Public Law 83–335

That section 401 of the Federal Food, Drug, and Cosmetic Act (21 U. S. C., sec. 341), is amended by inserting “ (a) ” after “Sec. 401.” and by adding at the end of such section the following new subsection:

“(b)“(b)

(1)(1)

Any action under subsection (a) for the issuance, amendment,

Initiation of action.

or repeal of any regulation shall be begun by a proposal made (A) by the Secretary of 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.

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“(2)“(2)

At any time prior to the thirtieth day after the date on which

Filing of objections.

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 object ions 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.

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“(3)“(3)

As soon as practicable after such request for a public hearing,

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. At 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. Such order shall be subject to the provisions of section 701 (f) and (g).”

21 USC 371.

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Sec. 2.

Section 701 (e) of the Federal Food, Drug, and Cosmetic Act is amended by striking out “401,”.

Sec. 3.

In any case in which, prior to the date of the enactment of

Hearings pending.

this Act, a public hearing has been begun, in accordance with section 701 (e) of the Federal Food, Drug, and Cosmetic Act, upon a proposal to issue, amend, or repeal any regulation contemplated by section 401 of such Act, the provisions of such Act, as in force immediately prior to the date of the enactment of this Act, shall be applicable as though this Act had not been. enacted.