Secretary under paragraph (3), the filing of such objections shall operate to stay the effectiveness of those provisions of the order to which the objections are made. As soon as practicable after the time for filing objections has expired the Secretary shall publish a notice in the Federal Register specifying those parts of the order which have been stayed by the filing of objections and, if no objections have been filed, stating that fact. "(3) As soon as practicable after such request for a public hearing, the Secretary, after due notice, shall hold such a public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. A t the hearing, any interested person may be heard in person or by representative. As soon as practicable after completion of the hearing, the Secretary shall by order act upon such objections and make such order public. Such order shall be based only on substantial evidence of record at such hearing and shall set forth, as part of the order, detailed findings of fact on which the order is based. The Secretary shall specify in the order the date on which it shall take effect, except that it shall not be made to take effect prior to the ninetieth day after its publication unless the Secretary finds that emergency conditions exist necessitating an earlier effective date, in which event the Secretary shall specify in the order his findings as to such conditions." SEC. 3. I n any case in which, prior to the enactment of this Act, a public hearing has been begun in accordance with section 401 of the Federal Food, Drug, and Cosmetic Act upon a proposal to issue, amend, or repeal any regulation contemplated by such section, or has
August 1, 1956 [H. R. 9547]
Federal Food, Drug, and C o s metic Act, amendments. 52 Stat. 1046.
Reg^ationsa 21 USC 343, 344, 3 4 6, 3 5 1, 3 5 2, 3:54, 364.
Hearings.
Notice in Federal Register.
Issuance of ord<ar by Secretary.
Prior hearings.
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