TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

subpart b - PROCEDURES FOR PUBLIC HEARING BEFORE THE COMMISSIONER

15.20 - Notice of a public hearing before the Commissioner.

  (a) If the Commissioner determines that a public hearing should be held on a matter, the Commissioner will publish a notice of hearing in the Federal Register setting forth the following information: (1) If the hearing is under 15.1 (a) or (b), the notice will state the following: (i) The purpose of the hearing and the subject matter to be considered.

If a written document is to be the subject matter of the hearing, it will be published as part of the notice, or reference made to it if it has already been published in the Federal Register, or the notice will state that the document is available from an agency office identified in the notice.

  (ii) The time, date, and place of the hearing, or a statement that the information will be contained in a subsequent notice.

  (2) If the hearing is in lieu of a formal evidentiary public hearing under 15.1(c), all of the information described in 12.32(e).

  (b) The scope of the hearing is determined by the notice of hearing and any regulation under which the hearing is held. If a regulation, e.g., 330.10(a)(10), limits a hearing to review of an existing administrative record, information not already in the record may not be considered at the hearing.

  (c) The notice of hearing may require participants to submit the text of their presentations in advance of the hearing if the Commissioner determines that advance submissions are necessary for the panel to formulate useful questions to be posed at the hearing under 15.30(e).

The notice may provide for the submission of a comprehensive outline as an alternative to the submission of the text if the Commissioner determines that submission of an outline will be sufficient.

[44 FR 22366, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982]