§10.55. Separation of functions; ex parte communications. — Inbound Citations

(f) In addition to the requirements of this section, the provisions of § 10.55 apply to the promulgation of a regulation subject to § 10.50 and part 12.

(a) The proceeding of a Board are subject to the provisions of § 10.55 relating to separation of functions and ex parte communications. Representatives of the participants in any proceeding before a Board, including any members of the office of the Chief Counsel of FDA assigned to advise the center responsible for the matter, may have no contact with the members of the Board, except as participants in the proceeding, and may not participate in the deliberations of the Board.

(a) Regulatory hearings are not subject to the separation of functions rules in § 10.55.

(d) Separation of functions (as specified in § 10.55 of this chapter) will not apply at any point in withdrawal proceedings under this section.

(d) Separation of functions (as specified in § 10.55 of this chapter) will not apply at any point in withdrawal proceedings under this section.

(h) Informal conferences under this part are not subject to the separation of functions rules in § 10.55 of this chapter.

(d) Separation of functions (as specified in § 10.55 of this chapter) will not apply at any point in withdrawal proceedings under this section.

(d) Separation of functions (as specified in § 10.55 of this chapter) will not apply at any point in withdrawal proceedings under this section.