[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR12.87]

[Page 156]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 12_FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
 
                      Subpart E_Hearing Procedures
 
Sec. 12.87  Purpose; oral and written testimony; burden of proof.

    (a) The objective of a formal evidentiary hearing is the fair 
determination of relevant facts consistent with the right of all 
interested persons to participate and the public interest in promptly 
settling controversial matters affecting the public health and welfare.
    (b) Accordingly, the evidence at a hearing is to be developed to the 
maximum extent through written submissions, including written direct 
testimony, which may be in narrative or in question-and-answer form.
    (1) In a hearing, the issues may have general applicability and 
depend on general facts that do not concern particular action of a 
specific party, e.g., the safety or effectiveness of a class of drug 
products, the safety of a food or color additive, or a definition and 
standard of identity for a food; or the issues may have specific 
applicability to past action and depend upon particular facts concerning 
only that party, e.g., the applicability of a grandfather clause to a 
particular brand of a drug or the failure of a particular manufacturer 
to meet required manufacturing and processing specifications or other 
general standards.
    (i) If the proceeding involves general issues, direct testimony will 
be submitted in writing, except on a showing that written direct 
testimony is insufficient for a full and true disclosure of relevant 
facts and that the participant will be prejudiced if unable to present 
oral direct testimony. If the proceeding involves particular issues, 
each party may determine whether, and the extent to which, each wishes 
to present direct testimony orally or in writing.
    (ii) Oral cross-examination of witnesses will be permitted if it 
appears that alternative means of developing the evidence are 
insufficient for a full and true disclosure of the facts and that the 
party requesting oral cross-examination will be prejudiced by denial of 
the request or that oral cross-examination is the most effective and 
efficient means to clarify the matters at issue.
    (2) Witnesses shall give testimony under oath.
    (c) Except as provided in paragraph (d) of this section, in a 
hearing involving issuing, amending, or revoking a regulation or order, 
the originator of the proposal or petition or of any significant 
modification will be, within the meaning of 5 U.S.C. 556(d), the 
proponent of the regulation or order, and will have the burden of proof. 
A participant who proposes to substitute a new provision for a provision 
objected to has the burden of proof in relation to the new provision.
    (d) At a hearing involving issuing, amending, or revoking a 
regulation or order relating to the safety or effectiveness of a drug, 
device, food additive, or color additive, the participant who is 
contending that the product is safe or effective or both and who is 
requesting approval or contesting withdrawal of approval has the burden 
of proof in establishing safety or effectiveness or both and thus the 
right to approval. The burden of proof remains on that participant in an 
amendment or revocation proceeding.

[44 FR 22339, Apr. 13, 1979 as amended at 64 FR 399, Jan. 5, 1999]