[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR10.55]

[Page 92-94]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 10_ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents
 
               Subpart B_General Administrative Procedures
 
Sec.  10.55  Separation of functions; ex parte communications.

    (a) This section applies to any matter subject by statute to an 
opportunity for a formal evidentiary public hearing, as listed in Sec.  
10.50(c), and any matter subject to a hearing before a Public Board of 
Inquiry under part 13.
    (b) In the case of a matter listed in Sec.  10.50(c) (1) through 
(10) and (12) through (15):
    (1) An interested person may meet or correspond with any FDA 
representative concerning a matter prior to publication of a notice 
announcing a formal evidentiary public hearing or a hearing before a 
Public Board of Inquiry on the matter; the provisions of Sec.  10.65 
apply to the meetings and correspondence; and
    (2) Upon publication of a notice announcing a formal evidentiary 
public hearing or a hearing before a Public Board of Inquiry, the 
following separation of functions apply:
    (i) The center responsible for the matter is, as a party to the 
hearing, responsible for all investigative functions and for 
presentation of the position of the center at the hearing and in any 
pleading or oral argument before the Commissioner. Representatives of 
the center may not participate or advise in any decision except as 
witness or counsel in public proceedings. There is to be no other 
communication between representatives of the center and representatives 
of the office of the Commissioner concerning the matter before the 
decision of the Commissioner. The Commissioner may, however, designate 
representatives of a center to advise the office of the Commissioner, or 
designate members of that office to advise a center. The designation 
will be in writing and filed with the Division of Dockets Management no 
later than the time specified in paragraph (b)(2) of this section for 
the application of separation of functions. All members of FDA other 
than

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representatives of the involved center (except those specifically 
designated otherwise) shall be available to advise and participate with 
the office of the Commissioner in its functions relating to the hearing 
and the final decision.
    (ii) The Chief Counsel for FDA shall designate members of the office 
of General Counsel to advise and participate with the center in its 
functions in the hearing and members who are to advise the office of the 
Commissioner in its functions related to the hearing and the final 
decision. The members of the office of General Counsel designated to 
advise the center may not participate or advise in any decision of the 
Commissioner except as counsel in public proceedings. The designation is 
to be in the form of a memorandum filed with the Division of Dockets 
Management and made a part of the administrative record in the 
proceeding. There may be no other communication between those members of 
the office of General Counsel designated to advise the office of the 
Commissioner and any other persons in the office of General Counsel or 
in the involved center with respect to the matter prior to the decision 
of the Commissioner. The Chief Counsel may assign new attorneys to 
advise either the center or the office of the Commissioner at any stage 
of the proceedings. The Chief Counsel will ordinarily advise and 
participate with the office of the Commissioner in its functions 
relating to the hearing and the final decision.
    (iii) The office of the Commissioner is responsible for the agency 
review and final decision of the matter, with the advice and 
participation of anyone in FDA other than representatives of the 
involved center and those members of the office of General Counsel 
designated to assist in the center's functions in the hearing.
    (c) In a matter listed in Sec.  10.50(c) (11) and (16) through (19), 
the provisions relating to separation of functions set forth in 
Sec. Sec.  314.200(f), 514.200, and 601.7(a) are applicable before 
publication of a notice announcing a formal evidentiary public hearing 
or a hearing before a Public Board of Inquiry. Following publication of 
the notice of hearing, the rules in paragraph (b)(2) of this section 
apply.
    (d) Except as provided in paragraph (e) of this section, between the 
date that separation of functions applies under paragraph (b) or (c) of 
this section and the date of the Commissioner's decision on the matter, 
communication concerning the matter involved in the hearing will be 
restricted as follows:
    (1) No person outside the agency may have an ex parte communication 
with the presiding officer or any person representing the office of the 
Commissioner concerning the matter in the hearing. Neither the presiding 
officer nor any person representing the office of the Commissioner may 
have any ex parte communication with a person outside the agency 
concerning the matter in the hearing. All communications are to be 
public communications, as witness or counsel, under the applicable 
provisions of this part.
    (2) A participant in the hearing may submit a written communication 
to the office of the Commissioner with respect to a proposal for 
settlement. These communications are to be in the form of pleadings, 
served on all other participants, and filed with the Division of Dockets 
Management like any other pleading.
    (3) A written communication contrary to this section must be 
immediately served on all other participants and filed with the Division 
of Dockets Management by the presiding officer at the hearing, or by the 
Commissioner, depending on who received the communication. An oral 
communication contrary to this section must be immediately recorded in a 
written memorandum and similarly served on all other participants and 
filed with the Division of Dockets Management. A person, including a 
representative of a participant in the hearing, who is involved in an 
oral communication contrary to this section, must, if possible, be made 
available for cross-examination during the hearing with respect to the 
substance of that conversation. Rebuttal testimony pertinent to a 
written or oral communication contrary to this section will be 
permitted. Cross-examination and rebuttal testimony will be transcribed 
and filed with the Division of Dockets Management.

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    (e) The prohibitions specified in paragraph (d) of this section 
apply to a person who knows of a notice of hearing in advance of its 
publication from the time the knowledge is acquired.
    (f) The making of a communication contrary to this section may, 
consistent with the interests of justice and the policy of the 
underlying statute, result in a decision adverse to the person knowingly 
making or causing the making of such a communication.

[44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54 
FR 9035, Mar. 3, 1989; 64 FR 398, Jan. 5, 1999]