[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR12.87]
[Page 124-125]
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
[[Page 125]]
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]
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